Archived Weekly Tips
in 2011 and 2012 Genetic Alliance Registry and BioBank created a weekly tips series tailored for advocacy organizations interested in registries and biobanks. We hope these tips will help you in your journey of creating and cultivating your registry or biobank and foster fruitful discussion.
1. Think about what you have learned in the past year Perhaps you attended a conference or webinar on biobanking that gave you useful information, or you had a conversation with someone who gave you practical advice. This is a great time to reflect about what you have learned in the past year. This exercise can also be done with others working on your biobanking initiative with you.
2. Identify a few attainable goals and one stretch goal Instead of making one large list, consider breaking your goals into 2-3 tasks per quarter that can be achieved. Your stretch goal should be something that you strive for but is challenging. For example, if you want to improve retention rates so participants are not lost to follow-up, you will want communicate regularly with your participants. A goal could be to provide regular updates (e.g. quarterly) about your registry or biobank to your community using your newsletter, website, listservs, etc.
3. Cultivate new relationships The New Year is a great time to meet new people and begin new relationships. We have an incredible resource of people knowledgeable about registries and biobanking in our community. Take this opportunity to reach out to a colleague or become involved in the discussion.
4. Pick one thing you want to become really good at What skills do you want to build in 2011? Is there one thing that you would like to become really good at in the New Year? We can't be experts in everything, but if we focus on one or two things, we are more likely to build our skill set.
So, what are your biobanking goals for 2011? What new relationships will you build in 2011? How can Genetic Alliance Registry and BioBank help you achieve your goals?
Once you have identified a goal, you should describe it as specifically as possible. Why is this goal important to you? Give reasons. Set a deadline for this goal, and identify specific steps to achieve it. It is also important to consider potential obstacles that could prevent you from reaching your goal, as well as qualities and experiences that will help you meet your goal.
- My goal is:
- My goal is important because:
- My target date/deadline is:
- Steps I´ll take to reach my goal:
- I will know I´ve reached my goal when/because:
- Potential obstacles that could prevent me from meeting my goal:
- Qualities and experiences that will help me meet my goal:
You will also want to review your progress at regular intervals, such as monthly or quarterly. I also find that telling people what my goals are makes me more accountable for achieving them.
Click here for more information on SMART goals.
Developing a registry or biobank communication plan will help you schedule targeted, regular updates to your community. In its simplest form, the plan should include the following:
- Target audience
- Communication vehicle
We also recommend that organizations require researchers using their data and samples to provide a summary of their experimental results in lay language, as well as a copy of the manuscript. To keep this information current, many organizations contact their investigators directly to update their publication information. This can be used as an opportunity to cultivate relationships with researchers. Some organizations may also require return of information on data or sample quality, and the types of experiments conducted with specific samples.
- Insurance – review any insurance policies (e.g. D&O insurance) to identify the expiration date and determine if coverage is still adequate for your current activities.
- Vendor contracts – review all vendor contracts to determine the length of the contract and if vendors are in good standing. This is also an opportunity to evaluate if your vendors are meeting your needs and if you need to identify additional vendors for future work.
- IRB documents – review the IRB approval letter to determine the length of IRB approval and when any reports or updates are due to the IRB. You should also review the approved study protocol and identify if there have been any changes over the past year. You will want to make the IRB aware of any changes to the study protocol.
- Additional registry and biobank SOPs – review any additional SOPs your organization has developed around your registry and biobank. This is a great opportunity to evaluate what is currently working and identify areas that could be improved.
- By entering this information in an excel spreadsheet, you can document your annual review and any follow-up items, making next year´s review even easier. Excel has many useful templates for project management. This is also a good time to schedule next year´s annual review on your calendar.
Organizations with registries and biobanks benefit when advisors with appropriate expertise donate their time to the organizations´ research efforts. Cultivating relationships with advisors is rewarding and involves time and effort. It is helpful to ask the following three questions:
- Who are your advisors? Advisors can be members of formal boards, committees and working groups, or individual clinicians, scientists and other professionals with an interest in your organization. It is important to identify all of your advisors, their expertise and the roles that they have within your organization. This will help you determine if you need to identify and cultivate additional advisors with other areas of expertise.
- What do you ask of your advisors? When building relationships with your advisors, it is beneficial for everyone involved to be clear about expectations, including the time commitment. In some instances, you may want help on a project that has specific timelines and deliverables (e.g. developing a registry questionnaire in the next six months). At other times, you may want advice on a new development in the field (e.g. understanding the results of a recently published research paper or information on a new treatment). By being clear with what we are asking and when we need it, we give our advisors the opportunity to evaluate if they are able assist us. If an advisor is unable to assist, ask them for a recommendation of another advisor for the specific request.
- When do you communicate with your advisors? It is also useful to examine your communication with your advisors. Do you interact with them regularly or do you ask for input when something comes up? Some organizations have regular meetings/ teleconferences, while others provide regular email updates of their progress. Regular communication helps your advisors stay involved and feel connected to your organization. This is also a great opportunity to acknowledge and thank your advisors.
When developing a registry questionnaire, it is useful to incorporate standardized data collection instruments where possible. Standardization will minimize some of the work of data collection, will increase the likelihood that data collected today will be compatible with data collected a few years from now, and will facilitate pooling of data between related registries and studies.
One way of standardizing data collection is to use scientifically validated survey instruments, such as the SF-36. Another approach is to use questions that others have used on a large scale. Here is a list of resources for potential questions and answers:
- NHANES (National Health and Nutrition Examination Survey)
- PROMIS (Patient-Reported Outcomes Measurement Information System)
- PhenX (consensus measures for phenotypes and exposures)
- dbGaP (database of Genotype and Phenotype)
- PRISM (Patient Registry Item Specifications and Metadata for Rare Diseases)
You will also want to identify any questionnaires currently being used to collect information on your condition of interest. Your medical and scientific advisors can help you identify existing data collection instruments. You will also need to design your own questions to capture specific information required for your registry.
Scientific meetings are great opportunities to connect with researchers and clinicians. You will be able to meet people in person that you have corresponded with by email, as well as identify potential advisors and others interested in your registry or biobank. Scientific meetings are very busy events, but with a little planning, you will have a very productive meeting.
Before the meeting:
- Review the program to identify the talks and posters you would like to attend. Poster sessions are great opportunities to have one-on-one time with the presenter.
- Make a list of clinicians and researchers you would like to meet. Ask your advisors if they can introduce you to individuals you don´t know.
- Schedule in-person meetings with your advisors and others you have been corresponding with by email.
- Practice your 30-second elevator speech about your organization and your registry or biobank. Practice responding to the question “How can I help?”
At the meeting:
- Attend the talks and posters you have identified. Introduce yourself to the presenter and tell them briefly about your registry or biobank. Ask them questions about their research.
- Exchange business cards with people you meet.
- Meet with your advisors. Take notes. Let them know where you need their help.
After the meeting:
- Follow-up with the clinicians and researchers you met at the meeting. Thank them for taking the time to speak with you and remind them of any follow-up action items you discussed.
- Identify additional scientific meetings you would like to attend and begin planning for them. Genetic Alliance´s Advocates Partnership Program offers unique networking opportunities at select scientific meetings.
Networking is an important skill to develop. For more networking tips, visit the Riley Guide.
Recruitment is an important aspect of any registry or biobank. Without participants, it is difficult to build your resource. But where do you begin your recruitment efforts?
- Outreach to your community: Use your organization´s communication vehicles, including your website, newsletters, and email communications, to recruit participants to your registry or biobank. Many organizations dedicate a few pages of their website to their registry or biobank. Others provide regular updates through their newsletters and email communications to their community. Some organizations use only digital communications, while other use both digital and print communications. Social media is playing an increasing role in recruitment efforts.
- Outreach to medical professionals: Announce your registry or biobank to your medical and scientific advisors. Your advisors may help recruit participants to your registry or biobank, and they will be knowledgeable if one of their patients asks a question. Also, by announcing your resource to medical professionals, you may identify individuals who are interested in studying data and samples from your collection.
- Outreach beyond your community: If you are recruiting outside of your community, you may want to consider listing your study with an online clinical trials recruitment site, such as www.clinicaltrials.gov or www.centerwatch.com.
- Outreach at community events: Events provide a great opportunity to recruit participants to your registry or biobank. Many organizations recruit participants at their annual conference, support group meetings, educational meetings, walks, or other events.
Once you´ve recruited participants to your registry or biobank, you must also have a strategy to retain them. Regular communication is an important aspect of retention. It keeps participants interested and engaged, and they will be more likely to respond to additional requests for information.
Provide timely updates to your participants about the progress of your registry or biobank. These can include updates on the number of participants enrolled, the number of research projects using the samples, or summaries of results from research projects. Targeted communications to your participants may also be appropriate (e.g. birthday or other appreciation cards).
The amount of effort and resources used for retention should be reflective of the ongoing requirements of participation. In other words, the more you ask of your participants, the greater the amount of effort you should place on retaining them. Remember, it is much easier and more fiscally responsible to retain current participants than to recruit new ones.
Detailed work is needed to build your survey instrument or data collection form. This planning phase, sometimes called pre-technical planning, is critical to developing your registry. Below are some questions you should consider when developing your registry questionnaire.
Developing your registry questionnaire takes thoughtful planning, and there are significant benefits to having a well-designed questionnaire.
- What information will you collect? Each registry is different, but many questionnaires collect medical information, participant demographics, lifestyle information, family history, genetic information, diagnosis/treatment information, and quality of life metrics.
- Where will the information be stored? Every question and answer must have a place, as you can´t scribble in the margins on a web-form.
- What questions will you ask? In week 7, we discussed potential sources of questions.
- What data type will you select for each answer? Specify answer choices and be explicit. If the answer is numeric, units will need to be specified. If text is required, there must be a text box to enter free text.
- What format will you choose for each answer? Checkboxes are most appropriate when there can be more than one choice (e.g. race), while dropdowns are preferred when there can be only one choice (e.g. marital status). Radio buttons can be used instead of dropdown menus, but they often take up more space. Free text should be used sparingly, but is often necessary to enhance specific answers.
With any registry or biobank, you are conducting a research study, and research ethics are an important consideration. Broadly, each research study must consider the following:
- Respect for persons – How can our research processes enact respect?
