HRPP Policies & Forms Chapter Two Created/Revised for AAHRPP June 1, 2007

REVISED POLICIES

Revised Policy SOP 202 Management of IRB The performance of the IRB Chairs, Vice Chairs, and IRB Members shall be evaluated on an annual basis. This periodic evaluation is conducted to assess performance taking into consideration, completion of education requirements, attendance, preparedness, knowledge and abilities in applying the ethical principles and regulations governing human research, and knowledge of IRB policies and procedures.

Newly Created Forms Chair/Vice Chair Evaluation Form Chair/Vice Chair Evaluation Form Board Member Evaluation Form Board Member Evaluation Form

Revised Policy SOP 403 Initial Review - Criteria for IRB Approval The IRB shall evaluate proposed research for scientific or scholarly validity based on the following: Whether the research uses procedures consistent with sound research design, which did not unnecessarily expose participants to risk. Whether the research uses procedures consistent with sound research design, which did not unnecessarily expose participants to risk. Whether the research is designed to answer the proposed question. Whether the research is designed to answer the proposed question. The importance of the knowledge reasonably expected to result from the research. The importance of the knowledge reasonably expected to result from the research.

Revised Policy SOP 404 Continuing Review As an outcome of continuing review, the IRB may require that the research be suspended or terminated as per SOP 411 Suspension or Termination of IRB Approval. As an outcome of continuing review, the IRB may require that any significant new findings that arise from the continuing review process and that might relate to participants’ willingness to continue participation will be provided to participants.

Revised Policy SOP 407 Unanticipated Problems Involving Risks to Participants or Others & Protocol Deviations Protocol DeviationsProtocol Deviations When a deviation occurs, the Investigator completes the protocol deviation form. When a deviation occurs, the Investigator completes the protocol deviation form. The Investigator determines if the protocol deviation meets the definition of an unanticipated problem according to the criteria indicated on the deviation form and submits the form to the IRB. The Investigator determines if the protocol deviation meets the definition of an unanticipated problem according to the criteria indicated on the deviation form and submits the form to the IRB.

SOP 407 If the IRB Chair determines that the protocol deviation is an unanticipated problem involving risks to participants or others or resulted from serious or continuing noncompliance, the deviation report will be reviewed at an IRB meeting. If the IRB Chair determines that the protocol deviation is an unanticipated problem involving risks to participants or others or resulted from serious or continuing noncompliance, the deviation report will be reviewed at an IRB meeting. If the IRB Chair determines the protocol deviation does not meet the criteria of an unanticipated problem, the deviation will be reviewed by the expedited procedure. If the IRB Chair determines the protocol deviation does not meet the criteria of an unanticipated problem, the deviation will be reviewed by the expedited procedure.

Revised Form Protocol Deviation Report Form Protocol Deviation Report Form

Revised Policy SOP 502G Emergency Use of FDA Regulated Products Planned emergency research is defined as planned research involving a life-threatening emergency where the requirement to obtain prospective informed consent has been waived. The research plan must be approved in advance by the FDA or DHHS and the IRB, and project, as well as its results, are publicly disclosed to the community in which the research is conducted.

SOP 502G The IRB will not review and waive the requirement to obtain consent for planned emergency research. Therefore, no planned emergency research can be conducted at OU.

Revised Policy 601 IRB Communication and Notification Notification to Institutional Offices and Officials The HSC IRB shall notify the HSC Office of the Provost, Senior Vice President and Provost as Institutional Official of IRB findings and actions. The Institutional Official shall receive a copy of the IRB meeting minutes for each IRB.

SOP 601 Questions, Concerns and Suggestions Regarding the Human Research Participant Protection Program Investigators can direct questions, concerns and suggestions regarding the Human Research Participant Protection Program to the HRPP Director. Investigators can direct questions, concerns and suggestions regarding the Human Research Participant Protection Program to the HRPP Director. Investigators can direct questions, concerns and suggestions regarding the Human Research Participant Protection Program that cannot be satisfactorily addressed by the HRPP Director to the Director of Compliance or the Institutional Official. Investigators can direct questions, concerns and suggestions regarding the Human Research Participant Protection Program that cannot be satisfactorily addressed by the HRPP Director to the Director of Compliance or the Institutional Official.

Revised Policy SOP 70l Consent Process & Documentation Waiver of Documentation of Informed Consent If documentation of informed consent is waived, the Investigator will ask whether the participant wants documentation linking the participant with the research, and the participant’s wishes will govern.

SOP 701 If the IRB waives the requirement of documentation of informed consent, the IRB may require the investigator to provide a written statement of the research to the participant. If the IRB waives the requirement of documentation of informed consent, the IRB may require the investigator to provide a written statement of the research to the participant. The IRB shall review and approve the written statement prior to the investigator providing the statement to the participant. The IRB shall review and approve the written statement prior to the investigator providing the statement to the participant. The consent form reviewed and approved by the IRB may also serve as the written statement. The consent form reviewed and approved by the IRB may also serve as the written statement.

SOP 701 Legally Authorized Representative For research conducted outside of Oklahoma, individuals who meet the definition of a legally authorized representative are those individuals as described under the applicable law of the jurisdiction in which the research will be conducted. If recruiting a participant from a legally authorized representative the investigator must report this category of participant on the IRB application and provide to the IRB the definition of legally authorized representative for the applicable jurisdiction.

