IRB practices and policies regarding the secondary research use of biospecimens

Background As sharing and secondary research use of biospecimens increases, IRBs and researchers face the challenge of protecting and respecting donors without comprehensive regulations addressing the human subject protection issues posed by biobanking. Variation in IRB biobanking policies about these issues has not been well documented. Methods This paper reports on data from a survey of IRB Administrative Directors from 60 institutions affiliated with the Clinical and Translation Science Awards (CTSAs) about their policies and practices regarding secondary use and sharing of biospecimens. Specifically, IRB ADs were asked about consent for future use of biospecimens, assignment of risk for studies using biobanked specimens, and sharing of biospecimens/data. Results Our data indicate that IRBs take varying approaches to protocol review, risk assessment, and data sharing, especially when specimens are not anonymized. Conclusion Unclear or divergent policies regarding biospecimen research among IRBs may constitute a barrier to advancing genetic studies and to inter-institutional collaboration, given different institutional requirements for human subjects protections. Electronic supplementary material The online version of this article (doi:10.1186/s12910-015-0020-1) contains supplementary material, which is available to authorized users.

• Completing this survey will take about 30 minutes of your time. The questions are primarily multiple choice, with a few open ended items.
• Taking part in this survey is completely voluntary. With the exception of Questions #1 and #2, which confirm your eligibility for this survey, you may skip any question that you prefer not to answer.
Your responses will be kept completely confidential and results will be reported in aggregate only. If you have any questions or concerns about your rights as a research participant, please contact the IRB Office at University Hospitals Case Medical Center (serving as the IRB of record for Case Western Reserve University ) at 216--844--1529. If you would like a copy of the aggregate results, please check the box at the end of the survey.
We very much appreciate your time and assistance, and look forward to receiving your input on these important topics. If you have any questions about this project, please do not hesitate to contact the Principal Investigator, Dr. Leona Cuttler, at Leona.cuttler@case.edu or 216--844--6253 or the Project Manager, Ann Nevar, at ann.nevar@uhhospitals.org or 216--844--6253.

DEFINITIONS
We use the terms below in several sections of the survey. Please return to this page as needed to review the definitions. at any time.
• "Your IRB" means the system of IRBs that you oversee (i.e., if you are at an institution that has multiple IRBs) • "Unspecified future use" means the purpose/focus of the future research is stated broadly, allowing for the possibility of a range of studies rather than restricting them to a particular medical condition or pre--defined research questions • "Anonymized" means the researcher will use samples/data that have no identifiers or codes linked to identifying information • "Coded" means the researcher will use samples/data that have a code that is linked to identifying information, but the researcher has no access to the key that links the code to identifying information • "Identified" means the researcher will use samples/data that have personal identifiers, or a code for which the researcher has access to the key that links the code to identifying information • "Tiered consent" means that, in the written consent, research participants are offered several choices regarding aspects of future research such as what types of research can be conducted with their biospecimens and whether they can be recontacted For how many years have you been an IRB Administrative Director? If your service has been intermittent, please count the total number of years.

_____ years 2.
Approximately how many new protocols involving human genetic research did your IRB review in the last year (2011)?
Approximately how many new protocols overall (i.e., genetic and non--genetic) did your IRB review in the last year (2011)?
_____ 1 --100 _____ 101 --500 _____ 501--1000 _____ >1000 Institution and Respondent(s): Institution ID #: Date: 4 II. CONSENTS FOR THE COLLECTION AND STORAGE OF BIOSPECIMENS AND ASSOCIATED DATA FOR GENETIC RESEARCH Case: For Questions 4 -10, imagine that a researcher at your institution plans to collect biospecimens and associated data for a specific study, but also wants to store them for future research.
What approach would your IRB typically take regarding the acceptability of the following potential aspects of such a protocol: In the situation described above, what approach would your IRB typically take with regard to….