- Beneficence – How can we assure our research is achieving benefits? And clear benefits for whom?
- Justice – How can we proceed equitable and fairly while addressing current injustices in the system?
Several recent events have influenced the public narrative on research ethics, including Rebecca Skloot´s book “The Immortal Life of Henrietta Lacks”, the destruction of 5 million discarded newborn blood spots in Texas, and the Havasupai/ Arizona State University settlement. Given these events, it is possible that business as usual practices can cause harm, and we often cannot anticipate what harm looks like.
Traditional systems for managing risk, including IRB review and the informed consent process, may not be sufficient, and additional standards and stewardship practices may be needed to guide us. As good stewards, we must engage our community and the public, be transparent about research practices and intentions, communicate openly and clearly, and ask permissions before using samples outside of original scope or intentions.
Listen to Sharon Terry discuss stewardship and The Immortal Life of Henrietta Lacks.
Learn more about updating your community with our week 3 tip.
Any research study, including registries or biobanks, requires approval from an Institutional Review Board (IRB). IRBs, established by the National Research Act in 1974, are charged with approving, monitoring and reviewing research, with the primary goal of protecting the rights of human subjects. IRBs are mandated by the Federal Government as part of the Code of Federal Regulations (CFR) (Part 46 [Protection of Human Subjects] of Title 45 [Public Welfare] and FDA regulations on IRBs at 21 CFR 56). This document compares the FDA and HHS Human Subject Protection Regulations.
Several types of IRBs exist, including local IRBs associated with universities and hospitals, and non-profit or for-profit IRBs, also know as external, central or independent IRBs. IRBs typically have at least five members, including one non-scientist and one community member not associated with the institution. Regardless of type, all IRBs are governed by the same regulations and have the same responsibilities.
According to the ICH GCP guidelines, IRBs should review the following documents:
- Research protocol(s)/amendment(s)
- Written informed consent document(s) and document revisions
- Participant recruitment procedures including advertisements
- Written information provided to participants
- Investigator´s brochure
- Available safety information
- Information about payments and compensation available to participants
- Investigator´s current curriculum vitae and/or other documentation evidencing qualifications
- Any other documents that the IRB may need to fulfill its responsibilities
IRBs also review the research protocol and other related documents at regular intervals (usually at least once a year). The principal investigator is responsible for reporting to the IRB any protocol deviations or changes to the protocol, all adverse reactions, and any new information that may adversely affect the safety of the participants.
Watch videos from OHRP (Office for Human Research Protections) to learn more about IRBs.
When working in any area, including registries and biobanks, it´s important to know where to find trusted information. What are the best practices, and who are the key organizations in the field?
In biobanking, best practices are needed to provide state-of-the-science guidance and to harmonize procedures for collection, processing, storage, and distribution of data and samples. While multiple best practices exist, there is not yet uniform adoption of these protocols. Three useful resources are listed below:
- The Department of Health & Human Services' (HHS) Agency for Healthcare Research and Quality (AHRQ) released a handbook, Registries for Evaluating Patient Outcomes: A User's Guide, that provides guidance for establishing, managing, and analyzing patient registries.
- The International Society for Biologic and Environmental Repositories (ISBER) has developed Best Practices for Repositories, focusing on the collection, storage, retrieval and distribution of biological materials for research.
- The National Cancer Institute (NCI) has developed NCI Best Practices that examine the scientific evidence for collection, annotation, processing, and storage of biospecimens.
Ownership and access to data and samples are two important issues that should be discussed early in the planning phase of your registry or biobank. While a number of viable models can be used, it is critical to know the answers to the following questions to decide which model is best for your organization:
- Who will own your data and samples? Many advocacy organizations choose to own their data and samples, as it gives them the most autonomy over their collection. This often requires using a third-party vendor for registry and biobank services. If you want to own your data and samples, it is important to make sure that the model you select supports advocacy ownership of the collection.
- Who will govern/ make decisions about your collection? It is critical to understand who has the power to make decisions about your registry or biobank. Many advocacy organizations also choose to be the decision maker, with support from their advisors or biobank oversight committee.
- Who will be able to access data and samples? To leverage the most research activity, many registries and biobanks make their data and samples available to all qualified researchers. Other models include making it available to a subset of researchers such as a consortium, or researchers at a single institution.
- Who will determine access to data and samples? In addition to broadly deciding who can have access, you will also need a process to release data and samples to specific researchers. Many organizations have a committee that reviews researcher applications and approves the release of data and samples.
Find these questions and more in our Start-up Guide: 54 questions to consider.
Four months into our weekly tip series, we have not made the case as to why advocacy organizations should be involved in research initiatives. Perhaps we have not made the case because it is obvious to us why advocacy organizations should be involved in registries and biobanks.
The current system of academic research and rewards is fractured and unable to facilitate true collaboration and sharing. The pharma R&D pipeline has not had significant increases in the past 50 years, and the number of new submissions at the FDA is trending downward. Our current system isn´t sustainable and we, as a community, have the opportunity and the obligation to change the biomedical ecosystem. AND we can´t do this without the involvement of individual advocates, citizen scientists, and advocacy organizations.
Advocacy organizations are key stakeholders for the development of registries and biobanks, and they are vital to the advancement of collaborative science. Advocacy organizations:
- Develop communities of trust
- Leverage scarce resources
- Understand the unmet research needs of the community
- Facilitate collaboration between diverse stakeholders
- Are committed to the cause for the long-term
- Are appropriate and dedicated stewards of data and sample
We have many examples of successful advocacy-initiated and advocacy-managed biobanks, through Genetic Alliance Registry and BioBank and others. It is clear that advocacy organizations, individual advocates, and citizen scientists are essential partners in transforming our current system.
With any complex endeavor, such as a registry or biobank, we often gather information from multiple sources, including the Internet, journal articles, our advisors, and others in the biobanking field. But how do we know that the information provided is accurate? How do we know the information is trustworthy?
One strategy is to use Genetic Alliance´s Trust it or Trash it? tool to ask the following questions:
- Who said it? – If it´s a written piece, it´s important to consider who wrote it, where the facts came from, and who paid for it.
- When did they say it? – It´s also important to know when something was written or updated, especially in fields that change very quickly.
- How did they know? – It´s also relevant to determine if the information pertains to you, and if it seems reasonable based on what you already know.
While the Trust it or Trash it? tool was designed to evaluate written information, it can also be modified to evaluate conversations you have with others. Remember, if it sounds too good to be true, it probably is.
For more information, including the developer´s version, visit http://www.trustortrash.org/.
As with any program initiative, it is important to develop a working budget. With a registry or biobank, it is essential to consider a multi-year budget that includes the costs of establishing and maintaining this resource. Each budget will be different, but you will want to consider the following elements:
- Start-up fees – These may include fees for joining, infrastructure development, software licenses, and database customization.
- Biorepository fees – These may include sample processing and storage fees. The number and types of samples will likely influence the total costs.
- Database fees – These may include fees to create records, fees for querying, or data use fees.
- Sample collection costs – These may include collection kits and materials, shipping, and collection fees, such as phlebotomy.
- Personnel costs – Remember to include staffing costs for overseeing and managing the day-to-day operations of your registry or biobank.
You will also want to include costs for printing and postage of recruitment materials, and travel for site visits to your vendors and/or continuing education of your biobank staff. Finally, you will want to include indirect costs in your budget.
The Foundation Center has an excellent tutorial on budgeting.
With any registry or biobank, it is important to develop a research study design. Your study design will be influenced by the research question(s) you are trying to answer. One aspect of study design is determining from whom you will collect data and samples. For example, some organizations collect data and samples from all individuals with a disease or condition of interest (e.g. all comers). Other organizations use specific inclusion and exclusion criteria to determine who can participate. Examples can include:
- Cases – individuals (unrelated) with the condition of interest
- Controls – individuals without the condition of interest
- Families – related individuals where some are affected
- Trios – two parents and an affected child
- Sib-pairs – two siblings and one parent
Your medical and scientific advisors can help you determine the most appropriate individuals to donate data and samples, as well as develop inclusion and exclusion criteria. You will also want to consider the budget implications of any potential study design.
When establishing a biobank, IRB approval is usually required for oversight of the collection, storage, and secondary use of samples. It is important to provide enough information in the protocol to satisfy obligations under applicable regulations and institutional policies, including 45 CFR 46 (the common rule), FDA human subjects regulations, HIPAA privacy regulations, and state and local laws. The following is an overview of information you should consider including in your research protocol:
- Name, purpose, and overall goals of your biobank.
- Information about research that will be conducted using specimens and data in your biobank.
- Information about administrative oversight, including the name of the individual with overall responsibility and the oversight mechanisms in place.
- Procedures for specimen and data collection, including details of the donor population, what data and specimens will be collected, how will they be collected, and where will they be collected.
- Protocols for recruitment and informed consent, including who will be recruited, how will they be recruited, and when will they be recruited, a description of collection sites, and information about the consent process and form.
- Procedures for participants to withdraw consent, and information about what will become of specimens and data when consent is withdrawn.
- Information about protection of subject autonomy and privacy of information, including information about access to identifying information and key codes, polices to protect participants, and policies for ensuring data and sample uses are consistent with consent.
- Specimen and data storage and retention procedures, including where data and samples are stored, how they are coded, processes for secure storage, and the length of storage.
- Specimen and data distribution procedures, including conditions of distribution, processes for ensuring appropriate access, secondary distribution policies, commercial use policies, user fee policies, and investigator usage agreements.
- Return of research results, including when individual results and incidental findings can be returned, and when aggregate or generalized results can be returned.
- Other issues, including plans if the principal investigator manager leaves and policies on rights to IP resulting from future research.
Remember to begin a dialogue with the IRB in advance of protocol preparation. The IRB is an important resource, and you should engage your IRB early and often during preparation of the protocol. More information about the IRB can be found in the week 13 tip.
This information was presented at the ISBER 2011 meeting in the Putting it all Together...Essential Components of a Biospecimen-relate Protocol Workshop.
