KATE SASAMOTO EDUCATION COORDINATOR IRBMED SEMINAR SERIES MAY 21, 2014 IRBMED Quick Tips

Anonymous, Coded, and De-Identified The terms anonymous, coded, and de-identified refer to three methods researchers use to protect study subjects’ privacy and confidentiality. Study data is anonymous when no one—including members of the study team—can at any point link the data to a subject’s identity. For example, a study in which subjects complete surveys may involve anonymous data, provided that the surveys contain no direct or indirect identifiers.

Anonymous, Coded, and De-Identified Study data is coded when researchers collect identifiable subject data, and then replace all identifiers with random series of numbers or letters Coding allows researchers to discuss a study with people outside their study team without revealing their subjects’ identities. Researchers should be sure to store all identifying information separately from coded study data. Note that coded data are not anonymous, since members of the study team have access to identifiers.

Anonymous, Coded, and De-Identified Study data is de-identified when a researcher destroys all of the information that might link study data, either directly or indirectly, to subjects’ identities. After de-identification, even members of the study team no longer possess means to link the data to study subjects.

Addressing IRBMED Contingencies Once a submission has been presented the Board can: Approve the submission as presented Approve the submission with contingencies  If specific changes are made or information clarified as directed by the IRB final approval will be issued  Depending on the nature of the requested contingencies, the Primary Reviewer may have to review the changes before approval can be issued Board Action Defer the Submission  The Board needs additional information before voting on the approval of the submission Disapprove the submission  The submission does not meet the applicable federal and institutional requirements for conducting human subjects’ research  Disapproval is rare as IRBMED works very hard with the study team to bring the submission into an approvable state

Addressing IRBMED Contingencies If you receive an Approval with Contingencies Letter or a Board Action Deferred Letter you must address all contingencies before submitting the changes back to IRBMED for review Failure to do so could result in the submission being sent back to the study team to address the outstanding contingencies If you do not agree with a requested contingency explain why-do not leave a contingency unaddressed If a contingency is to provide IRBMED with a progress report or information as the study progresses acknowledge and follow through on that requirement-it is a condition of IRBMED approval Only make the requested changes  If additional changes are made that were not originally requested by the Board the submission will have to be re-reviewed by the Board. This will delay final IRBMED approval.

Research with Prisoners The IRB is required to conduct special review of : Studies that intend to recruit and enroll prisoners Studies where a research subject becomes incarcerated Studies not originally reviewed for prisoner recruitment that seek to enroll a prisoner The IRB must review the study against specific protections for prisoners that are identified in OHRP Subpart C  45 CFR (a) identifies 7 additional requirements that must be met in order for the IRB to approve research involving prisoners  The requirements take into account the special circumstances of prisoners and serve to minimize further risks to subjects, ensure equitable subject selection, and ensure valid informed consent.

Research with Prisoners The study team is responsible for obtaining the following as necessary before interaction with prisoner subjects occurs: Certificate of Confidentiality OHRP Certification (if Federal Funding) through assistance from the IRBMED and the University of Michigan Office of Researh (UMOR), formerly the Office of the Vice President of Research (OVPR) Michigan Department of Corrections (MDOC) Certification if State Prison in Michigan (applicable if Federal or Non-Federal Funding). Bureau of Prisons Certification if Federal Prison in Michigan (applicable if Federal or Non-Federal Funding).

Electronic Data Security Encrypt sensitive/identifiable data  ITS Safe Computing can assist with encryption:  Ensure that the system used to store data is managed by U- M IT Professionals and is approved for storage of sensitive information  Adhere to data security plans as stated in your IRB approved application  Section 11

Specialty Consents IRBMED offers a variety of Specialty Consent Templates for:  Minimal risk studies that involve a single blood or tissue sample  Eligibility screen that poses no more than minimal risk to subjects  Humanitarian Use Device These templates and instructions for use are available on IRBMED’s website!

IRBMED Educational Opportunities Please visit our website to sign up for courses on a variety of topics. We offer classes at least twice per month!  More information at: research.med.umich.edu/irbmed Please join the IRBMED Announcements !  Bi-Weekly IRBMED Newsletter  Information regarding policy updates, changes, etc.  Upcoming Educational Opportunities (like future Seminar Series) 