Biobanking and Human DNA Sequencing, Informed Consent in Research Participation

The problem: We are investigating if biological material with human DNA sequence data is being collected in the United States with ethical, informed consent. Biobanking is the collection and storage of biological material, including blood, tissue or other specimens for research (or other) purposes. The concern raised by ethicists is that some biological material is being collected and stored without proper informed consent. This means that there might be patients or other study participants who were not properly informed about their biological material being used in a research study. This problem may be compounded when biological material is being used in conjunction with medical records without proper informed consent. We are looking to identify best practices for informed consent. Specifically, we are looking at Recruitment, Collection, Retention, Notification, and Withdrawal procedures at institutions that participate in biobanking and genetic testing studies. The following is happening with data collection: In order to do research, we are contacting organizations and universities asking a series of research questions. Once the questions are asked, data will be coded for analysis to identify trends. We are collecting informed consent forms, Biobank consent forms, Process of withdrawal forms and copies of Medical Records research consent forms to draw our conclusions. Why it’s important: This project is important because there is no national study that we have been able to identify addressing these concerns. It’s important to inform the public about how their biological material is being collected, maintained and withdrawn. The hope is that proper informed consent will allow participants to make informed decisions, to reap the rewards of participation and to know how to withdraw. This may lead to greater informed participation in research studies