Who needs to review my project?

Determining the Appropriate Review Procedure for a Project Involving Human Subjects

There are many different kinds of projects with human subjects. Different projects require different kinds of review procedures before the data collection and/or analysis component of the project can begin. The review procedure required by a particular project depends on the type of project it is and the “level-of-review” characteristics it includes. This document explains how to identify a project’s type, its level-of-review characteristics, and the review procedure it needs to undergo.

Members of the Whitman College community incur obligations for the respect and protection of human subjects when they undertake projects that

1. Will be conducted at and/or sponsored by Whitman College.
2. Involve the collection of data through intervention or interaction with human subjects, and/or the collection or analysis of personally-identifiable private information.

According to College policy, all such projects must include provisions for protecting the subjects’ rights and well-being. These provisions are largely determined by federal regulations for the protection of human subjects and are explained in detail in the Whitman College Policy on Studies Involving Human Subjects. In most cases, the data collection component of the project must be reviewed and approved by an authorized ethics reviewer to ensure that the project is consistent with the Code before data collection begins. For some kinds of projects, only the Chair of the IRB (or a designate in some cases) will serve as the ethics reviewer, but for many other kinds of projects, more extensive participation in the review process (a “higher level of review”) is required.

This document describes:

1. Three different human subjects project types
2. Six different level-of-review characteristics that elevate the level of review a project must receive
3. Two review procedures established by the College for projects of different types and characteristics
4. A series of steps outlining the process of submitting a proposal

IS MY PROJECT CONSIDERED RESEARCH?

HUMAN SUBJECTS PROJECT TYPES

A project’s type is determined by its purpose and design. In general, the more broadly applicable the results of a project, the higher the level of review it must receive. Human subjects projects at Whitman College fall into one of the following three categories

1. Type I: Limited inquiry for campus purposes only. An investigation designed principally to inform student learning, policy analysis, policy development, program evaluation, service improvement efforts, or other institutional purposes within the Whitman community (including students, faculty, staff, alumni, Board members, and/or administrators). This is not considered research that needs to undergo review by an IRB.
2. Type II: Research for a course. An investigation designed principally to provide instruction and experience in disciplinary research methods. The subjects in a research practicum may include individuals who are not members of the Whitman community; however, if data collection involves recording (either video or audio), or involves sensitive subjects or more than minimal risk to participants, then a higher level of review is required. If none of these apply, these kinds of investigations are not considered research that needs to undergo review by an IRB.
3. Type III: Federally-defined research. “A systematic investigation designed to develop or contribute to generalizable knowledge” [45 CFR 46.103(b)(1)]. The key difference between the first two project levels and a Level III project is that a Level III project is intentionally constructed to yield “generalizable knowledge.” This is considered research. This means that the intended audience for a federally-defined research project always includes other scholars and researchers with expertise in the subject matter and/or the methodology of the project. In order to speak to this audience, such projects must be rigorously designed to permit conclusions to be drawn about subjects other than those who are eligible for inclusion in the sample studied by the investigator (the “study population”). In addition, “generalizable” research also includes the intention to disseminate the project results to an audience outside a Whitman College classroom. This includes presentations at the Whitman College Undergraduate Conference, honors theses in the library, presentations at professional conferences, or publications. If an investigator is unsure whether project findings will be generalizable, it is advisable to assume that they will be and to apply for a higher level of review. This would permit future generalization and dissemination if warranted by the design and findings of the study.

LEVEL-OF-REVIEW CHARACTERISTICS

Within Type III, projects may have a number of additional characteristics that affect the level of review they must undergo (either expedited or full review). These characteristics usually require an investigator to take extra precautions to protect subjects’ rights and well-being; as a result, they also require increased participation in the review and approval process to make sure the appropriate precautions are built in to the design of the project. There are six different level-of-review characteristics that, together with project type, increase the level of review a project must receive before data collection begins:

1. More than minimal risk to subjects, including the use of deception
2. Need for special protections for potentially vulnerable subjects
3. Use of personally-identifiable private information
4. External dissemination of project findings
5. Ineligibility for exempt status (applicable only to federally-defined research projects)
6. Ineligibility for expedited review (applicable only to federally-defined research projects)

Each characteristic is briefly described below. These characteristics are discussed in considerably more detail in Whitman College Policy on Studies Involving Human Subjects, which defines each characteristic in detail.