Organizations with registries and biobanks typically work with vendors. It is unlikely that you will have the expertise and equipment within your organization for all operations, and selecting a good vendor is key to your program´s success. In addition to meeting all of your technical requirements, you will want to select a vendor that will be a good partner. Below are some tips to assist you in vendor selection:
- Learn from other advocacy organizations about their experiences
- Interview potential vendors
- Attend webinars and do site visits (if possible)
- Ask if potential vendors have other advocacy organization clients
- Talk to current and former clients
- Understand how much will you be able to customize the system to meet your organization´s needs
- Use tools for vendor selection in the GARB toolbox - How do I Select a Vendor?
With any vendor, it is important to determine if the vendor is willing to partner with you or is just interested in making the sale. Remember, if it´s too good to be true, it probably is.
- Good partners understand that the business of advocacy organizations is improving the health of people, and that the endpoint is not the registry or biobank.
- Good partners are transparent and open.
- Good partners are flexible and responsive.
- Good partners are visionary and creative.
- Good partners recognize the urgency of the situation, and that the time is now.
Many organizations focus on the technical aspects of registries and biobanks, determining what data and samples will be collected and the processes for collection. While these are very important aspects of a registry or biobank, it is also essential to develop procedures to manage your day-to-day operations. You will want to separate the processes related to your research study from other organizational processes such as fundraising.
You should begin by listing all tasks related to your registry or biobank. These may include answering questions from potential participants, consenting participants, assigning participant IDs, requesting and sending sample collection kits or registry questionnaires, communicating and following-up with participants, interacting with researchers or clinicians, and sending samples to researchers. Once you have listed the tasks, you should identify which ones will be performed within your organization.
You should then develop workflows for all organizational tasks and processes related to your registry or biobank. Be sure to include the staff members or volunteers assigned to each task, as well as the tracking systems in place. Remember that these processes must be consistent with the research protocol submitted to the IRB.
Contingency planning is an important activity for all major initiatives. It is a planning exercise that helps you think through the“what ifs” of a situation, and in many cases the worst-case scenario. The CDC recently released a campaign to help people prepare for emergencies, using the Zombie Apocalypse as an example. While the Zombie Apocalypse is extremely unlikely, there are useful lessons to be learned about emergency preparedness.
Contingency planning is useful for your registry or biobank. It is not expected that you will identify every possible situation and outcome, but rather that you think through possible scenarios and organizational responses. Remember, the worst-case scenario is unlikely, and this exercise will help you meet your goals and respond to any challenges you may face.
Things to consider:
- What is the worst-case scenario?
- What if you are over budget? If funding is insufficient?
- What if you are behind schedule?
- What if key people leave?
- What else should you consider?
In the movie, Field of Dreams, the main character hears a voice saying, “If you build it, he will come.” Unfortunately, it is not that simple with a registry or biobank. To maximize the use of your data and samples, you will need a strategy to make researchers aware of your collection. Below are some suggestions for promoting your collection to researchers.
- Communications to medical professionals – Alert your medical and scientific advisors and professional volunteers to your collection through a special communication or through your regular communication channels. This is a great opportunity to cultivate relationships with your advisors, the medical community, and researchers.
- Scientific meetings – Promote your collection at meetings that potential users may attend. Consider including information in a poster presentation, a podium presentation, an exhibit booth, or any society meetings you may have. Enlist help from your advisors to announce your collection to their peers in posters and presentations.
- Professional journals, society publications, or trade magazines – Consider writing an article about your collection for the medical or research community. Each type of publication will have different requirements for articles.
- A catalogue on your organization´s website – Post information about your collection on a section for researchers on your website. Including a catalogue will help potential users learn about the types of data and samples you have available.
Before making data and samples available to researchers, it is essential that you develop policies, sometimes known as data and sample use policies, about access to your collection. These policies should identify the types of investigators who can access the collection, as well as the process for accessing data and samples. Many organizations allow all qualified researchers to access the collection, while others may limit access to specific researchers (e.g. members of a consortium). There are many possible models, but the policy should be clear about any credentials or requirements needed to access the collection.
An application process for access to data and samples will also need to be developed. Typically, the application will include information about the researcher, their institution, how / for what purpose samples will be used, and a copy of the researcher´s IRB approval letter for the proposed research. The application should also include a lay summary of the research proposal that can be used to communicate this research to the community.
An oversight committee, sometimes known as a data or sample access committee, will review the application and determine if the researcher is eligible to receive data and/or samples. The oversight committee should include individuals who understand the research techniques being proposed, as well as representation from your organization. The oversight committee can be extremely helpful in prioritizing the use of limited samples.
Each organization will also need to determine any fee structures for data or sample use. It is also appropriate to require that researchers using data and samples acknowledge your organization in their presentations and publications. Find out more about how researchers should acknowledge your collection in the Week 4 Tip.
As you are planning your resource, you will to need determine if your collection will include biologic samples now or in the future. Collecting biological samples is important if adequate samples do not currently exist, or if current collections are fragmented and not shared. Advocacy organizations can also leverage their biobank sample collections to direct the research being done on their disease or conditions of interest.
Well-characterized biological samples are a very valuable research tool. However, sample collection is not a trivial undertaking, and proper planning is required. Advocacy organizations will need to work with their medical and scientific advisors to determine what is appropriate to collect. There are also technical considerations and resource considerations.
Some basic questions to consider include:
- What types of samples will you collect?
- From whom will you collect samples?
- Where will samples be collected?
- When will samples be collected?
- Who will collect the samples?
- How often will you collect samples?
- Do other similar sample collections exist?
OBBR has developed a brochure on the importance of high quality biospecimens.
As we discussed in Week 27, sample collection is not a trivial undertaking, and proper planning is required. In addition to deciding what to collect, you will need to determine how the samples will be processed and stored. Since most organizations do not have laboratory space, you will likely need to work with a vendor or partner for processing and storage.
Some basic questions to consider include:
- Where will samples be processed?
- How will samples be processed?
- Where will samples be stored?
- How will samples be stored?
- How will samples be accessed?
- For what types of experiments will samples be used?
*See Week 21 and 22 for tips regarding vendor selection.
A good working relationship with your IRB is vital to a successful research project. The IRB can helpful you navigate issues surrounding consent, participant withdrawal, incidental findings, returning results, and other questions that may arise during the study protocol. Susan Brown Trinidad shared these tips for working with your IRB at the Genetic Alliance 25th Annual Conference in June.
- Behave like a colleague
- Learn the ropes
- Consult early & often
- Respect the IRB’s time
- Offer to attend a meeting in person
- Cultivate friends
- Remember “please and “thank you”
- Assume the worst
- Expect (or demand) immediate results
- Cut and paste the grant text into the application
- Try to guess what they want to hear
- Attempt to sneak anything past the IRB
Successful registries and biobanks utilize professional volunteers to advise them on a variety of issues. It takes time and effort to build a professional volunteer network, and an important step is to map the landscape of your advisors. This will help you identify the strengths of your current advisors in the context of the tasks where you need assistance. Below is a list of questions to begin to map the landscape of your advisors.
- What tasks do you need assistance with?
- What expertise do you need?
- Who are your current advisors?
- What is their expertise?
- What roles do they have in your organization?
- What other relevant roles do they have?
- What knowledge gaps remain?
Remember, don´t overlook organizational politics. See our Week 6 Tip for more information on working with your advisers.
Biobanks can collect a variety of sample types, and recent tips (Weeks 27 and 28) have discussed considerations for sample collection, processing, and storage. It is vital to anticipate how samples will be used prior to collecting them, so they can be collected and processed appropriately. For example, different vacutainer tubes are used for blood collection, depending on how the blood will be processed in the lab.
Many biobanks collect blood and/or tissue. Blood is a robust source for DNA, as all cells in the body generally have identical DNA signatures. Blood can also be used to isolate PBMCs (peripheral blood mononuclear cells), study biomarkers, or make EBV-transformed cell lines (although this is not as common today since smaller amounts of DNA are needed for experiments). Blood is usually processed (e.g. DNA isolated) prior to being sent to researchers.
Tissue is often used to study changes in gene expression (RNA) and can be a source for cell line generation. Tissue samples can be processed prior to being sent to researchers, or sent to researchers directly as frozen pieces of tissue. Representative pieces of tissue may also be embedded in paraffin, sectioned, and stained to see the characteristics of the tissue (histology and pathology). Generally, tissue is much more complex to collect and process than blood, and the more complex the processing, the higher the cost.
As you are planning your collection, you will need to understand what biological materials and derivatives are needed from the research community. There are many options to consider, and below is a list of biological samples and common derivatives. While not comprehensive, this is a starting place for the discussion.
- Cell lines
- Cell lines
- Cell blocks
- Paraffin sections
- Frozen sections
- Frozen pieces of tissue
- Whole tissue from autopsy
Once you have decided what biological samples you will collect, you must then determine how you will collect them. Blood and tissue are the most commonly collected sample types. Blood collections are relatively straightforward, and can occur in collaboration with a healthcare provider or by non-traditional mechanisms, such as sending kits directly to participants or at outreach events. Outreach events are an excellent opportunity to bring your community together, educate about the importance of research, and collect samples. Tissue is collected exclusively at point of care with the collaboration of the provider. For all collections, it is important to include materials required for collection and instructions on how samples should be collected, stored, and shipped to the lab.
Below are common ways to collect blood and tissue:
- Collection at point of care with provider
- Sample donation kit mailed directly to participant
- Collection at outreach events
- Collection at point of care with provider
- Collection at autopsy (special arrangements required)
With any registry, it is important to determine who will enter data. This area has become a hot topic with strong opinions. Generally, data are entered by the participant, the provider, or the provider´s staff. This is influenced by the type of information collected and resources.
Research has shown that participants can accurately enter certain information, although complex information may be better obtained from the provider or the medical record. For example, participants often know if they have high cholesterol, high blood sugar, or hypertension, but they may not know the specific lab values. There are also many instruments that have been designed specifically to collect self-reported data (e.g. SF-36 Health Survey).
Resources may influence data entry, as providers usually need compensated to enter data. It is also possible to have providers verify specific information (e.g. diagnosis) or to have the participant release their medical records to the registry.
Whether you chose participant or provider-entered data, the questionnaire must be designed for the person entering the data. For example, if it is participant entered, it is helpful to define all medical terms. There is a place for both participant and provider-entered data, and many registries use a combination of the two.
