General Information and Procedures
The purpose of an Institutional Review Board (IRB) is to help ensure that researchers observe ethical guidelines developed to protect the well-being of research participants. Under most circumstances, all faculty, staff, and students planning to conduct research involving human participants must obtain approval by the IRB prior to any data collection. Approval also must be obtained prior to any changes in approved procedures that will affect the confidentiality or risk of harm to participants. Most protocols will be approved for one year, although the review interval may be shorter if the IRB determines that the degree of risk is more than minimal. It is the responsibility of the investigator to make sure that ongoing research is submitted for review before the approval lapses. More specific guidelines and recommendations are provided below.
When is it necessary to submit a research project to the IRB for review?
Faculty, staff, and student research that includes human subjects must be submitted for review if any of the following criteria apply:
- The research involves interaction with participants, or
- The research collects identifiable data of a personal nature (from participants or records) that the participants would reasonably expect to be confidential, or
- The research involves collecting data from participants from an especially vulnerable population, such as infants, children, people with mental illnesses, prisoners, or people undergoing medical procedures. You should consult with the IRB to obtain more information on relevant safeguards for special populations such as these, or
- The research involves more than minimal risk of physical or psychological harm or discomfort to participants. According to federal regulations (45 CRF 46), minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life. Your assessment of harm and discomfort should include consideration of emotional discomfort such as embarrassment or emotional pain, or
- The research involves deception of the participants at some point in the project, or
- The research project involves the solicitation of external funding. In this case, be aware that as of October 1, 2000, the federal government requires that all submissions for federal grants regarding research with humans be accompanied by a certificate of proof that the submitter has completed a course or workshop on the ethical treatment of human participants. Please contact the chair of the IRB for more information on this requirement if it applies to your project.
Research by students that involves human participants can be reviewed and approved through departmental procedures approved by the IRB if all of the following criteria are met:
- The research is not externally funded, and
- The research collects only anonymous data from participants and records, and
- The research does not involve collecting data from participants from an especially
vulnerable population (e.g., infants, children, people with mental illnesses, prisoners, people
undergoing medical procedures), and
- The research involves no more than minimal risk of physical or psychological harm or
discomfort to participants (see definition of minimal risk of harm above) and
- The research does not involve deception of participants
Academic Programs where students frequently use human participants in research projects must develop a procedure for evaluating student projects that meet the five points above. The procedure must be approved by the IRB prior to implementation. The psychology department endorses and follows the ethical standards of the American Psychological Association when it evaluates student research projects that meet the five points above. These guidelines are recommended for other departments as well.
Special Note: Individuals outside of the Oglethorpe University community who wish to conduct research on campus must submit their proposals for IRB review.
When is it not necessary to obtain IRB approval or departmental approval?
To address this issue, consider the guidelines adopted by the psychology department. The psychology department traditionally uses humans as research participants more than any other department. In that department, human participants are used in research projects in three ways. First, the faculty in the department sometimes use humans as participants in their own projects. For example, one professor measures people’s abilities to accurately decode nonverbal forms of communication. Second, the students in the department sometimes use humans as participants in their own projects. For example, a student may create a personality questionnaire and distribute the questionnaire to students via campus mail as part of an advanced research project, independent study, or honors project. Third, instructors in the department sometimes conduct small experiments in class to illustrate a point or to collect data for statistical analysis. For example, one instructor arranges for a person to unexpectedly enter a classroom and “steal” the instructor’s notebook. After a passage of time, the students (witnesses) answer a series of questions about what happened. They then use the data to test several hypotheses about eyewitness testimony and memory.
In the first two cases (i.e., faculty and student research), the psychology department must follow the IRB guidelines for review and approval. In the third case (in-class experiments), the department believes that these are pedagogical exercises, not research per se. Consequently, instructors are given the freedom to use activities that they believe are appropriate, as long as those activities conform to the ethical standards of the American Psychological Association. In short, all research in the psychology department will conform to the American Psychological Association’s ethical standards and, when appropriate, research projects will be submitted to the IRB for its review.
Academic programs in similar situations, with similar types of classroom projects, do not need to submit them for IRB or departmental approval. Note, however, that some ethical standards should be adopted and followed even in those pedagogical exercises.
What is the procedure for submitting proposals to the IRB?
The Oglethorpe University IRB conducts two types of reviews, standard and expedited. For a standard review, all IRB members read and review your proposal. For expedited reviews, only the IRB Chairperson will review the request. You may request an expedited review of your research if either of the following two points applies:
- Your study is an ongoing project that already has been approved by the IRB and has not changed or has changed in a way that will not affect confidentiality or risk of harm to participants. Whether or not changes in the procedures are introduced, all ongoing research must be reviewed by the IRB at least once a year.
- Your study involves no more than minimal risk of physical or psychological harm or
discomfort to participants and does not involve deception or the use of participants from an especially vulnerable population. If the IRB chairperson is concerned that your study may place participants at risk for more than minimal harm or discomfort, your project will be reviewed through the standard IRB procedures.
The materials to submit for standard and expedited reviews are identical and they should be submitted to the IRB chair. Please submit 2 hard copies of all materials. For standard IRB reviews, the procedure normally takes about four weeks. For expedited IRB reviews, the procedure normally takes about one week. Currently, the IRB chair is:
To request approval of your project by the IRB, you need to submit:
- A completed IRB Approval Request Form (available upon request from the IRB chair).
- A copy of your proposed informed consent form (see attached guidelines).
- Copies of any measures or questionnaires to be used in the study.
- If the investigator believes that written consent is not appropriate, he or she must provide
the IRB with a statement of the reasons why written consent should be waived. Alternatively, a script (which includes all the elements of consent) is sometimes used in obtaining oral consent from the participant. In this case, a copy of the script must be provided to the IRB.
Special Note: Be advised that if you plan to collect data at an off-campus facility (e.g., school, daycare center, and hospital) you are responsible for contacting that facility to inquire about its own IRB procedures. In most cases, schools, hospitals, prisons, and other settings have their own IRB procedures. Thus, if your project involves off-campus research, your protocol will need to be reviewed and approved by the Oglethorpe University IRB and possibly by a second IRB at the off- campus facility.
What if an IRB committee member wishes to submit a proposal for consideration?
If a standing member of the committee wishes to submit a proposal, it should be sent to the chair of the IRB for the appropriate type of review (standard or expedited). If the chair of the IRB committee wishes to submit a proposal, she or he will submit it to another member of the committee who will make the decision regarding standard versus expedited review. In all cases, if a standard review is necessary for a committee member’s proposal, the submitting member will be excused from all voting responsibilities regarding her/his proposal.
What happens when an approved research project is completed?
The IRB committee asks that investigators notify the committee chair once their project is completed and submit a brief summary of the results. This will help the committee keep records on all projects in the event of an external audit of research conducted at Oglethorpe University.