Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences (2014) / Chapter Skim
Currently Skimming:
2 Rationales, Definitions, and Procedures Related to Research Not Involving Human Subjects and the Proposed Excused Category of Research
2 Rationales, Definitions, and Procedures Related to Research Not Involving Human Subjects and the Proposed Excused Category of Research
Pages 33-58
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 33... ...
Abbott and Grady (2011) examined studies that evaluated different aspects of IRB functioning including structure, review costs, implementation processes, variation in outcomes or processes of IRB review of multicenter research, and outcome studies that examined IRB decisions and deliberation results.
|
From page 34... ...
The Association for the Accreditation of Human Research Protection Programs (2013) collects metrics on institutional and IRB characteristics, types of research conducted, sponsors of research, IRB review times, disapproval of research, IRB resources, audits, protocol deviations, and noncompliance reported to the IRB.
|
From page 35... ...
With regard to the regulatory framework itself, the committee started by reexamining the definitions of "human subjects" and "research" upon which the Common Rule is based, and in this chapter we recommend combining the two terms to simplify determinations of whether IRB review is needed and of what type. Building on this base, the committee found that many types of research using publicly available information sources should actually be considered "not human-subjects research," and we provide examples of these for cases where there is no reasonable expectation of privacy.
|
From page 36... ...
The committee offers recommendations for how these types of procedures might be implemented in the context of social and behavioral sciences. Chapter 5 returns to the topic of excused research to address in more detail informational risk and data protection plans.
|
From page 37... ...
In January 1981, 6 months before the revised Common Rule went into effect, HHS explained the introduction of broad exemptions for educational, behavioral, and social science research that it described as normally presenting little or no risk of harm to subjects, as follows: In taking this step, the Department anticipates that the work load of IRBs will be significantly reduced, as will the paperwork burden on those scientists whose research will be henceforth exempt. Also, since the IRB will be relieved of unnecessary work, research institutions are expected to have less difficulty in recruiting members of IRBs, and the IRBs will be able to concentrate more productively on projects which most deserve IRB attention.1 The revised regulations, however, left to institutions to "adopt any administrative procedures relative to exempt categories of research, if they deem them appropriate" (46 Fed.
|
From page 38... ...
where the risk of disclosure and the potential harm from it involve no risk or no greater than minimal risk or (b) where data protection plans and risk reduction mechanisms reduce the risk of disclosure to no greater than a minimal level.
|
From page 39... ...
They are not intended to offer a data security and protection structure for the confidentiality of private information while also allowing for appropriate scientific research involving human subjects. The committee therefore outlines a modification that would enable a system for excusal appropriate for research in the social and behavioral sciences while still protecting human subjects of research from greater than minimal informational risk.9 Overall, however, the committee's recommendations are consistent with the approach and aims of the ANPRM.
|
From page 40... ...
Instead, it would be registered and required to have a data protection plan appropriate to the level of informational risk it poses. The committee fully supports the ANPRM's underlying objectives -- first enunciated by HHS in 1981 -- namely, to focus IRB review on issues requiring human research protection, to address informational risk more effectively, and to better understand and define the different types of research covered by different levels of IRB oversight or review.
|
From page 41... ...
• Publicly available research data -- data that were collected for research purposes, but are publically available either because there are no identifiers in the dataset or the data have been certified for public use (see public-use data files below)
|
From page 42... ...
While gathering and analysis of publicly available information may meet the definition of research, use of such information, even if identifiable, does not constitute human-subjects research because it does not involve direct intervention or interaction and because the information is not private. The committee therefore concludes that, to clarify its scope, the Common Rule should explicitly classify as "not human-subjects research" those research activities that involve the use or gathering of publicly available information, including observation in public places, whether the information is identifiable or not, recorded or not, or accessible or not through any public medium (virtual, or otherwise)
|
From page 43... ...
types of publicly available data: (1) those which are obtained through nonresearch venues (e.g., the Internet, administrative records)
|
From page 44... ...
Increasingly these researchers are using "found data" or "harvested data" from existing sets of information that were collected by entities in the private and government sectors and that are publicly available. These data have scientific value because they (a)
|
From page 45... ...
In a report specifically addressing ethical decision making and Internet research, the Association of Internet Researchers describes the tensions between the notions of public and private: Individual and cultural definitions and expectations of privacy are am biguous, contested, and changing. People may operate in public spaces but maintain strong perceptions or expectations of privacy.
|
From page 46... ...
