Whitman College Institutional Review Board
August 2022: Whitman College has a new version of the IRB form. Please use this form for all submissions going forward.
July 2022: Whitman continues to operate under special protocols regarding the COVID-19 pandemic. The Whitman IRB requires all proposals to comply with these protocols and with Washington State requirements. Proposals should clearly identify and explain any COVID-related risks associated with their research (e.g., risks related to in-person research).
The purpose of the Whitman College Institutional Review Board (IRB) is to review all research conducted by Whitman-affiliated researchers that involves human participants. Our job is to evaluate ethical concerns related to research with human participants, ensure that risks and benefits are balanced, and ensure that risks are minimized as much as possible. We will evaluate your proposal with these guiding principles in mind.
Alissa Cordner, Chair of the IRB Committee 2022-2023 academic year
Helen Kim, Research Integrity Officer, 509-527-5187
Forms and Information
To submit a proposal
Download and complete the IRB form. Finalize other required materials, including:
- Consent form(s), if needed.
- Research instruments, including surveys, questionnaires, debriefing forms, list of interview topics, etc.
Note: If you are a student, do not submit your proposal until you have received consent to do so from your faculty sponsor or research advisor. The faculty sponsor must review the IRB form and all required materials before submission. The faculty sponsor should add their name and the date to the IRB Form indicating that they have reviewed the proposal and approve of sending it to the IRB for review. The IRB will include the faculty sponsor on all email correspondence related to student proposals.
Once you have finalized your proposal and other materials, email them all to firstname.lastname@example.org in a single email. Make sure all files are clearly named with the last name of the principal researcher. Students submitting IRB forms must CC their faculty sponsor on this email and any subsequent communications with the IRB.
IRB proposals not requiring full board review are reviewed on a rolling basis. Initial review is typically completed within two weeks. The full IRB committee convenes once per month to discuss proposals requiring full board review. Those meetings are typically the first Friday of each month at 9 a.m. Access the committee schedule. For a proposal to be discussed at a full board review meeting, it must be submitted by 5 p.m. the previous Friday.
Important Information about IRB Review of Research
- Definition of Research
- Risks to Consider
- Informed Consent
- Research Categories
- Student Research
- Faculty Research Involving Students
- Research Participant Compensation
Definitions of Research
Based on U.S. regulations that govern this review process, called The Common Rule, research is defined as: “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
A human subject (or research participant) is defined as “a living individual about whom an investigator (whether professional or student) conducting research,” which involves:
(i) Obtaining information or biospecimens through intervention orinteraction with the individual, and uses, studies or analyzes the information or biospecimens;
(ii) Obtaining, using, studying, analyzing, or generating identifiable private information or identifiable biospecimens.”
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 nonpublic 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. This includes work conducted for a senior thesis or presentations, such as the Whitman Undergraduate Conference.
The following activities are NOT considered research:
Surveys and interviews for the purposes of:
- Journalism, such as polls or interviews done solely for the college newspaper.
- Advocacy, such as a campaign to get students to stop smoking.
- 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.
- Classroom activities that are part of the instructional process. However, participation by students in any teaching activity that involves risk to the student, or is not necessary to the course of study or training in which it occurs, must be accompanied by the student’s voluntary, informed consent and must be reviewed and approved by the IRB. If the instructor and/or student wish to present or publish information beyond the classroom (e.g., in a departmental colloquium or in the Undergraduate 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, the faculty member may submit one proposal for the class. However, if each student’s project is fundamentally different, then separate proposals must be submitted.
- Treatment programs. Activities in which the primary purpose is 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.
- 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
- Some secondary data analysis. Analysis of secondary (already collected) data, such as existing surveys or databases, when all of the following conditions apply:
- The data is fully, publicly available.
- The data contain no identifiable private information whatsoever.
- The researcher will not attempt to identify participants in any way (e.g. linking multiple data sources together).
In general, the following kinds of investigations must be reviewed before data collection begins:
- Investigations in which the researcher creates or influences the situation in which the human subjects find themselves for the purposes of collecting information about those subjects. This includes naturalistic observational studies in which the presence of the observer may affect the situation, as well as ethnographic or participant observation studies and experimental manipulations whether in the field or the laboratory.
- Investigations in which the researcher interacts with the human subjects in order to obtain information from those subjects. Biological research in which people are measured or fluids drawn or collected obviously falls under interaction as well as questionnaire and interview research, even when the interaction is an informal conversation, yet the content of which will be recorded in notes at a later time.
