Institutional Review Board

Welcome to the main informational page of the Institutional Review Board (IRB). You'll find information below on what the IRB does, what kinds of research are and are not within the IRB's purview, and how to submit a proposal to the IRB to receive approval for your research. The actual submission process takes place in the IRB's portal on IRIS.

1. What is the IRB?
2. What kinds of research require IRB review?
3. Categories of review
4. How to submit a proposal
5. International Compilation of Human Research Standards
6. Frequently Asked Questions

What is the IRB?

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, which ensure that human subjects are protected from undue risk of harm as a result of participating in a research project. 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 laid out 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 is 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.

What kinds of research require IRB review?

The IRB reviews any research conducted on a human subject. A human subject means a living individual about whom a researcher 1) obtains and analyzes data or biospecimens through interaction or intervention with the individual, and uses, studies or 2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Forms of research on human subjects that must be reviewed includes:

• Faculty research
• Senior theses
• Student projects conducted outside the classroom (e.g., independent projects, projects funded by special grants)
• A limited set of classroom projects.

Generally, the types of research involving humans that do not fall within the IRB's purview include:

• Most classroom projects. If your project is a term paper, assignment for a class, etc., and will not be publicized beyond the classroom, it is not considered "research" by federal guidelines, and thus it is outside the IRB's purview. However, note that since retroactive approval cannot be given, a classroom project that may reasonably evolve into a conference presentation, journal article, or other widely-shared research should have its research protocol reviewed by the IRB before data collection, as the project may go beyond the classroom. (While senior thesis is technically listed as a "course" on your record, thesis projects are considered research and thus are under the IRB's purview.)
• De-identified public data. The use of data that are both publicly available (e.g., through a public website, publication, or subscription) AND de-identified (so that it is impossible to link a record to a particular individual) is not considered "human subjects research" and is thus not subject to IRB approval. Examples include public-use census data, National Election Studies, National Center for Health Statistics, etc. Investigators should contact the IRB if they are uncertain as to whether the data qualifies as “publicly available” or “de-identified.” 

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. This is inputted into the same submission form as all other proposals, although exempt proposals only require filling out a very brief portion of the form. Confirmation of exemption can be expected within one week.

The following exempt categories of research are used at Reed:

Exempt Category I: Educational Practices. This category is for research involving educational practices (e.g. instructional strategies) that are not likely to adversely impact students’ opportunity to learn. It is conducted in normal educational settings. The research could compare the effectiveness of different methods of instruction or classroom management or examine varying curricula.

Exempt Category II: Educational Tests, Survey Procedures, Interview Procedures, or Observation of Public Behavior. This category is for survey, interview, or observation data that 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 ensured that adequate provisions are in place to protect participants’ privacy and maintain confidentiality.

Exempt Category III: 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 exempt category II, 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 ensured that adequate provisions are in place to protect participants’ privacy and maintain confidentiality.

Exempt Category IV: Secondary Research for Which Consent is Not Required. This category applies to secondary research (i.e. reuse of data originally collected for a separate project) of identifiable information or biospecimens. Informed consent is not needed if at least one of the following criteria is met: (1) the research uses only publicly available private 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. (Refer to 45 CFR 46.104 for details.)

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 is not included in the exempt categories above but still poses no more than minimal risk to participants is 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 no greater than those ordinarily encountered in daily life or during routine physical or psychological tests.

The following expedited categories of research are used at Reed:

Expedited Category I: Minimal-risk biomedical interventions. (HHS Categories 1-4) 

• Researching the effects of medical devices or drugs posing minimal risk;
• Collecting biological specimens by non-invasive or minimally invasive means;
• Collecting medical data by non-invasive means.

Expedited Category II: Data repurposing. (HHS Category 5) 

• Research on data that have already been collected (with prior IRB approval);
• Research on data that will be collected for non-research purposes.

Expedited Category III: Minimal-risk recordings. (HHS Category 6) 

• Collecting voice, video, digital, or image recordings for research purposes, where the inherent identifiability in these recordings would not place the human subject at more than minimal risk of harm.

Expedited Category IV: Continuations. (HHS Category 7) 

• Continuing research (with prior IRB approval) where no more than minimal risk is presented.

The same submission form is used for expedited proposals as for other categories. Normally, an expedited review will be completed in 2-3 weeks.

Full Committee Review

Research that involves more than minimal risk must be submitted for full review. (Note that this is the least common type of review we typically see.) Full review requires a meeting of the IRB, with a quorum of its members present; as such, 3 meetings per semester are scheduled ahead of time. The deadline for submission of proposals requiring full review is approximately 10 days before the next scheduled committee meeting. Please see the Committee Calendar for submission deadlines.

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 (a subcommittee of) the IRB.

Research in the following categories requires full committee review.

1. Vulnerable participant groups
   • Children (<18 years of age) being asked to do risky or deceptive tasks,
   • Clinical populations (e.g. people with serious medical conditions),
   • Incarcerated or unhoused individuals,
   • Individuals who cannot provide informed consent (e.g. due to brain damage).
2. Stress- or pain-inducing procedures
   • the use of aversive or physically painful stimuli,
   • the induction of emotional distress (e.g. embarrassment, frustration, anxiety, loss of self-esteem, anger, or sexual arousal),
   • the induction of physical stress (e.g. through exercise, sleep deprivation).
3. Procedures that might lead to physical injury, including the consumption of any substance, (e.g., coffee, tea, tobacco, over-the-counter medications).
4. Procedures that might raise ethical objections in participants
   • deception by the researcher or confederates,
   • manipulations of participants’ attitudes or behaviors,
   • observation of behavior in non-public settings without advance consent.
5. The collection of personally sensitive data requiring unusual procedures to ensure confidentiality.

How to submit a proposal

1. You (and your adviser, if applicable) complete online CITI training to ensure that the research team is fully versed in concepts of privacy, consent, risk, and data security.
2. You fill out the following forms in Word:
   • submission form
   • consent form(s)
   • recruitment text & sample questions/stimuli
   • appendices for special cases (e.g. working with children, non-English speakers, individuals outside the US, Native/tribal groups)
3. Upload all forms + your CITI training certificate via IRB portal on IRIS
4. (For students:) Faculty adviser uploads their CITI certificate to their profile
5. (For students:) Faculty adviser approves submission on IRIS (or else the IRB won't even see it!)
6. IRB admin Kayla reviews, may ask for initial corrections (e.g. uploading missing forms)
7. IRB reviews, feedback sent via IRIS
8. You make changes, with highlights in yellow, to address feedback, and re-upload
9. IRB sends approval letter and email, and you can begin your research!

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.

Our student intern Jewel Colitre also holds drop-in office hours on Thursdays 4:45-5:45pm in the MRC. Come in with your questions!

Renewal

Federally-funded projects are approved for 1 year and require renewal for continuation of the work. Non-federally-funded projects do not need renewal.

Addenda

Investigators can submit addenda to the IRB for changes to an approved 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.