Seattle University IRB Policies and Procedures

The IRB Administration created the following policies and procedures according to Federal human subjects regulations and best practices in the field of human subjects research, while remaining sensitive to the unique nature of Seattle University and its other guiding policies. The goal of the Seattle University Institutional Review Board (IRB) is to assist, as quickly as possible, the conduct of research involving human subjects while at the same time protecting those subjects and the university. To do their part in promoting this goal, researchers must adhere to these policies and guidelines.

NOTE: in accordance with Federal regulations, researchers may not initiate studies involving human subject participants until IRB approval has been granted in writing. (IRB approval may not be granted retroactively.) Approval of proposed research is valid for one year upon written notification, as indicated in the approval letter. 

Faculty, staff, and student researchers are strongly encouraged to schedule a pre-submission consultation with the IRB Administrator or staff to receive guidance on submitting a protocol. Whether still in the idea stage, or nearing the final draft of submission, researchers will find that the approval process often occurs more quickly and more smoothly with the benefit of a pre-submission consultation.

Before initiating human subjects research, the investigator must submit a completed and signed IRB protocol submission form. Always check the Protocol Forms page to ensure using the most recent, updated form. For student research, a faculty adviser must review the proposed procedure and specific instruments prior to submission to the IRB. The faculty adviser must also review and initialize the submission checklist prior to signing off on a student protocol.

Protocols may be returned to the investigator for revision and resubmission in the following cases:

• using outdated IRB forms
• failing to include parts of the protocol (consent forms, email or phone scripts, recruitment flyers, instruments, etc.)
• not signing the protocol or not obtaining the signatures of all co-PIs (if, for any reason, the PI or other researchers are unable to sign the protocol, contact the IRB immeditately to discuss the circumstances)
• missing letters of support/permission from each institution where research will be conducted (if at schools, nonprofit organizations, businesses, etc.). Letters must be on letterhead and signed by the appropriate institutional authority -- emails are not acceptable substitutes.
• lack of or outdated human subjects training (after January 1, 2013, only CITI human subjects certification will be accepted for primary researchers and student researchers)

Individual Policies for Protocol Submissions

Be sure to read carefully through all applicable policies prior to completing an initial submission or post-approval request.

Informed Consent Policy:  detailed information about the reasoning and requirements of the informed consent process, from obtaining consent through documentation.

Research Involving Minors (Policy): in the state of Washington, "minors" are individuals under 18 years of age. Minors are designated a "vulnerable population," according to Federal regulations; and frequently--but not in all cases--research with minors requires full board review.

Research Involving Prisoners (Policy): any research involving incarcerated individuals, regardless of age, must be reviewed by the full board due to their status as a "vulnerable population."

Research with Pregnant Women, Fetuses, and Neonates (Form)

Research Involving Adults with Decisional Impairment (Form) 

International Research (Policy): conducting research abroad often involves preparing for different cultural norms and settings; and therefore additional human subjects protections may be necessary.

Policies for On-going Actions Post-Approval

Continuing Review / Downgrade to Exempt Policy:  Depending on the type of protocol, IRB approval is granted for 365 days (some non-federally funded, low-risk protocols may received flexed approval of two years). PIs must submit a Continuing Review Application one month prior to approval termination. If a PI will still be enrolling participants, collecting data, or interacting directly with the participants, a CRA must be filed every 365 days, or two years (as indicated on the approval letter). Lapses in IRB approval constitutes non-compliance with the Federal regulations and the requirements of the IRB. If a lapse does occur, all research must cease until approval is reissued. (Research conducted without IRB approval reflects non-compliance and may result in sanctions.)  If all data collection is complete and the PI will be conducting data analysis only, the PI may request to have the protocol reclassified as exempt, after which annual continuing reviews are no longer required.

Modification Request Policy: Federal regulations require that the IRB review and approve any changes in the approved research prior to implementation except when necessary to eliminate apparent immediate hazards to subjects. Modifications to protocols may be made at any time during the annual approval period. Many modifications are expeditable; but modifications that alter the risk level or significantly change the project’s goals or methodology will be reviewed and approved by the IRB (typically, at the next scheduled meeting).

 Unanticipated Problem - Adverse Event Policy: A researcher must submit an Unanticipated Problem–Adverse Event report if an unexpected (in nature, severity, or frequency) incident, experience, or outcome occurs that is related or possibly related to the research procedures, and subjects or others are placed at a greater risk of harm than previously realized or anticipated. An unanticipated problem may warrant corrective actions in the research protocol or the informed consent process/document in order to ensure the safety, welfare, or rights of participants. Please read the policy carefully to see the required timetable for reporting UPs or AEs.

Closeout Report Policy: Prior to study expiration, a Closeout Report may be submitted when no further contact with the participants will take place and all data and/or samples are permanently de-identified. A Closeout Report  must also be submitted if 1) the study is never initiated, and no enrollment takes place; and 2) a Primary Investigator leaves SU without requesting a change in PI. Following study closure, the researcher may not contact study subjects for further data collection. If the need for more data collection arises, the PI must inform the IRB immediately. The PI may request that the IRB re-open the study by means of continuing review, or a new protocol submission and review may be required.

 Review and Approval Process

If the submission meets the necessary criteria for human subjects research, the protocol will be processed according to review type determined by the IRB. (Please contact the IRB with any questions about review type.)

Expedited protocols are reviewed on a rolling basis by one or two IRB members, who will evaluate the submission and provide feedback (often requiring some changes). Once the researcher has responded to any questions or changes, and the protocol meets the conditions for approval, a letter of approval will be issued by the IRB office. (Only the full board may issue disapproval, regardless of review level.)

Full board protocols must be submitted by the deadline posted on the IRB home page to be reviewed at the next scheduled meeting. On all full board protocols, PIs should plan to be present for a short segment of the meeting in order to answer questions or provide clarifications.

Typically, one or two IRB members serve as primary reviewers when presenting on the protocol to the full board; however, all IRB members read and review all full board protocols. During the convened IRB meeting, the board discusses all protocols in the context of federal review and approval criteria. Any IRB member with a conflict of interest may participate in discussion but must recuse him/herself from the vote. However, a quorum must be maintained to take any voting action. Additionally, if the non-scientist member must exit or leave the meeting, all discussion/action must stop until that member's return. For any protocols involving incarcerated subjects (whether adults or youth), Federal regulations stipulate that a trained IRB member experienced with the prison population/system must be present as the prisoner representative.

 All voting totals (for, opposed, abstentions, recusals) must be documented in the IRB minutes. The PI will be informed of the IRB's decision and feedback within five business days of the meeting.

Appeal of IRB Decisions

If the IRB votes to disapprove a research protocol, it will include in its written notification a statement of the reasons for its decision, based on specific Federal regulatory criteria. A principal investigator may appeal this decision by writing a letter to the IRB requesting reconsideration. At the discretion of the chair, the investigator may make such an appeal in person and/or in writing to the IRB. An appeal of a disapproved research project must be reviewed at a full board meeting.

After review and discussion of appeal materials and/or presentation by the researcher, the IRB will vote by simple majority whether to approve the appeal and allow the research to commence. If the IRB upholds its vote to disapprove, suspend, or terminate a project, the decision may not be appealed again. Nor may it be reversed by the Associate Provost for Research or any other officer or agency of Seattle University, state government or Federal government. The IRB retains the final authority for approval of proposed research with human subjects.

Research Misconduct 

Seattle University, through its commitment to academic excellence and ethical leadership, strives to promote a climate of honesty in research. The University has established a policy on misconduct in research applicable to all research at the institution.

It is the responsibility of deans, department chairpersons, program directors, faculty advisers, and individual investigators to familiarize themselves with IRB policies and procedures. The University regards any infringement of these policies and procedures as a serious breach of professional standards. The University's willingness to defend researchers in litigation depends on strict adherence to policies and procedures regarding IRB approval. Interpretation of applicability of IRB rules and regulations are solely the legal right and responsibility of the IRB. General policy questions regarding human subjects research should be directed to the attention of the IRB (irb@seattleu.edu).

Sanctions 

All instances of human subject non-compliance will be reported to appropriate University officials, and may be reported to OHRP, according to stated Federal reporting requirements and guidelines (http://www.hhs.gov/ohrp/policy/incidreport_ohrp.html). University faculty, staff, and students who are found to be in violation of IRB policies and/or Research Misconduct may be subject to sanctions relating to their participation in research involving human subjects. Depending on the severity of the violation, sanctions may involve a written warning, temporary suspension of the research, termination of the research, or the permanent destruction of collected research data. Actions taken by the IRB and the University also will be subject to Federal reporting guidelines.