It is important to develop processes and procedures for the use of your registry. This includes designating personnel to enter data, assure data integrity, and maintain the registry. The Institute of Healthcare Improvement recommends the following:
- Develop tools for collecting data, using electronic systems when possible
- Develop tools for collecting data, using electronic systems when possible
- Train people who will be collecting and entering data into the registry (use test cases)
- Create a process for data entry
- Schedule and produce reports
- Ensure system security
- Make sure that people who need information from the system can get it in a timely manner
- Make sure staff are trained on data entry, backup, and security procedures
- Establish system backups
Procedures for biospecimen collection, processing and storage can lead to a wide variation in quality of specimens and data. For example, changes in specific transcript levels may be based on the ischemic time and not the disease. Pre-analytical variation includes both pre-acquisition and post-acquisition factors. (Pre-acquisition factors can include presence of antibiotics or other drugs, type and duration of anesthesia, and time of arterial clamp time. Post-acquisition factors include time at room temperature, temperature of the room, type of and time in fixative, and aliquot size to name a few.)
Ideally, every piece of relevant data should be collected to support future users who may have no connections to or understanding of the biospecimen collection protocols. Research is also needed to better understand how these variables affect molecular integrity, as some variables will have great influence on molecular pathways and others will not.
A number of initiatives are underway to better understand pre-analytical variation and biospecimen science:
- The Office of Biospecimen and Biorepositories Research (OBBR) has developed Biospecimen Reporting for Improved Study Quality (BRISQ) to guide researchers to capture information about the source and handling of biospecimens.
- The ISBER Biospecimen Science Working Group has developed the Standard PRE-analytical Coding for biospecimens (SPREC) to improve biospecimen research experimental protocols and to provide information about the biomolecular quality of samples.
- The Standardisation and Improvement of Generic Pre-Analytical Tools and Procedures for In Vitro Diagnostics consortium, better known as SPIDIA, has developed pan-European quality assurance schemes and guidelines for pre-analytical procedures, including sample collection, handling, transportation, processing, and storage of clinical samples.
Communicating openly is a key strategy for a successful registry or biobank. Openness and transparency enhance the community of trust and strengthen relationships with both participants and the greater community. An engaged community is more receptive to recruitment, and engaged participants are vital for retention, as it is much more difficult to recruit new participants than to keep those that are already participating.
Communication strategies to engage participants and your community include:
- Information about the research study
- Choices on how samples are used
- The informed consent process
- Timely research updates written at appropriate scientific literacy levels
- Sharing experiences through social networking
In any registry, it is vital to ensure that only authorized users can access your data. One strategy is to include a fine-grained hierarchy of authentication with users, groups, permissions and roles. A site administrator can create users and groups, and establish specific roles and permissions for each user or group. In addition, each user´s privileges should be verified by the system prior to displaying or changing a data point. Authentication logs should also be maintained to show changes to permissions and access, as well as changes to all data fields. Your software vendor should have protocols for chain of custody information and audit tracking in place to monitor data access, and activity reports should be available upon request.
There are a variety of staffing models that can be used for registries and biobanks, and most advocacy-driven research initiatives utilize a combination of paid staff and volunteers. At a minimum, you will need to determine who will be responsible for managing the following:
- Overall scientific direction of the project
- Regulatory compliance
- Day-to-day operations
- Interactions with participants and potential-participants
- Relationships with vendors and partners
- Transactions with researchers and others accessing your collection
- Financial oversight
- Communications with your community, the research community and the public
- Security and privacy
While there will likely be some overlap, it is essential that you identify roles and responsibilities for all individuals working on your registry or biobank. You may find it helpful to write job descriptions. It is also worth noting that the skill set needed for establishing the resource may be different than the skills needed to maintain the resource.
Medical and scientific advisors are important contributors to your organization´s registry or biobank. Their experience and connections can be a great asset to your program. Advisors can be involved in a variety of ways, including:
- Helping develop the overall scientific strategy of your registry or biobank. This includes designing the study (what data and/or samples should be collected and from whom?) and developing the questionnaire (what questions should be asked and who will complete the questionnaire?). Advisors can also help write or review protocols, including the research protocol submitted to the IRB.
- Providing scientific oversight for your registry or biobank. Advisors can serve on the registry or biobank oversight committee and help develop and review policies. They can also serve on the data and sample use committee to determine which investigators have access to the collection.
- Promoting your registry or biobank. Advisors can help promote your registry or biobank and generate awareness of your collection. They can assist with recruitment of potential participants by making information about your registry or biobank available in their practice. They can also inform other researchers about the collection. If they are users of the data and samples, they can acknowledge your organization to their scientific peers in posters and papers.
Registries and biobanks can be expensive, and it is important to develop a sustainable funding model for your program. Generally, costs can include start up fees, biorepository fees, database fees, sample collection fees and personnel costs. It is important to establish a budget (see Week 18 Tip) and raise funds for establishing and maintaining the resource. Many organizations fund their initiatives from multiple sources, including:
- Research grants – www.grants.gov is a good resource for federal opportunities. Most federal opportunities have very specific requirements that may only be feasible if your work is in alignment the agency´s goal. Exploring state and local funding initiatives is another possibility.
- Foundations – Foundations are a good fit if you can closely align the goals of your registry or biobank with the goals of the sponsor. There are many thousands of foundations that differ in the kinds of initiatives they support. It is important to establish a relationship with the foundation prior to seeking support. The Foundation Center has a variety of useful resources.
- Individual donors – Individual donors frequently support registries and biobanks. These individuals will typically have a connection to the community served. There are also many recognition opportunities that can be implemented for varying levels of sponsorship.
- Cost recovery mechanisms – Passing costs on to those who use the samples is a common practice in biobanking. However, cost recovery alone is not sufficient to fund a biobank, as researchers could never pay for the “true cost” of obtaining a sample.
Cost recovery, the practice of passing costs on to those who use samples, is common in the biobanking field. Many funders actually require that a cost recovery plan be in place to receive funds. To develop a cost recovery plan, you must first understand your operational costs. Operational costs include staffing, freezer and liquid nitrogen tank costs, materials and reagents, database management and maintenance, and consenting/following-up with donors. You may also have additional operational costs not listed here. In calculating your costs, don´t forget to take into account the administrative burden of invoicing and collecting fees. Slow or no payment can be real issues for day-to-day operations.
In addition to understanding your operational costs, you should also identify a goal for cost recovery. It is unrealistic to assume cost recovery will fund all operations of your biobank, as most researchers could not afford the “true cost” of a biospecimen. Some biobanks use cost recovery to pay for physical materials and reagents, and utilize other funding sources (e.g. grant funding) for salary support. Others use a fee for service model to help defray the cost of storage and distribution of samples. (Remember to include the costs of shipping samples if applicable.) Biobanks who have significant grant support can typically charge lower fees, and this model is not sustainable for all biobanks.
Even if your biobank is well funded, it is important to have a cost recovery plan to promote good stewardship of biospecimens as a finite resource. Consider who will be using your samples when developing your plan. Tiered-fee structures and membership models may be appropriate but require more administration. Waivers could be an option for those without sufficient funding to pay fees. Additionally, you can request that investigators using your samples request funds in their grants.
In today´s world more than ever, we are encouraged to collaborate and partner with others. Partnerships can help us achieve more with less, and broaden our reach. Partnerships have amazing potential, and it´s important to evaluate each potential partnership. When approached by a potential partner, consider the following:
- What is involved? – What is the potential partner asking of your organization? What is the outcome? What are the deliverables? What resources are involved (time, money, personnel, and organizational/personal capital)? Are roles and responsibilities clear?
- What is the benefit? – How will both parties benefit? Can you articulate the value? What are the potential pitfalls? Is this something you can´t do/ can´t do well without the partner?
- Is it strategic? – Do your missions align? Is this within the scope of your strategic plan? Is it a good opportunity? Does the partnership make sense?
The usefulness of a registry is directly related to the quality of data within the registry. Data quality can be improved through appropriate questionnaire design (Week 11), data standardization (Week 7), and data curation. Data curation is the “the active and ongoing management of data through their lifecycle of interest to science.”* Once data are entered, it is essential that data are curated.
One strategy for data curation is to review and approve each completed questionnaire. Many registries provide the opportunity for a completed questionnaire to be temporarily stored and then migrated to the database once it has been reviewed and approved. This provides an opportunity to correct any ambiguous or erroneously entered data. Each questionnaire is unique, but there are some common elements that warrant examination.
- Have all questions been answered?
- Do answers have the appropriate format? (e.g. Are dates entered correctly?)
- Do the answers make sense? (e.g. Are questions about pregnancy only completed by women?)
- Are there specific questions vital to the study that should be reviewed?
If necessary, the registry coordinator can contact the individual who completed the questionnaire for clarification. If there are particular questions that users consistently have difficulty answering, you may want to modify those questions. Starting with high quality data is an important step for building a better registry.
Many registries use online data capture forms where the participant, a parent, or a provider enters the data. In special cases (e.g. lack of internet access), the participant will complete a paper questionnaire, and someone within your organization must enter the data manually. It is important to develop protocols for data entry that include the information collected, how it is collected, and how it will be entered. These protocols should be written down and included as part of a formal training for all who encounter data.
When entering data, be consistent with both the data and the process. A checklist is a useful tool to ensure data are entered the same way regardless of who completes the entry. You should also periodically check data you are entering against the paper questionnaire for accuracy. When you have finished entering data, verify all information is complete and review the entered data for errors.
It is good practice to have one individual enter data, and another review data. Be sure to capture who entered the data and when it was entered, as well as who reviewed it. It is also a good exercise to have two team members enter the same data and check its reliability. Finally, be sure all data entry personnel are given adequate time to enter data.
A scientific director is a vital part of the research team. The scientific director is responsible for guiding the overall research strategy, providing scientific and regulatory oversight, and managing day-to-day operations of your organization´s registry or biobank. The scientific director works closely with medical and scientific advisors and other members of the research team to achieve these goals.
