IRB Process and Submissions

IRB Process & Submissions

IRB Review & Approval

Federal regulations and KP policy prohibit the involvement of human subjects in research until the IRB has reviewed and approved the research, including the protocol and informed consent process. The IRB must:

  • Approve all research and research documents prior to use, and
  • Review and monitor the progress of the research, with special emphasis on the experience of human participants, until the project is complete and a final report has been received and accepted by the IRB.

The IRB has the responsibility and authority to verify whether projects qualify as human subjects research or are exempt from IRB review.

IRB Inquiries

The IRB Inquiry Form is found in the IRBNet Forms and Templates. Use this form when:

  • You are not sure if your project requires IRB oversight, or
  • You would like a formal determination from the IRB as to whether the project requires IRB oversight, or
  • You are conducting research with specimens or data that are not individually identifiable to the research team, but the project involves genetic research.

Upload the Inquiry Form in the IRBNet in place of, or in addition to, a protocol. Note: Inquiries do not require Core Data or Study Team Forms.

If your funding agency requires IRB approval before you have developed the materials needed to submit your study to the IRB, contact the IRB office directly to discuss solutions.

IRB Appeals

IRB decisions can be appealed in accordance with the IRB Appeal Procedures.

Preparing New Studies for IRB Review

New studies must be created and submitted in the IRBNet system for Institutional Review Board (IRB) review. IRB review ensures that risks to participants are minimized and the risk/benefit ratio is reasonable; selection of participants is equitable; and the protocol includes provisions to protect participants' privacy, monitor their safety, and keep their information confidential.

All forms and templates for new IRB submissions can be found here:

Forms & Templates

Research Involving Vulnerable Populations

For research involving children, the IRB is guided by the principle that every effort should be made to help minor participants understand the risks and benefits associated with the research and to determine whether or not they wish to participate in the research.

The IRB considers these main issues when reviewing research involving children as participants:

  • The potential risks and benefits associated with the study and the risk-benefit analysis;
  • The need for parental permission; and
  • The ability of minor participants to assent or dissent to participation in the study

 

Determinations for Children

Decision Charts

Collaborate with CHR

Clinical Research Support Services (CRSS) provides experienced research administration, implementation, and coordination of clinical trials conducted in the Kaiser Permanente Northwest (KPNW) care delivery system and at the CHR Research Clinic.

Explore CRSS

The Operational Interaction Committe (OIC) reviews new investigator research and quality improvement projects for KPNW learning health system collaborators.

KPNW Research Collaborator Guide

Explore Collaborations

Secondary Uses of Data and Biospecimens

Researchers proposing a new project with existing data or biospecimens from another source should review our guidance document.  It addresses considerations for IRB review, informed consent, and genetic research.

Guidance:  Secondary Uses

Certificates of Confidentiality

Certificates of Confidentiality are issued for studies that collect individually identifiable sensitive information whose disclosure could have adverse consequences for subjects or damage their social or financial standing, employability, or reputation. Examples of research involving sensitive information include collection of:

  • Genetic test results (including from the medical record)
  • Mental health information
  • Alcohol or substance use disorder diagnosis, treatment, or referral information
  • Illegal activities
  • Sexual activities
  • HIV status
  • Cognitive impairment
  • Information that could be damaging to participants' financial standing, employability, or reputation

Studies funded by the NIH are automatically issued a Certificate of Confidentiality.  Participants should be informed about the Certificate and its meaning during the consent process.

Study Modifications

A change in a study's design, activities, staff members, or documents must be approved by the IRB before being implemented.

  • When a study modification package is created, the Core Data Form may need to be revised to reflect the study modification. For example, if you are adding a funding source or changing a data-only study to one with participant interaction, you will revise those sections of the protocol as well as the applicable information in the Core Data Form. All changes you make should be clearly described in the Modification Form and reflected in the documents using tracked changes.
  • To revise a previously approved document in IRBNet, download the most recent Word version from the Designer page, under Project Administration.  Accept all changes in the Word document, then track new changes only, so that the document you upload shows what is changing with this modification.