1. More than minimal risk to subjects
   
   According to federal regulations, a project poses only minimal risk when “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” (45 CFR 46.102(i)). Projects that often pose more than minimal risk include:
   • those that ask subjects for information about personal or sensitive topics (e.g., sexual behavior or attitudes; use of or attitudes about drugs or alcohol; family dynamics; friendships; body image; religious or political beliefs; relationships with co-workers or care-givers);
   • projects that involve deception;
   • projects that require physical exertion beyond that required for daily routines;
   • projects that impose physical or psychological stress on subjects;
   • projects that manipulate an individual’s physiological requirements (nutrition, sleep, etc.); and
   • projects that manipulate an individual’s psychological or social characteristics (imposing isolation, affecting self-esteems, etc.).
   Projects that involve more than minimal risk to subjects require a higher level of review.
2. Need for special protections for potentially vulnerable subjects
   
   Subjects are considered to be members of “vulnerable populations,” according to federal regulations, when they are:
   • minors (i.e., under age 18, but see the policy for international populations);
   • residents of health care or long-term care facilities;
   • mentally disabled;
   • pregnant;
   • incarcerated;
   • economically or educationally disadvantaged.
   Participation in human subjects projects may pose greater risks to these persons, depending on the nature of the project. The involvement of potentially vulnerable subjects may therefore require additional measures to protect these subjects’ rights and well-being. This in turn increases the obligation of the College to verify that the appropriate protections have been built in. Consequently, if a project involves members of vulnerable populations, the highest level of review is usually required.
3. Use of personally-identifiable private information
   
   Personally-identifiable private information is non-public information about a subject that includes identifiers – names, ID numbers, specific demographic information about the subject, or other identifying details – that would allow the investigator (or others with whom the investigator shares project findings) to identify the information as belonging to the subject. In other words, it is information that can be linked with a specific individual. Projects that involve the use of personally-identifiable private information – such as obtaining a non-public list of the members of a student organization to recruit project participants, collecting information through face-to-face interviews, distributing surveys where identification numbers are matched to individual names or other identifying details, or analyzing data from transcripts or other educational records – require a higher level of review.
4. External dissemination of findings
   
   Dissemination refers to the sharing of project findings with others. Dissemination may be:
   • electronic (e.g., posting project findings on a website)
   • written (e.g., submitting a research paper to a journal or providing a report to a community organization)
   • oral (e.g., making a presentation)
   • visual (e.g., preparing a project poster and putting it in a public space)
   • or any combination of these.
   In many cases, projects involve internal dissemination only, which means that the findings will be shared only with members of the Whitman community (students, faculty, staff, alumni, Board members, and/or College administrators) and/or with the subjects who participated in the project. One common example of this is projects that involve a class presentation. However, some projects involve external dissemination to audiences outside the Whitman community. For example, presentations at the Undergraduate Conference are considered external dissemination, as are honors theses that are available in Penrose library. Projects with external dissemination require a higher level of review.
5. Eligibility for exempt status (applicable only to federally-defined research projects)
   
   “Exempt status” is a federally-designated level-of-review characteristic that is only associated with Level III projects. Exempt status means not subject to review by the full IRB. It does NOT mean “not research,” “not subject to any review,” or “not subject to the provisions of the Whitman College Policy on Studies Involving Human Subjects.” In order to be eligible for exempt status, a project MUST have the following characteristics:
   • The research procedures must present no more than minimal risk to the subjects
   • Identification of the subjects and/or their responses must present no more than minimal risk to the subjects, or the project must have been designed to include privacy and confidentiality protections that result in minimal risk of disclosure
   • The research is not federally-classified
   In this case, the proposal must be submitted for review by the Chair of the IRB. The research may not begin until the Chair confirms the exempt status of the project.
6. Eligibility for Expedited Review. (applicable only to federally-defined research projects). “Expedited review” is a federally-designated level-of-review characteristic that applies only to Level III projects which are not otherwise exempt from college-wide IRB review (see above). Expedited review refers to review by only one or two members of the IRB, rather than by the full IRB. Projects are subject to expedited review (but not full IRB review) if they consist of one or more of the following kinds of research activities:
   1. Data collection in which the subjects’ information is confidential
   2. Data collection from public officials or candidates
   3. Data collection that is already governed by federal regulations requiring confidentiality (e.g., HIPAA [Health Insurance Portability and Accountability Act] or FERPA [Family Educational Rights and Privacy Act])
   4. Analysis of existing data which are publicly-available
   5. Program evaluation for public agencies
   6. Consumer studies with safe foods or flavors
   
