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Chapter VII - IRB Management

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SIGNATORY OFFICIAL
The Signatory Official on the Genetic Alliance FederalWide Assurance ensures that adequate facilities, equipment, and resources are available to support all IRB-related activities. The Signatory or Institutional Official is also responsible for approving organizational relationships with other organizations/institutions or sites wherein the human participant research activities may be or will be conducted.

The IRB reports to the Signatory Official through the IRB Chair.

APPOINTMENT OF IRB CHAIR AND MEMBERS
The IRB Chair and Members of the IRB will be appointed by the Signatory Official.

  • In appointing the IRB Chair, primary consideration will be given to current or past Members of the IRB;
  • The IRB Chair should be highly respected individuals fully capable of managing the IRB and the matters brought before it with fairness and impartiality. The task of making the IRB a respected part of the organization will fall primarily on the shoulders of this individual;
  • The terms of appointment of the IRB Chair and IRB Members are based on a contract and will be reassessed periodically by the Signatory Official.

Only the Signatory Official has the authority to terminate the appointments of the IRB Chair and IRB Members. Termination of appointment (or resignation of appointment by the IRB Chair, or its Members), shall be subject to a minimum of 3 months advanced notice unless extenuating circumstances exist.

THE IRB CHAIR
The IRB Chair will hold leadership responsibility for IRB review and approval of human participant research in accordance with current guidelines, organizational policies, and federal and state regulations governing human participant protections.

In addition, the IRB Chair will:

  • Oversee the recruitment, orientation, continuing education and retention of IRB members;
  • Oversee the development and implementation of appropriate policies, procedures and guidelines directed at human participant protections and the functions and activities of the IRB. The IRB Chair or his/her designee is responsible for reviewing the IRB’s policies and procedures for currency, accuracy and consistency on an ongoing basis but not less than every three years. Ad hoc committees will be formed to review guidance issued by regulatory agencies to determine whether updates to the policies and procedures are required;
  • Reside over IRB meetings;
  • Communicate IRB meeting decisions, directives, and sanctions relating to known or suspected problems in the conduct of human participant research to involved investigators;
  • Have authority to request audits of human participant research activities;
  • Have the authority to suspend some or all research activities if exceptional human participant safety issues are identified. (Note that this authority is only exercised if an action is required prior to a convened meeting and it is not feasible to assemble an emergency meeting) When this authority is exercised, it will be reported at the next convened IRB meeting;
  • Represent the IRB in interactions related to issues surrounding the ethical and regulation-compliant conduct of human participant research;
  • Approve written correspondence to state and federal regulatory agencies having jurisdiction over human participant research;
  • Represent the IRB at national and local meetings related to human participant protections.

All research investigators involved in the conduct of human participant research that falls under the authority of the IRB take direction from the IRB Chair.

THE IRB MEMBERS

  • The IRB will be comprised of at least five members, with varying backgrounds and expertise to provide complete and thorough review of research activities commonly conducted by the organization;
  • The membership of the IRB will be sufficiently qualified through the experience and expertise of its members and the diversity of its members, including consideration of race, gender, and cultural backgrounds and sensitivity to community attitudes for safeguarding the rights and welfare of human research participants;
  • IRB members should be able to ascertain the acceptability of the proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice;
  • The IRB includes both men and women;
  • The IRB includes members of more than one profession;
  • The IRB includes at least one member who represents the perspective of research participants;
  • The IRB includes at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in non-scientific areas;
  • The IRB includes at least one member who is not otherwise affiliated with Genetic Alliance, and who is not part of the immediate family of a person with such affiliation (i.e., “unaffiliated member”);
  • When reviewing research that involves a vulnerable population, individuals knowledgeable about and experienced in working with these participants will be present for the IRB meeting or the review will be tabled.

