Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences (2014) / Chapter Skim
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3 Determining Minimal Risk in Social and Behavioral Research
3 Determining Minimal Risk in Social and Behavioral Research
Pages 59-88
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From page 59... ...
But there is very little in the Common Rule itself or subsequent guidance that provides help with defining or assessing risk.2 The only definition of risk in the human subjects protection regulations is for minimal risk (45 C.F.R.
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From page 60... ...
that IRBs and investigators have adequate guidance for avoiding underestimation and overestimations of minimal risk; and (c) that categories of research that may be reviewed through an expedited review adequately reflect the broad spectrum of social and behavioral science research.
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From page 61... ...
. Defining the General Population Standard Drawing on recommendations from the Belmont Report and more recent federal committees and independent reviews (Institute of Medicine, 2004; National Human Research Protections Advisory Committee, 2001; Secretary's Advisory Committee on Human Research Protections, 2005, 2008; U.S.
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From page 62... ...
As long as the Common Rule minimal risk definition remains the default criterion for risk categorization of research involving children, the Office for Human Research Protections (OHRP) must ensure that the application of the recommended general population standard does not result in the inadvertent application of an adult minimal risk standard to child participants.
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From page 63... ...
For such research, the reference in the current minimal risk definition to routine medical or psychological examinations or tests is insufficient; the definition should be expanded to explicitly include educational examinations or tests. Additionally, the committee believes that restricting the definition of routine "examinations or tests" has caused confusion in IRB evaluation of prevention and intervention research in both biomedical and social and behavioral research contexts.
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From page 64... ...
• Apply age-indexed criteria for determining the probability and magnitude of harms or discomfort in the daily life of, and in rou tine medical, psychological, or educational examinations, tests, or procedures of, infants, children, and adolescents (if the Common Rule minimal risk definition remains the default criterion for risk categorization of research involving children)
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From page 65... ...
AVOIDING OVERESTIMATION AND UNDERESTIMATION OF HARM The definition of minimal risk in the Common Rule has confounded the research community since the human subjects protection regulations were first promulgated. The first comments warned that the vagueness of the definition would cause variability and confusion, and this outcome has certainly come to pass (Ceci and Bruck, 2009; Fisher et al., 2007; Wendler et al., 2005; Westra et al., 2011)
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From page 66... ...
. Indeed, mission creep has persisted in IRB review despite statements throughout the Final Regulations Amending Basic HHS Policy for the Protection of Human Research Subjects that the exempt and expedited categories were specifically included to help reduce IRB burden in reviewing social science research that poses no risk, low risk, or minimal risk (U.S.
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From page 67... ...
In the absence of guidance to distinguish social vulnerability from research vulnerability, this wording appears to have inadvertently led IRBs to overestimate research risks for these populations, a particular problem for social and behavioral research studies. For example, there is an abundance of investigator reports of survey studies for research on sexuality, drug use, and other health-relevant behaviors in which IRBs have created barriers to research implementation based on the empirically unsupported claim that surveys or interviews on such topics may harm participants by encouraging them to engage in the behaviors being studied (Fendrich et al., 2007; Fisher, 2002, 2003; Fisher et al., 2013, p.
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From page 68... ...
) , some IRBs have included in their evaluation of social harm the consequences for the entire group of conducting social and behavioral research studies involving members of populations suffering from current and historical discrimination, if the study includes collection of data on socially stigmatizing topics such as substance abuse or antisocial behavior.
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From page 69... ...
In its response to the ANPRM, SACHRP noted that an IRB's evaluation of whether the harms and discomforts of research subject to expedited review meet minimal risk standards should take into account steps taken to minimize risk.5 The committee agrees with this SACHRP recommendation that regulations harmonize criteria for evaluating the level of risk for informational and other types of research harms by requiring consideration of the adequacy of steps taken to minimize risk in the calibration of magnitude and probability of harm. In Recommendation 3.3, below, we recommend 4 Quoted text is from "Categories of Research That May be Reviewed by the Institutional Review Board (IRB)
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From page 70... ...
These categories continue to be useful ways to discuss potential harm, but only if they are embedded within a framework more conducive to assessing minimal risk within the context of risk-minimizing procedures and distinguishing between the harms produced by the experimental methods and informational risk. The next sections of this chapter discuss traditional categories of harm within an experimental method/participant protections framework, with special emphasis on both ensuring adequate protections against greater than minimal risk and reducing overestimation of harm for social and behavioral research.
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From page 71... ...
Avoiding Overestimations of Physical Harm in Social and Behavioral Research Misconceptions regarding physical harms have also created barriers to appropriate estimation of minimal risk levels for social and behavioral
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From page 72... ...
At present, IRBs do not have sufficient guidance in distinguishing among physical harms that may be the consequence of inadequate disclosure protections, indirect harms associated with an ineffective intervention, and the very small number of direct physical harms that may be induced by the research procedures themselves. Potential Harms Resulting from Inadequate Confidentiality Protections for Social-Behavioral Research The ANPRM devotes considerable attention to issues of informational risk, which it contends represents one of three relevant categories of potential harm: "physical, psychological and informational" (76 Fed.
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From page 73... ...