Not all study modifications require full IRB committee review.  IRB staff can often review minor changes through an expedited review process in the RSPO office.

Examples of study modifications:

  • A new or revised consent form
  • A new or revised telephone script
  • Revised enrollment criteria
  • Revised study activities
  • Extension of the study period
  • A new or added study investigator, including a temporary change of principal investigator, or study staff
  • A new or added study site (facility)   

Continuing Review

Current federal regulations require that all IRB-approved studies deemed greater than minimal risk be regularly reviewed and reapproved until the project is complete and a final report has been accepted by the IRB. Revisions to the Common Rule effective January 21, 2019 eliminate the continuing review requirement for most minimal risk research.

  • Continuing review is a meaningful and substantive evaluation by the IRB of the conduct of a research project and related documents and events. It takes place at least annually following a project’s initial approval to determine if a project can continue.
  • When continuing review and renewal of IRB approval is required, it must be conducted whether or not there has been any activity on the study, even if the study is still pending a funding award.
  • If the IRB determines that a study does not require continuing review, the study staff only needs to update the IRB regarding proposed changes to the approved study plan.

The electronic IRB (IRBNet) system sends principal investigators (PIs) courtesy reminders when a continuing review submission is due. These reminders are sent at 60, and 30 days prior to study approval expiration.

Submission Deadlines:

Greater than minimal risk - Submission of a complete and accurate progress or final report is due by the first business day of the month prior to the month in which IRB approval expires.

Minimal risk - Submission of a complete and accurate progress or final report is due 4-6 weeks prior to expiration.

  • Please note that if you wait until you receive the 30-day reminder to submit your continuing review for a greater than minimal risk study, you will miss the submission deadline.
  • It is the PI’s responsibility to ensure that a progress report to reapply for approval is submitted to the IRB by the submission deadline.

Late Submissions

  • Investigators and project managers should notify IRB staff as soon as possible if they are unable to submit a complete and accurate progress or final report by the submission deadline.
  • The IRB staff will work with the study team in these circumstances to complete continuing reviews before study approval expires but cannot guarantee IRB review prior to approval expiration.

Lapse of Study Approval

  • IRBNet sends out reminder notices at 60, and 30 days before a study’s IRB approval will lapse.
  • If IRB approval lapses, no study activity can continue except to protect the safety of participants. The PI must report to the IRB immediately to discuss the appropriateness of this plan if study activity needs to continue for participant safety.
  • The KPNW IRB has the discretion to not review any new studies for PIs or co-PIs who have lapsed studies until all delinquent reviews are completed.
  • The IRB may determine that continuing noncompliance has occurred if there is evidence of multiple instances of the same noncompliance, including repeated study expirations or failure to respond to the IRB’s requests.

When can I submit a final report to close my study?

A final report may be submitted when ALL of the following criteria have been met:

  1. Enrollment is closed,
  2. Participants have completed all research-related interventions,
  3. Data collection is complete, and
  4. Data analysis of identifiable private information described in the IRB-approved research plan has been completed.

For multi-site studies: If you have completed data collection and analysis at KPNW and have no other responsibility in the trial, the study may be closed at KPNW even if it is continuing elsewhere. However, if you are the prime awardee for the study, you must keep the study open until all four criteria above are met at all engaged sites.

If I get questions after a publication and want to look at the data again, do I need to keep the study open? Not necessarily. It is acceptable to look at raw data after a study has closed IF you just want to answer a question, but you cannot perform additional analysis on that data, unless it is de-identified first (the identity of the subjects may not be readily ascertained by the investigator or associated with the information.)

Reportable Events & Incidents

Investigators must report certain events and incidents to the IRB during the course of a study. Investigators are responsible for reporting within the timelines specified in NWRC.HRP.071, Prompt Reporting Requirements.

Additional Guidance:

Related Policies: