With the Belmont Report providing guidance, the federal government began the process of harmonizing the regulations that had been issued by various agencies into what is called the common rule, now adhered to by many federal agencies. The common rule refers to the regulations presented in the Code of Federal Regulations, Title 45, Part 46, Protection of Human Subjects (Protection of Human Subjects, 2001). In print these regulations are often referred to as 45 CFR 46. For a more detailed history of these regulations, see Anderson (1996).
In formulating 45 CFR 46, the government made a key decision to decentralize the process of protecting human subjects of research. The regulations require colleges, universities, hospitals, research institutes, and other organizations that conduct human research and receive federal funding to establish local Institutional Review Boards (IRBs). The local IRB’s function is to assure that research done under the auspices of the institution is done with ethical regard to the rights and welfare of human participants. In colleges and universities, the regulations require the local IRB to review and approve all research done with humans, unless after an initial review the IRB itself declares that the research is exempt. The regulations also provide for the possibility that some types of research may be eligible for “expedited” review, that is review by an alternate process rather than by the entire IRB.
IRB Membership and Review Process
IRBs require interviewing researchers to submit their proposed research for review before they begin their project. In the case of doctoral candidates, the IRB review is an additional process separate from the approval of the dissertation proposal by their doctoral committee. The IRB review may seem like an obstacle and may cause anxiety for new researchers. One way to gain confidence and a sense of autonomy in the review process is to read 45 CFR 46 on the “Protection of Human Subjects” (2001). While the regulatory language may initially seem difficult, studying it can assist new researchers to overcome feeling intimidated by the regulations. (Researchers can easily access 45 CFR 46 on the Internet by searching 45 CFR 46.) My own experience is that rather than being an obstacle, an IRB review, when done well, almost always leads researchers to a heightened awareness of important ethical issues embedded in their proposed research.
In universities, IRBs are composed of faculty members knowledgeable about research, at least one representative from outside the university, and administrative staff (Protection of Human Subjects, 2001, 46.107). Each local IRB will have its own application format, but basically IRBs ask researchers to describe briefly the aims of the research, the nature of their participants, their research methodology, the researchers’ qualifications to do research, the risks and benefits involved in the research, and how the researchers will obtain informed consent from their potential participants.
Other countries have similar review processes for research with human participants. The Office for Human Research Protections (OHRP) has developed an International Compilation of Human Subject Research Protections. The Compilation lists the laws, regulations, and guidelines of over 50 countries where research that is funded or supported by the Department of Health and Human Services is conducted. The Compilation provides direct web links to each country’s key organizations and laws, whenever available. The Compilation can be accessed on the OHRP website: http:\\www.hhs.gov\ohrp\international\index.html#NatlPol (OHRP email communication, July 20, 2005). If your research originates in the United States but will be carried out abroad, you will have to comply with your local IRB process and your host country’s formal review process. Equally important, in some countries, which may or may not have formal review processes, researchers must be sensitive to local cultural expectations of what is ethical (Cleary, 2005).
In 2000 and 2001, two deaths of participants in medical research at prominent United States hospitals made national headlines. Investigations revealed that the participants had not been fully informed about the risks they faced in participating in the research (Kolata, 2001; Stolberg, 2000). Consequently, the federal government has increased its efforts to strengthen the IRB process. Early in their program, doctoral candidates should inquire about their local IRB process. If they plan to do research abroad, they should make early contact with the host country to inquire about its review of research process. They might also see Hubbell (2003) for an excellent description of complexities that may occur when interviewing abroad.
Source: Seidman Irving (2006), Interviewing As Qualitative Research: A Guide for Researchers in Education And the Social Sciences, Teachers College Press; 3rd edition.