MSU HRPP Manual Section 1-5

Use of the National Cancer Institute Central Institutional Review Board

Michigan State University (MSU) has entered into an authorization agreement with the National Cancer Institute (NCI) Central Institutional Review Board (CIRB) to serve as IRB of record on NCI-sponsored pediatric and adult clinical trials.

As part of the authorization agreement and Division of Responsibilities between the NCI CIRB and MSU, MSU has agreed to the certain responsibilities when NCI CIRB is the IRB of record for a study. These responsibilities are shared between, including but not limited to, the institution, the Human Research Protection Program (HRPP), the Institutional Review Boards (IRB), and the investigators and research staff conducting research for which the NCI CIRB serves as IRB of record. These responsibilities include:

  1. Comply with the NCI CIRB’s requirements and directives.

  2. Report to the NCI CIRB the names of any Component or Affiliate Institutions. Sparrow Hospital and McLaren – Greater Lansing have been designated as “affiliate institutions.” Any changes must be submitted and approved by the NCI CIRB before subjects can be enrolled at those sites.

  3. Ensure the safe and appropriate performance of the research at the Signatory Institution and at all Component and Affiliate Institutions. This includes, but is not limited to:

    1. Ensuring the initial and ongoing qualifications of investigators and research staff;

    2. Overseeing the conduct of the research;

    3. Monitoring protocol compliance;

    4. Maintaining compliance with state, local, or institutional requirements related to the protection of human subjects;

    5. Providing a mechanism to receive and address concerns from local study participants and others about the conduct of the research; and

    6. Investigating, managing, and providing notification to the NCI CIRB of any study-specific incidence, experience, or outcome that seems to rise to the level of an unanticipated problem and/or serious or continuing noncompliance. When notifying the NCI CIRB of a potential unanticipated problem and/or serious or continuing noncompliance, the institution must provide a plan to manage the incident, experience, or outcome, including measures to prevent similar occurrences.

NOTE: As part of ensuring safe and appropriate performance of research the Signatory Institution has the authority to observe any aspect of the research process including observing the consent process. The CIRB retains the authority to direct this to be done when necessary.

  1. Provide updates in a timely manner to the NCI CIRB whenever a Signatory Institution Principal Investigator (PI) is replaced. The CIRB requires submission and approval of the Annual PI Worksheet prior to finalizing the replacement PI.

  2. Notify the NCI CIRB when a regulatory deficiency has been cited on an audit that occurred during the time that the NCI CIRB was responsible for study review.

  3. Complete and submit the Annual Signatory Institution Worksheet, the Annual Investigator Worksheet, and any other worksheets/forms required by the NCI CIRB for participation.

  4. Have CIRB-approved PIs complete and submit the Study-Specific Worksheet to open a study.

  5. Incorporate NCI CIRB-approved boilerplate language into the NCI CIRB-approved model consent form to create the consent form to use for a specific study:

    1. Make no language changes to the consent form with the exception of NCI CIRB-approved boilerplate language;

    2. Obtain NCI CIRB approval of changes to the boilerplate language prior to implementation; and

    3. Obtain NCI CIRB approval of translations of the consent form prior to implementation.

  6. Maintain a regulatory file for each study under NCI CIRB purview as per local institution and sponsor policy. See HRPP Manual 4-7 “Recordkeeping.”

  7. Notify the CIRB if a study participant becomes incarcerated while enrolled in a study under the CIRB’s purview. If the investigator deems it in the best interest of the study participant to remain on the study while incarcerated provide justification to the CIRB.

NCI CIRB Approved PIs – Annual Investigator Worksheet
For NCI CIRB to serve as IRB of record, MSU investigators are required to complete the “Annual Investigator Worksheet,” and any other worksheets/forms required by the NCI CIRB for participation. This worksheet must be approved by the NCI CIRB prior to use of the NCI CIRB as IRB of record for that investigator.

The PI is responsible for oversight of each NCI CIRB study where they are approved as the PI and is responsible for assuring that NCI CIRB requirements and Standard Operating Procedures (SOPs) are followed.

Study-Specific Worksheet to Open a Study
CIRB-approved PIs are responsible for completing and submitting the Study-Specific Worksheet to open a study. PIs must also complete and submit to the MSU HRPP an external IRB submission in the MSU IRB online system including the HRP-513 - Template - External IRB Request, the consent form template(s) with MSU specific information (CIRB-approved MSU boilerplate text), related funding materials, and any Health Insurance Portability and Accountability Act (HIPAA) templates for MSU covered entities. While the NCI CIRB is serving as IRB of record, other HRPP compliance requirements are still applicable (e.g., Conflict of Interest, HIPAA, Environmental Health and Safety). The new study submission can be completed concurrently with the submission of the Study-Specific Worksheet via IRB Manager to NCI CIRB. While the NCI CIRB may serve as the IRB of record, the PI remains responsible for complying with HRPP Manual 4-6 “Responsibilities of Investigators.”

