FAQs

Virtually any question about the IRB and its procedures can be answered by consulting the IRB Handbook. However, a number of frequently asked questions are answered below in the following categories:

  • Does my project need reviewing by the IRB?
  • What level of review does my project require?
  • When should I submit my proposal?

Do I Need Review?

The first step in determining whether you need your project requires IRB review is to determine whether the work you are undertaking meets the Federal definition of "research" using "human participants" as described in 45 CFR 46 (The Common Rule). Here "research" is defined as follows:

"[A] systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."

and "human participants" are defined as: "[A] living individual about whom an individual (whether professional or student) conducting research obtains 1) Data through intervention or interaction with the individual or 2) Identifiable private information"

IRB approval must be obtained prior to any data collection for research involving human participants, if the research is sponsored by the College (this includes activities undertaken as part of the instructional process); is conducted by or under the direction of any faculty, staff, or student of the College in connection with institutional responsibilities or using any property or facility of the College; or involves the use of the College’s non-public information to identify or contact prospective students.

If the results of the work are meant to be published or disseminated to an unrestricted audience, or even if this is viewed as a possibility, then the work counts as research.

If you have determined that your project does require IRB review, you must then decide whether your project qualifies for Exempt, Expedited or Full Review. Please follow the links for a description of each.

The following activities are NOT considered "research" and do NOT require any review by the IRB:

Surveys and interviews for the purposes of:

1. Journalism (as protected by the freedom of the press and subject to journalistic ethics), such as polls done for the College newspaper.

2. Advocacy (as protected by freedom of speech), such as a campaign to get students to stop smoking.

3. Internal College use only, such as surveys of members of the College community where the results are made available to a limited audience within the College community; or evaluations of College faculty, programs, or services.

4. Class activities

    1. Data collected from human participants (both in and outside the classroom) as part of the instructional process do not require IRB review as long as they meet the following requirements       
      1. the information will not be presented or published beyond the classroom
      2. the data collection process will not constitute more than minimal risk (i.e. the likelihood of harm or discomfort are not greater than those experienced in everyday life)
    2. However, participation in any teaching activity (whether it is to be published or not) that involves more than minimal risk to the student must be accompanied by the student’s voluntary informed consent and must be reviewed and approved by the IRB.
    3. If the instructor/and or student wish to present or publish information beyond the classroom (e.g. in a departmental colloquium or a student research conference), the activity is considered research and must be reviewed by the IRB in advance of the research being conducted if it involves human participants. If the activity involves the entire class using similar protocols, then the faculty member may submit one proposal for the class. However, if each student’s project is fundamentally different, then separate protocols must be submitted.

5. Activities in which the primary purpose is of specific benefit or treatment to the individuals involved such as counseling, social work, physical or psychological therapy, or psychological testing.These activities are subject to the norms of confidentiality and standards of practice of the relevant professionals.

6. Oral histories: Oral history interviewing activities are “not designed to contribute to generalizable knowledge and therefore do not involve research as defined by Department of Health and Human Services (HHS) regulations at 45 CFR 46.102(d) and do not need to be reviewed by an institutional review board (IRB) (Office for Human Research Protection, 2004) ”. For additional information, please see: http://www.historians.org/Perspectives/Issues/2004/0403/0403new1.cfm.

Levels of Review

If you have decided that your activity falls under the Federal definition of "research", then you need to decide what level of IRB review is necessary. If you are uncertain whether your project needs review, please see the page Do I Need Review?

New Proposals and Status Determination: There is a three-level structure for the IRB review of research involving human participants.

  1. Exempt: At least one IRB committee member will verify that a proposal meets the necessary qualifications for exemption from continuing review.
  2. Expedited: Research that presents no or minimal risk to participants is eligible for expedited review upon request. Expedited projects require an annual review.
  3. Full: Research which does not meet exempt or expedited status will be submitted to the chair for review by the IRB committee.

Please click on each Level to see a fuller description of what studies fall under each level of review.

Most research conducted at the C of I will tend to fall under Exempt or Expedited Status. Research involving more than minimal risk and research with prisoners automatically require a Full Review.

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 or during the performance of routine physical or psychological examinations or tests.

When should I submit my proposal?

At the beginning of fall and spring semesters the IRB chair will publish, for the benefit of the C of I community, meeting dates for that semester.

All protocols submitted for Full Review are due to the chair of the IRB by the first of the month in which the researcher wishes the protocol to be reviewed.  For example, for a protocol to be reviewed in the November meeting, the completed protocol must be received by the chair by November 1.  If the first day of the month falls on a weekend or a school holiday, the following Monday or the first official work day after the holiday will be the due date.  Any protocol received following the first day of the month will normally be held for review the following month.

Exempt and expedited proposals are accepted on a rotating basis. A decision will be rendered within 2 weeks. However, if a proposal is referred to a full board either because 1) the proposal does not meet the criteria for exempt or expedited or 2) the Chair or designee does not approve the proposal, the proposal will be referred to the next scheduled full board meeting.

The IRB Committee will meet the third week of each month starting in September and through May to review protocols received the first of that month.  For the month of January, protocols are due by January 3rd for review during the third week of January.  There will be a special meeting in May for all summer protocols. All summer protocols must be submitted by May 1st. The specific day during the third week will be determined by the chair of the IRB by the end of the first full week of the month.  This will be announced to the IRB members and all researchers who submitted protocols.  If no protocols are received by the first, there will be no meeting of the IRB for that month unless other business is pending.

The researcher is responsible for providing the number of copies required by the level of review required (see below).  The IRB will issue to the principal investigator a signed cover sheet and/or letter of status within one week of the review meeting.

Level of Review/Number of Copies

Exempt: 1 Original/Signed, 1 Electronic File

Expedited: 1 Original/Signed, 1 Electronic File

Full: 1 Original/Signed, 1 Electronic File