Research.medicine.umich.edu



Regulatory guidance for setting up a biospecimen collection using the Central BiorepositoryFirst: Reach out to the CBR as soon as possible! – to get advice and support for grant, IRB, and other applications before you prepare and submit them for review, and to get in the CBR onboarding queue. There may even be biospecimens already in the CBR that can support your grant application or make it unnecessary for you to collect new biospecimens.You will (almost certainly) need IRB approval. Any research activity that includes interaction with research participants (e.g., a blood draw) requires IRB approval. Any research activity that includes investigators being readily able to ascertain the identities of research subjects requires IRB approval. Setting up the CBR Laboratory Information Management System for a new collection normally requires using participants’ Medical Record Numbers, which means investigators will readily be able to ascertain their identities.Research that uses information from the Michigan Medicine HIPAA Designated Record Set (roughly, the clinical records) requires authorization from the individual (see consent, below) or approval from the HIPAA Privacy Board (which at U-M is integrated with IRBMED).If you already have an IRB approval for collecting the biospecimens and/or data, this approval should be updated to indicate that these materials will be stored in the CBR (see the next section, below).So the only situation when it could be possible to set up a collection using the CBR and not need IRB approval is if you were amassing a collection consisting only of biospecimens collected anyway for a clinical purpose, and no links to identifying information will exist. This would require special approval by the CBR Governance Committee, and no groups have ever ended up wanting to arrange things this way. This IRB approval will probably be through a HUM application. Sometimes it can be useful to also submit a REP application.In general, HUM applications are needed for the biospecimen collecting activities, and REP applications are needed for activities around the biospecimen collection – like physical storage, data security, and administrative infrastructure. Because of this division, for example, REP applications do not ask about informed consent documents that will be used in recruitment of new participants, and so a HUM is necessary to capture that piece. Ideally, if biospecimens are put into storage there is an approved REP application describing the facility that will have custody of them. HUMs get linked to REPs in the eResearch system. The CBR has its own REP that your HUM can be linked to; in the HUM, you can leave pointers so that IRBMED staff know to make this link:HUM page 01, question 1.1.2 for "related projects": enter REP# and the Repository Title – the CBR’s eResearch title is “University of Michigan Medical School Central Biorepository,” and its number is REP00000002.HUM page 11, question 11.6: check "Retain for future research use" (and others as applicable)HUM page 11-4, question 11-4.2: check "Only at the University of Michigan"?OR?"UM and Other Institutions" (as applicable)HUM page 11-4, question 11-4.3: Refer to the REP. The REP application comprehensively addresses these questions.?These links will be shown in the REP’s eResearch space under “Related Projects” tab, and in the HUM’s space under “Document/Related Records” tab. Links are “live” (can be used to navigate from HUM to or from REP) for study team members listed on both applications, as well as for IRB staff and reviewers.?If you will be storing some collected biospecimens in your own lab space, rather then sending them all to the CBR for storage, or if your collection will include its own special administrative elements, it may make sense to complete your own REP. Your HUM(s) can then be linked in eResearch to your REP, and your HUM(s) and/or your REP also be linked to the CBR REP. Your HUM(s) will need to describe how you will obtain informed consent and HIPAA authorization from each participant, along with the documents you will use. CBR policy requires that the IRBMED repository consent templates be used.If there are contractual or other reasons why this won’t work, the CBR Governance Committee can approve a deviation.The repository consent templates are actually two documents, each one page, which must be used together. One is textual and the other is an illustrated pamphlet. You’ll need to decide whether you can use just these repository consent documents, or whether you’ll need to use them in addition to a standard informed consent document from IRBMED.IRBMED Leadership has approved the following principle about when it’s appropriate to use the repository documents alone:“Projects that include plans for no more than the following may seek consent under the single signature of the biorepository consent documents:?(a) interactions and interventions reasonably designed to enhance the research value of the collection being assembled for future research; and?(b) data generation and management with risks/benefits that fall within those of in vitro human research in general, as described in the documents.”So, for example, administering a survey to collect data whose purpose is to annotate the biospecimens in order to make them more valuable for research – that would not trigger the need to have a separate, standard consent document. A clinical trial, on the other hand, would. The thinking here is that the participant may want the research intervention, which may benefit them, without having to participate in the biobanking portion and future research using the biospecimens.When filling out the text-only Informed Consent Template document:Indicate the name of the biorepository collection in the top paragraph and that it is connected into the CBR – e.g., “the Ann Arbor Genomic Biobank, which takes part in the University of Michigan Medical School Central Biorepository.”Include the procedures by which the biospecimens will be collected. It may be especially useful to indicate whether these are additional to any clinical procedures. Include contact information for both the PI and the CBR Director.Include or remove the bullet point about information from surveys, as appropriate to your activity.Under “How will my privacy be protected?”, add the following bullet to the end of the list: The UMMS Central Biorepository has obtained a Certificate of Confidentiality?from the National Institutes of Health, so we can keep your?information private in a court or other legal proceeding.?The Certificate will not allow us to withhold your?information from the government if it is necessary for a?federal audit or evaluation of federally funded research.?Also, if you or a member of your family voluntarily?discloses information about yourself or your participation?in this repository, the Certificate will not prevent that?information from being used in court.When filling out the illustrated informational pamphlet:Include contact information for both the PI and the CBR Director at the bottom of the middle panel on the first page in the digital document. In the left panel on the second page, include information about the collection procedures as possible. If you are using a separate standard informed consent (see IRB principle, above), it is appropriate to make reference to that separate document where more details about procedures will be provided. Keep or remove the statement about informational surveys in the box numbered 2 in the bottom left-middle of the second page.Describe the physical risks of any collection procedures that are additional to procedures that will be done for clinical purposes.Keep the language about the Certificate of Confidentiality. ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download