RESPONSIBILITIES OF IRB MEMBERS
General Responsibilities of all IRB Members include:

  • Reviewing research study proposals and evaluating them from the perspective of the regulatory criteria for approval addressed under 45 CFR 46.111, 21 CFR 56.111 (if applicable); and any other relevant ethical, scientific or compliance considerations;

  • Reviewing informed consent documents and evaluating them from the perspective of addressing the required and additional elements of informed consent addressed under 45 CFR 46.116, 21 CFR 50.20 (if applicable) and any other relevant ethical or compliance considerations;

  • Attending at least 70% of IRB meetings in person, unless exigent circumstances prevent such attendance on an occasional basis; reporting promptly at the designated time that the meeting convenes; and remaining in attendance at the meeting until the full agenda has been addressed;

  • Participating in IRB deliberations concerning issues inherent to proposed research studies and related informed consent documents, and making recommendations for reducing risk and improving the informed consent process and otherwise for improving human participant protections;

  • Voting for full approval, approval subject to modification(s), reconsideration, or disapproval of the human participant research;

  • Evaluating the risk level (i.e., minimal or greater than minimal) of the proposed research.  In performing this evaluation, IRB members will use the following absolute definition for "minimal risk" at 45 CFR 46.102(i) unless the research is directed at prisoner-participants:

"Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life (i.e., of the general population) or during the performance of routine physical or psychological examinations or tests."

  • Deciding, for research studies of greater than minimal risk, if IRB continuing review of the research is warranted on a more frequent basis than the requisite annual review;

  • Deciding, for research studies involving greater than minimal risk, complexity, or conflict-of-interest concerns, if the informed consent process and/or other aspects of the research study should be audited by the IRB;

  • Deciding, for research studies involving an unapproved device, if the device and its proposed use constitute a non-significant or significant risk to research participants;

  • Deciding, for research studies subject to IRB continuation approval, if verification is required from sources other than the investigator that no material changes have occurred since previous IRB review;

  • Recommending improvements to IRB policies and procedures to enhance the IRB review process and/or human participant protections;

  • Informing the IRB Chair of noncompliance problems or ethical issues;

  • Displaying behaviors in accordance with legal and ethical principles accepted by the IRB; including, but not limited to, maintaining confidentiality/non-disclosure of human participant research submitted for IRB review and approval, and good faith participation in IRB deliberations without appearance of discrimination or conflict-ofinterest.

IRB ROSTER
The IRB membership roster will include the following information and will be used to determine relevant expertise in making protocol assignments at convened meetings:

  • Names of members;
  • Earned degrees;
  • Representative capacities;
  • Scientific/nonscientific status;
  • Affiliation status (whether the IRB member or an immediate family member of the IRB member is affiliated with the organization);
  • Employment or other relationship between each IRB member and the organization.

COMPENSATION OF THE IRB LEADERSHIP
The IRB Chair and Members will be compensated for their IRB duties and responsibilities. The rate of compensation is at the discretion of the Signatory Official who will consider the professional background of the individual and the expected time commitment of the appointed position to IRB activities.

MINUTES OF CONVENED IRB MEETINGS
The minutes of IRB meetings will document the presence of a quorum, the time the meeting is convened and adjourned, recusals due to conflict of interest, and separate deliberations, actions, and votes for each protocol undergoing initial or continuing review by the convened IRB. Reasons for votes of disapproval or abstention will also be documented. The Common Rule (32 CFR 219.115) requires that the minutes of IRB meetings shall be recorded in sufficient detail to show:

  • Attendance at the meetings. The list of attendees must include the names, earned degrees, professional expertise (including status as non-scientist), and institutional affiliations of the participating individuals. They may be categorized in the following manner: the primary members participating, the alternates participating on behalf of the primary members absent, and the primary members absent. This information may be presented in an IRB Membership tabular roster format;
  • Actions taken by the IRB;
  • Vote on actions including the number of members voting for, against, and abstaining;
  • The basis for requiring changes in, deferring, or disapproving research;
  • Written summary of the discussion of controversial issues and their resolution.

The list of attendees will also include the names of all non-member persons attending any part of the IRB meeting and may list them as guests, if appropriate.

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