- Investigations in which the research uses already existing data about human subjects in which the identity of the subjects is known from the data or the data are of such a personal nature that people might reasonably expect the data to be held in confidence. Obvious examples would be transcripts or medical records. Less clear-cut examples might include email posts to a listserv or letters written to a public person, depending on when the records are opened.
All other types of data collection require approval, including all research involving minors, and surveys of or experiments on adults (those 18 years of age or older).
Risks to Consider
All research involves some risk. According to federal regulations, “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.”
Physical and health risks clearly need to be considered. Additionally, several other categories of risk also need to be considered. One is the possibility of creating mental or emotional distress (including embarrassment to the participant). For example, asking questions about some aspects of a participant’s background might trigger traumatic memories and could be viewed as an emotional risk.
Another category of risk is the risk of the loss of privacy. Asking very personal questions on a questionnaire or in an interview, where the investigator will be able to link the answers to the participant, constitutes a loss of privacy. In addition, there may be potential for compromise of confidentiality, if through publication of your work or inadvertent disclosure some participants could be identified with their responses.
It is also necessary to consider possible risks to researchers. These may be physical in nature (e.g., if the research poses the danger of bodily harm) or mental/emotional in nature (e.g., if the research topic is potentially traumatizing). The research design should minimize risks to researchers as well as risks to participants.
The investigator’s obligations include designing the study so that the incidence of risk and stress are minimized to the greatest degree possible, describing these risks accurately in the protocols and minimizing the number of participants who are exposed to these risks. The investigator must make appropriate provisions for care of the participants in the course of the study. The investigator is responsible for terminating the study if hazards or risks to participants become apparent or may be incompatible with the benefits of the study. Investigators must report to the IRB any injuries or adverse reactions associated with the study.
Participants must be fully informed about the nature of the research, the procedures, the risks and the benefits, and must agree voluntarily to participate. This agreement is called “informed consent.”
The IRB expects that research projects involving human participants will secure informed consent from all participants. Researchers must indicate the type of consent they will use in their IRB proposal.
In most research projects, informed consent should be written informed consent involving a consent form that is signed by participants before data collection commences, and is securely stored by the researchers. It is good practice to provide a copy of this consent form to participants.
Informed consent documents must contain the following information (not necessarily in this order or this particular wording):
- A statement that the study involves research.
- A description of any reasonably foreseeable risks or discomforts to the subject.
- A description of benefits to the subject or others that may be reasonably expected from the research.
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which they are otherwise entitled.
- A statement describing how confidentiality of records identifying the subject will be maintained.
- If relevant, the disclosure of appropriate alternative procedures or course of treatment, that might be advantageous to the subject.
- For medical research involving more than minimal risk, an explanation as to whether or not any compensation or any medical treatments are available if injury occurs during study participation.
- The identification of an individual the subject can contact for answers to questions related to the research, research-related injury or their rights as a research subject.
- This should include the researcher, the faculty sponsor if relevant, and the Whitman College IRB ( email@example.com).
- For research involving only certain types of participants, a statement regarding who is eligible for participation (e.g., only adults 18 years of age and older).
If there is minimal or no risk and securing written informed consent is impossible or impractical (e.g., a telephone survey or certain observations of public behavior), the investigator may apply to have the requirement waived by the IRB. Sometimes this involves verbal consent, where the contents of the consent document are shared aloud with research participants.
In some situations, implied or situational consent may be possible. The federal Common Role only authorizes research with implied, situational or no consent if all of the following conditions are met:
- The research is of no more than minimal risk,
- Using implied or situational consent will not harm to participants, and
- The research could not “practicably be carried out without the waiver or alteration.”
In some qualitative or ethnographic research, implied or situational consent may pose less of a risk than written, signed consent. In many ethnographic situations, offering a printed form itself is a risk to participants and may create harm instead of ensuring informed consent. Implied or situational consent may be appropriate in research situations where participants are to determine whether and how to converse and interact with the researcher.
Sometimes research also involves community consent, in which some community authority must approve the research before any individual community member is asked to participate (otherwise the approached individuals may be at risk of sanction for engaging in anti-community activities).
For more information about consent in qualitative research, see Stuart Plattner, “ Human Subjects Protections and Anthropology.”
