Upcoming Changes to the Common Rule Presentation to the SPARC meeting UNC General Administration By Deb Paxton North Carolina State University

Changes to the Common Rule Common rule is the standard for human subjects protections 14 federal agencies have signed on to the common rule and therefore follow the common rule All DHHS Department of Commerce NSF Consumer Product Safety Commission VA USAID DOD Department of Housing and Urban Development NIJ Department of Education Department of Agriculture Department of Transportation Department of Energy NASA Changes recently published with an implementation date of January 19, 2018 (longer for cooperative studies)

Changes to the Common Rule Broad changes to: Scope IRB operations Informed consent Exemptions (see handout from PRIM&R)

Changes to scope Definition of research Definition of human subject Definition of clinical trial “….one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.” Identifiable data/specimens – definition of “identifiable” to be regularly revisited and revised if necessary Definitions of vulnerable populations pregnant women and people with physical disabilities are no longer listed as vulnerable to coercion or undue influence Inclusion of tribal law when appropriate

Changes to IRB operations sIRB Formalization of reliance agreements “Checking the box” is no longer an option institutions will need to codify the application of human subjects protections to non-human subjects research Continuing review of research is not required for: research that received expedited review research that was reviewed under “limited” IRB review research that have completed data collection and are now only analyzing data or accessing follow up clinical data from regular clinic visits

Changes to informed consent New language to clarify PI responsibilities regarding informed consent New elements specific language about collection of identifiable data/specimens biospecimens genomes Broad consent for data/specimen repositories Recruitment/screening waivers Electronic signatures accepted Consent forms for clinical trials posted online Legally authorized representatives

Exemptions Wording changes “readily ascertained” clarification of application of exempt criteria to subparts B, C, and D Addition of “benign behavioral interventions” exemption of intervention is not allowed if deception is involved unless prospective agreement to deception has been obtained Limited IRB review opens exemption categories to non-anonymous, non-harmless research if it undergoes “limited IRB review” Exemption of secondary use of existing, identifiable data/specimens “Broad” consent referenced and reviewed

Limited IRB Review In order to approve a project under “limited review,” the IRB does not need to find the traditional criteria for IRB approval, but instead must determine: Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is appropriately obtained NOTE THERE IS NOT AN OPTION FOR A WAIVER HERE Broad consent is appropriately documented or waiver of documentation is appropriate If a change is made for research purposes to the way identifiable private data/specimens are maintained, there must be adequate provisions to protect the privacy of subjects and maintain the confidentiality of data. Additional protections for subjects culnerable to coercion or undue influence remain in place.

Broad Consent Broad consent is for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens.  Information to be included in Broad consent: A description of any reasonably foreseeable risks or discomforts to the subject; A description of any benefits to the subject or to others that may reasonably be expected from the research; A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled When appropriate A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit; For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

Broad Consent, Continued A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens. A description of the identifiable private information or identifiable biospecimens that might be used in research, whether sharing of identifiable private information or identifiable biospecimens might occur, and the types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimens; A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained, and for which they may be used for research “indefinitely” is an option Unless details about specific research studies are provided, a statement that they will not be informed of the details of any specific research studies that might be conducted using the subject's identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies; Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the subject in all circumstances, a statement that such results may not be disclosed to the subject An explanation of whom to contact for answers to questions about the subject's rights and about storage and use of the subject's identifiable private information or identifiable biospecimens, and whom to contact in the event of a research-related harm.