Upon receipt of the new study submission, any affiliate sites will be notified of the use of the NCI CIRB (i.e., Sparrow Health System or McLaren Greater Lansing). These sites will notify the MSU HRPP if the study can be conducted at their site. Investigators are responsible for fulfilling requirements at affiliate sites. Note that ANY sites in addition to Sparrow Health System and McLaren Greater Lansing must be submitted by the MSU HRPP to the NCI CIRB and approved by the NCI CIRB before subjects can be enrolled at those sites.

The NCI CIRB notifies the institutional contacts when approval is received from the NCI CIRB. Human subjects cannot be enrolled in the research and/or clinical investigation until the PI receives a reliance acknowledgement letter from the MSU HRPP. A reliance acknowledgement letter will not be issued until the MSU HRPP receives notice from the affiliate institution that the research can be conducted at the site.

Prisoner Research

Researchers must promptly notify the NCI CIRB if a study plans to enroll or enrolls a prisoner as a subject. The PI must also notify the NCI CIRB so it can conduct the review as required by subpart C.

Audits

The NCI CIRB must be notified when a regulatory deficiency has been cited on an audit that occurred during the time that the NCI CIRB was responsible for study review.

Local Unanticipated Problems and Serious or Continuing Noncompliance

Local unanticipated problems occur at and are limited to a specific institution. Local noncompliance is noncompliance that occurs at an institution and does not impact the trial nationally. Local noncompliance may include complaints, protocol deviations, and site visit findings.

The study team must notify the MSU HRPP promptly of any study-specific incidence, experience, or outcome that may potentially be a local unanticipated problem and/or local serious and/or continuing noncompliance. The PI is responsible for reporting the event to the NCI CIRB if they determine that the study-specific incidence, experience, or outcome potentially meets the definition of a local unanticipated problem and/or serious and/or continuing noncompliance. When notifying the NCI CIRB of a potential unanticipated problem and/or potential serious and/or continuing noncompliance, the PI must provide a management plan to manage the incident, experience, or outcome, including measures to prevent similar occurrences. The PI must report the events to the NCI CIRB in the timeframe required by the NCI CIRB. See the NCI CIRB SOPs for current timelines, definitions, and processes.  The study team must provide the MSU HRPP with the NCI CIRB determination.

The PI is required to report serious adverse events and protocol deviations to the coordinating group, per the Group’s guidelines. These events are not reported to the CIRB unless the PI believes they represent a potential unanticipated problem per the definition included in the NCI CIRB SOPs.

If the MSU HRPP becomes aware of a potential local unanticipated problem involving risks to subjects or others or potential local serious and/or continuing noncompliance, they will typically notify the PI. However, the MSU HRPP in its discretion may determine that reporting the incident directly to the NCI CIRB is necessary (e.g., subject complaint).

Post Approval Monitoring

For each study for which the NCI CIRB serves as the IRB of record and has a subject enrolled, the Compliance Office will perform a site visit to monitor protocol compliance. See HRPP Manual 8-10 “Site Visits” for the process.

Subject Complaints
MSU provides a mechanism to receive and address concerns from local study participants and others about the conduct of the research. See HRPP Manual 9-4 “Subject Complaints” for the process.

Informed Consent Documents

The NCI CIRB does not allow any language changes to the consent form(s) with the exception of NCI CIRB-approved boilerplate language. This means that the consent template text cannot be deleted or changed. However, where the consent template designates a field to enter information (e.g., study doctor, telephone number), this information may be inserted into the consent template. In the fields that request contact information for an IRB, the contact information for the MSU IRB is to be inserted as instructed (e.g., name and phone number: Michigan State University, 517-355-2180). In addition, NCI CIRB approval of translations of the consent form(s) must be obtained prior to implementation.

Informed Consent Amendments

The investigator must notify the MSU HRPP of any amendments to the informed consent document(s). The consent form template(s) with MSU specific information (CIRB-approved MSU boilerplate text) must be submitted either via email or as an Update in the MSU IRB online system prior to use to assure that no language changes to the consent form(s) with the exception of NCI CIRB-approved boilerplate language have been made.

NCI CIRB Approved Boilerplate Language

Prospective NCI CIRB approval of changes to the boilerplate language must be obtained prior to implementation. Such changes are submitted through the Annual Signatory Institution Worksheet for Michigan State University and can only be submitted by the MSU Institutional Contact(s). The boilerplate language must be included in the consent form as appropriate. Check with the MSU HRPP for the current NCI CIRB Approved Boilerplate Language.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 4-25-2016.  Revision 1 approved by Senior VP for Research and Innovation on 1-18-2019. Revision 2 approved by Assistant VP Regulatory Affairs on 10-6-2021.

Related HRPP Manual Sections