The Organization, known as The University of Texas at Austin, formally grants the Institutional Review Board (FWA #2030) the following authorities:
- To approve, require modifications to secure approval, or disapprove all research activities overseen and conducted by the organization.
- To suspend or terminate approval of research that is not being conducted in accordance with requirements or that has been associated with unexpected serious harm to participants.
- To observe, or have a third party observe, the conduct of the research.
- To indicate that officials of the organization may not approve a protocol that has not been approved by the Institutional Review Board.
Vice President for Research - University Policy
The University recommends, but does not require, that each Department and/or distinct Research Unit create a DRC to provide initial, peer review of human subject research. The following guidelines are provided to Departments/Research Units in determining whether to create a Departmental Review Committee (DRC) which bests reflects its size and discipline.
- If the department or research unit has had a history of submitting any proposals to the IRB for review at any level, then it is strongly recommended that a DRC be formed. (The Department may check with the Office of Research Support (ORS) to ascertain this information).
- A DRC should be comprised of a minimum of one faculty member.
- If the volume of submissions within a department or research unit is greater than 25 per year, then it is recommended that the DRC be comprised of 1-2 faculty members.
- Departments or research units that do not wish to form DRCs should formally notify the or Office of Research Support in advance to permit the ORS to act as the DRC of record for the designated academic year.
The purpose of the Departmental Review Committee is to provide first tier review of human subjects research by investigators of similar training. Thus, scientific merit and relevant research design are considered important questions to be asked by the DRC. The DRC is asked to specifically address the following questions using the Application Form:
- Does the research use procedures consistent with sound research design?
- Is the research design sound enough to reasonably expect the research to answer its proposed question?
- What is the importance of the knowledge expected to result from this research?
A list of recommended training references for DRCs is provided in Section 3.16 of The University of Texas at Austin Institutional Review Board Policies and Procedures Manual. While DRCs are encouraged to provide direct review of the research protocol and informed consent process, the DRCs do not make final decisions about research determinations. Applications listing DRCs must have DRC approval prior to submission. Final decisions about human subjects research are made by the in the Office of Research Support.
- Public and/or published data sets, accessible without restriction (e.g., password not needed*) and containing no readily identifiable, individual information.
- Inter-University Consortium for Political and Social Research (ICPSR)
- U.S. Bureau of the Census
- National Center for Health Statistic
- National Center for Education Statistics
- National Election Studies
- Public and/or published data sets, accessible without restriction (e.g., password not needed*), and containing readily identifiable information and where individuals can reasonably expect this information to be available to the public (examples include letters to the editor, blogs)
- Public and/or published data sets, with restrictions to access, that contain data that is presented in aggregate form only (e.g., zip code); thus individuals cannot be identified.
Andrew Karberg M.A., Tamara Davis Ph.D., Ali Cloth M.A.
This paper profiles program evaluation1 issues relating to human subjects research. (JAN. 2005)
Program evaluations implement a variety of methodologies to accomplish diverse objectives2. Some program evaluations constitute human subjects research and others do not3. If a program evaluation is research4 and uses human subjects5, then it requires approval. Generally, program evaluations not requiring human subjects review involve data internally collected and analyzed for the normal course of business. These evaluations' goals range from simple descriptive statistics to qualitative information, and examples include program enrollment data, constituent demographics, and outcome analyses. Therefore, irrespective of human subject involvement, these program evaluations remain internal and thus do not contribute to generalizable knowledge.
However, program evaluations publishing results in scholarly journals likely require approval. The assumption being that publishing the findings generalizes the data. Moreover, evaluations connected to groups' or individuals' outcomes and affecting the development or implementation of other programs similar in nature, are generalizable human subjects research and require human subjects review. Furthermore, an evaluation6 impacting upon the replication of other programs or services and the population at large or public policy, should be reviewed and monitored. Finally, funding source may impact a program evaluation's human subjects requirements. Financially supported human subjects research implemented by third party agencies are subject to review by Institutional Review Boards.
Program evaluation is an example of applied social science research. Beneficial and valuable program evaluations require knowing the basic principles of social science, experimental design, and data collection methods. Successful program evaluations frequently demonstrate an understanding of the relationship between theoretical concepts of human behavior or social structure, and pragmatic interventions. Regardless of any determination of a program evaluation as research , all human subject participants deserve appropriate ethical research conduct including competency, full informed consent, and confidentiality.
2. There are three major categories of program evaluation: Needs assessments (formative evaluations) establish whether or not a program is feasible or necessary; process evaluations determine whether or not a program's implementation is congruous with its conception; impact evaluations (summative or outcome evaluations) ascertain whether or not a program meets its goals.
4. See 45 CFR 46.102 (d): Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. Research refers to this definition throughout this paper.
5. See 45 CFR 46.102 (f) Human subject means 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. Consistent with 45 CFR 46 subparts B, C, & D vulnerable populations require additional safeguards and protections.
6. For example, a school or social service agency wants to clarify the impact that a program has on a specific population of individuals. In order to effectively replicate a project in more schools or agencies, researches could establish baselines at the program's outset, and then at the end of the project's implementation conduct an impact evaluation. These types of program evaluations may include the administration of measures to individuals, focus groups, or interviews, and thus are human subjects research.
To learn more about Social Security Numbers, visit Information Resources Use and Security Policy page Reduction of Use and Collection of Social Security Numbers.
ORAL HISTORY POLICY UPDATE (May 18, 2004):
“Application of the Department of Health and Human Services Regulations for the Protection of Human Subjects at 45 CFR 46, Subpart A to Oral History Interviewing,” the Office of Research Support has determined that in general oral history projects are not subject to the requirements of the HHS regulations, and therefore, those that are not subject to the requirements of HSS regulations can be excluded from review. Oral History is defined by the Oral History Association as, “a method of gathering and preserving historical information through recorded interviews with participants about past events and ways of life.” Oral history is excluded from review when the interviews are not designed to contribute to “generalizable knowledge,” as defined in 45 CFR 46. Oral history interviews typically provide unique perspectives to the event, and thus would not be considered to be information from which systematic generalizations could be made. The following departments represent disciplines that may use oral history methodology and thus may be affected:
Middle Eastern Studies
Latin American Studies
Theater / Dance