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Washington State University

HRPP policies & procedures manual

800: IRB-required investigator actions

1. Purpose

This policy describes what the IRB requires of investigators in the conduct of research, whether it is single-site or multi-site.

2. Policy

It is the investigator’s responsibility to keep the IRB informed of unexpected, protocol- related, non-serious and serious adverse events and other unexpected findings that could affect the risk/benefit ratio of the research.  An investigator is responsible for the accurate documentation, investigation and follow-up of all possible study related adverse events. Investigators are also responsible for informing government and other sponsors of any unanticipated or serious adverse events, as appropriate.

3. Specific policies

3.1 IRB review of research

All human subject research that is conducted by or under the direction of any employee, faculty, staff, student, agent, or affiliate of WSU in connection with his or her institutional responsibilities must be reviewed by the IRB.

3.2 Investigator expectations

It is an expectation that the investigator will:

  • Disclose any conflict of interest (financial or other) that may affect the relationship with the research subject or the outcome of the research.
  • Have sufficient time to conduct and complete the research.
  • Ensure that all persons assisting in the research are adequately trained and informed about the protocol.
  • Consider whether other procedures involving less risk are more appropriate when designing the research and will employ sound scientific design in the conduct of research.
  • Minimize risk to the subject.
  • Monitor subjects for potential harm and takes steps to minimize or lessen those harms when possible.
  • Modify his/her research designs to mitigate potential injuries in on-going research.
  • Develop and implement appropriate recruitment techniques.
  • Equitably recruit and select subjects for the research.
  • Obtain and document informed consent.
  • Quickly respond to requests of information or complaints.
  • Keep current on policies and procedures that affect human subject protections.
  • Seek guidance from IRB or other areas as appropriate.
  • Maintain research records, such as signed and dated consent documents, correspondence with IRB, supporting data, and any medical records associated with the research.

3.3 Informed consent

The investigator must obtain informed consent from subjects prior to their enrollment into the research. The investigator must use the informed consent document approved by the IRB.  Approval and expiration dates are indicated on the first page of the consent document. Consent documents are valid only during the dates indicated on the form, and the investigator may use the forms only during the period for which they are valid. Investigators must follow federal guidelines and University policy for obtaining informed consent.

3.4 Reports of unanticipated problems involving risks to subjects or others

The IRB must be informed of any serious, unexpected, or unanticipated problems involving risks to subjects or others that occur during the approval period.  See 408: Unanticipated Problems for more information.

3.5 Changes in approved research/amendments

Changes in approved research during the period for which approval has already been given may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to human subjects.

Investigators or sponsors must submit requests for changes to the IRB in writing using an amendment form.  If the change represents more than a minimal risk to subjects, it must be reviewed and approved by the full IRB.  Minor changes involving no more than minimal risk to the subject will be reviewed by the expedited review process. Changes in exempt projects can be approved by the IRB coordinator. See 402: Amendments/Study Updates for more information.

3.6 Continuations/renewals and project closure

Continuations

The length of time approval is given to a research protocol will be no more than one year, and is dependent on the risk involved with the research. Investigators are responsible for requesting renewal in anticipation of the expiration of the approval period. Investigators or their designees and/or sponsors are required to provide a periodic report regarding their investigation prior to the end of the approval period, or upon completion of the study. For renewal of approval, a continuing review form will be provided to the investigator 45 days before study expiration date. A second reminder will be sent one (1) to two (2) weeks before the expiration date.

Project closure

All studies need to be closed once completed. A closeout report form needs to be filled out and sent into the IRB office.

Exempt studies

May be closed when all contact with the subjects is completed.

Expedited studies

May be closed when all subject contact is complete and the study does not involve an FDA-regulated drug or device.

Full-board studies

May be closed when data analysis is completed or sponsor indicates close of the study.

3.7 Student-conducted research

The IRB does not review classroom projects/activities. Classroom projects/activities are generally considered to be conducted for a class assignment and turned in to the faculty/instructor. If the class assignment involves subjects from vulnerable populations or if the subjects are members of vulnerable populations, the Office of Research Assurances should be contacted for advice and assistance. In certain situations where a class project will be used as part of larger research, IRB review and approval may be required. Contact the IRB coordinator for help and assistance in determining the need for and completing the appropriate application. See additional guidance on the IRB web page, Do I need IRB review?.

3.8 Education requirement (CITI human subject training)

Non-exempt (expedited and full-board) applications

All researchers (PIs on the nonexempt IRB application) must complete human subject protection education prior to (or concurrent with) submitting a non-exempt human subject research application to the IRB. In addition, refresher education will be required every 5 years.

WSU uses human subject education provided by CITI (Collaborative Institutional Training Initiative). The CITI program is widely accepted as an industry standard among university IRBs and by the federal government. The IRB requires the completion of the CITI social/behavioral modules identified with WSU. The researcher may submit a certificate indicating completion of human subject education from the CITI program along with their application. The researcher is responsible to maintain records of their human subject education and provide copies or relevant information of completion along with their application submissions.

The IRB will verify the CITI program requirement for the principal investigator on the non-exempt IRB application only. A non-exempt IRB application may not be approved until the principal investigator has completed the CITI program. The principal investigator on the IRB application is responsible to ensure that all other research personnel are properly trained (preferably through CITI) and have the experience necessary to perform the research.

Exempt applications

All researchers (principal investigators on the exempt applications) should complete human subject protection education, preferably prior to submitting the application to the IRB. WSU uses human subject education provided by CITI (Collaborative Institutional Training Initiative) .

Note: Funding agencies may require all personnel be having documentation of human subject training for exempt and non-exempt applications.

More information about CITI training.

3.9 Record keeping

It is the responsibility of the principal investigator to maintain records of:

  • All correspondence with the IRB
  • Copies of forms submitted to the IRB
  • Original IRB stamped consent document (all versions)
  • Signed consent documents
  • Protocols and amendments (all versions)
  • Any other documentation requested by sponsor (for funded research)

3.11 Finder’s fees and bonus payments

Finder’s fees pose a potential conflict of interest for the conduct of the research and, therefore, are not allowable. Faculty, staff, students, and all others conducting human research under the purview of WSU are strictly prohibited from offering or receiving any finder’s fee or other inducement, in cash or in kind, for the purpose of referring patients as candidates for participation in research.

Likewise, no individual or organization conducting human research under the auspices of the University may receive “bonus payments” from sponsors that are tied to the rate or timing of subject enrollment. Examples: an additional payment of $5,000 to sites if they can recruit an additional five (5) subjects in a week, or additional payment to sites that reach their recruitment goals.

4. Applicable regulations and guidelines

21 CFR 56.109, 56.111, 21 CFR 54

45 CFR 46.109, 46.111

5. Forms

None

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

WhoTask
IRB coordinatorProvide investigators with complete information package on preparing IRB submissions, securing initial and ongoing approval of research, and providing all required reports.

Secure all necessary information for ongoing IRB review and approval.

Provide guidance to investigators on IRB process.

Check all incoming studies to confirm if principal investigator and key personnel have completed the CITI training and, if not, e-mail the principal investigator a reminder to complete the training before study approval can be given.

Distribute communications to and from investigators to appropriate IRB staff and members in a timely manner.
ORA director, IRB coordinator Provide investigators with appropriate training in preparing IRB submissions, conducting the informed consent process, fulfilling ethical obligations and investigator responsibilities.