There are three categories of IRB review for research involving human subjects: full board, expedited, and exempt. All three (even exempt) require IRB review before researchers begin any data collection. This is because only an IRB is authorized to determine whether research is exempt from IRB review. For a detailed description of the research categories, see “ Detailed Research Categories and review the Federal Regulation 45 CFR 46.”
Note: This is distinct from activities that are not considered “research with human subjects.” See the Definition of Research section to determine whether your research falls under IRB review.
Exempt research: Research can be approved as exempt if it involves no more than minimal risk and fits one of the exempt review categories as defined by federal regulation 45 CFR 46. Studies that may qualify for exempt must still be submitted to the IRB for review. The exempt categories include: certain types of education research; certain types of surveys, interviews, educational tests and public observations with adult participants; benign behavioral interventions; analysis of previously collected and identifiable data; and taste and food evaluation studies.
In general, a project cannot be exempt if it 1) involves more than minimal risk, 2) involves a vulnerable population or 3) involves the collection of identifiable personal information.
Expedited research: Research can be approved as expedited if it involves no more than minimal risk and fits in one of the federally designated expedited review categories. The expedited categories include: research involving previously collective materials; collection of data from voice, video, digital or image recordings made for research purposes; certain types of clinical, medical and/or biological research; and qualitative or survey research on individual or group characteristics or behavior.
A research project may not qualify for expedited review if identification of the participants and/or their responses would reasonably place them at risk of criminal or civil liability; be damaging to their financial standing, employability, insurability or reputation; or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to the invasion of privacy and breach of confidentiality are no greater than minimal.
The majority of projects reviewed by the Whitman IRB fall into the expedited category. These projects do not require review by the full IRB.
Full Board Review
All other research requires review by the full IRB. This includes research involving more than minimal risk; most research involving children or other vulnerable populations; most research involving deception; and most research involving invasive medical or biological specimen collection methods.
The full IRB committee convenes once per month to discuss proposals requiring full board review. Those meetings are typically the first Friday of each month at 9 a.m. See the current schedule. For a proposal to be discussed at a full board review meeting, it must be submitted by 5 p.m. the previous Friday.
At Whitman College, part of the educational process includes understanding and participating in research. Students participate in the full scope of a research project, including formulating research questions, devising protocols, writing a careful description for proposed activities, carrying them out and reporting the results. In particular, students must learn to consider the ethical dimension of activities involved and any risks to human participants.
As with faculty and staff research, student research (or research practice) that involves human participants must have approval from the IRB.
All researchers, including students, are required to have adequate training in research ethics prior to receiving IRB approval. Adequate training includes undergraduate or graduate level training in research methods and ethics (e.g., a research methods course). If the researcher has not completed adequate ethics training in a Whitman College class, they must complete the CITI Basic certification before submitting an IRB proposal.
Course projects whose results are to be presented only to current class members are not required to be reviewed by the IRB. However, if the instructor hopes that some student projects may produce results of high enough quality to justify public presentation (e.g., to the Whitman Undergraduate Conference or a professional conference), then all projects involving human participants should be reviewed by the IRB. A professor may submit one proposal for the entire class, if appropriate. The results of research projects involving human participants may not be presented outside a classroom setting unless the research was approved by the IRB in advance, and approval can never be given retroactively to work already done. Because federal law explicitly prohibits retroactive approval, no appeal can be made to any campus body to overturn this requirement of the policy.
Special note regarding student thesis projects: All student theses that include human participants must be approved by the IRB before the research begins. This enables all student theses to be presented publicly (e.g., at a conference, a professional publication or filed in Penrose Library). Additionally, submitting a proposal serves an educational purpose for students. Senior theses are meant to be an introduction to original research, which, in graduate school and beyond, does include the process of considering the ethical implications of one’s research project and submitting a proposal to an IRB.
The instructor and the IRB are responsible (i.e., liable) for ensuring that there are minimal risks, to both the participants and the student researchers.
Faculty Research Involving Students
Faculty who involve students in research with human participants, either as participants or as researchers themselves, have special responsibilities to those students.
- No one may be forced or coerced into being a research participant. When research participation is a course requirement or an opportunity for extra credit, students must be offered an equitable alternative if they choose not to participate.
- The instructor should discuss ethical considerations, the nature of risks that may be involved, the role of the IRB and what safeguards are to be used.
- The instructor is responsible (i.e. liable) for minimizing risks to student researchers, as well as to participants.