Confidentiality Risk Minimization Social and behavioral science investigators will face unnecessary barriers to excused and expedited review if IRBs overestimate the confidentiality risks described below by focusing on all possible harms that might arise from a breach of confidentiality rather than following current regulatory language on the HHS website, which directs IRBs to classify as minimal risk protocols that include "reasonable and adequate [investigator implemented] protections" that would ensure that "risks related to invasion of privacy and breach of confidentiality are no greater than minimal." The committee believes the final regulations should reaffirm this directive and incorporate it directly into the Common Rule.
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From page 74... ...
There are, however, social-behavioral research studies in which the design of the study has a high probability of producing data that may require mandatory disclosures, such as situations in which state law requires that certain types of researchers report particular activities, such as child or elder abuse. The legal harms to participants posed by these studies are a function of these reporting responsibilities, and these harms should be distinguished from harms produced from the experience of answering questions about these issues.
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From page 75... ...
Recommendation 3.3: HHS should harmonize regulations such that decisions regarding the level of potential informational, physical, and psychological research harms must take into account whether reason able and appropriate protections will be implemented to reduce the probability and magnitude of harm or discomfort to no more than minimal. Guidance Recommended: OHRP guidance should be issued to assist in • determining whether steps to minimize risk are sufficient for re search designs to be categorized as minimal risk; and • distinguishing between physical and psychological harms associ ated with informational risk (e.g., the harm derives from inappro priate use or disclosure of information, which could be harmful to the study subjects or groups)
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From page 76... ...
Including Social and Behavioral Science in the Expanded List for Review Categories of Research The committee welcomes the ANPRM proposal to expand the list of research categories appropriate for expedited review. Although the current category 7 list of expedited research includes a wide range of social and behavioral research methods,6 IRBs too often use intuition rather than scientific data to classify social and behavioral research studies as greater than minimal risk and to either require that the protocol undergo full board review or require the research investigators to modify their protocols to address psychological reactions of high magnitude but very low probability.
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From page 77... ...
13) To date, pediatric and developmental research scientists still encounter obstacles to scientifically valid and socially valuable research as a result of beliefs that all research involving children must be subject to full board review or to risk/benefit assessments that overestimate the harms and discomforts of procedures meeting expedited review criteria (Fisher et al., 2013, p.
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From page 78... ...
For example, under current conditions IRBs have had difficulty distinguishing social and behavioral research procedures, such as surveys that meet criteria for exemption, from those that should undergo expedited review. Without explicit guidance, this confusion may extend to instances in which research that should be classified under the new proposed category of excused research is erroneously subjected to expedited review.
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From page 79... ...
Recommendation 3.4: HHS should clarify in regulations the conditions under which research methods, that might otherwise be classified under the new excused category, are appropriate for expedited review because the specific nature of the research procedures and/or the characteris tics of the subject population require consideration of human subjects protections beyond those normally applied for excused research, in order to ensure that harm or discomfort created solely by the research procedures are not greater than minimal risk. Guidance Recommended: The committee offers below elements of a guidance statement that would help investigators, IRBs, and research and academic institutions understand when studies implementing the methods described under the excused category require expedited re view.
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From page 80... ...
• OHRP should take steps to ensure that investigators and IRBs appropriately apply categories for expedited review to research involving children and adolescents and do not by default require research involving children to undergo full board review.
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From page 81... ...
RESEARCH INVOLVING GREATER THAN MINIMAL RISK AND REQUIRING FULL BOARD REVIEW As discussed above, the majority of social and behavioral science research methods pose harms of no greater than minimal risk either in and of themselves or once appropriate human subjects protections are instituted that ensure the probability and magnitude of harm posed by research participation are minimal. Rare instances of greater-than-minimal-risk social and behavioral research might occur, for example, when a psychological or behavioral intervention study involving individuals with serious mental health disorders includes treatments that have a reasonable possibility of exacerbating distressful or maladaptive psychological or behavioral symptoms (for instance, a study testing effectiveness of exposure therapy for
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From page 82... ...
IRBs should be directed to only assign such studies for full board review if the research procedures pose greater than minimal risk and appropriate human subjects protections may not be sufficient to reduce such risks to the level of minimal risk. Procedural Improvements Needed: In determining whether research poses greater than minimal risk, investigators and IRBs should draw on established scientific or professional knowledge to help determine whether the probability and magnitude of harms associated with the research procedures themselves pose greater than minimal risk and that appropriate human subjects protections may not be sufficient to reduce them to minimal risk levels.
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From page 83... ...
Recommendation 3.5: To streamline expedited and full board review and procedures, HHS should eliminate the requirement for continuing review for expedited research. Guidance Recommended: OHRP should offer specific guidance on time limits for conducting expedited reviews and processing research under full board review.
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From page 84... ...
Journal of Empirical Research on Human Research Ethics, 7(2)
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From page 85... ...
. Preserving and enhancing the responsible conduct of research involving children and youth: A response to proposed changes in federal regula tions.
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From page 86... ...
. Protecting Human Research Subjects: Insti tutional Review Board Guidebook.
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From page 87... ...
. Final regulations amending basic HHS policy for the protection of human research subjects.
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