Christine Yalda, J.D., Ph.D. Chair, Human Research Review Committee Grand Valley State University

Determining what types of research require what levels of IRB oversight is a complex issue deeply affected by 21 st century transformations in social and behavioral science research and the accompanying challenges to the ethical, efficient, and effective conduct of research. ~ National Academy of Sciences, 2014 This NPRM seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. This proposed rule is an effort to modernize, simplify, and enhance the current system of oversight. ~ NPRM Summary, 2015

NPRM SBER Goals (NPRM, 2015; Pritchard, 2015) Increase participants’ ability and opportunity to make knowing and voluntary decisions to participate in research (informed consent, respect, autonomy, transparency) “Reduce harm and increase justice by increasing uniformity of subject protections in areas such as information disclosure risk, coverage of clinical trials, and coverage of IRBs” (beneficence, justice, participation) Facilitate promising research through clearer regulations, more efficient review process, and elimination of requirements that do not enhance protections (effectiveness, efficiency, transparency) Build public trust in the research system (legitimacy)

Reduced Scope of Review (NPRM, 2015) Some activities no longer within IRB purview. Level of IRB review more proportional to seriousness of harm or potential danger. As specified, studies deemed not research, low risk, or otherwise protected will be outside the scope of regulations (excluded)(§101). Additional exempt categories reflect low risk due to nature of study activity, appropriate data security and privacy protections, use of secondary data, and prior consent for future data use, e.g. benign research, secondary research (§101). Note broad consent required for future use of identifiable private information (§116). HHS will maintain a list of activities considered to involve no more than minimal risk – expedited review categories (§§ 102, 110) Researchers will make their own exempt determinations without administrative or IRB review (federal web-based decision tool) (§104).

Reduced Scope of Review (NPRM, 2015) Unless IRB determines otherwise, no continuing review for expedited studies or studies when only activity is data analysis or accessing follow up data in standard clinical setting. Researcher must still provide annual update that research is ongoing and no changes have been made requiring continuing review (§109). With some exceptions, single IRB mandated for cooperative research by US institutions within US. Primary IRB to be determined by agency supporting or conducting research or lead institution (§114). Deferral permitted for non-covered institutions (§114).

Increased Protections: Vulnerable Populations (NPRM, 2015) Adds economically or educationally disadvantaged persons to list of vulnerable persons, thus requiring IRB inclusion of member expertise in this area if the board regularly reviews research involving this population (§107). IRB’s expertise to review research involving vulnerable populations framed in context of expertise on subjects’ vulnerability to coercion or undue influence BUT Do excluded studies and new exempt categories increase vulnerabilities?

Increased Protections: Clinical Trials (NPRM, 2015) The regulations define clinical trials as A research study in which 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. (§102) The regulations apply to all non-exempt clinical trials conducted at a US federally-funded institution, regardless of study funding source, unless the clinical trial is subject to FDA regulation (§101).

Increased Protections: Consent Process and Documentation ( NPRM, 2015) Consent process to minimize possibility of coercion and undue influence (reasonable person standard) (§116). Consent form must provide sufficient detail, be clearly organized, and highlight key information needed to make participation decision (§116). Language about potential use of de-identified data in future studies must be included (tied to secondary research exemptions) (§116). Additional basic elements address consent about use of bio- specimens and release of clinically relevant research results (§116). No exculpatory language is allowed (§116). All other information should be in the appendices (§116).

Increased Protections: Broad Consent (NPRM, 2015; Pritchard, 2015) Broad consent for unspecified future use of identifiable private information (§116). Exemption to Label and Track (§104(f)(1)). Exemption for Specific Secondary Research Use (§104(f)(2)). Both categories subject to reasonable and appropriate safeguards as identified by HHS and/or other applicable federal regulations (§105). Limitations on use, release, and disclosure (§105).

Questions & Comments?

References US Government Publishing Office (2015, September 8). Notice of proposed rulemaking, Federal Register, 80(173) Retrieved from 08/pdf/ pdf 08/pdf/ pdf Pritchard, I. (2015). Regulating behavioral research: Back to the future? PRIMER Conference, Boston, MA