4.
…Asking participants' consent to store biospecimens/data for future research use? Our IRB would typically: In this situation, would your IRB typically review the original consent form that participants signed (assuming there was one) to determine whether the researcher's proposed new study is within the scope of the potential uses described in the original consent?
Never Rarely Sometimes Usually Always When the samples/data the researcher will use are: ¡ ¡ ¡ ¡ ¡ If you answered never to all three-13a and 13b and 13c-skip to Question 16. 14.
When your IRB reviews a consent form to determine whether a new proposed study is within the scope of the potential uses originally described, what approach does it typically take? Choose one.
_____ Ensure that the proposed study is consistent with the uses described (i.e., look for affirmative statements in the original consent form suggesting that the new use would be allowed) _____ Ensure that the proposed study is not inconsistent with the uses described (i.e., ensure there are no statements suggesting that the new use would be contrary to language in the consent) Thinking about the situations in which a researcher at your institution wanted to obtain biospecimens/data from an outside institution, how often has it occurred that the biospecimens/data were collected and/or stored under policies that differed substantively with those at your institution? Choose one. 25. Thinking about collaborative genetic research between institutions, how often has your institution entered into an Inter--Institutional Agreement (i.e., an agreement whereby one institution agrees to rely on another institution's IRB review of the research)? Choose one.

_____
_____ Never _____ Rarely _____ Sometimes _____ Often _____ Always _____ I am unsure whether or not this has occurred _____ Other; please specify: ____________________ 26.
Please share any thoughts that might help clarify your IRB's policies and practices with regard to sharing stored biospecimens/data: V. BIOSPECIMENS AND DATA: WRAP UP 27.
In the standard consent--to--treat form in use at your institution's health care facilities, which of the following is most commonly used regarding the storage and potential research use of residual biospecimens collected for a clinical purpose? Choose one. _____ Disclosure (no choices) (i.e.,form discloses possibility of research use but does not offer a choice about such use) _____ Disclosure with opt in (i.e., form discloses possibility but research use cannot occur unless patient opts to allow this) _____ Disclosure with opt out (i.e., form discloses possibility and research use occurs unless opts to refuse this) _____ No disclosure (i.e., form does not disclose possibility and research use can still occur) _____ Researchers must get specific consent (i.e., research use of residual biospecimens must be addressed separately from consent--to--treat form) _____ Unsure / don't know _____ Other; please specify: ____________________ Does your IRB have written policies or guidance concerning the: 1) collection, 2) storage, 3) use, and/or 4) sharing of biospecimens/data in genetic research and/or more general policies that apply to genetic research? _____Yes _____No _____Unsure / don't know If yes, we would very much appreciate your willingness to share copies of all relevant policy documents/guidance with us. There are several options for doing so, including: • Email your policies as an attachment to the Principal Investigator, Leona Cuttler, M.D. at leona.cuttler@case.edu • If your policies are posted on a publicly accessible web page, please provide us with the URL • Fax a copy of each policy document to Leona Cuttler at 216--844--8900 Your documents will be kept confidential and your institution will not be identified in any reports of the results of this project. 36.
As part of this project, we will be conducting follow--up phone interviews with IRB administrative directors concerning their IRB's policies and practices with regard to banking and sharing biospecimens/data. If you would prefer that we not contact you to invite your participation in an interview, please check the box below.
_____ I prefer NOT to be contacted to discuss participating in an interview 37. Is your IRB AAHRPP--accredited?

_____ Yes _____ No
Institution and Respondent(s): Institution ID #: Date: 21 SURVEY IS NOW COMPLETE Thank you for taking the time to share your experiences and opinions concerning the protection of research participants in collaborative genetic research involving the collection, storage, and use of biospecimens and associated data.
Your responses will be invaluable for helping us identify policy priorities that could strengthen and facilitate collaborative genetic research across academic institutions in a way that optimally protects human subjects.
Your responses will be kept confidential and results will be reported in aggregate only. If you would like to receive the aggregate results of the study, please check the box and indicate the preferred address for mailing.
I would like to receive the aggregate survey results. If yes, please --check the box □ and --include your e--mail address: _________________