Marshall University

Huntington, WV

  

SUBJECT:  Primary and Secondary Reviewers

 

PURPOSE:  To conducts substantive and meaningful research protocol reviews by utilizing a Primary and Secondary Reviewer system.

 

POLICY:  To utilize a primary and secondary reviewer system to ensure comprehensive protocol reviews are conducted by the convened IRB.

 

SCOPE:  This policy covers all research activities undergoing the convened review process.

Primary or secondary reviewers are utilized for initial reviews, continuing reviews, review of protocol changes, and review of reports of unanticipated problems involving risks to subjects or others.  Primary reviewers may be utilized when there is a serious or continuing noncompliance issue involving a human subject protocol. 

 

RESPONSIBILITY:

 

Chairman – The IRB Chairman is responsible for identifying primary and secondary reviewers based on the reviewer’s educational background, past experience, and board certification, if applicable.  He/she assigns research protocols to be reviewed by the primary and secondary reviewers in a systematic manner.

 

Primary Reviewer - The primary reviewer is considered the lead reviewer on the IRB for research assigned to him/her.  He/she is responsible for (1) being versed in the methodology and other aspects of the research; (2) conducting an in-depth review of the research and completing the Protocol Assessment checklist form provided; and (3) leading the discussion of the research at the convened meeting.

 

Secondary Reviewer - The secondary reviewer is also responsible for (1) being versed in the research methodology and other aspects of the research; (2) conducting an in-depth review of the research and completing the Protocol Assessment checklist form provided; and (3) discussing the protocol at the convened  IRB meeting.

 

IRB Members – The IRB members are responsible for serving as primary and secondary reviewers at the call of the Chairman.

 

IRB Coordinator – The IRB coordinator is responsible for acquiring and maintaining resumes/curriculum vitae from members and consultants.  The coordinator is responsible for documenting who is assigned to review the protocols and for assuring each reviewer receives the protocol package prior to the meeting.

 

The Primary and secondary reviewers also have the responsibility evaluate whether a protocol involves categories of participants vulnerable to coercion or undue influence, and if so, then they should notify the IRB Chair so that he/she can ensure that one or more individuals who are knowledgeable about or experienced in working with these participants (as designated on the IRB roster) is present at the meeting.

 

PROCEDURE:

 

Initial Convened Review

The Chairman assigns primary and secondary reviewers based on the credentials and background of the reviewer in relation to the type of research protocol being reviewed.  The Chairman is responsible to ensure that at least one of these individuals will be present at the meeting and has the appropriate scientific and scholarly expertise to conduct an in depth review of the protocol.  If such an IRB member cannot be identified, the Chairman will defer the protocol review to another IRB with appropriate expertise or obtain consultation.  The primary and secondary reviewers are given the following at least two weeks prior to the scheduled IRB meeting:

 

The reviewers are responsible for evaluating the material and conveying their evaluation to the IRB.  The reviewer will utilize the Protocol Assessment Checklist submitted by the investigator to evaluate specific criteria outlined.  The Protocol Assessment Checklist will be filed with the protocol in the Research Office.

 

Other IRB members are provided with the same essentials as the reviewers with the exception of the clinical investigator's brochure (when one exists), unless the reviewers have deemed it is necessary.  All IRB members will be provided with materials for review one week prior to the scheduled IRB meeting.  All IRB members who are not primary or secondary reviewers must review all provided materials in enough depth to be familiar with and prepared to discuss the information at the convened meeting.  This material will include initial review, continuing review, and reviews requiring modifications to previously approved research.  If an IRB member would like to obtain the information provided to a primary or secondary reviewer he/she can contact the Office of Research Integrity (ORI).

 

The Principle Investigator will present his protocol to the convened IRB.  The primary reviewer will lead the discussion with additional inquiries from the secondary and other IRB members.  The PI will answer any questions posed by the IRB members.  Prior to voting on the protocol, the PI will leave the room.  The primary and secondary reviewers will make any additional comments concerning the protocol prior to voting.  The PI will be notified of the results within 2 weeks of the IRB approval.

 

When review is conducted using the expedited procedure, at least one reviewer will receive and review all information that the convened IRB would receive.

 

Continuing Convened Review

The IRB conducts substantive and meaningful continuing review of research at intervals appropriate to the degree of risk, but not less than once per year.  Continuing reviews are conducted by the convened IRB unless the research falls into one or more of the categories appropriate for expedited review. 

 

The Chairman is responsible to ensure that a primary reviewer will be present at the meeting who has the appropriate scientific and scholarly expertise to conduct an in depth review of the protocol.  If such an IRB member cannot be identified, the Chairman will defer the protocol review to another IRB with appropriate expertise or obtain consultation.  The primary reviewer is given the following at least two weeks prior to the scheduled IRB meeting:

 

Two weeks prior to the convened meeting, the reviewer is provided with the above listed continuing review materials.  Other IRB members are provided with the same essentials as the reviewers with the exception of the clinical investigator's brochure (when one exists), unless the reviewers have deemed it is necessary.  All IRB members are required to review all materials in enough depth to be familiar with and prepared to discuss the information at the convened meeting.  The IRB members can contact ORI to obtain the protocol file and relevant IRB minutes before the convened IRB meeting.  ORI can also provide a copy of all the information that was given to the primary reviewer.

 

When review is conducted using the expedited procedure, at least one reviewer will receive and review all information that the convened IRB would  receive.

 

Convened Review of Modifications to Previously Approved Research

For convened review of modifications to previously approved research the following is required:

 

Review is conducted using the Modification Protocol Assessment Form, and at least one reviewer will receive and review all information that the convened IRB receives.   All IRB members will be provided with materials for the modification review one week prior to the scheduled IRB meeting.

 

When a convened IRB review of modifications is required, the IRB Chair is responsible to ensure that at least one IRB member with the appropriate scientific and scholarly expertise will conduct an in depth review of the protocol and be present at the meeting.  If such an IRB member cannot be identified, the Chair will defer the protocol review to another IRB with appropriate expertise or obtain consultation.

 

 

FOLLOW-UP RESPONSIBILITY:  Director, Office of Research Integrity

 

 

 

 

Revised 5-1-2007