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 Kayla Johnston, IRB Administrative Coordinator. Please note that the submission process for proposals has changed. You can now upload your proposals to the online portal in IRIS. Investigators are no longer required to deliver a hard copy to the IRB Administrative Coordinator.
- 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. What kind of research requires review by the IRB?
The IRB reviews any research conducted on a human subject. A human subject means a living individual about whom an investigator (whether professional or student) conducting research: 1) obtains data information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or 2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
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 need to provide documentation of approval to Reed’s IRB.
2. Categories of Review
There are three categories of review: Exempt, Expedited, and Full Review.
Exempt
Certain categories of research are exempt from formal IRB review; however, these projects still require documentation of the processes used to protect participants’ privacy. Thus, a brief description of the research is required, but exempt proposals will be much shorter than those in other categories. Confirmation of exemption can be expected within one week.
The following exempt categories of research are used at Reed:
Exempt Category 1: Educational Practices. This category is for research involving normal educational practices (such as instructional strategies) that are not likely to adversely impact students’ opportunity to learn. It is conducted in established or commonly accepted educational settings. The research could compare the effectiveness of different methods of instruction or classroom management or examine varying curricula.
Exempt Category 2: Educational Tests, Survey Procedures, Interview Procedures, or Observation of Public Behavior. This category is for survey, interview, or observation data that meets at least one of these three criteria: (1) information is not identifiable, (2) disclosure outside of the research would not place participants at risk of harm, or (3) information could be identifiable but the IRB has conducted a limited to review to ensure that adequate provision are in place to protect participants’ privacy and maintain confidentiality.
Exempt Category 3: Benign Behavioral Interventions. This category includes research procedures that are “brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.” As with category 2, the data should meet at least one of these three criteria: (1) information is not identifiable, (2) disclosure outside of the research would not place participants at risk of harm, or (3) information could be identifiable but the IRB has conducted a limited to review to ensure that adequate provision are in place to protect participants’ privacy and maintain confidentiality.
Exempt Category 4: Secondary Research for Which Consent is Not Required. This category applies to secondary research of identifiable information or biospecimens. Informed consent is not needed if at least one of the following is met: (1) use of publicly available identifiable information, (2) information is recorded by the investigator in such a way that one cannot easily identify the participants and the investigator will not contact nor re-identify the participants, (3) research is regulated by HIPAA, or (4) data are analyzed by a federal agency and federal legal requirements are met.
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.
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.
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
Expedited Review
Research that poses minimal risk to participants and is not included in the exempt categories will be subject to an expedited review process, in which two members of the IRB review the proposal. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Research falling into this category will require more complete descriptions than research that is Exempt or subject to Limited Review, but because the research raises few, if any, ethical issues, these descriptions are usually short. Normally, an expedited review will be completed in approximately two to three weeks.
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 review cycles per 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:
- approval.
- request for revisions that can be accepted by the Chair, by a designated member of the IRB, or by the Administrative Coordinator 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.
- 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).
- 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.
- Procedures that might lead to physical injury, including the consumption of any substance, (e.g., coffee, tea, tobacco, over-the-counter medications).
- 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.
- The collection of personally sensitive data requiring unusual procedures to ensure confidentiality.
3. Proposal Submission Procedures & Instructions
Students should discuss their proposals with a faculty advisor 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. After online submission, the proposal will be forwarded to the faculty advisor for official approval.
The Committee encourages you to ask questions before submitting a proposal. The Chair and the IRB Administrative Assistant, Kayla Johnston, welcome your questions at any time. A list of committee members can also be found on the Committee Members page.
Proposals are submitted through the online portal:
SUBMIT YOUR IRB PROPOSAL ONLINE
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 within one week. 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.
Renewal
In the past, projects were approved for 1 year and required renewal for continuation of the work. These continuations are no longer required, except for federally funded projects.
Addenda
Investigators must submit addenda to the IRB if there are any changes to the research protocol. Addenda can be submitted through the online portal. You will hear back with an approval or a request for more information within one week.