Institutional Review Board (IRB) Policies and Procedures
Contact: IRB Chair: firstname.lastname@example.org
Will you do research involving human beings? If so, you need to know about the Institutional Review Board (IRB) 2016-17
In general, if you’re doing research involving human participants, you need an IRB approval. The exceptions, described as an ‘exempt’ category, are explained under item 1 below.
The IRB form is not long, but must be complete; copies of documents to be used should be emailed along with the form. Both are submitted electronically to the IRB chair.
We ask that you submit your proposal at least ten days before you need approval; however, most reviews are e completed much more quickly. Some are eligible for expedited review (see item 10). This determination is based upon what is to happen in the research, not upon the researcher’s schedule.
Any research involving human subjects must be actively sponsored by a faculty member or a staff member who regularly conducts research. This individual should either submit the form or, in the case of a student researcher, submit the ‘faculty endorsement form’ when the student submits the proposal (see items 4 and 5).
Two important Notes:
IRB proposals should be submitted by WJC Faculty, staff members who have experience conducting human subjects research, and students (with a faculty sponsor and faculty endorsement form). Researchers from elsewhere must work with a person in one of the first two cateogries, and that person submits the proposal.
IRB approval must be obtained BEFORE data collection begins.
Institutional Review Board: Overview FAQ
1.I’m going to study some people; does my project need to be reviewed by the IRB?
Quite possibly, but there are categories of projects that qualify for EXEMPT status., as follows. (**We understand ‘ solely for pedagogical purposes’ to mean that the project involves activities normally a part of curriculum in that discipline, whose substance or findings will not be offered for public presentation beyond the classroom. For example, Schoenrade’s Psych 321 students do present their results at Colloquium Day and at student conventions, and so must seek IRB review.
Exemptions from Review:
Activities not encompassed within the above definitions of research and human subject do not require IRB review, approval, and oversight. Under normal circumstances, the following activities would not be considered human subject research:
(**We understand ‘solely for pedagogical purposes, Point D,’ to mean that the project involves activities normally a part of curriculum in that discipline, including activities not involving individuals beyond the assigning class, whose substance or findings will not be offered for public presentation beyond the classroom. For example, Schoenrade’s Psych 321 students invite participants beyond their classes and do present their results at Colloquium Day and at student conventions, and so must seek IRB review.)
- A)Journalism interviews or investigations;
- B) Oral history interviews;
- C) Interviews or observations conducted by architects for use in designing a structure;
- D) Student activities conducted solely for pedagogical purposes; **
- E) Quality assurance, program evaluation, or institutional research activities intended solely to evaluate and improve an organization’s programs or services, with no application of findings outside the organization; or
- F) Feasibility studies to determine the potential utility or viability of a specific, proposed service or facility, with no application of findings to other services or facilities
(This clause was added to the guidelines in Spring, 2012, and the language is taken from the Report of the Secretary’s Advisory Committee on Human Research Protections, 2005, http://www.hhs.gov/ohrp/archive/sachrp/mtgings/mtg08-05/min08-05.pdf.)
2. Who Submits a Research to the IRB?
Any student, faculty, or staff member collecting data and/or conducting research (including, but not limited to surveys, opinion polls, interview studies, correlational studies, laboratory or field experiments) involving human subjects. Additionally, any researcher from off-campus who wishes to conduct research on WJC’s campus and involve human subjects must involve a WJC faculty or qualified staff member and have that person submit the proposal. (Please see item 7 below.) (Exceptions are listed in Point 1 above.)
3.What is the IRB’s Role?
The IRB is charged with ensuring that research conducted by any member of the campus community meets ethical standards described by the Department of Health and Human Services (DHHS). The ethical standards concern such matters as appropriate informed consent of participants, protection from harm, protection of privacy, appropriate caution when disseminating information, and refraining from exploiting particularly vulnerable populations. The IRB members offer a evaluation of the research with respect to ethical concerns that is, presumably, somewhat more objective in this regard than those of the researcher(s) proposing the research.
4.How are Proposals Submitted to the IRB?
Proposals should be submitted electronically to the chair of the IRB at email@example.com. The researcher will complete a standard form requested by the IRB. This form can be found on the Curry Library home page in the “Resources” section under “Institutional Review Board.” The form includes spaces for detailed descriptions of procedures and be accompanied by attachments with copies of any questionnaires or assessment instruments. If there are several instruments being used, it is easiest for IRB members if these can be combined in one attachment. The materials supplied should usually include an informed consent statement. An example consent statement will appears in the IRB resource list.
Where specific equipment and/or non-print materials is to be used, these should be described in sufficient detail to allow a careful assessment of the research. If the IRB members deem it necessary, they may request the opportunity to view the actual materials (e.g. if a video too large to email is to be used and an ethical concern is raised.)
5. Note concerning student researchers:
If the researchers are students, the electronic submission should closely preceded or followed by a faculty sponsor endorsement. The student researcher(s) will submit the proposal with a cc to the faculty sponsor, and the faculty sponsor should respond to the IRB chair using the format described in the public folder. (This helps assure that the faculty sponsor is aware of and agrees with what is in the proposal, and helps avoid lengthy delays resulting from repeated returns of the proposal for more information.) The intent is that the faculty supervisor has reviewed and given guidance on the proposal BEFORE it is submitted to the IRB. (Our reasoning is that many students are first-time researchers and faculty supervisors have more experience with the essentials of a proposal and its construction.)
