This course will discuss the fundamentals of the federal regulations that govern all human subjects research. It will specifically focus on how Institutional Review Boards (IRBs) apply those regulations to research conducted on social, behavioral, or educational topics. Social, behavioral and educational research is typically conducted by social scientists and educators, but may also be conducted by physicians or others when they focus on social, behavioral, or educational issues. This module will also discuss the roles and duties of IRBs as well as the types of IRB reviews that are conducted with social, behavioral and educational research. The module will conclude with a brief quiz.
- Define the following OHRP terms:
- Human Subject
- Vulnerable Populations
- Classify the Level of Review (Exempt, Expedited, Full, Continuing)
- Understand the Role and Duties of the IRB
Social Behavioral and Educational Research
This course will help you understand specific terms used by Institutional Review Boards. It will discuss the roles and duties of the IRB along with the types of IRB reviews that are conducted.
Social Behavioral and Educational Research (SBER) encompasses a broad area of research. The National Institutes of Health (NIH) Behavioral and Social Sciences Research (BSSR) defines behavior as: psychological processes like cognition, emotion, temperament, motivation and biobehavioral interactions. Social is defined as sociocultural, socioeconomic, sociodemographic status and biosocial interactions involving levels of social context from small groups to complex systems and societal influences. (ref 95) For additional information on these definitions, example topics, methodology and research, visit the Office of Behavioral and Social Sciences Research.
Educational research is closely related to the definitions of the BSSR, but focuses on the process through which learning occurs. This includes formal and informal processes of education that affect learning and attainment. It may not always be possible to delineate where social, behavioral or education research begins.
Research is directly defined in the Code of Federal Regulations (CFR) 46.102(d) as “. . . a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” (ref 13) ‡
The definition of research also helps us to understand what is NOT considered to be research—for example, if a group of students were practicing administering surveys to each other. This is not research, but rather training for those students. The simple collection of information does not constitute research rather we must consider the purpose and use of the data collected. The use of the word “research” in practitioner or everyday usage is very different from scientific applications.
CFR 46.102(f) refers to the definition of human subjects in research.
A human subject is “…a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” (ref 13) ‡
We can see through this direct definition that it is not only important who the subject is—it must be a human being and not, for example, an animal (animal research requires a IRB review by an Institutional Animal Care and Use Committee), but what is done to or with that subject is also important. Both intervention and interaction may constitute research. This would include collecting data through means of an interview or discussion. It also pertains to the collection of identifiable private information.
There are, however, many commonly used terms in research that are not directly defined, but guidance is given as to the meaning of these terms within the Code of Federal regulations. (ref 13) ‡
The Code of Federal regulations does not directly define “vulnerable populations,” but does provide general guidance on who should be considered to be a vulnerable population. CFR 45, section 46.107 states: “If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons . . .” CFR 45, section 46.111 (a) (3) also states: “. . . vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons or economically or educationally disadvantaged persons. . .” 45 CFR part 46 offers specific guidance on vulnerable populations. Subpart B discusses pregnant women, human fetuses and neonates. Subpart C discusses prisoners, Subpart D discusses children. Under the “Policy and Guidance” portion of the OHRP’s website, there is a section on “Vulnerable Populations.” In this section, specific mention is made of the following populations: individuals with AIDS and HIV, children, prisoners. It should be understood that the different groups of individuals that the CFR has mentioned while discussing “vulnerable populations” are not exhaustive. This ambiguity allows IRBs latitude when considering individual research proposals to protect other groups of individuals who, while not enumerated in the CFR, are, in fact, vulnerable. A more in-depth discussion of vulnerable population is contained in a separate training course. (Go To Vulnerable and Protected Populations Course) (ref 13) ‡
Confidentiality is part of Respect for Persons outlined in the Belmont Report (ref 4). It was defined in the 1993 Institutional Review Board Guidebook in Chapter 3 (ref 15). “Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure without permission.” In research proposals, IRB reviewers examine how the research data will be protected from unauthorized access—or even authorized access, in the case of a government subpoena to provide research data. For the majority of research that is conducted, this means following routine practices like using codes for individual’s identities, disposing of hard copies of data sheets or computer sheets, allowing only authorized persons to have access to the data, and storing research data properly.
In the case of research on sensitive topics, it may be necessary to keep the identity of the participants confidential. For these studies, even the signing of a consent form may put the subject at risk since the consent form in and of itself is a record of participant’s identity. In this case, IRBs may waive the requirement for signing a consent form, allowing anonymity for the subject.
Types of IRB Review
As a researcher or member of the research team you should be aware of the different types of IRB reviews as defined by OHRP. The type of review required may impact the amount of time that project spends within the review process. For example, a study with more than minimal risk requires review by the full IRB committee (see Full Review below). The level of review will also impact what additional steps the reviewer must do to insure risks are minimized when possible. There are four types of IRB Reviews: Exempt Review, Expedited Review, Full Review, and Continuing Review. In addition to these reviews, there is also a Non-Human Subject Determination.
