Protecting Participants and Facilitating Social and Behavioral Sciences Research (2003) / Chapter Skim
Currently Skimming:
1 Introduction
1 Introduction
Pages 9-22
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 9... ...
human participant protection system, with legal obligations under the Common Rule, are federal agencies that sponsor research with human participants, the Office for Human Research Protections (OHRP)
|
From page 10... ...
Although there is wide consensus on the role of informed consent in protecting and respecting the rights of human research participants, in practice the IRB review system appears to pay too little attention to the process of helping individuals decide about participation and too much attention to documenting consent to formally satisfy federal requirements. Often, the result is the creation of a consent form with hard-to-understand "boilerplate" language that does not really enable prospective participants to appropriately assess the risks and benefits of participation (see, e.g., Sieber, Plattner, and Rubin, 20021.
|
From page 11... ...
It is also likely to lead to choices by IRBs to subject research protocols to levels of review, such as full board review, that are not needed to protect participants in research that poses no more than minimal risk of harm. More stringent review than is necessary often delays research, sometimes results in inappropriate changes in research designs, and creates cynicism in the research community about the proper role of human participant protection (see, e.g., American Association of University Professors, 20011.
|
From page 12... ...
and three topics in depth: . We consider informed consent in terms of the obligation of IRBs to focus more on the consent process and less on the consent form, the obligation of SBES researchers to conduct research on effective consent processes and documentation, and the obligation of OHRP to provide guidance that will enable IRBs and researchers to make participant protection paramount in considering consent procedures for specific research protocols.
|
From page 13... ...
We discuss human participant protection issues for SBES research in the context of the Common Rule (45 CFR 46, subpart A) , which applies generally to all human participants and has been adopted by most agencies that sponsor research with humans (see Box 1-1~.4 We do not have the expertise and do not address issues of added protections for children, pregnant women, and prisoners, which are covered in other 445 CFR 46, from which we quote extensively in our report, is the DHHS enactment of the Common Rule; other agencies' enactments are found in other volumes of the Code of Federal Regulations.
|
From page 14... ...
Similarly, the panel reviewed human research participant protection guidelines of 5 this committee was replaced by the Secretary's Advisory Committee on Human Research Protections in October 2002; see Appendix B 6We were not able to obtain input directly from participants in SBES research, who cover a wide range of populations or else represent the general population as distinct from a group of patients with a specific disease as is characteristic of much clinical research.
|
From page 15... ...
Following a summary of principles and practices for human research participant protection that were articulated in the landmark Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979) , the chapter considers more fully issues of harm, benefit, risk, and minimal risk.
|
From page 16... ...
Several recommendations call for OHRP to provide guidance to IRBs and researchers, in recognition of OHRP's leadership role in the federal system. OHRP responsibilities include not only monitoring the operations of IRBs that review DHHS-funded research, but also providing guidance on human research participant protection for the federal and nonfederal sectors, developing educational programs, and exercising leadership for human participant protection for the U.S.
|
From page 17... ...
At present ten departments and seven agencies have adopted the Common Rule by regulation, executive order, or legislation: the Departments of Agriculture; Commerce; Defense; Education; Energy; Health and Human Services (DHHS) ; Housing and Urban Development; Justice; Transportation; and Veterans Affairs; and the Agency for International Development, the Central Intelligence Agency, the Consumer Product Safety Commission, the Environmental Protection Agency, the National Aeronautics and Space Administration, the National Science Foundation, and the Social Security Administration.
|
From page 18... ...
Authority may approve, require modifications to, or disapprove all research covered under the Common Rule at its site (some IRBs review research from more than one institution) ; may suspend or terminate research that violated IRB requirements or resulted in unexpected serious harm to subjects; no covered research may proceed without IRB approval.
|
From page 19... ...
Informed Consent · Unless waived by an IRB, investigators cannot involve humans in research without obtaining informed consent. · The information provided in seeking informed consent must include eight elements (e.g., "description of any reasonably foreseeable risks or discomforts to the subject")
|
From page 20... ...
supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (I)
|
From page 21... ...
moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
|
From page 22... ...
if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S.
|
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.