A Jewell non-faculty staff member who has experience in conducting empirical research may also serve as supervisor for student research.
6. What Kinds of Responses to the Proposal Do NOT Fall Within the IRB’s Role?
(This section is included because IRB’s sometimes make people uneasy or even annoyed, and we wish to minimize that reaction.)
- The IRB does not offer a judgment concerning the methodological quality of the research. (For example, psychologists do not always agree with the methods used by sociologists, but a member who is a psychologist may not reject a proposal on that basis.)
- Neither does it offer an evaluation of the merit of the research topic. (On rare occasions, a particular topic may be judged ethically sensitive; only in that instance would the topic be a focus of the IRB’s function.)
- Neither does the IRB evaluate the quality of writing in the proposal. If writing is unclear on a point that may pertain to ethical acceptability, the IRB members will, of course, ask for clarification on that point. (If errors are so numerous as to make it difficult to follow the proposal, it may be returned for correction prior to review.)
- Finally, the IRB does not serve as a forum for expressing or acting on conflicts between individuals or disciplines on campus. Regrettably, this occasionally happens on some campuses; it is imperative that members put aside personal and disciplinary annoyances when evaluating proposals.
7. I have a friend or colleague who wants to do research at Jewell. Or I lead a student group that wants to do research. Does every proposal need to have a faculty member involved?
If a faculty member is not one of the primary researchers, the proposal must be sponsored by a faculty member (or a staff member who regularly conducts research). This sponsorship should not be in name only; the faculty or staff member should be in agreement with the purpose and procedures of the research, and be prepared to take responsibility for the procedures and outcomes. That is, the faculty sponsor BECOMES the researcher on the project for the purposes of the Jewell IRB.
8.Who is on the IRB?
Membership consists of at least five members (This is a federal specification; at Jewell, the IRB generally includes 7-8 members.) At least three should be faculty members, one a non-faculty staff member, and one an individual not otherwise affiliated with Jewell. A student member also serves. Ideally, membership on the committee should continue for at least three years. Most of the members should have some familiarity with empirical research procedures. There should be at least one non-scientist on the committee.
9.What is the Review Procedure?
Each member of the committee receives an electronic copy of the form and attachments, reviews it with the ethical standards set by the DHHS in mind (though concerns need not be limited to those points), and submits an evaluation indicating that a) it is ethically acceptable, b) it will be ethically acceptable with certain changes specified by the committee member, or c) it is ethically unacceptable, and why. The chair then communicates with the other members to discuss any areas of non-consensus, and communicates the IRB’s decision to the researcher(s) via email. If there are concerns sufficient to judge the proposal ethically unacceptable, the researcher must decide whether to revise the proposal (such revision may include further explanation and/or changes in procedure) and resubmit it or cease that particular project.
If a member communicates an ethical concern, but a majority of the committee members does not judge the matter of concern, the chair may nevertheless alert the researcher to the fact that such a concern was raised, as a cautionary note, while still indicating that the proposal has been approved by the IRB.
10. How Long Does the Review Process Take?
Under normal conditions, the IRB anticipates being able to communicate its initial decision within no more than ten days, of the receipt of the proposal and often quite a bit fewer (assuming it is received during the regular academic semester.) If it is appears that this will not be possible (for example, because numerous proposals are received within a given week), the chair will communicate that information to the researcher as soon as possible after the receipt of the proposal.
Some proposals may be eligible for expedited review, a truncated procedure also described within the national guidelines. (These are generally very low-risk, non-invasive studies in which little or no personal information is communicated.) Upon receipt of a proposal, the chair will determine whether the proposal is eligible for expedited review. If it is, one member of the committee with significant experience in research proposal review (who is not the researcher submitting the proposal) will complete the review and either a) communicate that the proposal is acceptable or b) send the proposal to the rest of the IRB membership, and inform the researcher of this action. (That is, an expedited review can result in acceptance, but rejection must come from the larger IRB.)
11. What happens if I am in a hurry to start?
There are have been numerous occasions on which the IRB has been able to offer a response in considerably less than ten days. We cannot, however, offer hastened review simply because the researcher has planned to conduct the research on a specific date. We will conduct the review as quickly as possible given the other responsibilities of the members, but we must ask that the researcher plan ahead enough to allow for the ten-day review interval.
12. If I want to make minor changes or re-conduct the same study, do I have to go back through the entire review process?
Usually not. Minor changes (such as wording of questions, or addition of a few questions of a similar nature) do not require re-review. More substantive changes (e.g. addition of a new instrument or inclusion of a different subject population) require notification to the IRB, but, since a review has already been completed, the members can generally respond fairly quickly indicating whether the changes pose any problems. If a previously approved study is to be re-conducted or re-activated, the researcher should simply notify the IRB chair that the study is again being conducted. Testing the same hypothesis in a different way–for example, using a new set of measures–does constitute a new study and does require a new review.
13. I have more questions and/or I need a proposal form. Where do I go?
With questions please contact Dr. Patricia Schoenrade, IRB chair, at firstname.lastname@example.org or by calling 816-415-7583. Forms are available on the Curry Library website or from Dr. Schoenrade.