Below you will find information about the Reed IRB and instructions on how to obtain approval of research involving human subjects at Reed. Please refer questions to Joan Meyer, IRB Administrative Assistant.
- What kind of research requires review by the IRB?
- Categories of Review
- Proposal Submission Procedures & Instructions
- Proposal Review Process & Approval
- International Compilation of Human Research Standards
- Frequently Asked Questions
1. Research that must be reviewed includes:
- faculty research projects;
- senior theses;
- projects conducted outside the classroom by students (e.g., independent projects, projects funded by special grants);
- a limited set of classroom projects.
According to the provisions of the Federal Wide Assurance filed by Reed College, federally-funded research involving human participants sponsored by Reed must be reviewed according to the regulations set forth in 45 CFR 46. The College also certified that all research involving human participants at Reed, independent of funding source, will be conducted in accordance with the ethical principles enunciated in the Belmont Report. Thus, for both ethical and legal reasons, the College has committed itself to a process of internal review of all research involving human participants.
The internal review will be conducted by the IRB.
Projects conducted on the Reed campus by non-Reed investigators must also undergo review by the Reed IRB. Projects conducted by Reed investigators at off-campus sites having their own process of institutional review will undergo minimal additional review at Reed.
2. Categories of Review
Exempt from Full Committee review
Certain categories of research are exempt from formal IRB review. However, the individual investigator cannot make the determination that the research is exempt. Further, many “exempt” projects still require documentation of the processes used to obtain participants’ consent. Thus, a brief description of the research is required, but “exempt” proposals will be much shorter than those in other categories.
Review of applications for exemption will be conducted by a designated member of the IRB, usually the Chair. Confirmation of exemption can be expected within one week.
The following categories of research may be exempt:
A. Research evaluating the efficacy of educational practices in an educational setting.
B. Research involving the analysis, synthesis, or study of existing data or documents when these are publicly available or when the information is recorded in such a way that individuals cannot be identified. See definition of “anonymous” below.
C. Research involving the use of surveys, interviews, educational tests, psychological tasks or observation of public behavior when the obtained information is anonymous or when disclosure of the individual subject’s responses would not create a risk of adverse consequences to the subject.
Public behavior is behavior occurring without the intervention of the researcher, and which the individual could reasonably expect to be observed. Observation of reactions to “staged” events and of behavior occurring in private settings (e.g., at home, in a bathroom stall) or in settings in which individuals have reasonable expectations of a limited audience (e.g., classrooms, meetings of identified groups) is not exempt.
Anonymous means that the individual participant cannot be identified from the data themselves, and no identifying information is linked to the data. Video and voice recordings are not anonymous. Interview or survey data in which recorded demographic characteristics or descriptions of specific incidents could easily lead to the recognition of the individual respondent are not anonymous.
Examples of adverse consequences include:
- placing participants at risk of criminal or civil liability
- damaging the participant’s academic standing or standing in any ongoing program, financial standing, employment status or employability, insurance status or insurability
- damaging the participant’s reputation
D. Research approved by an off-campus IRB.
Certain categories of research are eligible for an expedited review process, in which three members of the IRB will review the proposal. Research falling into this category will require more complete descriptions than research that is likely to be exempt, but because the research raises few, if any, ethical issues, these descriptions are usually short. Normally, an expedited review will be completed in approximately three weeks.
Research that presents no more than minimal risk to human participants may qualify for expedited review. Examples of risks that require review by the full IRB are specified in the section on Full Review (below). The assessment of risks requires evaluation of the specific circumstances of the proposed research, but research falling into the following categories often presents minimal risk:
A. Collection of data from voice, video, digital, or image recordings made for research purposes.
B. Research on individual or group characteristics or behavior (e.g., research on perception, cognition, motivation, identity, language, communication, religious or cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, or human factors evaluation. NOTE: Some research in this category may be exempt and some may require full committee review.
