News from Denver: AHHRPP conference 2018

AAHRPP conference held April 20-22 in Denver.

Big News OHRP issued another Notice of Proposed Rulemaking (NPRM) on April 20 proposing a delay of implementation of revised Common Rule until 1/21/19. 3 burden-reducing provisions would become effective on 7/19/18: 4 categories of research deemed not to meet research definition Continuing review Review of grant application or contract proposal

Big News Public comment period open until May 21. 3 options: Delay implementation until 1/21/19 Go ahead with July 19 implementation Make additional comments to Common Rule revision which would necessitate further consideration and public comment

Single IRB (sIRB) Single IRB review/oversight for multi-site research NIH mandate Provision in revised Common Rule AAHRPP new element 1-9

Single IRB (sIRB) Issues to consider Local context of participating sites sIRB will use local context form to collect pertinent information on local subject populations and culture of the research entity that may affect sIRB decision-making Reliance agreements that delineate responsibilities of sIRB and reliant sites For NIH mandate, create process for determining sIRB for given grant

Broad consent Provision of revised Common Rule Provides alternative method of consent for future use of tissue Requires specific language: Commercial benefit to subject Time period of tissue use Tissue may be used for research that you otherwise wouldn’t have consented to

Broad consent Refusals to consent must be tracked and honored Recommendation to define scope of refusal as narrowly as possible (for example: “If you refuse to participate, your tissue will not be used by this researcher for the indicated purposes in the future.” Danger that scope of refusal will be too broad and will disable research that the subject otherwise might have consented to in the future

THAT’S ALL, FOLKS!