Advocacy organizations involved in research need someone internally to carry out these duties, either as paid staff or a high-level volunteer (e.g. board member or executive team member). This individual should be knowledgeable about the field and the research enterprise, have strong project management skills, and have experience working with professional volunteers. Previous experience with registries and biobanking is helpful, but not required, depending on the expertise of your medical and scientific advisors.
In some organizations, this individual is a scientist, and in others it is senior staff working closely with medical and scientific volunteers. It is essential that the scientific director understand the unique challenges of non-profit organizations functioning in the research space. Finally, establishing a research program often requires a different set of skills/experiences than maintaining one.
Research coordinators are essential contributors to the research team. The research coordinator interacts with participants and potential participants, answering questions about the research study and making sure study requirements are completed. The research coordinator also works closely with the scientific director and other members of the research team.
Research coordinators must have strong interpersonal skills for working with study volunteers. Strong administrative and organizational skills are also required, as the research coordinator is often responsible for keeping study logs and other administrative paperwork. Both the size of the research study and amount of follow-up required will determine if the research coordinator position is a full-time or part-time position.
Participants who donate data or samples to your registry or biobank are trusting you. They trust you will be consistent and accountable, act in their best interest, respect their wishes on how their data and samples will be used, and be good stewards.
To be effective stewards, it is essential to be transparent about research practices and intentions, and to communicate openly and clearly with participants. Consider the following governance questions:
- What do people expect?
- What will the data be used for and by whom?
- Who will make decisions?
- How will we know what happened?
- How will we feed the system?
- What will we communicate out?
For more information, review our good governance checklist.
When embarking on a registry or biobank, we often have many questions. It is common to ask others who have gone down this path about their experiences, relying on advice from current advisors and new contacts. We must filter this information, and we need to know if the individuals providing the information have any conflicts of interest or bias.
For your organization's formal advisors (e.g. medical advisory board, scientific advisory board, biobank oversight committee, etc), it is recommended to have a policy about disclosing potential conflicts of interest. This is also good practice for board members and other professional volunteers. You should ask individuals to identify the following:
- Financial ties (major investor, founder, consultant, employee) to companies involved with registries or biobanks.
- Compensation (honoraria, speaker's bureau, consulting fees) from pharmaceutical or biotech companies.
- Any grant funding, including industry funding.
- Formal research collaborations and competing research projects.
For more discussion on the topic, read Courtney Humphries' article, Deeply Conflicted.
Biobank collections are precious and in many instances not replaceable. The samples are priceless, with immense scientific value. It is possible to insure the facility and equipment, but insurance for loss of samples is almost always cost prohibitive. If you do insure your collection, it is important to assess the cost of obtaining similar samples, including labor and all logistics for acquiring and storing the replacement samples. It is very challenging to assign a value to the collection itself.
Instead of focusing on insurance, a better strategy may be to focus on risk management and preventing loss in the first place. This can be accomplished by:
- Storing samples in multiple freezers and routinely splitting samples from the same case into separate freezers.
- Separating critical batches of samples to different sites. If offsite storage is not possible, store samples in different tanks or freezers in different rooms.
- Utilizing higher floors to decrease flood risk.
- Using internal controls, automated monitoring, routine maintenance and staff training to minimize risk of loss.
It is important to develop policies and procedures for backing up data in your registry. If using a registry vendor, a reputable vendor will have backup policies and procedures in place. Additionally, you will need to develop an adequate back-up strategy to protect information that is accumulated prior to being entered in the vendor´s software as well as important internal files about your registry.
Some things to consider when backing up data:
- Determine when and how frequently backups are done. You will want to schedule backups based on how frequently data changes. For example, data that changes weekly may not need to be backed up every day. Data that changes hourly will need to be backed up several times a day. You can stagger full back-ups with incremental backups to capture those files that have changed since the last complete backup.
- Determine who is responsible for backing up data. Integrate backing up data into workflow by scheduling it as a required task. You may also want to keep a manual log to verify that backups have been completed as scheduled.
- Determine where you will store your backup data. It is usually standard protocol to store backup data offsite. Consider the location. For example, if you live in an area where flooding is common, consider storing back-ups on a higher floor and not in the basement.
- Test your backups periodically to ensure your procedures are working properly. By restoring your data in an alternate location, you will be able to determine if your backups are complete. If they are not complete, you will be able to adjust your protocol.
- Experts suggest having three different backups of your data. Using the cloud is an additional option for backing up important data.
Developing a registry or biobank is a rewarding yet significant undertaking. We hope these weekly tips have provided a starting point for dialogue about planning and cultivating your resource. Some final words of advice:
- Don´t duplicate efforts - registries and biobanks are expensive and administratively burdensome
- When possible, develop partnerships to share data and resources
- Ensure you registry or biobank is sustainable over time
- Use common data fields/ controlled vocabulary to allow comparison with multiple data sets
- Retention is key - it is much harder to recruit new participants than to keep those that are participating
- Sample collection is resource intensive – know what samples you need to collect and from whom
- Prior proper planning prevents poor performance
As 2011 draws to a close, it is a good time to reflect on the registry and biobank resolutions you made in Week 1. How did you do?
- Did you meet your goal?
- Did you meet your stretch goal?
- Did you cultivate new relationships?
- Did you learn or improve a skill?
- Are you ready to set registry and biobank resolutions for 2012?
Thank you for being part of our registry and biobank weekly tips series. Please complete this short survey to help us develop useful and informative tips for 2012.
Wishing you a happy and healthy new year filled with bytes and aliquots!
Happy New Year from Genetic Alliance Registry and BioBank! It´s 2012, and we begin our 2nd year of weekly registry and biobank tips. The beginning of a new year is always an excellent time for planning. It is an opportunity to assess your biobanking program with fresh eyes, set SMART goals for the coming year, review relevant policies and procedures, review budgets and financial statements, and even become better organized.
The calendar is an underutilized tool for working smarter, not harder. This is a great time to update your 2012 biobank calendar with the following:
- IRB protocol expiration and renewal dates
- Vendor contract expiration and renewal dates
- Warranty expiration dates
- Equipment service dates
- Grant submission deadlines
- Grant reporting deadlines
- Fundraising appeal dates
- Scientific meeting dates
- Abstract submission deadlines
- Scheduled communications to your participants
- Scheduled communications to your data and sample users
- Data backup schedules
- Key financial dates
- Other important dates
Thank you for being part of our registry and biobank weekly tips series. Please complete this short survey to help us develop useful and informative tips for 2012.
Wishing you a happy and healthy new year filled with bytes and aliquots!
Have you ever wondered how your biobank measures up? Are you following best practices in your day-to-day operations? ISBER, the International Society for Biological and Environmental Repositories has developed a Self-Assessment Tool (SAT) to help repository operators determine how well their repository follows the ISBER Best Practices.
The SAT contains 158 confidential questions, and each page of the survey corresponds to a section of the ISBER Best Practices document, including organizational requirements of a repository; records management; facilities; storage equipment and environments; quality assurance and quality control; safety; training; biological material tracking; packaging and shipping; specimen collection; processing and retrieval; and ethical issues for human specimens.
By completing the SAT, you will receive personalized feedback and a risk-balanced assessment score that will help you evaluate how well your repository conforms to ISBER Best Practices. You will also be notified of areas where your responses deviate from ISBER best practices recommendations. The SAT can also be used without submitting the results for analysis. This is a great tool to evaluate your biobank practices.
Operating a registry or biobank requires acting ethically and with professional integrity. The Atlanta Clinical & Translational Science Institute (ACTSI) has developed a series of case studies focusing on ethical dilemmas in scientific research and professional integrity. These case studies cover a number of topics related to responsible conduct in research, including allocating credit, animal use, authorship, conflict of interest, confidentiality, data interpretation and management, data representation, drug trials, informed consent, intellectual property, mentoring, misconduct, participant recruitment, and protocol deviation. Each case is followed by a brief, expert opinion that suggests strategies for resolution. The scenarios focusing on informed consent and participant recruitment are particularly useful.
Yes. A thoughtful and comprehensive business plan is essential, and all registries and biobanks should have one. A business plan is a living document that outlines all critical aspects of your operation. In many cases, it is used to seek support from funders. It also functions as a roadmap for a new venture. A business plan is helpful in identifying key elements for your resource, including:
- What will you need to start your registry or biobank?
- What resources (time, money, people, etc.) are needed?
- What is required to cover your costs? To sustain your resource?
- What is required to make a profit? How long will it take?
- What information will potential customers (researchers, donors, etc.), vendors, and investors need to know?
In next week´s tip, we will discuss key elements of the business plan.
Business plans are essential for many endeavors, and all registries and biobanks should have one. There are several essential elements of any business plan, including:
- Executive summary – The executive summary explains who you are and provides an overview of the entire plan. This concise summary is the first thing a potential partner or investor will read, and a compelling executive summary will encourage further reading.
- Market analysis – The market analysis section demonstrates your knowledge of the industry and your target market.
- Company description – This section provides a high level description of your company/organization.
- Organization and management – This section describes how your company/organization is structured and provides information about key people on the team.
- Marketing and sales management – This section tells how you will market your business, services, and products.
- Service or product line – This section describes the services and products your company/organization offers.
- Funding request – This section is your funding appeal and includes current funding needs as well as funding needs for the next five years.
- Financials – The financials sections should include both historical and prospective financial data.
- Appendix – This section is usually provided on an as-needed basis, and is tailored to the individual reading the business plans.
Remember, a business plan is a living document that should be reviewed periodically and updated as needed. The US Small Business Association has a number of resources for writing business plans, including business plan templates.
Next week we will discuss additional considerations for biobank business plans.
We´ve stressed the importance of a business plan for registries and biobanks, and highlighted the essential elements. Biobank business plans also have some additional considerations. The Government of Western Australia, Department of Health has developed guidelines for human biobanks, genetic research databases, and associated data. This document provides best practices and guidelines for biobanks, as well as recommendations for the business plan.
A biobank business plan should:
- Include a financial model that the biobank intends to adopt over its lifespan
- Be explicit and transparent about the nature and source of its financing/funding
- Set out the financial and scientific feasibility of the biobank, examining any assumptions made or risks identified with establishing the biobank
- Ensure that the biobank has sufficient professional staff and resources to operate effectively in all aspects
- Include plans for ensuring the ongoing financial and public support of the samples and data throughout its existence
- Include a business strategy in the event that funding is terminated or its nature changed
REDCap, or Research Electronic Data Capture, is a secure web application for building and managing online surveys and databases. REDCap was developed by the informatics core at Vanderbilt University to assist academic biomedical researchers in managing their research studies. Commercially available clinical and translational research databases can be cost-prohibitive, and NIH and NCRR supported REDCap´s development.