Revised Policy SOP 901 Quality Improvement Investigator-initiated studies, where the investigator holds an IND/IDE, are the primary targets of routine evaluation. When assuming the role of the sponsor, the investigator is evaluated to ensure compliance with the additional regulatory requirements as outline in SOP 802 Sponsor Responsibilities and good manufacturing practice. SOP 802 Sponsor Responsibilities SOP 802 Sponsor Responsibilities

SOP 901 The investigator is required to submit an annual report to the FDA and is notified by the IRB sixty days in advance of its due date. Compliance with this requirement is monitored by the IRB staff via the continuing review application.

SOP 901 Observation of the Consent Process The IRB has the authority to observe, or have a third party observe, the informed consent process of research it has approved, and to verify that the study is being conducted as required by the IRB and within the institutional policies and procedures and site-specific procedures, as appropriate. Before the IRB or third party observes the consent process, verbal consent of the participant may be sought.

SOP 901 The IRB may determine it is necessary to observe the informed consent process in order to provide additional protections and may conduct informed consent observations in the following situations: Non-compliance per SOP 903, Non-compliance per SOP 903, Unanticipated problems involving risks to participants or others per SOP 407, Unanticipated problems involving risks to participants or others per SOP 407, Protocol deviations as per SOP 407, Protocol deviations as per SOP 407, Participant complaints, or Participant complaints, or or any other situation the IRB deems appropriate where additional protections are necessary. or any other situation the IRB deems appropriate where additional protections are necessary.

Consent Observation Informed Consent Observation Checklist Informed Consent Observation Checklist

SOP 901 IRB Internal Evaluations/Improvement Plan The HRPP shall measure and improve the program’s effectiveness, quality, and compliance with organizational policies and procedures and applicable federal, state, and local laws.

SOP 901 IRB Internal Evaluations Improvements to the HRPP program shall be implemented based upon measures identified through routine evaluations of the program. These improvements include education programs, IRB member and staff training, revising Policies and Procedures, and form changes. Improvements to the HRPP program shall be implemented based upon measures identified through routine evaluations of the program. These improvements include education programs, IRB member and staff training, revising Policies and Procedures, and form changes. The improvements shall be monitored and measured to determine effectiveness. If necessary, additional improvements shall be implemented. The improvements shall be monitored and measured to determine effectiveness. If necessary, additional improvements shall be implemented.

VA-Specific Revisions

Consent Requirement If someone other than the investigator will be conducting the interview and obtaining consent, the investigator must formally delegate the responsibility to an individual who has received appropriate training to perform this activity.

VA-Specific Revisions For VA research the legally authorized representative is defined as the following persons in the following order of priority: Health-care agent. Health-care agent. Legal guardian or special guardian. Legal guardian or special guardian. A close relative of the patient eighteen years of age or older, in the following priority: spouse, adult child (18 years or older), parent, sibling (18 years or older), grandparent, adult grandchild (18 years or older), close friend (18 years or older). A close relative of the patient eighteen years of age or older, in the following priority: spouse, adult child (18 years or older), parent, sibling (18 years or older), grandparent, adult grandchild (18 years or older), close friend (18 years or older).

VA-Specific Revisions Exempt Research Category #2 Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless:  Information obtained is recorded in such a manner that human participants can be identified, directly or through identifiers linked to the subjects; and

VA-Specific Revisions Exempt Research Category #2 Any disclosure of the human participants' responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or reputation. NOTE: The Department of Veterans Affairs (VA) also includes loss of insurability in this category. Any disclosure of the human participants' responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or reputation. NOTE: The Department of Veterans Affairs (VA) also includes loss of insurability in this category.

VA-Specific Revisions Continuing Review For VA research that expires because continuing review is not completed the IRB shall notify the sponsoring agency, private sponsor, Office of Research and Development, Office of Research Oversight, or other Federal agencies, as appropriate.

VA-Specific Revisions Drug Dispensing & Accountability The investigator shall provide the pharmacy with a signed copy of the VA Form to document each participant’s consent to participate in the study. The investigator shall provide the pharmacy with a signed copy of the VA Form to document each participant’s consent to participate in the study. The Investigator shall inform the Chief, Pharmacy Service, and the R&D Committee when the research has been terminated. The Investigator shall inform the Chief, Pharmacy Service, and the R&D Committee when the research has been terminated.

Sponsored Research Agreements Contracts shall: Identify who is responsible to provide and pay for medical care for research-related injuries. Identify who is responsible to provide and pay for medical care for research-related injuries. Include language stating the sponsor will promptly notify the organization of any study results or findings that could affect the conduct of the study, participant safety, participant’s willingness to continue in the study, or the IRB’s approval to continue the study. Include language stating the sponsor will promptly notify the organization of any study results or findings that could affect the conduct of the study, participant safety, participant’s willingness to continue in the study, or the IRB’s approval to continue the study.

REVISED FORMS

Revised Forms New Research Project Application New Research Project Application New Research Project Application New Research Project Application Determination of Human Research Worksheet Determination of Human Research Worksheet Determination of Human Research Worksheet Determination of Human Research Worksheet

Revised Consent Template Consent Template Consent Template

Revised Reviewer Checklists New Study Reviewer Checklist New Study Reviewer Checklist –Full Board Review Full Board ReviewFull Board Review –Expedited Review Expedited ReviewExpedited Review –Exempt Exempt Continuing Review Checklist Continuing Review Checklist Continuing Review Checklist Continuing Review Checklist VA Criteria VA Criteria VA Criteria VA Criteria Waiver of Consent Waiver of Consent Waiver of Consent Waiver of Consent

Effective Date June 1, 2007