UPDATED UT POLICIES & POSITION PAPERS:

University Departmental Review Policy

University Authority:

The Organization, known at 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.

Return to Top

Institutional Review Boards: Departmental Review Committees (DRC)

Vice President for Research - University Policy

The University recommends, but does 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 4.6. 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.

Return to Top

Human Subjects Marketing Research is Classified into Three Categories:

I. Marketing research does not require review when:

The project is neither systematic nor generalizable (this is not research per 45 CFR 46); AND

Researchers do not intend to either use data for publication or further research (new policy, old policy required class project); AND

Researchers do not recruit from any subject pool; AND

Researchers do not offer extra course credit as an incentive to participate (for these types of projects it is inappropriate to use extra course credit and the subject pool)

* An example of this type of research is conducting an informal marketing survey for O's on customer satisfaction.

II. Marketing Class Projects:

Marketing research class projects are essentially heuristic projects, and are completed as part of a specific class assignment. All class projects require completion of the
Class Project Form. While later publication or dissemination are possible, at the time of submission, the student intends to only use the data for the class and associated course requirements.

Class projects cannot recruit participants from the subject pool(s); AND

Class projects cannot offer extra course credit as a participation incentive, unless alternative means for obtaining course extra credit exist (and are fully disclosed in the consent form) and professors debrief participating classes regarding relevant research issues; AND

Class projects should avoid using sensitive topics and employing vulnerable populations; AND

Marketing class projects should be submitted in advance to ORS using the class project form available on our Forms page.

* An example is conducting marketing research as a class assignment on the types of cars that students desire to purchase.

III. Marketing Research that requires review:

Human participants marketing research is systematic AND generalizable. The investigator designs the research study with a clear intent to disseminate or publish the results / data. This research may or may not involve sensitive topics, subject pool recruitment, or recruitment incentives (again researchers must present participants with alternatives for earning extra course credit and provide research debriefing to participating classes). These studies require review and should be submitted to ORS using access.

* Examples include:

Class projects on sensitive topics: drugs, alcohol, or covert intelligence recruitment

Dissertations

Theses.

Return to Top

Public and/or published data sets not subject to Human Subjects Review:

Public and/or published data sets, accessible without restriction (e.g., password not needed^*) and containing no readily identifiable, individual information.
Examples include
- 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.

* or in those cases where you must register with a site or organization to gain access, the registration for login and password must be without qualification - anyone could register with this site.

Return to Top

Journalism Education and Human Subject Issues

Mercedes Lynn de Uriarte, Ph.D. Journalism Department, University of Texas at Austin (JAN 2005)

Note: This paper is meant to provide a profile of issues and talking points in journalism education related to .

Journalism education at the graduate level faces a more complex situation in regard to Human Subject oversight. This complexity revolves around the split nature of most departmental missions. This is most critical at the Master's Degree level where on the one hand, aspiring journalists and mid-career professionals seek more intense preparation for today's newsrooms, including both the daily standard assignments and those of investigative reporting. On the other, some programs prepare MA students to continue later in a PhD program by introducing them to academic research.

Of the 104 accredited journalism programs, for instance, 32 award an MA. Those MA programs are specifically professional tracks where the student seeks only to prepare for an advanced position as a reporter, editor or news director. Those programs seek to duplicate as much as possible the sort of assignments, challenges and ethical demands found in the typical newsroom under protections of the First Amendment. Of the 420 institutions listed in the AEJMC Directory offering journalism education (which includes both accredited and non-accredited programs) fewer than 35 award the PhD, where more intense traditional research is required; most of these departments include preparation at the MA level for those who wish to continue in a PhD program. As part of the process there, research within the traditional academic definition is often required at both the MA and the PhD level and is more appropriately shaped by guidelines.

Because journalists are charged with contributing to an informed electorate, understood as a necessary element of a strong democracy, they regularly interact with human sources to gather necessary information. These interactions, however, are not part of research as defined by the academic community or by the federal government. They do not have replicability, do not form a provable base of general knowledge or in other ways meet traditional research requirements.

Preparation for a press career falls into another arena where, among other issues, those of censorship or "prior restraint" arise. The submission of articles meant for review before they are undertaken conflicts with freedom of expression.

Instead press interactions with sources are shaped by ethical guidelines, some of which are concerned with the treatment of and later impact upon those sources. Aspiring journalists at the undergraduate level and those more advanced at the graduate level take courses in which they study, discuss and otherwise internalize these ethical standards.

All ethics guidelines drafted by newsrooms as well as those by leading professional Associations, such as, the American Society of News Editors, the Radio and Television News Directors Association, the Association of Managing Editors-mandate accuracy, respect of source privacy and protection for confidentiality when agreeing to "off the record" information. They also admonish members of the press to "do no harm,"-which includes capricious or irresponsible handling of both sources and the information provided by them. Additionally, all newsrooms maintain close contact with legal experts to avoid the complications of libel suits that might result from violation of these ethics In other words, newsrooms address the matter of information gathering from human sources as appropriate to the objectives of the profession.

However, research done by students in the PhD programs or the MA preparation for PhD programs in Journalism is appropriately guided by Human Subjects oversight. The School of Journalism provides a useful distinction: an exception is made for faculty members and their students in the school's PhD program who are working on strictly academic projects undertaken as basic research and intended for publication. This category might include things like surveys of reader responses to current events, or studies of editors' attitudes toward their newspapers.

These sorts of things, as opposed to magazine articles or newspaper stories about the same subjects, would have to pass all the regular criteria. Interview subjects would have to be given consent forms, their identity would have to be kept secret, etc. None of this is required of works of journalism.

As a first step in addressing federal requirements and academic standards, all journalism programs should draft statements that clearly define the separate roles of press practice and traditional academic research. Faculty should be aware of the differing criteria and all students should be familiarized with it. This should greatly decrease confusion and the resulting stress fostered by vague understandings of the distinct roles.

Moreover, the Association for Education in Journalism and Mass Communication, the largest association serving journalism educators with a membership of 3,500, might contribute toward the drafting of a more universal standard to address these distinctions within research programs housed among its institutional representation of more than 420 universities and colleges. Conversation with AEJMC representatives in the process of gathering information for tics paper indicated that both the AEJMC Standing Committee on Research and the Media Ethics Division Committee discussed this matter in their sessions over the past few years.

However, of primary importance for faculty, press professionals and students is the Constitutional protection of the press and those being educated to serve within its ranks. Issues of prior restraint should allow the to also acknowledge the necessity for separation between journalism programs based on the activity within them.

Return to Top

Program Evaluation & Human Subjects Research

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.

1. Program Evaluation is the inquiry into past, present, and potential human service programs to understand or clarify their need, working process or impact.

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.

3. 45 CFR 46.110.

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.

Return to Top

Social Security Numbers

To learn more about Social Security Numbers, visit Information Resources Use and Security Policy page Reduction of Use and Collection of Social Security Numbers.

Return to Top

Oral History

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: