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Washington State University

HRPP policies & procedures manual

300: Principal investigator eligibility and submission requirements for IRB review

1. Purpose

The purpose of this policy is to outline the requirements with regards to the eligibility to serve as principal investigator on WSU’s human subject research applications and the required documents and supporting information for IRB review.

2. Policy

Washington State University is committed to safeguarding the rights and welfare of all individuals who serve as subjects in research conducted by agents of the University. To accomplish this goal, the University reserves the right to review and approve the training and experience of individuals who wish to assume leadership responsibilities for research with human subjects before granting status as principal investigator.

Applications and related documentation will be submitted electronically. Signatures may be electronic, as well.

IRB members often rely solely on the documentation submitted by investigators for initial and continuing review. Therefore, this material must provide IRB members with enough information about a study to assess if it adequately meets the criteria for approval.

A protocol requiring review will be scheduled for IRB review when IRB staff has determined that the information and materials submitted present an adequate description of the proposed research.

3. Specific policies

3.1 PI eligibility

It is the Washington State University Human Research Protection Program’s policy that tenured, tenure-track, and fixed-term (clinical track or research track) Washington State University faculty who are certified by Washington State University as having received training in the conduct of research using human subjects are eligible to serve as principal investigators (PI) for projects involving human research subjects.

Other faculty and staff members with an active appointment who fall into one of the following categories may be eligible to serve as PI pending approval from both the head of the unit to which the faculty or staff member belongs (chair, director or dean) and the vice president for research:

  • Emeritus faculty
  • Visiting faculty
  • Adjunct faculty
  • Clinical faculty who have primary appointments at another institution
  • Visiting scientists
  • Residents
  • Postdoctoral and clinical fellows
  • Staff whose appointments include responsibility for the direct, independent design and direction of research

Graduate and undergraduate students are not permitted to serve as a PI for research protocols involving human research subjects. Washington State University employees, who may otherwise be eligible under the above categories to be considered for PI status, cannot serve as a PI for a research protocol involving human subjects when they are conducting the research project as partial fulfillment of their graduate student obligations or training. When Washington State University employees wish to conduct research involving human subjects as part of their graduate or undergraduate program, their faculty advisor must serve as the PI of record for the research protocol and application.

3.1.1 Definitions

Principal investigator: An individual vested by the university with the primary responsibility to independently design, conduct, and supervise research involving human subjects

Tenured, tenure-track and fixed-term faculty: Those for whom WSU is the primary employer

Clinical faculty: Those for whom a non-WSU entity is the primary employer

3.1.2 Procedures

All individuals who have been designated as principal investigator on WSU IRB projects prior to November 28, 2018 will retain their eligibility to serve as PIs on these projects. Beginning on November 29, 2018, emeritus faculty, visiting faculty, adjunct faculty, clinician faculty with primary appointments at other institutions, visiting scientists, residents, postdoctoral and clinical fellows, and staff whose appointments include responsibility for the direct, independent design and direction of research should follow the application procedure described below.

Individuals  who do not meet the above criteria and would still like to be considered as PI for research involving human subjects must obtain approval from the  Human Research Protection Program (HRPP) manager. The HRPP manager will review the request based on the following information and considerations:

  • A description of the project, including title, scope of work, and sponsor, and how the project aligns with the individual’s responsibilities or authority over the project
  • Current curriculum vitae and description of experience in the conduct of research involving human subjects (if applicable)
  • Letter of appointment with WSU
  • Documentation of training in the conduct of human subjects research for institutional certification
  • A letter of support and recommendation for PI status from the appropriate WSU authority (head of the unit to which the faculty or staff member belongs; chair, director or dean), describing the applicant’s job title and expected duration of affiliation with WSU, the applicant’s qualifications, and the level of mentorship that will be provided (if applicable)
  • Endorsement of the recommendation by the principal investigator, if the proposed research is a component of a funded sponsored project for which the applicant is not the PI

The Human Research Protection Program manager will approve, approve with conditions, or deny the application, and will notify the appropriate parties of the decision. When appropriate, the requestor can appeal the manager’s decision to the director, Office of Research Assurances.

