Marshall University

Huntington, WV

 

SUBJECT:  Non-Member Attendance at MU IRB Meetings

 

PURPOSE:  To define the conditions in which non-Institutional Review Board (IRB) members (investigators and guests) may attend an IRB meeting and to establish guidelines for such participation.  The procedures are designed to maintain the confidentiality of information shared as part of the activities of the IRB since unauthorized disclosure of any confidential information to any person or entity may cause irreparable harm to the parties protected.

 

POLICY:  To maintain strict confidentiality of the issues discussed and the materials presented at IRB meetings and to require that certain requirements of guests be met before they may attend an IRB meeting.  

 

SCOPE:  This policy applies to all non-IRB Members who may have reason to attend an IRB meeting and the procedures to be followed to protect the confidentiality of the proceedings. 

 

Investigator:

The primary- and secondary-reviewer team may request investigator attendance at the Marshall University Institutional Review Board (IRB) meeting in which his/her research is being reviewed.  The principal reason for having the investigator at the meeting is to answer questions posed by the Board members in an effort to clarify minor ambiguities within the protocol and consent form so that delays in approving the protocol can be minimized.  It is the IRB policy that investigators and members of the research team who attend the IRB meeting will do so after meeting the following criteria:

The investigator(s) and research team members (such as study coordinators) who will be attending must contact the IRB Administrative office two business days prior to the scheduled meeting date to confirm their scheduled appointment time.  These appointments normally will occur in 10-15 minute increments.  Note that scheduled times are not exact as some protocols may require more or less discussion than others.

The primary- and secondary-reviewer team will present the study and the investigator and research team will be given time to answer questions related to the study.  IRB members are not limited in their presentation, discussion, or deliberation time.  After the question period, the investigator and research team will be asked to leave the room until the discussion and vote are concluded.  The investigator will be instructed as to when he/she may leave in case the IRB members have additional questions.

The decisions by the IRB are sent to the investigator or designee via email or by hard copy letter.  No verbal answer regarding the status of the study is permitted during the meeting. 

 

Guests:

Guest attendance at the IRB meeting is for observance only and must be sponsored by a current IRB member.  Guests who wish to observe the IRB meeting to learn about research such as students, new faculty members or staff who are not affiliated with a particular research protocol, or visitors from other Institutional Review Boards (IRB) may attend the IRB meeting if the following criteria are met:

The Guest's Sponsor is required to contact the IRB Administrative office no later than 4pm on the Friday prior to the next scheduled meeting date to request consideration of their attendance.  The Chairperson will make the decision concerning the request and the Sponsor will be notified.  If the Chairperson approves the attendance of the individual, the individual is responsible for approaching the Chair to introduce themselves upon entering the room before the beginning of the IRB meeting.  A confidentiality statement must be signed.   Also, any individual may be asked to leave the meeting for speaking out in violation of the observance only rule or if the Chair determines a sufficient need.

 

 

FOLLOW-UP RESPONSIBILITY:  Director, Office of Research Integrity

 

REFERENCE:  M-3, Part I, Chapter 15

 

 

 

 

Revised 5-1-2007

 

  

 

IRB Guest Non-Disclosure Agreement