COTTAGE HEALTH SYSTEM POLICY

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SUBJECT:

IRB Education, Compliance and Audit Activities

Education, Compliance, Audits

 

DEPT: IRB POLICY #: 8012.17

 

GOAL:  

Through education, audits, and compliance procedures, the CHS IRB aims to ensure the ethical and safe practices of local human subject research under its purview.

 

POLICY:  

Regulations require IRBs to ensure the safety of research participants and the ethical practice of investigators through mandatory education and auditing programs, and through compliance oversight.

 

 

PROCEDURE :

To comply with guidelines set forth by the Department of Health and Human Services (DHHS) Office for the Protection of Research Participants (OHRP), Cottage Health System and the CHS IRB has established educational training and oversight mechanisms (appropriate to the nature and volume of its research) to ensure that research investigators, IRB members and staff, and other appropriate personnel maintain continuing knowledge of, and comply with, relevant ethical principles, relevant Federal Regulations, OHRP guidance, other applicable guidance, state and local laws, and institutional policies for the protection of human subjects.  To further comply with OHRP guidances:

  • IRB members and staff complete relevant educational training before reviewing human subject research; and
  • research investigators complete appropriate institutional educational training before conducting human subject research.

 

I.  Education

 

General Education

  • The CHS IRB has established a library which includes books, videos, brochures, and regulations (laws, codes, federal guidelines). 
  • The IRB has the "Investigator 101" research bioethics training program available on CD.  IRB members, investigators, and research staff with computer capacities may check-out the "Investigator 101" CD and provide the IRB with a certificate of completion.

 

Member Education

  • Each month IRB members receive an educational topic of the month that is mailed to them with the IRB meeting materials and is subsequently reviewed at the full board meeting. The education material is saved and filed with the monthly meeting material packet and is documented in the Annual IRB Report.
  • Annually, or at appropriate intervals relevant to new IRB membership, the IRB Administrator will provide the members with a Research Quiz designed to test and reinforce knowledge of research bioethics and human subjects research regulations.
  • The IRB’s goal is to allow for money in the budget for one or two members to attend a seminar on research bioethics each year.

 

Investigator and Research Staff Education

  • The IRB maintains binders containing records of research bioethics training for investigators and research staff.  Certificates of completion, seminar outlines, or other documentation of attendance/completion is accepted for filing.
  • The IRB has established a web-based tutorial on research regulations and institutional requirements.
  • As previously noted, the "Investigator 101" CD program is available through the IRB office.  It is also relevant and appropriate for study coordinators and other members of the research staff.
  • At IRB audits of investigative sites, the IRB utilizes its findings as a way to provide education in the areas needed.  All audits, while investigative in nature, are designed to educate the physician and his staff and are not meant to be punitive.  Following the audit, the Audit Report may provide additional advice and/or requests to improve study procedures.  Similarly, audits may result in additional in-services focusing on specific topics.
  • As part of its minimal education requirements, the Investigator will receive various regulatory documents with the Investigator Agreement. Investigators will be required to read all documents, and sign-off as having done so  (see policies 8012.01 and 8012.05).

 

II.  Compliance

In addition to regularly scheduled continuing reviews of all active studies, investigators must provide the IRB with all revisions and amendments, adverse events (from all sites), and any recruitment plans.  All changes to the study must be approved by the IRB before being initiated.  Failure to report changes or unanticipated problems to the IRB can result in an on-site audit and/or suspension of the study.

 

In order to monitor compliance as per OHRP recommendations, the CHS IRB requests copies of all monitor reports and external audits performed on trials under the IRB's purview.  The CHS IRB requires copies of written documentation and reports resulting from site monitoring and auditing by the study sponsor.  If no written report is obtained, the investigator is required to send a memo outlining the review and all of its findings.  When sponsors highlight potential problems, a for-cause audit can be initiated by the IRB.

 

The IRB may ask the investigator to submit one or more signed consent documents and may witness the consent process in order to monitor compliance in this area.

 

III.  Auditing of IRB-Approved Research

On-site audits of investigative sites are conducted periodically to ensure compliance with regulations and provide education as needed.  During an on-site audit, the primary focus of review includes:

  • Medical record review
    • Documentation of informed consent; dated prior to initiation
    • Documentation of research participation
    • No unreported adverse events
  • Conduct of study
    • Consent form used is the currently approved version
    • All recruitment materials have been reviewed and approved
    • All amendments to the protocol have been reviewed and approved
    • The investigator is using the current copy of the protocol
    • The investigator and all research staff are knowledgeable in the conduct of the study and IRB requirements

 

Questionnaires  have been developed which may be sent to participants to determine voluntary participation, understanding of research treatments/procedures, and adequacy of the investigator's consenting process.  Mailing of participant questionnaires is coordinated with study audits and investigators may decline their patients' participation.

 


 

Cottage Health System Institutional Review Board

Research Participant Questionnaire

 

The Cottage Health System Institutional Review Board (IRB) is a special committee that oversees the rights and safety of members of our community participating in research studies. The IRB has approved the study you are in and it is important for us to find out more about your enrollment process.

 

We are required by federal guidelines to keep research studies safe and ethical for you and others like you. To help us do this, we ask you to answer the following questions and return this survey as soon as possible to the Cottage Health System Office of Research in the enclosed, self-addressed envelope. Or FAX it to (805)  682-6584

 

We would like to thank you in advance for your time and wish you the best of luck in your study.  This survey is completely anonymous: do not sign your name or put a return address on the envelope.

Please tell us in your own words what type of study you are enrolled in and why:

 

  • Do you feel you were pressured in any way to join the study?  Yes    No
  • Were you told that the program you were enrolling in was a research study and not the current therapy?  Yes    No
  • Do you feel you had adequate time to review the consent form and ask any/all the questions you may have had about the study?      Yes    No
  • Were all of your questions answered satisfactorily?      Yes    No
  • How many days did you have the consent form before you had to sign it and return it?
  • Was the study presented to you in a clear and easy-to-understand fashion, so that you had no doubts about what the study was about?      Yes    No
  • Were you given the option to drop out of the study at any time?      Yes    No
  • Were you given any inducements for joining (such as money, free medication, etc)?      Yes    No

 

Thank You!

 


12/08

 

 

COTTAGE HEALTH SYSTEM POLICY

RECOMMENDED BY: Leilani Price DATE: 12/03

ORIGINAL POLICY EFFECTIVE DATE: 2/04

APPROVED BY: .. DATE: ..

DATE REVISED: 4/08 DATE REVIEWED: 4/06, 4/08, 4/11