C. Certain biological measurements, such as:
- collection of blood samples by finger stick, heel stick, ear stick.
- collection of other biological specimens by noninvasive means.
- collection of physiological data through noninvasive procedures (e.g., EEG, heart rate).
D. Non-invasive questionnaires and/or straightforward, non-risky procedures that involve no deception with children under the age of 18, given that direct parental consent is obtained.
E. Continuing review of research previously approved by the IRB. This category includes most addenda to previously approved projects and requests for continuation of approval beyond one year. These proposals may be reviewed by the Chair.
Full Committee Review
Research that is not exempt and that does not qualify for expedited review must be submitted to the IRB for full review. This type of review requires a convened meeting of the Committee, with a quorum of its members present. Thus, 3-4 review cycles/semester have been established. Please see the Committee Calendar for scheduled meetings and submission deadlines.
The deadline for submission of proposals requiring full review is approximately 10 days before the next scheduled committee meeting. This allows a one-week period for preliminary review by IRB members, who provide feedback and questions to the Chair. Researchers can expect feedback from the Committee within a few days of the meeting. Possible actions include:
- request for revisions that can be accepted by the Chair, by a designated member of the IRB, or by the Administrative Assistant to the IRB.
- request for revisions that must be re-reviewed by the IRB or by a subcommittee of the IRB.
Research in the following categories requires full committee review.
A. Vulnerable participant samples (e.g., children under 18 years of age who are being asked to do somewhat risky or deceptive procedural tasks, clinical populations, incarcerated populations, individuals who for one reason or another cannot provide informed consent).
B. Procedures that involve the intentional induction of stress, or for which stress to the participants might be an unintended consequence, such as:
- the use of aversive or physically painful stimuli.
- the induction of emotional distress, such as embarrassment, frustration, anxiety, loss of self-esteem, anger, or sexual arousal.
- the induction of physical stress through procedures such as exercise, sleep deprivation.
C. Procedures that might lead to physical injury, including the consumption of any substance, (e.g., coffee, tea, tobacco, over-the-counter medications).
D. Procedures that might raise ethical objections in participants, for example:
- deception by the researcher or confederates.
- manipulations of participants’ attitudes or behavior.
- observation of behavior in non-public settings without advance consent.
E. The collection of personally sensitive data requiring unusual procedures to ensure confidentiality.
3. Proposal Submission Procedures & Instructions
Students must have a faculty advisor review and approve their proposals before they are submitted to the Committee. Students should expect substantive feedback from their advisors and are advised to leave ample time for review and revision prior to submitting their proposal. The Submission Form must be signed by your faculty advisor to indicate their approval of your project.
The Committee encourages you to ask questions before submitting a proposal. The Chair and the IRB Administrative Assistant welcome your questions at any time. A list of committee members can also be found on the Committee Members page.
A hard copy of the proposal and supporting documents must be submitted to Joan Meyer, IRB Administrative Assistant, in Psy 116. An electronic copy of the proposal and supporting documents must also be emailed to Joan Meyer at email@example.com.
Some proposals require additional materials beyond the Submission Form. Please see the Submission Forms & Materials page for a checklist and further instructions.
4. Proposal Review Process & Approval
Investigators should expect to receive feedback and requests for revisions from the Committee after the initial review. Revisions are typically reviewed by the Chair within a few days. Approval is granted once the Committee’s concerns have been addressed by the investigator.
All revisions require review and approval by a faculty advisor, so it is important to work closely with them throughout the review process.
Approval expires after one year.
Continuation & Addenda
Investigators must submit addenda to the IRB if there are any changes to the research protocol. Addenda can be submitted in the form of an email to Joan Meyer at firstname.lastname@example.org outlining the changes to your research. Your addendum will be forwarded to the committee and you will hear back with requests for more information, changes, or approval within a few days.
If you intend to continue research beyond one year, you must submit a Continuation Form to the IRB in advance of the approval’s expiration.