Please tell me about the process that was used to develop your institution’s guidance that addresses human subjects’ protections in biobanking. Again, this includes all written and unwritten documents, policies, standard operating procedures, etc.
Did the process you just described for how your biobanking guidance was developed differ from the way other human subjects guidance was developed at your institution?
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If someone wanted to change the guidance at your IRB, how would that be approached?
We are interested in regard to
consent for the collection and storage of biospecimens for future research,
sharing of biospecimens across institutions, and
use of biospecimens/data beyond what was specified in the original consent.
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In the phone survey, you indicated that 1) OHRP policies/guidance documents, 2) AAHRPP accreditation standards, and 3) advice and/or requirements of institutional legal counsel were most influential in the development of your IRB’s policies and practices. Can you please tell me more about what role each of these had with regard to your biobanking policies and practices?
These probes were used with questions 5 through 10:
Was there anything distinctive or special about how the guidance came about compared to the general process you described above?
Was there a lot of debate about what would be the appropriate guidance or what would be unacceptable?
Is there continuing discussion or controversy about this issue?
On that survey, we asked about offering choices on consent forms when a researcher plans to collect biospecimens and associated data for a specific study but also wants to store them for future research. You told us your IRB would typically [interviewer described responses from the survey].
On the survey, we asked about IRB oversight when a researcher wants to conduct a new study using biospecimens/data that have already been collected and stored. You told us your IRB would typically [interviewer described responses from the survey].
On the survey, we also asked about IRB review of the original consent documents when a researcher wants to conduct a new study using biospecimens/data that have already been collected and stored. You told us your IRB would typically [interviewer described responses from the survey].
On the survey, you told us that when your IRB determines that a new proposed study is outside the scope of the future uses described in the original consent form, it would typically [interviewer described responses from the survey].
On the survey, we posed a situation where a researcher at your institution proposes a study that would involve biospecimens/data that she would obtain from an outside source. If the biospecimens/data were collected/stored under policies that differed substantively from those at your institution, you said your IRB would typically [interviewer described responses from the survey].
Finally, on the survey we asked about the situation of a research participant who contributed biospecimens/data to a stored collection but now wants to withdraw consent. You said your IRB would typically [interviewer described responses from the survey].
What role, if any, did the institutional experience with adverse events in genetic research have in influencing the development of your biobanking policies and practices?
Is there anything I have not asked you but you think is important regarding the bases for your (or other) IRB’s guidance on human subject protection in biobanking?
