IRB Classroom Guidance

Student/Classroom Research Projects

IRB Guidance Document
Effective September 2, 2015

 

Texas A&M University (TAMU) requires that all research involving human subjects conducted by faculty or staff affiliated with the university, be reviewed and approved by the Institutional Review Board (IRB) prior to initiation, regardless of the source of funding and regardless of its federal status as an exempt, an expedited, or a full review project. Investigators may not solicit subject participation or begin data collection until they have received written approval from the IRB.

The IRB further requires that all student research activities are supervised by a faculty member; however, some types of student research activities may not require IRB review. TAMU supports a wide range of both undergraduate and graduate student research projects using human subjects ‐‐ from course‐related research exercises to dissertation studies. This document is intended to clarify IRB policy and procedures as they relate to student and classroom research projects.

Independent Research Projects

Independent research projects are those that employ systematic investigation designed to contribute to generalizable knowledge. Theses, dissertations, and honors research projects involving human subjects that are considered research as defined by 45 CFR 46 (i.e., “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”) always require review by the IRB. Investigations designed to develop or contribute to generalizable knowledge are those that seek to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program.

While such research is often disseminated through scholarly publication or presentation of the data, research results do not have to be published or presented to qualify the experiment or data gathering as research. A study designed to contribute to "generalizable (scholarly) knowledge" fits the definition of research, regardless of publication. For additional information regarding the submission and review of such projects, please visit the IRB website at http://rcb.tamu.edu/humansubjects or contact irb@tamu.edu.

Research Methods Training/Curriculum

Research projects for which the overriding and primary purpose is a learning experience in the methods and procedures of research does not meet the federal definition of research and is therefore generally not subject to (i.e., is excluded from) IRB review/approval. Curriculum projects in which students conduct research involving human subjects need not be reviewed by the IRB if the following conditions are satisfied:

1. The project involves minimal risk to subjects (i.e., when "the risks of harm anticipated in the proposed research are not greater considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests"). A

2. The project does not involve sensitive topics or confidential information that could place a participant at risk if disclosed. B

3. The project does not involve persons from vulnerable populations as participants. C

4. The project must involve the voluntary participation of individuals without any coercion or pressure being placed upon them by the researcher.

5. The results of the project will not be distributed outside the specific classroom and/or institutional setting or used for publication or used for any other classroom project, although the results may be presented to the specific course instructors or peers in that specific course for educational purposes or as part of a class assignment in the specific course. Data gathered as a classroom project may not be used for future human subjects research studies at Texas A&M University without prior IRB approval. Data gathered without prior IRB approval as a classroom project may not be used or retroactively approved for future human subjects research studies.

Responsibility for Oversight of Student Projects/Classroom Activities

Each faculty and department has the responsibility for: (1) assessing whether student projects/classroom activities involving human participants meet eligibility for review or exclusion from IRB review; (2) overseeing these activities; and (3) assuring that ethical principles are adhered to in the conduct of those activities.

Consent and information sheet templates are included here for use in classroom projects. Documentation used for classroom projects shall not include reference to the Texas A&M University Institutional Review Board(s) or the Texas A&M University Human Research Protection Program.

Faculty advisors of both undergraduate and graduate students must be certified to conduct research with human subjects. IRB Training Certification is offered through CITI (for more information please visit http://rcb.tamu.edu/humansubjects/training). For questions regarding TAMU’s policies relating to the conduct of human subjects research, please visit the IRB website at http://rcb.tamu.edu/humansubjects or contact .

With regard to classroom projects, faculty instructors are encouraged to become fully familiar with each student's project(s). A checklist is available for assessing whether or not classroom projects meet the criteria for exclusion from IRB review. It is also important that instructors who teach research methods courses educate students regarding the existence of Human Subjects

Panels and discuss the relevant ethical issues surrounding the use of human subjects in research.

The IRB staff is available to conduct presentations on human subjects research in your class. For further information, please contact .

Consent Template (DOC)

Information Sheet Template (DOC)

 

Footnotes

A Minimal Risk ‐ Student research projects that fit the categories below are generally considered minimal risk. For additional information or specific questions regarding this standard, please contact irb@tamu.edu.

1.) Research conducted in an educational setting involving normal education practices, such as research that examines or compares regular and special education curriculum including but not limited to instructional strategies/techniques, curricula, or classroom management methods.

2.) Research involving the use of educational tests, survey procedures, and interview procedures.

3.) Observation of public behavior if confidentiality or anonymity is maintained.

4.) Research with subjects who are elected or appointed public officials or candidates for public office, regardless of whether the subjects may be identified or the information is sensitive.

5.) Research on individual/group characteristics or behavior in such areas as perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, social behavior, etc. provided that confidentiality or anonymity is maintained.

6.) Research employing oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

7.) Collection of data from voice, video, digital, or image recordings for research purposes.

8.) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if one of the following is true: the sources are publicly available or the information is recorded by the investigator in a way that subjects cannot be directly or indirectly identified.

 

B Sensitive Topics – Any interview, survey or questionnaire that proposes to investigate opinions, behaviors, and/or experiences regarding, but not limited to, any of the following sensitive topics requires IRB approval:

  • sexual orientation, incest, rape, sexual molestation, deviant sexual behaviors or attitudes regarding sexual conduct (pedophilia, bestiality, etc.), practices of contraception, abortion and/or pregnancy

  • substance use and/or abuse including, but not limited to, alcohol, marijuana, steroids, amphetamines, narcotics and any prescription medication legally or illegally obtained

  • questions regarding mental health (e.g., suicide, depression, obsessive compulsive behaviors including, but not limited to, gambling, smoking, eating, etc.)

  • traumatic experiences of an individual, including war or combat experiences of veterans

 

C Vulnerable Populations (for the purposes of classroom research) may include: pregnant women, neonates, and fetuses; children (with the exception of observational studies); prisoners and persons at high risk of incarceration or deportation; mentally disabled; socioeconomically disadvantaged individuals; individuals in traumatic or emergency situations; and any other persons who cannot act as autonomous agents because of various handicaps or specific circumstances. Projects involving such subjects require IRB review and submission of a protocol for approval prior to beginning the research. Projects must comply with the regulations set forth in the Family Educational Rights and Privacy Act (FERPA) and the Protection of Pupils Rights Amendment (PPRA).