. In providing guidance concerning Internet research and human subjects regulations, SACHRP advises that If individuals intentionally post or otherwise provide information on the internet, such information should be considered public unless existing law and the privacy policies and /or terms of service of the entities receiving or hosting the information indicate that the information should be con sidered "private." (Secretary's Advisory Committee on Human Research Protections (2013, p.
|
From page 47... ...
and Panel on Data Access for Research Purposes (National Research Council, 2005) and proposes to classify as not human-subjects research public-use datasets that have been certified by statistical agencies or by participating archives as sufficiently protected against the disclosure of human subjects to be acceptable for public access and use.10 We further recommend that researchers who 10 Recommendation 2.4 is derived from the recommendation on public-use data files approved by the National Human Subjects Protection Advisory Committee at its January 28-29, 2002, meeting.
|
From page 48... ...
Consistent with the ANPRM, the scope of excused research covers studies that have minimal informational risk and that involve interaction or intervention with human subjects or use of pre-existing research or nonresearch data that include private information. The category is tailored to a swath of human-subjects research where the research procedures themselves involve informational risk, but where that risk of disclosure is no more than minimal when appropriate data security and protection plans are in place.
|
From page 49... ...
Additional guidance is provided in Chapter 3 on key elements that need to be considered in determining whether research requires expedited review. Recommendation 2.6: HHS should specify in the revised Federal Regulations that excused research covers studies where the research procedures involve informational risk that is no more than minimal (when appropriate data security and information protection plans are in place)
|
From page 50... ...
Examples of Excused Research As stated in Recommendation 2.6, excused research covers studies where the research procedures involve informational risk that is no more than minimal and includes • use of pre-existing research and non-research data that include private information, including use of extant research data under restricted use provisions or use of non-research data that are ac cessible but include private information about individuals that they may not expect to be public; or • benign interactions and interventions14 that involve methodologies that are very familiar to people in everyday life and in which ver bal, behavioral, or physiological responses would be the research data collected. Although research designated as "excused" would not, under the committee's proposed approach, need to be reviewed by an IRB, the research would be registered and subject to audit; consent procedures would be in 13 Seeexample #8 in the following section, "Examples of Excused Research"; and for information on deceptive techniques that should receive expedited IRB review, see the section, "Ensuring Adequate Classification of Excused and Expedited Categories," in Chapter 3.
|
From page 51... ...
Examples like these might instead be designated as expedited if the specific nature of the research procedures and/or the characteristics of the subject population suggest a need for special expertise to determine modifications to ensure that harm or discomfort created solely by the research procedures are not greater than minimal risk. These examples are not intended to be exhaustive but merely to illustrate the research methods used in a substantial amount of research that is conducted in the social and behavioral sciences.
|
From page 52... ...
5. A study of learning and distraction in which adult volunteers are asked to memorize nonsense syllables while being distracted by, for example, having to flag particular words among a string of words rapidly presented over earphones.
|
From page 53... ...
(The committee provides examples of excused research in this chapter and then elaborates on the difference between the two categories in Chapter 3.) As stated in the paragraph above, protections are built into the category through requirements for registration of the research and development of data protection plans.
|
From page 54... ...
Recommendation 2.9: HHS should revise the Federal Regulations to in clude the procedures under which research is excused from IRB review. The revised regulations should stipulate that such research can begin 1 week after registering a form that briefly describes the purpose of the research, the activities to be engaged in by research subjects, the subject population, consent procedures, and a data protection plan.
|
From page 55... ...
Adapting a central proposal from the ANPRM, the committee's position is that a key element of excused research is that it presents no, or no greater than minimal, informational risk, even if research subjects are asked about physical or psychological well-being. Thus, whereas excused activities are those that primarily pose no greater than minimal informational risks to human subjects (either by virtue of the research activities themselves or by virtue of adequate mitigation of risk via a data protection plan)
|
From page 56... ...
Chapter 3 discusses the expedited category in much detail and provides criteria to consider when deciding if research can be excused or should receive expedited review by an IRB. Appendix B at the end of the report provides a summary table showing the differences between the categories of "not human-subjects research," research that is "excused" from IRB review, and research that would receive "expedited" IRB review in terms of characteristics of the research, how they would be handled procedurally, and types of studies in each category.
|
From page 57... ...
. Considerations and Recommendations Concerning Internet Research and Human Subjects Research Regula tions, with Revisions.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.