Frequently Asked Questions

Frequently Asked Questions about Protection of Human Subjects And the Institutional Review Board at Ripon College

• What is the Institutional Review Board?

As mandated by Federal Regulations, Ripon College has established a procedure and committee to review in advance proposals for research that will involve human subjects. The purpose of the review is to assure that the rights of human participants will be protected.

The Institutional Review Board at Ripon is a committee consisting of three faculty members, the Dean of Faculty, one additional administrator, and one community member.

• What research needs to undergo prospective review?

Any research project that will gather data from human subjects should undergo at least some review by a faculty member or department. Thus, all researchers, including students, faculty, staff, and administrators who are involved in collecting data from people or about people that will be used for purposes of generalization must submit their research proposal(s) for review, even if the research is being conducted off campus.

Examples of research involving human subjects include data collected from social surveys and interviews, participant observation, psychological experiments, observational studies, classroom surveys, evaluation research, market surveys, telephone and mail surveys, focus groups, and generalizations from available records. All stages of research and data collection involving human subjects, including pre-tests and pilot studies, as well as the final data collection are subject to the review process.

Research in which the only involvement of human subjects will be in the use of educational tests, survey procedures or observation of public behavior do NOT require submission of a proposal to the IRB unless (i) information is recorded in such a manner that human subjects can be identified, and (ii) any disclosure of the responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation. However, before proceeding such research should be reviewed by someone within the department for which the research is being conducted.

Most other research projects involving the use of human subjects will require submission of a proposal to the IRB. When in doubt about whether a proposal requires IRB review or not, the investigator should consult with the department for which the research is to be conducted.

There are two tiers of review for proposals being submitted to the IRB: one for proposals in which the methodology undeniably poses no discernable threat to the well being of any subjects (“Tier One”); and one for research that has at least some discernable potential for harm to a human participant (“Tier Two”). Procedures for using each are described more fully below.

• Why is IRB review needed?

Federal Regulations (Code of Federal Regulations, chapter 45, Section 46.11 6) require that all proposals for research involving human subjects be submitted for prior review to the Institutional Review Board (IRB). The United States Department of Health and Human Services (HHS) requires all researchers conducting human- subjects research to provide prospective subjects with informed consent.

An exception to the informed-consent rule may be obtained if: (i) the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality; or (ii) the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normal required outside of the research context.*

• Which rights need protection?

Three human rights must be safeguarded by researchers: freedom from harm, privacy, and voluntary participation.

(1) Participants have the right not to be harmed by participating in research. Thus, they have the right not to be exposed to physical, emotional, or psychological dangers without very strong justification, and even then only after agreeing to participate with fully informed consent.

(2) Human participants have the right to privacy, i.e., to determine how information obtained from them is used, whether it is publicly shared, etc. They therefore have a right to confidentiality and a right to full disclosure (i.e., informed consent) regarding the study they participate in.

(3) Human subjects have the right to freely choose to participate or not participate in studies, to know what it is they are volunteering to participate in, and even to withdraw their participation in a study after it has begun. Again, they should be informed of such rights.

Because human subjects have many rights that need protection, the Department of Health and Human Services of the U.S. Government has taken the position that all research involving humans needs some form of review.

• What are the two “tiers” of review used by the IRB at Ripon College?

Tier 1 Review is for research that in the professional judgment of the department involved entails no clear potential for harm to any of the human participants. Such research might involve classroom “research” used for demonstrative purposes; surveys that ask generic, non-controversial questions; etc. Although such projects need consideration, they can receive expedited review. In general, research in which the probability and magnitude of harm or discomfort are not greater in and of themselves than those ordinarily encountered in everyday life or during the performance of routine physical or psychological examinations or tests is subject to Tier 1 review. *

Tier 2 Review is for procedures that could pose some imaginable danger to at least one human participant. Such studies might involve, for example, surveys or interviews that address potentially controversial topics (e.g., abortion), or laboratory experiments that bring participants in contact with electronic equipment. In general, research in which the probability and magnitude of harm or discomfort are greater in and of themselves than those ordinarily encountered in everyday life or during the performance of routine physical or psychological examinations or tests is subject to Tier 2 review. *

The judgment as whether to submit a proposal to Tier 1 or Tier 2 review is left to the department or departments involved in the research. When in doubt about whether a proposal is more appropriately reviewed under Tier 1 or Tier 2, the researcher is advised to consult with a member of the department for which the research is being done or with a member of the IRB.

• How does the review process at Ripon College work?

First a potential researcher must fill out the IRB Proposal Form, obtainable from the Dean of Faculty, that reports: the kind of review recommended (Tier 1 vs. Tier 2); a description of the research protocol; an indication of any potential threats or dangers to human participants; a copy of the form to be used to obtain informed consent; copies of the data-collection instrument(s) (e.g., questionnaires or surveys); a statement regarding whether deception is used in the research and, if so, what kind is involved; a statement of the debriefing procedure; etc.; and any useful supplementary information.

One copy of a Tier 1 proposal should be submitted; electronic submisstion is preferred.  Tier 2 proposals must be submitted electronically.

The form is submitted to the Dean of Faculty, who will review the Tier 1 proposals to determine whether any should be advanced to Tier 2 review. Those Tier 1 proposals that the Dean agrees pose no discernable threat to the well being of human subjects will be approved and the researchers notified.

The Dean of Faculty will also review Tier 2 proposals and determine whether any (along with the Tier 1 proposals advanced to Tier 2) require supplemental information. If so, the researcher will be requested to supply the necessary information.

Upon receipt of all necessary information, the full IRB will discuss the Tier 2 proposals. In some cases, the researcher involved may be asked to meet with the IRB personally. Following review, each proposal will either be approved or returned to the researcher with a written statement of concerns and recommendations.

• When should a research proposal be submitted for review?

A non-exempt proposal (see above) must always be submitted, and the review completed, before the research begins.

Proposals that clearly are of Tier 1 level may be submitted at any time, allowing perhaps one week for review.

While Tier 2 proposals can be submitted at any time, it should be remembered that the potential exists for the proposed research to be delayed while additional information is obtained or discussions of the proposal occur. Researchers should give themselves and the IRB plenty of lead time, and submit proposals at least two or three weeks before they plan to begin data collection.

• What if I have a question not addressed in these FAQs?

For student researchers: In most cases, the faculty member supervising your research can answer your questions or direct them to the appropriate resource.

For faculty and staff researchers: The Dean of Faculty often will be able to answer questions. However, cases that pose new policy issues will require a meeting of the full IRB. In all cases, an effort will be made to answer a researcher’s question(s) as quickly as possible.

• To sum up . . .

All research involving human subjects must be reviewed, and falls into one of three categories. Some research is exempt from IRB review if it uses standard social research procedures (described above), maintains anonymity, and is not potentially damaging to subjects. Such research must be reviewed by the faculty members and/or departments responsible. Tier 1 research must be reviewed by the IRB, but involves minimal risk to subjects. Such research is reviewed by the Dean of Faculty. Tier 2 research must be reviewed by the IRB, and poses some potential risk to subjects. Such research is reviewed by the entire IRB committee.

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* Some of the wording in these sections is drawn directly from Federal guidelines for Institutional Review Boards.