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Washington State University

HRPP policies & procedures manual

101: Activities requiring IRB review

1. Purpose

The purpose of this policy is to describe specific activities that require IRB review and the applicable regulations and definitions.

2. Policy

Investigators engaged in research involving human subjects research participants (as defined below) and all other activities which, even in part, involve such research must be reviewed and approved by the WSU IRB.

An institution becomes engaged in human subjects research when its employees or agents:

  1. Intervene or interact with living individuals for research purposes, or
  2. Obtain individually identifiable private information for research purposes.

No intervention or interaction with human participants in research, including recruitment, may begin until the IRB has reviewed and approved the research protocol.

Specific determinations as to the definition of research or human subject and their implications for the jurisdiction of the IRB under WSU policy are determined by the IRB.

3. Specific policies

The WSU IRB reviews and approves research in accordance with:

  • FDA regulations
  • DHHS regulations or other Common Rule regulations
  • Any other applicable federal, state or local regulations

Definitions

Human subjects research under FDA regulation

Activities are human subjects research under FDA regulations when they meet the FDA definition of “research” [21 CFR §50.3(c), 21 CFR §56.103(c), 21 CFR §312.3(b), or 21 CFR§812.3(h)] and involve a “subject” as defined in FDA regulations 21 CFR §50.3(g), 21 CFR §56.103, 21 CFR §812.3(p).

An activity is FDA-regulated research when:

  • The activity involves any use of a drug other than the use of an approved drug in the course of medical practice 21 CFR 312.3(b). This is the meaning of “experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act” in the definition of “clinical investigation.”
  • The activity evaluates the safety or effectiveness of a medical device 21 CFR 812.2(a). This is the meaning of “experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act.”
  • The results of the activity are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.

In the above criteria “approved” means “approved by the FDA for marketing.”

Under FDA regulations, individuals are considered “subjects” when they become subjects in research, either as recipients of the test article or as controls.  If the research involves a medical device, individuals are considered “subjects” when they participate in an investigation, either as individuals on whom or on whose specimens an investigational device is used or as controls.

The following activities also require IRB approval under FDA regulations:

Human subjects research under DHHS or other common rule regulations

Activities are human subjects research under DHHS regulations when they meet the following definitions:

  • “Research” means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
  • “Human subject” means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Intervention

Includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.

Interaction

Includes communication or interpersonal contact between investigator and subject.

Private information

Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).

3.2 Determining if an activity meets the definition of human subjects research

When the IRB office receives an IRB application, the coordinator will determine if the activity meets the definition of human subject research. If it does not, the coordinator will inform the principal investigator (PI) that the research activity does not require IRB approval.

3.3 Activities requiring review

This list is not all-inclusive.

Clinical investigation
  • Experiments using a test article (drug or device) on one or more human participants that are regulated by the Food and Drug Administration or support applications for research or marketing permits for products regulated by the Food and Drug Administration.
    • Products regulated include; foods, including dietary supplements that bear a nutrient content claim or a health claim; infant formulas; food and color additives; drugs for human use; medical devices for human use; biological products for human use; and electronic products.
Standard diagnostic or therapeutic procedures
  • The collection of data about a series of established and accepted diagnostic, therapeutic procedures, or instructional methods for dissemination or contribution to generalizable knowledge.
  • An alteration in patient care or assignment for research purposes.
Innovative procedures, treatment, or instructional methods
  • A systematic investigation of innovations in diagnostic, therapeutic procedure, or instructional method in multiple research participants conducted to compare to standard procedure.
Repositories (e.g., data, specimen, etc.)
  • Preliminary activities typically designed to help the investigator refine data collection procedures. This data is to be included in the publication.
  • A storage site or mechanism by which identifiable human tissue, blood, genetic material or data are stored or archived for research by multiple investigators or multiple research projects.
Retrospective data

Retrospective review of subject records with the intent to report and/or publish the summary.

Emergency use of an investigational drug or medical device

Whenever emergency care is initiated with prior IRB review and approval, under DHHS regulations the patient may not be considered to be a research subject in a prospectively conceived research study. The data derived from the use of the test article may not be used in a prospectively conceived research study.

Ethnographic research

The investigator or his/her staff will participate, overtly or covertly, in people’s daily lives for an extended period of time. They will be watching what happens, listening to what is said, asking questions and collecting data to create a broader understanding of a particular environment, ethnic group, gender, etc.

Internet research

Online websites are set up for the purposes of collecting data regarding a particular topic. This may include the completion of questionnaires/surveys, personal data, etc.

Pilot studies

Activities including those involving only one individual may be subject to the same scrutiny as a full scale research project. Although the data derived from a pilot activity may not be included in the full scale research project, the activity would still need IRB review prior to conducting the activity.

Student-conducted research

Student-conducted research activities that meet the definition of research with human participants and that are conducted by students for work toward a degree.

3.4 Failure to submit project for IRB review

Engaging in activities that qualify as research that are subject to IRB review without obtaining such review is in violation of University policy. Each case will be evaluated by the Graduate School and additional actions may be requested.

If an investigator begins a project and later finds that the data gathered could contribute to the existing knowledge base or that the investigator wishes to publish the results, the investigator must submit a proposal to the IRB for review as soon as possible.

4. Applicable regulations and guidelines

45 CFR 46.102
21 CFR 50, 56, 312, 812

5. Forms & guidance

Decision tree for all projects
3 determinants of the need for IRB review

6. Procedures employed to implement this policy & assignment of responsibility

WhoTask
ORA director, chair
or IRB staff
Determine whether research activities require IRB review.
Provide investigators with guidance on appropriate IRB submission
requirements.