REDCap can run on a number of operating systems (Linux, Unix, Windows, Mac), and has some infrastructure requirements, including a web server with PHP, a MySQL database server, and an SMTP email server. It is not difficult to support, and one support person can manage hundreds of projects. To use REDCap, the user´s institution must be part of the REDCap Consortium, and there are required end-user license agreements. The technical core must also be affiliated with the user´s institution, and not a third-party vendor or service provider.
REDCap is not considered open-source software, and is available at no charge to institutional partners. The REDCap Consortium currently includes 326 active institutional partners, more than 28,430 projects, and more than 40,510 users across the consortium. For more information on REDCap and becoming a consortium partner, contact the Vanderbilt REDCap Team.
Social media can be a very useful tool for interacting with your community. Many organizations use social media (e.g. Twitter, Facebook and others) as a broadcast communication tool, updating their community and the public about progress or new developments with their registry or biobank. This is just the beginning. Social media can also be used strategically to listen to and engage with your community. Radian6 has created a wonderful resource, 30 ideas for your social media plan in 2012 that provides insight on how to use social media more effectively. Once your social media plan is in place, be sure to time your posts for when your audience is most likely to be listening.
Nearly 60% of computer security breaches are caused by user error. According to a recent article in the Economist, repeated warnings about being vigilant are often ignored. Users continue to download files, not recognizing the risk. Others actively disable security features, as these features may slow down the system. Following good security practices and being vigilant are essential for anyone who uses a computer or smartphone. This is especially important for individuals involved with a registry or biobank.
TechSoup has suggested 7 tips for avoiding common threats at your organization. These tips are designed for small and mid-sized nonprofits to create a healthy and secure computing environment.
- Practice “security awareness”
- Secure your endpoints
- Create a security policy for your organization
- Keep roles separate
- Establish backup and redundant systems
- Keep your systems patched
- Minimize exposure
Learn about the top 10 computer security threats of 2012 and how to be smart with your smartphone.
Having strong passwords is an important aspect of computer security. How do you know if your password is appropriate? How many passwords is it reasonable for one person to remember? How do you handle passwords for highly sensitive information, such as participant information in a registry or biobank?
TechSoup suggests having different passwords for different functions, such as nuisance logins, private logins, community logins, and highly sensitive logins. They also provide suggestions for developing strong passwords (e.g. use the first letter of each word in a phrase), as well as recommendations for organizational policies regarding passwords.
In all research studies involving people, including registries and biobanks, the research protocol is submitted to the IRB for approval prior to beginning the work. When we actually conduct the research, we may find more efficient and improved ways to do the work. When this happens, it is important to let the IRB know of any modifications to the approved protocol.
For registries and biobanks there are key areas where you are likely to make modifications to the protocol over the life of the research study. Ask the following questions:
You should review your protocols regularly to make sure you are doing what you said you would do. Remember, protocols can and should be modified as new needs arise.
- Are you collecting new sample types?
- Are you collecting new data elements?
- When you release data and samples to investigators, are you following the process described in the IRB-approved protocol? (It is important that all individuals requesting data and samples follow the approved data and sample release process, and that the process is documented.)
Biobanks are developed for different purposes. Some are developed to study a specific disease or condition, others are developed to study populations, and still others are developed for other reasons. When setting up your biobank, you will need to decide if you are going to anonymize or de-identify your samples. This will also need to be established in your approved IRB protocol.
- Anonymized means that the links between the sample and the donor are irretrievably broken and the individual cannot be re-identified.
- De-identified means that the identifiers have been removed, and it would be difficult to identify the individual. However, someone (usually the steward of the collection) has the ability to re-identify the individual (e.g. having the code that can relink the donor to the sample).
The most important difference is that de-identified samples can be re-identified, and anonymized samples cannot. Being able to re-identify the donor is important when providing incidental findings, returning results, or re-contacting for additional research. It is important to note that genetic information cannot truly be anonymized and can be identified with a reference sample.
Learn more about the issues in Suspect Creatures from the Council for Responsible Genetics.
Engaging the community is vital for a successful registry or biobank. An engaged community will be more likely to participate and to stay involved for the lifecycle of the project. Steve Buttry discusses community engagement in detail in the Buttry Diary. He highlights tools and techniques for engagement (e.g. social media, blog networks, crowd sourcing, etc.). He also suggests these approaches should be used together (think overlapping circles, not silos) for the most effective engagement, achieving outreach, conversation, and collaboration.
How do we express gratitude to research participants and sample contributors? Without their involvement, research will be stagnant and will not advance. We know that biobanks and other clinical data repositories have changed "business as usual" for researchers, for research oversight, and for research participants. We must show gratitude and reframe how we interact with research participants and sample contributors.
Watch People Matter – The Future of Research to understand how important samples are to advancing the research enterprise, as well as the importance of expressing gratitude to sample contributors and engaging the public in research.
- One way to express gratitude is to return results. A recent consensus statement in Genetics and Medicine discusses returning individual research results (IRRs) and incidental findings (IFs) within the context of the biobank research system. The authors suggest that the biobank itself should “shoulder significant responsibility” in the process. (Read the Nature commentary.) Participants appreciate aggregate results and knowing what is happening with research in which they are involved.
- Another way to express gratitude is to treat participants like partners. A recent paper in Nature Reviews Genetics describes participant-centered initiatives (PCIs), which use social media technologies as a basis for long-term interactive partnerships. PCIs enable participants to have a greater role in experiments, as well as more control over how their data are used. Here, participants are equal partners to researchers, and PCIs include participants in the decision making process.
- A very simple way to express gratitude is to thank participants for their involvement and contributions.
During a crisis or emergency, communication is key, and a good communications plan is essential. Your organization should be able to communicate promptly, accurately, and confidently to multiple audiences. Each audience will want to know how they may be impacted.
FEMA (Federal Emergency Management Agency) has created a tool for developing a crisis communications plan. The tool lists possible audiences (e.g. customers, employees, media, community, management, etc.) and suggested messages for each audience. Contact information for these audiences must also be readily available during the crisis.
We hope your registry or biobank never has to endure a crisis. If you do, a crisis communications plan can minimize impact through good communication.
What would happen if we freely shared our data, samples, and results? If we realigned our current research incentives? If we formed interdisciplinary research teams that could harness the power of information and big data? If we actively involved research participants and citizen scientists? Could we build better disease models? Could we get results that matter for people and better health? Could we get there faster?
The 3rd Annual Sage Commons Congress, Building Better Models of Disease Together, April 20-21 in San Francisco, attempts to answer these questions. The Congress will explore how early investments in technical and legal data sharing platforms are beginning to pay off in faster science, increased patient engagement, and disruptive projects that can shake up the entire pharmaceutical industry. The Congress program will include deep dives into the Synapse technical platform and Portable Legal Consent systems that together make data about individual research participants the key to large-scale disease research. There will be a free live webcast of the Congress sessions, and videos of all the presentations including Congress Unplugged! will be available on the website and iTunes shortly after the Congress. The Twitter hashtag #SageCon is again being used for real time microblogging by @SageBio, @GABioBank, and many other live and virtual participants.
We hope you follow along and consider joining the movement.
With any endeavor, including biobanking, it is important to stay current and up-to-date. Below are some resources to help you.
- Biopreservation and Biobanking – a journal dedicated to the field of biospecimen procurement, processing, preservation, and banking
- BioCor – a resource for advancing the science, technology, and practice of preservation
- Biospecimens Interest Group – a seminar series of timely topics in biobanking
- Genetic Alliance Registry and BioBank Bulletin – a monthly bulletin about registries and biobanks
- ISBER – the international society for biopreservation and biobanking
- OBBR – a resource to ensure that human specimens available for cancer research are of the highest quality
Questionnaire design is art form. A poorly defined registry questionnaire can give you ambiguous, or even misleading, results. Previously, we provided tips for developing your registry questionnaire and resources for good questions. Here are some additional pearls from Design Staff on survey question development.
- Only ask what you need to know and can act on
- Keep surveys short
- Start broad, then move to specific and sensitive
- Group related questions together
- Randomize answers to avoid response order effects
- Avoid images and be aware of your survey's visual design
- Pre-test your survey
Who owns the data and samples in your registry or biobank? This is an important question to consider while planning your registry or biobank. Depending on the governance model, a number of stakeholders, such as the biobank, the sample contributor, the principal investigator, the university, or others, could own the data and samples in the resource.
In a recent survey, the CFIDS Association of America asked 255 potential biobank participants who should own their specimen. Nearly two-thirds (64%) responded that the biobank should have ownership of their specimen, while almost one-third (31%) responded that the individual should own their own specimen. The remaining 5% suggested that the researcher or their physician should own the specimen.
It is important to communicate to participants and potential participants who will own their data and samples, and any rights they may have to the data and samples. This information is typically included within the informed consent form. For more on ownership, view our Week 15 Tip.
Community advisory boards (CABs) are becoming a mainstay of clinical research. The NCI Dictionary of Cancer terms defines a community advisory board as “In medicine, a group of non-scientist volunteers that serves as a link between a community and clinical trial researchers. A Community Advisory Board may review and monitor clinical trials and help teach the community about the trials. Also called CAB."
CABs are also becoming more common in biobanking. The Mayo Clinic includes a 20-member CAB in their overall governance strategy. This CAB is tasked with ensuring that “the community's voice is heard in shaping the current and future plans and maintenance of the Mayo Clinic Biobank”. While limited guidance exists on developing effective CABs specifically for biobanks, the CDC has created Best Processes for CABs.
A major reason that new therapies fail is due to lack of good natural history studies. Natural history studies are essential for clinical studies and contribute to therapy development along with interventional trials. They are used to develop diagnostic guidelines, identify biomarkers, and educate both the medical community and the patient community about a disease or condition. They are especially important for understanding rare diseases, with small patient populations. Because natural history studies are disease specific, and not therapy specific, it is appropriate to conduct them outside of the traditional therapeutic development program.
