ANPRM Proposals and OHRP Table Comparison of Existing Rules with Some of the Changes Being Relevance to Risks & Harms in Social, Behavioral and Educational Sciences
ANPRM: Minimal Risk Questions Raised SBR Risks IRB SBR Risk Evaluaiton Questions have been The nature of SBR risks is Some IRBs overestimate raised about the often significantly the magnitude and appropriateness of the different from biomedical probability of reasonably review process for SBR research; the difference is foreseeable SBR risks not adequately reflected in the current rules Given paucity of data Little evidence that IRB Over ‐ regulating SBR suggesting significant risks risk over ‐ estimation may distract from in certain types of effectively protect attempts to identify those research surveys and research subjects from SBR studies that do pose interviews the current psychological or and merit significant system over regulates informational risks oversight such research
Expedited Review & “Data Security Protections” Current Rule Changes being Considered Rationale for Change Issue 10: Research that poses minimal risk This list would be updated now, and at Determinations about risks should be based and includes only research activities in a list regular intervals. upon appropriate data. approved by the HHS Secretary is eligible to be reviewed in an “expedited” manner (e.g., with one reviewer, instead of a convened IRB). Issue 1: There are no specific data security Specified data security protections would Setting uniform specific standards will help protections for IRB ‐ reviewed research apply to such research, calibrated to the to assure appropriate privacy and outside of broad requirements for level of identifiability of the information confidentiality protections to all subjects, protecting privacy and confidentiality. being collected. without administrative burden of needing IRB review of each study.
Exempt Review Current Rule Changes being Considered Rationale for Change Issue 14: Six categories of studies These studies would no longer be fully They would be subject to the new data exempt from the regulations security protections and for some qualify as “exempt” from the regulations, meaning that they do not studies (e.g., those using biospecimens) have to comply with any of the new consent requirements would apply. requirements of the regulations. Issue 15: The categories of studies that The criteria for determining whether a Clearer criteria will increase qualify as “exempt” are clearly defined. study is exempt would be more clear ‐ transparency of the system and reduce It is difficult to determine whether a cut and less open to interpretation the time and effort spent in determining study qualifies as exempt. whether or not a study qualifies as exempt.
SBR Specific Exempt Review Current Rule Changes being Considered Rationale for Change Issue 17: Research involving educational This exempt category would be The new data security protections tests, survey procedures, or observation broadened by eliminating criteria (i) and obviate the need for (i) and (ii). of public behavior are exempt except if, (ii) for studies that involve competent both (i) information is recorded is adults. identifiable, and (ii) disclosure could create significant informational risk. Issue 18: Currently, SBR that involve The ANPRM seeks public comment on To identify areas of research that do not certain types of well ‐ understood whether studies using common SBR warrant the current degree of interactions with subjects (e.g., asking methodologies can be identified that regulatory oversight so that review someone to watch a video and then should be eligible for exemption. requirements are better calibrated to conducting word association tests), are the level of risk. not exempt from IRB review.
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