Protecting Participants and Facilitating Social and Behavioral Sciences Research (2003) / Chapter Skim
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6 Enhancing the Effectiveness of Review: Minimal-Risk Research
6 Enhancing the Effectiveness of Review: Minimal-Risk Research
Pages 143-164
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From page 143... ...
research with an expedited procedure. Some IRBs do not exempt or expedite any research, even when they agree that it is minimal risk, and others do not do so for certain categories of eligible research (see Boxes 1-1 and 1-2 in Chapter 1 for categories of exempt research and categories of research that can be expedited, respectively)
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From page 144... ...
Researchers need to be proactive in developing knowledge that will help inform assessments by IRBs and investigators of harm and risks for various types of research and help determine appropriate procedures for participant protection in research protocols. GUIDANCE ON THE REVIEW PROCESS OHRP should develop detailed guidance for IRBs on using the minimal-risk provisions of the Common Rule for four reasons.
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From page 145... ...
For example, the 1995 Bell survey found that IRBs were most likely to use an expedited procedure, as a matter of standard practice, to review minimal-risk protocols that involved such methods as collecting nail and hair clippings and scraping dental plaque. Taking high-volume and low-volume IRBs together, 75 percent had such a practice for nail and hair clippings, and 66 percent had such a practice for dental samples.
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From page 146... ...
on what kinds of social, behavioral, and economic sciences (SBES) research protocols qualify as "research" with "human subjects." OHRP should also develop detailed guidance, including examples, regarding SBES research that IRBs are strongly encouraged to exempt from review and research that IRBs are strongly encouraged to review with an expedited procedure.
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From page 147... ...
Purely exploratory activities, such as contacting representatives of employers to determine their policies for cooperating with surveys of their employees, or asking a few colleagues to react to a questionnaire format, do not, in our view, fit any definition of reviewable research. A type of activity involving a "systematic investigation" that may or not be "research" under the Common Rule is research with human participants conducted by undergraduate students in SBES courses in political science, economics, psychology, and other subjects.
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From page 148... ...
. We agree with the importance of instilling an awareness of human research participant protection issues among undergraduates, and there is also always the possibility that an undergraduate may design a project that poses a serious concern.
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From page 149... ...
. When individuals are interviewed in their capacity as knowledgeable agents of an organization and not as the direct objects of inquiry, and no attempt is made to include any of their characteristics in the study analysis, then the analysis is not likely research with "human subjects." Organization research often raises issues that are similar to research with human participants in regard to protecting confidentiality (of organizations in this case)
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From page 150... ...
The research does not involve individual human participants and no issues of protection of humans arise. Exemption After determining that a protocol clearly covers human subjects, the next stage in the IRB decision process is to determine if the protocol qualifies for and should be exempted from IRB review.
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From page 151... ...
Yet an IRB might want to review such a survey with an expedited procedure to satisfy itself that the interviewer script provides adequate information to obtain respondents' informed consent. Whether an IRB decides to exempt such research might well depend on how effective the IRB believes it has been in providing guidance and training on ethical research practices to investigators at its institution.
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From page 152... ...
This type of observational research generally qualifies for exemption from IRB review under category (2) of the Common Rule listing of exempt research categories (see Box 1-11.
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From page 153... ...
Beginning in the late 1960s, when computers first became widely used for data analysis, the number and richness of available publicuse microdata files from federal statistical agencies and other sources has grown enormously (see Chapter 51. These files, which the source agency processes to minimize the risk that individual respondents can be re-identified, add significantly to the infrastructure for cost-effective research in many SEES fields.
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From page 154... ...
However, it can be conducted in a much more expeditious manner with regard to elapsed time, and it saves on the time required for IRB business totaled over all IRB committee members (see Chapter 21. The Common Rule authorizes publication in the Federal Register of a list of categories of research that, if the research is minimal risk, may be reviewed by an expedited procedure.
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From page 155... ...
of the current list of research eligible for expedited review (see Box 1-21. Laboratory Behavioral Research Box 2-1 in Chapter 2 provides two examples of types of laboratory research that readily qualify for review with an expedited procedure.
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From page 156... ...
that IRBs could review with an expedited procedure.3 The Oral History Association has developed extensive guidelines for the conduct of oral histories on such topics as informed consent, archiving and protection of confidentiality, legal releases governing when interviews may be made available, and many other aspects of ethical research using this method (see "Principles and Standards" and "Oral History Evaluation Guidelines" at http://www.dickinson.edu/oha t4/10/200311. We believe that OHRP guidance could draw from these guidelines to encourage IRBs to develop a checklist that would allow for expedited review of many types of oral history as a matter of standard practice.
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. CONTINUING REVIEW Recommendation 6.2: Institutional review boards should use efficient procedures to review minor changes to minimalrisk research protocols that arise during the period of authorization.
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From page 158... ...
permits IRBs to use an expedited procedure to review "minor changes in previously approved research during the period (of one year or less) for which approval is authorized."4 Researcher concerns about these provisions are similar to those about the functioning of IRBs in general: that continuing review is perfunctor~r and not sufficient for human participant protection and that the requirement for IRB approval of changes is cumbersome and imposes needless delays, even when the changes are minor and the review is expedited.
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From page 159... ...
Yet there is hardly any quantitative data on risks and harm of SBES research that could inform policy on human research participant protection or contribute to improved research practice. We believe it is incumbent on SBES researchers, as part of sound, ethical research practice, to adopt procedures to debrief respondents (or samples of them)
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From page 160... ...
ONGOING DATA SYSTEM Recommendation 6.4: The Office for Human Research Protections should establish an ongoing system for collecting and publishing data that can help assess how effectively IRBs protect human research participants, how efficiently they review research, and how commensurate review is with risk. There is astonishingly little hard information about the operation of the IRB system for human research participant protection in the United States today and how IRBs are interpreting provisions of the Common Rule.
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From page 161... ...
It asserted, "a fact that has repeatedly confounded this committee's deliberations is the lack of data regarding the scope and scale of current protection activities" (Institute of Medicine, 2002:41. It called for DHHS to "harmonize safety monitoring guidance for re7Some agencies have captured basic information, such as dollar funding and number of participants, on research they support that involves human participants.
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From page 162... ...
By design, CHIRP seeks some variation, reflective of community standards variation, and it does not want to increase threats to human participants by overly loose review nor to impede the progress of science by overly harsh prohibitions of research. The data system might provide a tool to measure both the average behavior of IRBs and the extent to which some IRBs are departing from that typical behavior.
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From page 163... ...
IN-DEPTH STUDIES Recommendation 6.5: Federal research funding agencies, including the National Science Foundation and the National Institutes of Health, should fund in-depth studies to better understand the operations and effects of the IRB system and to develop useful indicators of IRB performance. It is not easy to devise performance measures for IRBs and other indicators that are feasible to collect, easy to define in a consistent
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From page 164... ...
As we noted in Chapter 4, the National Institutes of Health recently had a research program to study aspects of IRB operations, such as informed consent. This program should be continued and expanded.
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