Non-Human Subjects Determination
Increasingly, journals and grant guidelines may require an official letter of non-human subjects determination for studies. As reviewed previously, a human subject is defined by Federal Regulations as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” (45 CFR 46.102(f)(1),(2)) To determine if a project or study qualifies for a non-human subjects determination, the IRB will review what data is obtained by the researcher. If the investigators are not obtaining data through intervention or interaction with living individuals, or identifiable private information about the individual, then the research activity may meet the criteria of non-human subjects study. (ref 13) ‡
Categories of Exemption
There are types of research that are exempt from continuing IRB oversight. These include the following:
- Research in commonly accepted educational settings involving normal educational practices †
- Research involving the use of educational tests, survey procedure, interview procedures or observation of public behavior †
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded in such a way that subjects cannot be identified
- Research and demonstrated projects conducted by or subject to the approval of department or agency heads to study public benefit or service programs
- Research involving taste and food quality evaluation and consumer acceptance studies (ref 16)
- In the social and behavioral sciences, by far, the most common of these are the first three.
The Code of Federal Regulations 46.110(b) states that “An IRB may use the expedited review procedure to review either or both of the following: (1) some or all of the research appearing on the list and found by the reviewers(s) to involve no more than minimal risk, (2) minor changes in previously approved research during the period (of one year or less) for which approval is authorized.” Expedited reviews can be conducted by the IRB chair or by experienced members of the IRB designated by the chair to conduct this type of review. A convened meeting is not required.
The following types of research are contained on this list: (ref 17) ‡
- Certain clinical studies of drugs and medical devices
- Collection of blood samples under particular circumstances
- Protective collection of biological specimens for research purposes by noninvasive means
- Collection of data through some noninvasive procedures
- Research involving materials collected solely for non-research purposes
- Collection of data from voice, video, digital, or image recordings made for research purposes
- Research on individual or group characteristics or behavior
Research that is greater than minimal risk and/or does not meet any of the categories of expedited review requires review by the full, convened board. Majority vote by a quorum is required for a full committee decision. The IRB must include members with expertise in specific vulnerable populations in order to review those studies; for example, the IRB must include a prisoner representative any time research with prisoners is reviewed.
The Code of Federal Regulations 46.109(e) states that “An IRB shall conduct continuing review of research . . . at intervals appropriate to the degree of risk, but not less than once per year. . . ” (ref 17) ‡
The 1993 IRB Handbook stresses the importance of continuing review. While a researcher can make a best guess as to the potential risks of any research, once research has begun, other risks may come to light. The IRB will determine the timeframe for the continuing review based on the level of risk. For examples, some studies might have a three month continuing review. Continuing review may also be necessary if the risks or benefits of a specific research project change over time. And, of course, a continuing review will be conducted at least once per year. (ref 19)
Adverse Event Reporting
The OHRP provides guidance for both unanticipated problems and adverse events that may occur during the course of research. An unanticipated problem must be unexpected, related or possibly related to participation in the research, and the research may place subjects at a greater risk than was previously known. An adverse event encompasses both physical and psychological harm.
In order for an adverse event to require reporting it must be unexpected, and it must meet the same three criteria of the unanticipated problem: it must be unexpected, related (or possibly) to participation in the research, and it may place subjects or others at a greater risk for harm.
The report of the unanticipated problem must identify the research protocol in particular, provide a detailed description of the adverse event, provide an explanation that the adverse event is also an unanticipated problem, and a description of changes or proposed changes in response to the unanticipated problem. (ref 20)
Role and Duties of the IRB
The Code of Federal Regulations provides specific guidance as to the composition of IRBS. Every IRB must have at least five members. The members’ backgrounds should be diverse enough to allow the IRB to conduct knowledgeable reviews. This diversity should include educational diversity, gender diversity, and cultural diversity. IRBs should never be comprised of individuals from only one gender or profession. Also, if the IRB reviews research involving any vulnerable population on a regular basis, there should be at least one individual on the board that has special knowledge and experience working with these subjects. (CFR 45, 46.107 (a)) Each board should have at least one individual who is primarily involved in science and one individual who is involved in a non-science area (46.107 (c)). Members of the IRB should not have a conflicting interest when reviewing any project (46.107 (e)). Any potential conflict of interest should be fully disclosed. (ref 13) ‡
IRB Written Procedures
The Code of Federal Regulations 46.108 states that every IRB will follow written procedures and, except during expedited reviews, each IRB meeting must be convened when a majority of the members of the IRB are present. Approval of research must be done with a majority vote.
IRB Record Keeping
The Code of Federal Regulations 45, 46:115 (ref 29) ‡ provides guidance on IRB record keeping. IRBs must maintain adequate records that document the activities of the IRB. These records must include the following:
- copies of all research proposals that are reviewed
- approved sample consent documents
- progress reports submitted by investigators
- reports of injuries to subjects
- records of continuing review activities
- copies of correspondence between IRB and investigators
- a list of IRB members
Minutes of IRB meetings must be maintained and must contain the following:
- details of actions taken by the IRB
- votes taken
- the basis for requiring changes in research or the basis for disapproving research
- a written summary of the discussion of controverted issues
- statements of significant new findings provided to subjects
Records required by CFR policy should be retained for at least 3 years and records relating to research should be retained for at least 3 years after the research has been concluded. (ref 29) ‡
‡ The Code of Federal Regulations (CFR) referenced in this article is to a hypertext document maintained by the U.S. Department of Health & Human Services. (ref 13) However, one can obtain the most up-to-date version of the CFR, in PDF format, directly from a website maintained by the U.S. Government Printing Office. (ref 14) At time of writing this article, the latter PDF download for 2012 contains the same content for this article as the document found on the U.S. Department of Health & Human Services website.
† Category 1-2 cannot be used for research involving children, except for use of educational tests (cognitive, diagnostic, aptitude, achievement) or research involving observations of public behavior when the investigator(s) do not participate in the activities being observed. Children are defined in the HHS regulations as “persons who have not yet attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.”