3.2 Submission requirements for initial review

Investigators applying for initial approval of a proposed non-exempt research protocol must submit (as pertinent to the research under consideration):

  • Non-exempt application form
  • Research protocol or protocol summary
  • Investigator’s brochure or device specifications
  • Questionnaires & assessment instruments
  • Proposed informed consent document/assent and permission documents (if applicable)
  • Recruitment materials, proposed subject instructions
  • Data Safety Monitoring Plan (DSMP) or Data and Safety Monitoring Board Plan (DSMB), if applicable for more than minimal risk research
  • Investigational New Drug (IND) or Device Exemption (IDE) assignment letter
  • Addenda as appropriate for the project (If Addendum 1 is not submitted, IRB may move forward with the application review since this is not a critical part of the paperwork. However, during approval the deficiency should be addressed.)

Documents translated to a native language may be submitted after the English version has been accepted.

IRB staff will check that all questions on the form have been answered, as required. If unanswered questions remain, the IRB must document the deficiencies so that questions can be either sent to the investigators for completion or noted for the reviewer to include in his/her comments.

If for any reason the application is downgraded to exempt status, then Addendum 1 is no longer required. In such cases, IRB staff will document the reason why Addendum 1 is not included.

If Addendum 1 is missing during initial review but is still required for the non-exempt application, IRB staff will also note this to ensure that investigators provide Addendum 1 prior to final approval.

In addition, applicants may be required to submit:

  • Disclosure of significant financial interest
  • Documentation of completion of required training
  • FDA Form 1572 (drug study) or signed investigator agreement (device study)
  • Addendum 7; HIPAA documentation, documentation of approval by another University committee, e.g., Biosafety Committee and Radiation Safety Committee
  • Contract of funding agency minus the budgetary pages
Submission requirements for exempt research

Investigators applying for acknowledgement of exempt status must submit the following as part of the electronic application. (Electronic signatures are valid.)

  • Exempt application form with all appropriate signatures
  • Protocol summary (abstract)
  • Recruitment materials
  • If additional IRB review is being sought at another institution: name, address and telephone number of the other institution’s IRB

There are instances where a non-exempt protocol can be bumped down to exempt review due to low risk of the research. If that is the case, the IRB staff will proceed with the exempt review using the non-exempt application, but either remove the paperwork that is not needed or simply say “not applicable.” The correction on the paperwork and informing the PI of the paperwork correction should be documented.

3.3 Submission requirements for modification/amendment and continuing review modification/amendment

During the approval period, investigators must submit documentation to inform the IRB about changes in the status of the study before implementing changes including, but not limited to:

  • Request for amendment form
  • Current approved consent/assent document if the consent will be changed
  • Revised IRB submission form if change is significant
  • Any other relevant documents provided by the investigator
Continuation/renewal of IRB approval

At least 14 days prior to the IRB approval expiration date, investigators requesting renewal of an approved research project must submit (at minimum) the completed continuing review form.

IRB staff will send courtesy notices prior to expiration.

3.4 Action taken if documentation is inadequate or if additional information is required

If the IRB or staff determines that the submitted documents are not adequate, investigators may be required to submit additional information, or their presence may be required to answer questions or explain the details of the study. No incomplete submissions will be reviewed by the IRB.

4. Applicable regulations and guidelines

45 CFR 46.115

21 CFR 56.108 (a)(4)

21 CFR 312, 812

5. Forms

Non-exempt application

Exemption determination application

Request for amendment

Continuing review form

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

WhoTask
IRB coordinator
  • Ensure that complete submission information is available and provided to all investigators.

  • Date stamp and document receipt of all submissions.

  • Review submission for completeness. Note any missing information.

  • Contact other committee(s) to check on status of study review and or approval.

  • Evaluate and review claims for exemption from IRB review, document.

  • Evaluate submissions that fit requirements for expedited review. Route to chair or reviewer.

  • Prepare submissions for IRB review.
    Request from investigator/project ORA director any missing elements from incomplete submissions.

  • Add new submissions for full IRB review to agenda for next meeting.
ORA director, chair,
IRB coordinator
  • For full-board new studies/continuations/modifications: Review submissions, assign to primary/secondary reviewers and/or determine if expert consultation is needed.

  • Review high-risk studies and route to full board.

  • Review studies involving vulnerable populations and route to full board.