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

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1 Michigan State University Human Research Protection Program Subject: Use of the National Cancer Institute Central Institutional Review Board Section: 1-5 This policy and procedure supersedes those previously drafted. Approved by: Vice President of Research and Graduate Studies, Related Sections: 4-7, 6-8-B, 8-10, 9-1, 9-2, 9-4 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, the Institutional Review Boards, 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: a. Ensuring the initial and ongoing qualifications of investigators and research staff; b. Overseeing the conduct of the research; c. Monitoring protocol compliance; d. Maintaining compliance with state, local, or institutional requirements related to the protection of human subjects; e. Providing a mechanism to receive and address concerns from local study participants and others about the conduct of the research; and f. 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; 1

2 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. 4. Provide updates in a timely manner to the NCI CIRB whenever a Signatory Institution Principal Investigator is replaced. The CIRB requires submission and approval of the Annual Principal Investigator Worksheet About Local Context prior to finalizing the replacement Principal Investigator; 5. 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; 6. Complete and submit the Annual Signatory Institution Worksheet About Local Context, the Annual Investigator Worksheet About Local Context, and any other worksheets/forms required by the NCI CIRB for participation; 7. Have CIRB-approved Principal Investigators complete and submit the Study- Specific Worksheet About Local Context to open a study; 8. Incorporate NCI CIRB-approved boilerplate language into the NCI CIRBapproved model consent form to create the consent form to use for a specific study: a. Make no language changes to the consent form with the exception of NCI CIRB-approved boilerplate language; b. Obtain NCI CIRB approval of changes to the boilerplate language prior to implementation; and c. Obtain NCI CIRB approval of translations of the consent form prior to implementation; 9. Maintain a regulatory file for each study under NCI CIRB purview as per local institution and sponsor policy. See HRPP Manual 4-7, Recordkeeping. And 10. Conduct full board review of any study enrolling prisoners, since the NCI CIRB is not constituted to review studies enrolling prisoners. NCI CIRB Approved Principal Investigators Annual Investigator Worksheet For NCI CIRB to serve as IRB of record, MSU investigators are required to complete the Annual Investigator Worksheet About Local Context, 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. Study-Specific Worksheet About Local Context to Open a Study CIRB-approved Principal Investigators are responsible for completing and submitting the Study-Specific Worksheet About Local Context to open a study. MSU principal 2

3 investigators must also complete and submit to the MSU HRPP the Use of the NCI CIRB Form, including the consent form template(s) with MSU specific information (CIRB-approved MSU boilerplate text) 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 MSU HRPP Use of the NCI CIRB Form 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 Principal Investigator remains responsible for complying with HRPP Manual 4-6, Responsibilities of Investigators. Upon receipt of the Use of the NCI CIRB Form, 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 investigator is responsible for notifying the MSU HRPP when approval is received from the NCI CIRB. Human subjects cannot be enrolled in the research and/or clinical investigation until the principal investigator 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 MSU HRPP if a clinical investigation plans to enroll or enrolls a prisoner as a subject. The NCI CIRB is not constituted to review studies enrolling prisoners. See HRPP Manual 6-8-B, Prisoners. 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. Potential Unanticipated Problems and Serious or Continuing Noncompliance The principal investigator must notify the MSU HRPP Director promptly of any studyspecific incidence, experience, or outcome that seems to rise to the level of an unanticipated problem and/or serious or continuing noncompliance. The MSU HRPP investigates, manages, and provides 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 MSU HRPP must provide a plan to manage the incident, experience, or outcome, including measures to prevent similar occurrences See HRPP Manual Sections 9-1, Unanticipated Problems Involving Risks to Subjects or Others and 9-2, Noncompliance. 3

4 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, Research 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 (included below). 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, ). 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 ed to the MSU HRPP (irbdocs@ora.msu.edu) 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 About Local Context for Michigan State University and can only be submitted by the MSU Institutional Contact(s). The boilerplate language below must be included in the consent form as appropriate. 1) No costs will be paid If you are injured as a result of your participation in this research project, Michigan State University will assist you in obtaining emergency care, if necessary, for your research related injuries. If you have insurance for medical care, your insurance carrier will be billed in the ordinary manner. As with any medical insurance, any costs that are not covered or are in excess of what are paid by your insurance, including deductibles, will be your responsibility. The University s policy is not to provide financial compensation for lost wages, disability, pain or discomfort, unless required by law to do so. The study sponsors will not pay for medical treatment for injury. This does not mean that you are giving up any legal rights you may have. You 4

5 may contact [insert principal investigator s name and phone number] with any questions or to report an injury. 2) Within the privacy or confidentiality section that describes the organizations that might have access to records include the statement: Michigan State University Human Research Protection Program 3) Include the following contact information for projects with Dr. Tamkus as Principal Investigator: Study Doctor: Research Site: Deimante Tamkus M.D. Michigan State University at Breslin Cancer Center 401 W. Greenlawn Ave. Lansing, Michigan Telephone: (517) After Hours Telephone: (517) ) In addition, the Department of Pediatrics and Human Development may use the following header. Any changes to the header must be reviewed and approved by the NCI CIRB prior to implementation. 5