Irb communication with the investigator




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University of Oklahoma

Office of Human Research Participant Protection




SOP: 601

IRB COMMUNICATION WITH THE INVESTIGATOR

1. POLICY


The IRB shall notify investigators in writing of all decisions made by the IRB. Open and frequent communication shall be maintained among the IRB, the investigator, and the investigator’s research team.

The IRB shall foster open communication with the investigator regarding questions, concerns, and suggestions that pertain to the HRPP program. The IRB shall answer questions as promptly as possible. Concerns and suggestions that cannot be satisfactorily addressed by HRPP or IRB staff shall be addressed in a meeting with the appropriate administrative individuals.

Opportunity for improvement in the IRB review process is based upon voluntary feedback of investigators and as such, investigators are encouraged to offer suggestions and discuss concerns regarding the HRPP program and IRB review process.
Specific Policies

1.1 New Research Projects

1.1.1 All submissions shall be processed per SOP 301, Research Submission Requirements and SOP 302, Administrative Review and Distribution of Materials.


      1. Once a research project is reviewed by the convened IRB, the IRB shall forward a letter to the investigator regarding the decision of the IRB to approve, contingently-approve, defer, or disapprove the project.

      2. After the IRB Chair reviews and approves research projects meeting one of the Expedited Review Categories, the IRB Administrator shall forward a letter to the investigator regarding the approval of the project. If the IRB Chair requires revisions or submission to the convened IRB, the IRB Administrator shall notify the investigator via email or telephone.

      3. If the research project receives a contingent approval status and is pending receipt and review of requested revisions and/or information from the investigator or sponsor, the IRB shall receive a response within 60 days of the date of notification; however, this period may be extended if the investigator/sponsor communicates a need for an extension. If the investigator does not respond within 60 days, the IRB staff shall inform the investigator that the research project is being administratively withdrawn.

      4. Oklahoma City Campus IRB: If the research project is deferred or disapproved by the convened IRB, the IRB Chair shall notify the investigator, by telephone, of the IRB’s decision immediately following the IRB meeting, followed by written notice per 1.1.2.

      5. Norman Campus IRB: If the research project is deferred or disapproved by the convened IRB, the IRB Chair shall notify the investigator via email of the IRB’s decision immediately following the IRB meeting followed by written notice per 1.1.2.

1.2 Submissions Involving On-Going Research Projects

The IRB shall notify the investigator of the review decision of all submissions related to on-going research projects. These decisions may include:



  • All revisions, additions, or deletions to a research project.

  • Notification of an impending continuing review and the outcome of the project once it has been reviewed.

  • Actions to withdraw or inactivate a research project and the reason such action is being taken.

  • Status of all adverse events submitted for review.

  • Necessity to conduct an audit as described in SOP 903, Non-compliance/Scholarly Misconduct.

1.3 Appeal of IRB Action

An investigator may appeal the revisions required by the IRB in the protocol and/or informed consent form. This appeal shall be in writing and submitted to the IRB office. Investigators may also appeal an IRB decision to disapprove a study. Any such appeal shall be in writing or in person and shall be reviewed by the full IRB at a convened meeting. If the IRB denies the appeal and disapproves the study, the Investigator’s institution shall not override the IRB’s decision.



    1. Pending items over 60 days

The IRB Administrator shall send a pending withdrawal letter to the investigator after the study or amendment has been in pending status for 60 days.

2. SCOPE


These policies and procedures apply to all research submitted to the IRB.

3. RESPONSIBILITY


The HRPP Director or designee is responsible for overseeing all IRB communications.

The IRB Administrator is responsible for generating appropriate correspondence in response to IRB meetings and decisions and for distributing IRB correspondence to appropriate parties.

The IRB Chair is responsible for contacting the investigator in the event of an IRB action of deferral or disapproval and for drafting the disapproval letter for the IRB Administrator.

The HRPP Director is responsible for all communication with OHRP, FDA, and University officials.


4. APPLICABLE REGULATIONS AND GUIDELINES


21 CFR 56.109, 56.113

45 CFR 46.109, 46.113


5. REFERENCES TO OTHER APPLICABLE SOPs


This SOP affects SOP 403, Initial Review – Criteria for IRB Approval and 409, Categories of Action.

6. ATTACHMENTS


601-A Protocol Pre-Review

601-B Protocol Contingent Approval - Full Board

601-C Protocol Final Approval – Full Board, Expedited, Exempt

601-D Protocol Deferral – Full Board

601-OS-D Protocol Disapproval – Full Board

601-F Protocol Form 310

601-G Protocol Inactivation by Board, PI, Sponsor

601-H Protocol Pending Withdrawal

601-I Protocol Withdrawal Request by PI, Admin.

601-OS-I Not Human Research Determination

601-OS-J Human Research Determination

601-J Protocol Exempt Status

601-K Protocol Development Approval

601-L Protocol Emergency Use Approval

601-M Amendment Pre-Review

601-N Amendment Contingent Approval

601-O Amendment Final Approval – Full Board & Expedited

601-OS-E Amendment Disapproval

601-Q Amendment Pending Withdrawal

601-R Amendment Withdrawal – PI, Admin.

601-S Continuing Review Contingent Approval

601-T Continuing Review Approval – Active & Closed Enrollment

601-OS-U Miscellaneous Approval

601-OS-A Continuing Review Deferral

601-V Continuing Review Periodic Report Request

601-W Protocol-Deviation

601-X Unanticipated Problem Noted & Accepted

601-Y Unanticipated Problem Noted, Action Required

601-OS-B HIPAA, No PHI

601-OS-C Notice of Study Expiration

601-OS-F QI Routine Evaluation Letter

601-OS-G QI For-Cause Evaluation Letter

601-OS-H QI Evaluation Report

602C-A Contract-Hold Notification Email



7. PROCESS OVERVIEW

7.1 The IRB Administrator shall process new research projects, revisions to currently approved research, and continuing review of research documents per SOP 301, Research Submission Requirements and SOP 302, Administrative Review and Distribution of Materials.

7.2 The IRB review is conducted as per SOP 401, Research Exempt from IRB Review, 402, Expedited Review, or 403, Initial Review – Criteria for IRB Approval, as appropriate.

7.3 The Investigators shall submit requested revisions within 60 days of receiving written IRB notification.

7.4 The IRB Administrator shall conduct periodic review of outstanding items, including telephone calls and/or emails to investigator regarding outstanding issues.

7.5 IRB Administrator shall consult with the HRPP Director or designee for items outstanding greater than 60 days; a pending withdrawal notification shall be drafted and presented to the IRB Chair or designee for signature.

7.6 After the IRB Chair’s signature is obtained, pending withdrawal notification shall be sent for new projects and protocol modifications/ amendments.

7.7 In the case of outstanding continuing review items, SOP 404, Continuing Review is followed.

7.8 The IRB Administrator shall forward investigator appeals of requested revision(s) to the IRB (for the next available meeting agenda) or the IRB Chair for review.

7.9 Final IRB determinations shall be adhered to by the investigator; final determinations cannot be overruled by the institution.



    1. All documentation shall be retained per SOP 304, Documentation and Document Management.

    2. Investigators who have questions, suggestions or concerns may utilize the web form to communicate with the IRB.

APPROVED BY:________________________________ DATE:2/1/2007

NEXT ESTABLISHED REVIEW DATE: May 2009


Version No. 4 Page of

Effective Date: 2/1/07

Supersedes Document: 11/14/06

SOP 601




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