Extensive front end planning is essential for effective natural history studies. A critical mass of investigators, research sites, and active patient advocacy groups are needed. For rare diseases, key steps for good natural history studies include finding the first patient, identifying an advocacy group, developing a contact registry, and eventually developing a patient registry. Advocacy groups are vital contributors to the development and implementation of both contact registries and patient registries. It is also relevant to note that natural history studies for academic publication are not equivalent to natural history studies for regulatory submission.
View the the NIH Natural History Studies Workshop, May 15-16, 2012.
- NHS should be considered knowledge development programs.
- NHS should be conducted as a community effort that includes investigators, NIH, industry, advocacy groups, and the FDA.
- NHS should have widespread origination, and results should be widely available.
- Data ownership and access are important issues in NHS. Negotiate data access and publication rights early.
- Good knowledge about natural history comes from soundly planned and conducted studies.
- Proper planning of NHS cannot be emphasized enough. If possible, involve someone experienced with the drug development perspective during design.
- NHS are multiyear studies that evolve over time.
- Good NHS have specific aims and an analysis plan.
- NHS require living and evolving protocols. Protocols should not be static, and new knowledge will help to refine the protocol.
- Bias is a significant problem in NHS. There is more potential for bias in NHS than in randomized-controlled trials.
- If wrong choices are made in NHS, wrong choices can be made during drug development, and the program can fail. Additionally, poor quality data may mislead in the interventional stage.
- NHS are disease specific, not therapy specific, and should be conducted outside of traditional therapeutic development programs.
- Time effects are an important consideration in NHS.
- Medical care can change the natural history of a disease.
- Combining research and clinical visits on same day if possible will make participation in NHS easier.
It is not always efficient to do things alone. This is especially true for non-profit organizations with limited resources. There are appropriate times to cooperate, collaborate, pool resources, and organize together. The Stanford Social Innovation Review has developed a two-part series on organizing alliances of multiple organizations, and suggests the following key elements:
- An executive council focused on the big picture
- A leadership team to develop the strategy
- Program management teams to implement the strategy
- Projects that are well-defined with clear deliverables
- Project work groups involving community members
- Support staff
- Clear mechanisms for community engagement
Additionally, all elements are connected by a culture of accountability. While this article has been developed for organizational alliance, it is clear how this structure can be applicable to biobanks, generally, and biobank alliances.
ResearchMatch is an online tool that matches people who want to participate in research studies with researchers looking for people to participate in their studies. The goal of ResearchMatch is to bring together the right participants with the right researchers. ResearchMatch can be used to recruit for any IRB-approved study, including registries and/or biobanks. Individuals and research organizations can participate, and currently 321 trials at 70 institutions are available for matching with volunteers.
ResearchMatch is a Clinical and Translational Science Awards (CTSA) initiative funded by the National Center for Advancing Translational Sciences, part of the National Institutes of Health.
The International Society for Biological and Environmental Repositories, (ISBER) has updated its 2012 Best Practices for Repositories to include two new sections. The first covers cost management, providing guidance on assessing costs during the development of a repository and analyzing the costs associated with the ongoing maintenance and operation of the repository. The second, Specimen Access, Utilization, and Destruction, addresses issues on data sharing, including the proper transfer of specimen-specific and donor-specific data, and security concerns for the distribution of data. ISBER's Best Practices for Repositories reflect the collective experience of its members and has received broad input from other repository professionals. The best practices document presents effective practices for the management of specimen collections and repositories.
Several of our tips have focused on questionnaire design. A good questionnaire is essential for obtaining useful data. Design staff offers suggestions of what to avoid, as well as useful alternatives.
- Avoid leading questions; instead ask questions in neutral ways
- Avoid agree/disagree statements, instead use an item-specific rating scale
- Avoid “double-barreled” questions, instead ask one item per question
- Avoid asking “why” to get at motivations, instead focus on intent
- Avoid vague terms, instead ask specific questions to avoid interpretation
- Avoid hypothetical questions, instead ask about current experiences
- Avoid comparison questions, instead use separate surveys
Setting up a biobank is major undertaking. Like any project, it can be divided into 5 stages: initiation, planning, execution, monitoring and controlling, and closing. While most projects move in a linear fashion, it is sometimes necessary to revisit previous stages as more information becomes available and additional knowledge is gained. The main goal of the initiation phase is to create a basis document for the project. The basis document should include the following information:
About the project
- Who initiated the project?
- Why was the project initiated?
- What is the overall vision/ goal of the project?
- What are the objectives to be delivered?
- What is the overall project framework (legal, financial, quality, time, etc)
About the project organization
- Who has the responsibility for further project development?
- What resources does the project manager control?
- What is the time-line for the project?
- To whom does the project manager report?
The planning stage is then used to create more concrete plans around the basis document. Read more from Roger Bjugn and Bettina Casati, who remind us if you fail to plan, you plan to fail.
In project management, the planning stage follows the initiation stage (Week 79´s Tip). The planning stage builds on the basis document created in the initiation stage. According to Bjugn and Casati*, the planning stage should, at a minimum, include the following:
- Are the overall project objectives sound?
- What should the deliverables be, and how should they be measured?
- Complete a stakeholder analysis
- Complete an analysis of cost, quality, and time
- Complete a risk analysis
- Prepare a detailed project plan with activities, sequence of activities, and resources required
- Give recommendations on how to proceed (or not to proceed)
* Roger Bjugn and Bettina Casati. Biopreservation and Biobanking. June 2012, 10(3): 239-244. doi:10.1089/bio.2011.0047.
A challenge for many registries and biobanks is long-term sustainability. These large initiatives are resource intensive, and for long-term success, it is important to have buy-in from key stakeholders. A key strategy for success is to conduct a stakeholder analysis1, a process that includes identifying and engaging internal and external stakeholders in the project. A typical stakeholder analysis includes 5 steps: identification, attributing values, prioritizing, devising a plan for engagement, and monitoring.
When identifying key stakeholders, begin by brainstorming all the individuals who impact or are impacted by the project. Stakeholders likely fall into groups or categories based on common interests. For a biobank, these categories may include:
- Your organization
- Organizational leadership
- Patients, families, and research participants
- Public bodies
- Political bodies
- Medical professionals and researchers
Next week we will discuss attributing values and prioritizing the stakeholders identified above.
1 Roger Bjugn and Bettina Casati. Biopreservation and Biobanking. June 2012, 10(3): 239-244. doi:10.1089/bio.2011.0047.
Once you have identified key stakeholders (Week 81), the next step is to attribute value, as you must understand how these individuals can influence your registry or biobank1. A simple way to attribute value is to develop a power-interest matrix, assigning high power/lower power, and high interest/low interest to each stakeholder. This can be represented graphically with power on the y-axis and interest on the x-axis. Another, more involved method is to identify each stakeholder´s influence, their interest in the project, and their attitude toward the project (i.e. their ability to “back” or “block” the project).
Once you have assigned values, prioritizing stakeholders is next. Prioritization can be done using the value exercise above or a simple high, moderate or low impact classification scheme. It is important to consider how this information will be used and who will have access to it. It is possible that if stakeholders are aware of how they are prioritized, it may alter their attitudes toward and interest in the project.
You are now ready to engage your stakeholders.
1Roger Bjugn and Bettina Casati. Biopreservation and Biobanking. June 2012, 10(3): 239-244. doi:10.1089/bio.2011.0047.
Now more than ever, collaborations are key to advancing science. Great collaborations are amazing and enriching experiences that often lead to ongoing collaborative relationships. Unfortunately, many have also experienced collaborations that aren´t so great. Productive collaborations take time and energy. Here are some tips to help you succeed.
- Collaborations should be mutually beneficial, and it is important to develop rapport and trust with potential collaborators. Consider working together on a pilot project first, to see if your work styles are compatible, and if you like working with a potential collaborator.
- Understanding and managing expectations is vital to a successful collaboration. Setting ground rules will help clarify what each individual brings to the collaboration, what they will be contributing, and the timeline for contributions. This is also a good time to discuss confidentiality, data sharing, authorship, how to resolve disagreements, and how to deal with scientific misconduct.
- Once the collaboration begins, good communication is key, especially if the project gets behind schedule or there are other setbacks. Someone should be assigned the role of project manager to ensure that agreed-upon tasks are completed, and completed on time.
If you have a registry or biobank, you will be working with an Institutional Review Board. The NIH has compiled a number of Bioethics Resources and offers training for Protecting Human Research Participants. Genetic Alliance has also developed a number of resources about IRBs and IRB protocols for registries and biobanks.
Genetic Alliance Weekly Tips and Webinars
- Research Ethics and Stewardship, Week 12
- The Institutional Review Board, Week 13
- The IRB protocol, Week 20
- Tips for working with your IRB, Week 29
- Stewardship, Week 47
- The IRB protocol: Are you doing what you said you would do?, Week 63
- Demystifying the IRB Webinar, December 2011
- Biobank Governance Webinar, October 2010
Well-designed and conducted natural history studies are essential for the development and approval of new therapies. These studies are also instrumental in helping us understand progression of disease and identify potential biomarkers. We have previously discussed natural history studies in our Week 73 and Week 74 tips. The Code of Federal Regulations, 21CFR314.126, has identified 7 elements in an adequate and well-controlled natural history study. These include:
- A clear statement of the objectives, and proposed and actual methods of analysis in the protocol and in the reporting of results
- A design that permits a valid comparison with a control to assess drug effect
- Methods of adequate assurance of patient selection
- Patient assignment that minimize bias and assures group comparability
- Efforts to minimize bias of all parties: patients, investigators, observers, and analysts
- Endpoints that are well-defined and address the clinical primary hypothesis
- Analysis of results that allow interpretability of the effects of the drug
In May, NCATS held a workshop on Natural History Studies of Rare Diseases: Meeting the Needs of Drug Development and Research. The workshop summary is now available, along with videos of the event. One of the first steps toward a natural history study is identifying individuals with a condition, identifying an advocacy group, developing a contact registry, and eventually developing a patient registry.
Biospecimen science is an increasingly rich area of scientific inquiry. Here are two resources to help you stay on top of this important and emerging field.