   In addition to the above list (which determines the difference between exempt and expedited), in order to be eligible for expedited review, a project MUST have all of the following characteristics:
   • The research procedures must present no more than minimal risk to the subjects
   • Identification of the subjects and/or their responses must present no more than minimal risk to the subjects, or the project must have been designed to include privacy and confidentiality protections that result in minimal risk of disclosure
   • The research is not federally-defined
   
   If these requirements are met by a research project, it may undergo expedited review if it consists of one or more of the following kinds of research activities:
   1. Scholarship of teaching and learning projects
   2. Data collection which is EITHER anonymous OR no more than minimal risk (if it is both, the project is exempt)
   3. Analysis of existing data which are private but anonymized by the investigator before publication
   4. Research procedures which are federally-designated as eligible for expedited review, including:
      1. Selected types of clinical studies of drugs and medical devices
      2. Selected types of blood sample collection by finger stick, heel stick, ear stick, or venipuncture
      3. Prospective collection of biological specimens for research purposes by noninvasive means
      4. Selected types of data collection through noninvasive procedures routinely employed in clinical practice
      5. Research involving existing data, documents, records, or specimens that have been, or will be, collected for non-research purposes
      6. Data collection from voice, video, digital, or image recordings previously made for research purposes
      7. Selected studies of individual or group characteristics or behavior
      8. Most instances of continuing review of research previously approved by the full IRB

Federally-defined research projects which are neither eligible for exempt status nor eligible for expedited review must undergo the highest level of review (full IRB review) before the human subjects data collection or analysis can begin.

REVIEW PROCEDURES

Whitman College has established two kinds of review procedures to fulfill its ethical and legal obligations for the respect and protection of human subjects. They are as follows

1. Review by instructor or supervisor. Responsibility for ensuring compliance with the Code rests with the instructor (in the case of student projects) or the supervisor (in the case of faculty or staff projects). When a project is being conducted by a student organization, the faculty adviser to the organization assumes this responsibility. Investigators, instructors and supervisors are encouraged to consult at any time with a member of the college IRB for advice on interpreting and applying the Code. If a student project is required to be submitted to the IRB, it requires instructor, supervisor, or adviser review and approval. Please see the policy on the website for more details on when class projects and student research are required to undergo IRB approval.
2. IRB review. Responsibility for ensuring compliance with the Code and, in the case of federally-defined research, for verifying that a project is exempt from full IRB review, rests with the IRB. Some kinds of projects require expedited review (i.e., review by only one or two IRB members); others require full or convened review (i.e., review by all members of the IRB). The specific review procedure a project must undergo depends on its type and its level-of-review characteristics, as described above.

Project investigators (or instructors or advisors for student projects) are encouraged to contact any member of the Whitman College IRB for help in identifying the appropriate project type, level-of-review characteristics, and review procedures for their projects.

Steps for Submitting a Proposal

1. Determine whether your project meets the definition of research. If it does meet the definition of research, continue to step 2. If your project does not meet the definition of research, you do not need to submit your project.
2. Determine whether your project meets the criteria for “Exempt Review”. If your project does meet the criteria for “Exempt Review”, download and fill in the forms for Exempt Review. These forms include contact information and a brief questionnaire to confirm that your project should be Exempt. Then submit the forms online. You may not begin your research until the status of your project is confirmed by the IRB.
3. If your project requires either Expedited or Full IRB review, download and fill in the forms for “Full Review”. The entire set of forms must be completed in order for your proposal to be considered by the committee. If you are a student, your faculty advisor must approve your proposal before they are reviewed by the IRB. The Chair of the IRB will determine whether your project meets the criteria for “Expedited Review”, in which case the Chair or a designate will review your proposal. If your proposal requires full IRB review, then all members of the IRB will review your proposal. You may not begin your research until you receive approval by the IRB.
4. If your project is denied approval, you will receive a letter explaining what aspects of your project were troubling to the IRB. You will then be invited to respond to that letter, detailing how you will address the concerns of the IRB. If your response adequately addresses the concerns of the IRB, you may then be granted approval.