ISSUES TO ADDRESS

Starting and running a Registry and/or Biobank can provide a more accessibly way to contribute to research. Nevertheless, there are certain issues that one needs to address in order for the registry and biobank to operate effectively.

 

Informed Consent

Organizations running Registries and Biobanks must properly inform their participants about the process of collecting their samples. Informed consent is the process through which participants, capable of making their own health decisions, are made fully aware of the procedure of donating their health information and/or sample.  Through informed consent, participants will be made aware of all potential uses of their information and/or samples.  Prospective participants are offered information through one or more methods, including: pamphlets, videos, websites, forms, live interviews and/or a telephone hotline.  After prospective participants feel that they can make an informed decision, the consent form is signed and represents legal documentation that proper procedures were followed.

 

Privacy and Confidentiality

Prospective participants for registries and/or biobanks may be concerned about privacy.  Some worry that health information could be shared in a way that will harm them, and negatively affect their career, family and insurance.  To address some of these concerns, Congress passed the Health Insurance Portability and Accountability Act (HIPAA) in 1996 and the Genetic Information Nondiscrimination Act (GINA) in 2008 to help protect health information.

It is important to ask the biobank or registry what regulations they follow.  These vary greatly from institution to institution and there are no set standards for all institutions.

Participants should ask about the privacy and confidentiality policies of the biobank or registry and make sure they understand them.