- The International Society for Biological and Environmental Repositories (ISBER) has developed the Biospecimen Science Literature Compilation (BSLC). BSLC is a rich resource of published literature organized by category, including guidelines, methods, and derivative sub-types. Each article hyperlinks to source documents, where available, or PubMed abstracts.
- The Biospecimen Research Database (BRD), a joint venture of the Office of Biorepositories and Biospecimen Research (OBBR) and the National Cancer Institute Center for Bioinformatics (NCICB), contains peer-reviewed literature pertinent to the field of human biospecimen science. Manuscripts included in BRD are annotated to include biospecimen parameters, results, and variables encountered in the biospecimen lifecycle.
Launching a registry or biobank is a large undertaking with many moving pieces. Without proper project management tools, it is easy to get overwhelmed and behind. There are a number of tools that are available, at different price points. These tools have been reviewed in 30 online project management and collaboration tools, and 7 online project management tools to keep you organized. Another option is to use Google Calendar as a project management tool.
Common data elements (CDEs) enable data to be shared across registries. By using CDEs, registry operators can ensure that data are defined in the same way, and use the same standards and vocabularies. The Office of Rare Disease Research (ORDR), with the National Institutes of Health (NIH), has established CDEs for rare disease registries. These CDEs capture a minimum level of data needed for most rare diseases. Registry developers will need to supplement their questionnaires with additional information specific to the disease or condition of interest.
ORDR has just released the second version of CDEs for the Global Rare Disease registry. There are 72 CDEs in the following categories:
- Contact information
- Socio-demographic information
- Family history
- Anthropometric information (height and weight)
- Patient reported outcomes
- Medications, devices, and health services
- Clinical research participation and biospecimens
A GUID, or global unique identifier, is a code that can be used to link data across registries, biorepositories, and other studies. A GUID is generated for each participant based on information available on his or her birth certificate (e.g. first, middle and last name, birth date, birth city, state and country). GUIDs, conceived by the Simons Foundation Autism Research Initiative (SFARI) and implemented by the National Autism Research Database (NDAR), are generated with an algorithm. Researchers can then access information from individuals participating in multiple studies without knowing their identities. GUIDs can also be used to link biological samples to donor information. To learn more, watch NDAR´s video explaining GUID.
Registries and biobanks must develop policies and procedures on returning results to their participants. Results can be aggregate results, individual research results (IRRs), or incidental findings (IFs). As with all policies, it is important that your registry or biobank has the resources to implement them. This is a complex area, and you will want to work closely with your IRB in developing these policies. Here are two resources to continue the discussion.
A consensus statement in Genetics and Medicine discusses returning IRRs and IFs within the context of the biobank research system (primary research or collection sites, the biobank itself, and secondary research sites). A multidisciplinary team of authors, led by Susan Wolf, JD, suggests that the biobank itself should shoulder significant responsibility in the process. When re-identification is possible, the authors recommend that biobanks work to: (1) clarify the criteria for evaluating findings and the roster of returnable findings, (2) analyze a particular finding in relation to this, (3) reidentify the individual contributor, and (4) recontact the contributor to offer the finding. The authors also offer 10 recommendations for new and existing biobanks.
The Public Population Project in Genomics (P3G) published a Policy Statement concerning the return of IRRs and IFs to participants. The statement suggests that researchers, in collaboration with their IRB or Ethics Review Committee, should consider returning IRRs and IFs to participants if the following criteria are met: 1) the participant has consented thereto in the initial consent form or at a later time; 2) the findings are analytically valid (i.e., confirmed independently); 3) they reveal a significant risk of a serious health condition; and, 4) they are actionable. Additional scenarios for returning IRRs and IFs exist when there is likely therapeutic benefit.
Every registry or biobank needs a data dictionary to ensure consistency of terminology. A data dictionary is “a descriptive list of names (also called representations or displays), definitions, and attributes of data elements to be collected in an information system or database.” (AHIMA e-workgroup on EHR Data Content 2006)
Data dictionaries are essential elements for planning a database AHIMA (American Health Information Management Association) has created recommendations for developing a data dictionary, and NDAR (National Database for Autism Research) has excellent data dictionary examples.
There are a number of challenges to conducting rare disease research. One of these is locating and accessing high-quality biospecimens. Rare disease biospecimens are often stored in redundant, siloed, fragmented collections with variable associated data. Additionally, these samples are geographically dispersed and difficult to locate. Rare Disease-HUB (RD-HUB) provides a searchable database to help researchers find biospecimens collected and stored by domestic and international biorepositories.
RD-HUB is managed by the Office of Rare Diseases Research (ORDR) at the NIH, and both rare and common diseases are included in the resource. RD-HUB can assist investigators and others locate and identify specific biospecimens, and facilitate sharing of material and information. RD-HUB also builds awareness of biorepositories and samples collections. RD-HUB includes a convenient list of fields required and frequently asked questions for entering biorepository data. If you have a biospecimen collection, be sure to register your collection at RD-HUB today, and if you are looking for biospecimens, search RD-HUB today.
Sample utilization is a challenge for many biorepositories. Biorepositories spend far more resources collecting samples, and often few resources are available for marketing, advertising, and distributing samples. A good biorepository collection follows the highest biospecimen science and ethical standards. A great biorepository collection follows the highest biospecimen science and ethical standards AND is distributed widely.
Ken Carbone´s Co.Design blog provides great insight into branding and marketing. He breaks down the formula for successful branding, utilizing the principles Unify, Simplify, Amplify.
- Unify – know who you are and believe it.
- Simplify – create a clear and compelling message that everyone understands.
- Amplify – reinforce your identity consistently and strategically.
We will discuss tips for marketing your biobank collection effectively next week.
In last week´s tip, we discussed principles of branding/marketing. In the next few weeks we will provide additional strategies for marketing your biobank collection effectively. But why is marketing so important?
- Researchers are unaware of existing collections.
- Biobanks/repositories need to demonstrate use of their biospecimen collections to justify continued support.
- It is ethically imperative to ensure biospecimens are used, and used appropriately.
- People that donate biospecimens want them to be used, and we have a responsibility to the donors to make sure they are used.
- Scientific advances cannot be made from biobanks if biospecimens are not well utilized.
- Effective marketing is essential to making sure your collection is well utilized.
How do you let researchers know about your registry and/or biobank collections? There are a number of strategies that other biorepository managers have used successfully to market their collections to investigators, both within and outside their organizations and institutions.
Internal marketing strategies
- Exhibit at internal functions and meetings (e.g. annual retreats)
- Send email blasts to investigators
External marketing strategies
- Exhibit at national meetings
- Advertise in peer-reviewed journals
- Announce collection in newsletters to potential investigators
- Target research offices at major medical centers
- Utilize a contact management software to track potential leads
Marketing strategies for both audiences
- Highlight your collection on your website
- Create a catalog for your website
- Request referrals from other biosample users (i.e. word of mouth)
- List your samples RD-HUB or NCI Biospecimen Locator
Emergency preparedness is essential when disaster strikes, and two public health initiatives can help you be prepared for an emergency.
- APHA´s Get Ready: Set Your Clocks, Check Your Stocks campaign is a reminder to refresh emergency supplies before a disaster occurs. APHA suggests that when you change your clocks for daylight savings time, you should check your preparedness kit to make sure items aren´t missing and food hasn´t expired. If you haven´t created a stockpile yet, this is a great time to create one.
- The CDC´s Preparedness 101: the Zombie Apocalypse is a clever primer for preparing for emergencies. While the Zombie Apocalypse is extremely unlikely, there are useful tips and tools for emergency planning.
The NCI Specimen Resource Locator is a database to help researchers locate human specimens (tissue, serum, DNA/RNA, other specimens) for cancer research. It includes tissue banks and tissue procurement systems with access to normal, benign precancerous and cancerous human tissue from a variety of organs. Online query tools match resources to specific researcher needs. Information is displayed for each resource, including contact information, availability and access requirements, fees, and links to resource web sites. If there is no direct match, a request can be emailed to the NCI Tissue Expediter, a scientist who can rapidly match investigators with appropriate tissue and data resources, and can help identify potential research collaborators.
In addition to having quality control (QC) metrics in place to ensure sample integrity, it may be useful to capture user experiences with your biorepository. One simple way is to provide a short survey to biosample users to solicit feedback. Some questions to consider include:
- What type of samples did you request from our biorepository?
- Did the samples arrive as expected?
- Did the samples have the amount of material you expected?
- Were the samples the quality you expected?
- Did you perform any additional QC metrics? If yes, which one(s)? What was the outcome? Did any fail QC?
- Did the samples perform as expected in your experiments? If not, please provide additional details.
- Would you use samples from our biorepository again?
- Would you recommend samples from our biorespository to a colleague?
If you are building a biorepository, it is important to design your resource appropriately to meet an identified scientific need. Here are some planning pearls:
- Solicit input before you build
- Find out what researchers need, and how they need it
- Define goals based upon needs
- Consider a prospective collection, or combination of prospective & banking
- Ensure consent language doesn´t unnecessarily restrict downstream use
- Develop a business plan for your biorepository
- Remember the five P´s – Proper planning prevents poor performance
Thank you so much for subscribing to our weekly registry and biobank tip series. Over the past 100 weeks, we have covered a wide variety of topics, creating a robust set of tips about establishing and maintaining a registry and/or biobank. In the last tip of the series, we have identified additional resources that may be helpful for the ongoing development of your resource.
BBRB – Biorepositories and Biospecimen Research Branch is responsible for developing a common biorepository infrastructure that promotes research sharing and team science, in order to facilitate multi-institutional, high throughput genomic and proteomic studies.
GRDR – Global Rare Diseases Registry provides the rare disease community a resource of standardized aggregated de-identified patient information to accelerate research and advance therapeutic development.
ISBER – International Society for Biologic and Environmental Repositories is the only international forum that addresses the technical, legal, ethical, and managerial issues relevant to repositories of biological and environmental specimens.
PCORI – Patient-Centered Outcomes Research Institute is authorized by Congress to conduct research to provide information about the best available evidence to help patients and their health care providers make more informed decisions.
Best wishes as you continue to advance your registries and biorepositories.