Researchers in the social and behavioral sciences and the humanities often assert that the regulations for the protection of human research subjects do not really apply to the kind of research that they do, believing that the rules were written exclusively for biomedical research. There is a kernel of truth in this because revelations in the early 1970s about egregious medical experiments provided the impetus for developing federal standards for protecting human research subjects.
However, a close reading of the regulations will find mention of research methods and topics of inquiry relevant for researchers in the social and behavioral sciences and the humanities. Methods include surveys, ...view middle of the document...
* Allow for the amendment of approved protocols. This process can be used effectively when it is not possible to know at the outset how a study will evolve, for example when the study employs community-based participatory research methods.
* Require that IRBs have the necessary competence to review specific research activities.
This module will provide an overview of the federal regulations so that researchers can become conversant with their basic provisions. The full text of the regulations is available on line. For a complete discussion about the flexibility in the regulations regarding the consent process, see the module Informed Consent.
By the end of this module, you should be able to:
* Determine whether research is exempt from the regulations or not
* Describe the criteria for expedited and full board review
* Summarize the authority of an IRB
* Describe the kinds of review that approved research may need
Title 45 Code of Federal Regulations Part 46: Protection of Human Subjects
The Department of Health and Human Services (DHHS) regulations are sometimes referred to as 45 CFR 46, a label that identifies their location in the Code of Federal Regulations. You will probably see 45 CFR 46 quoted in your institution's policies and resource materials.
Subpart A of 45 CFR 46 is often referred to as the "Common Rule." Although these regulations were first drafted and adopted by DHHS, most departments that fund research in the social and behavioral sciences, including the National Science Foundation and the Department of Education, subsequently adopted the regulations as part of their own Codes of Federal Regulations.
Additional Protections for Vulnerable Subjects
Three subparts have been added to the basic provisions, Subpart A, of the federal regulations:
1. Subpart B: Pregnant women, human fetuses, and neonates
2. Subpart C: Prisoners
3. Subpart D: Children
Note: The additional protections for prisoners and children are covered in other modules and will not be discussed here. The additional protections for pregnant women, human fetuses, and neonates are most relevant in biomedical research.
Some federal agencies that adopted the Common Rule have also adopted some or all of the other subparts of the DHHS regulations, but others have not. For example, while the Department of Education has adopted the additional protections for children, the National Science Foundation has not.
Assurances with the Office for Human Research Protections
Every institution conducting research with federal support is required to enter into an agreement called an "assurance." Most assurances are negotiated with the DHHS' Office for Human Research Protections (OHRP). An assurance identifies the regulations for protecting research subjects that the institution will follow and the ethical principles it will adopt. In the United States these are the Common Rule and the Belmont Report. The assurance also...