IRBMED IRBMED Seminar Series: Quick Tips Privacy and Confidentiality

IRBMED Adverse Event Reporting Guidance  IRBMED has updated its guidelines for reporting internal adverse events effective April 3 rd, 2015  The new guidance reduces study team burden by limiting which types of internal adverse events must be reported to the IRBMED  Examples of what will no longer require reporting per the new guidelines: Unrelated and Unexpected non-serious AEs Unrelated and Expected AEs, unless the events appear to be occurring at a greater severity or frequency than known or expected Non-serious AEs of mild or moderate severity, unless the events appear to be occurring at a greater frequency than known or expected

IRBMED

Adverse Event Reporting Guidance  Obligations for reporting internal AEs to sponsors and regulatory agencies have NOT changed  Reporting procedures for external AEs have NOT changed  Please see IRBMED Guidance: Adverse Event Reporting at: research.med.umich.edu/irbmed

IRBMED Flexibility Initiatives  To exercise existing flexibility in the application of federal regulations to non-federally funded, non-FDA regulated studies, IRBMED will introduce two new flexibility initiatives on May 1 st: Exemption 7 Two year approvals  Exemption 7 and Two year approvals join IRBMED’s existing flexibility initiative, Exemption 2A  These initiatives allow IRBMED flexibility in application of federal regulations to non-federally funded research, while continuing to apply the highest ethical standards for the protection of human subjects  IRBMED decides whether or not a project is applicable for a flexibility initiative

IRBMED Flexibility initiatives  Neither Exemption 7 or a two year approval is applicable to studies that include any of the following: Federal funding or federal training grants (direct or prime sponsorship) FDA regulated components Sponsor or other contractual restrictions Clinical research interventions (including behavioral interventions) Prisoners as subjects Receipt of an NIH issued Certificate of Confidentiality to protect identifiable research data

IRBMED Exemption 7  This exemption eliminates the need for principal investigators to submit yearly scheduled continuing reviews if the only study activity is data analysis  To be eligible for Exemption 7, studies transitioning (at SCR or during AME) from an existing regulated application must meet the following criteria: Research activity is limited to a single dataset containing identifiable information, Research poses no more than minimal risk to subjects  All other regulatory requirements remain unchanged

IRBMED Two Year Approvals  Two year approvals allow the IRBMED approval period to be lengthened beyond one year  To qualify for two year approval, studies must: Pose no more than minimal risk to subjects  Examples of qualifying research may include, but are not limited to, the following: Secondary use of identifiable data/specimens (prospective and retrospective), not otherwise exempt Survey, focus group, or interview projects not otherwise exempt  All other regulatory requirements remain unchanged