2.0 Institutional Review Board

2.1 Purpose of the Institutional Review Board
2.2 IRB Scope and Authority
2.3 Activities Requiring IRB Review and Approval
2.4 Principles Governing the IRB
2.5 Selection and Composition of the IRB
2.6 IRB Meetings

2.6.1 Meeting Materials
2.6.2 Quorum
2.6.3 Attendence
2.6.4 Minutes

2.7 Education of IRB Members
2.8 IRB Records

2.1 PURPOSE OF THE INSTITUTIONAL REVIEW BOARD

The Drake University Institutional Review Board (IRB) is charged with the responsibility of determining 1) whether human subjects have volunteered for a research endeavor by means of informed consent and 2) whether risks to these subjects are outweighed by potential benefits to them and importance of the knowledge to be gained by the research. In considering ethical issues and government guidelines, the evaluation of risk involves estimating the potential for injury to the subject by reason of direct application of an experimental procedure or circumstance or by reason of the subject's exclusion from ordinary standards of practice of care. Rights of subjects regarding confidentiality and access to professional care and counsel are included in IRB deliberations so that human dignity, rights, and physical, psychological, behavioral and social welfare are protected.

2.2 IRB SCOPE AND AUTHORITY

All human research authorized and conducted under the jurisdiction of Drake University is subject to review by the IRB for risk, benefit, and informed consent without regard to the source of financial, physical (facilities) or logistical support. This review must be conducted before a project can be started. The IRB is responsible for any research activity that involves physical, psychological, behavioral or social welfare of human subjects that is conducted within, supported by or otherwise the responsibility of Drake University.

The IRB shall have the authority to disapprove, discontinue, suspend or limit research involving human subjects and, by its recommendations to the Provost of the University, can effect action that withholds or withdraws financial or approved support from projects involving human subjects that are not in compliance with University policies or federal regulations. University administrators (Departmental Chairs, Deans, Provost, President) should remind prospective investigators of IRB requirements whenever a proposed activity involves human subjects.

2.3 ACTIVITIES REQUIRING IRB REVIEW AND APPROVAL

To determine if the proposed activity requires review by the Drake IRB, answer the following three questions:

• Is the proposed activity research?
  Research is a systematic investigation that includes research development, testing and evaluation and is intended to develop or contribute to general knowledge. If, according to this definition, the proposed activity is not research, then IRB review is not required. If the proposed activity is research, continue with the next question.
• Does it involve human subjects?
  Research investigators must determine whether their proposed research will involve human subjects. Regulations define "human subject" as a living individual about whom an investigator (whether professional or student) conducting research obtains 1) data through intervention or interaction with the individual or 2) identifiable private information. If you determine that the research does not involve human subjects, then IRB review is not required. If you determine that the research does involve human subjects, IRB review is required. If it is not clear whether the research involves human subjects, seek assistance from the IRB Chair.
• Will it be authorized and conducted under the jurisdiction of Drake University?
  All research involving human subjects regardless of the funding status or the source of any funding is under the jurisdiction of the University. In cooperative research projects involving one or more institutions in addition to Drake University, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with the individual IRB policies.
• Does research not intended for publication require IRB review and approval?
  Even research involving human subjects that is not intended for publication requires IRB approval.

Additional activities requiring IRB review and approval include classroom instruction involving research activities. (See Section 5.1 for additional information.)

2.4 PRINCIPLES GOVERNING THE IRB

The IRB is guided by federal regulations and ethical principles regarding all research involving humans as subjects. DHHS (45CFR46) and FDA (21CFR50 and 56, 21CFR312 (Investigational New Drugs) and 21CFR182 (Investigational Devices) are the primary agencies that regulate the IRB. In addition, the IRB is guided by The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979).

The IRB weighs risks to which research subjects may be exposed that may result in physical, psychological, social and economic harms.

• Physical Harms: Minor pain, discomfort or injury
• Psychological Harms: Stress, feelings of guilt or embarrassment caused by talking about sensitive subjects or being manipulated or deceived as part of the research
• Social and Economic Harms: Invasions of privacy and breaches of confidentiality

2.5 SELECTION AND COMPOSITION OF THE IRB

IRB members are selected from the faculty and from the community-at-large to ensure representation of professional expertise and community attitudes. Members shall be diversified as to race, gender, cultural background and sensitivity to community attitudes. (45CFR Sec 46.107)

Institutional Review Board (at least nine members, three-year terms)

This Committee is responsible for reviewing all research proposals involving human subjects in order to protect and assure the rights of research subjects as defined by ethical considerations and government guidelines. Members should have the professional competence and knowledge necessary to review and evaluate research proposals to determine compliance with federal standards and Drake University guidelines, and to evaluate proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional competence and practice.

The Committee shall consist of at least nine members, and shall meet the following specifications: (a) at least six faculty members including the chair at least four of whom shall be tenured; one shall have primary expertise in a nonscientific area; all except the member from the non-scientific area shall have expertise in conducting human subjects research; (b) at least one individual who is neither affiliated with, nor a member of the immediate family of anyone affiliated with, the institution; (c) one designee from the Office of the Provost who shall serve ex-officio.

The committee chair shall be appointed by the Provost and shall serve a two-year term. The Provost shall designate a Vice Chair from among the tenured faculty on the committee who will serve as Chair when necessary, including situations in which the Chair must step down due to conflict of interest.

IRB members are not compensated for their service. The University provides general liability insurance coverage for IRB members while serving as members of the IRB.

2.6 IRB MEETINGS

Except when an exempt or expedited review procedure is used, proposed research must be reviewed at convened meetings at which a majority of the members of the IRB are present (45CFR Sec 46.108). Monthly meetings of the full IRB will be scheduled for each semester prior to its start. These dates will be publicized, and proposals that require full-board review at the next meeting will be given a deadline of one week prior to each meeting. In addition to review of protocols, the agenda specifically routinely will include:

• Review the Administrative Procedures for the Institutional Review Board and Human Research Protections Policies, making additions and voting on revisions
• Consideration of changes to IRB forms and any additional information that generally should be sought from research investigators in the future

Prior to each meeting, an agenda is sent to participating investigators and all IRB members (and consultants), notifying them of the date, time and place of the meeting. In addition to the regularly scheduled meetings, the IRB Chair may call emergency meetings of the IRB as necessary to review research protocols or address issues of noncompliance or serious and/or unexpected injury to research subject(s).

Meetings are conducted in accordance with Roberts Rules of Order and all action requires a voice or show-of-hands vote of the members present following discussion and the making and seconding of a motion. The Chair does not vote, except to break a tie. An IRB member may abstain from voting for any reason, without explanation.

2.6.1 Meeting Materials

The Chair shall provide each member of the Board with an electronic or physical copy of the following materials prior to the regularly scheduled meeting:

• The Agenda
• A copy of the minutes from the previous meeting that will include information on official IRB activities conducted through the IRB since the previous mailing of the minutes, such as protocols reviewed to determine exempt status, protocols reviewed by expedited review and adverse event reports received
• A copy of the IRB application, protocol and informed consent document for each new project subject to full IRB review
• A copy of documents for those continuing research projects to be reviewed by the full board. If necessary, this should include an unsigned copy of the most recently approved consent/assent documents(s) for those projects in which subjects are still being enrolled
• Any other information necessary for the meeting

Except for a copy that must remain on file with the IRB, sensitive documents such as protocols and consent forms considered at a convened meeting are collected and destroyed after each meeting.

2.6.2 Quorum

A majority of members must be present, in person or via teleconference or webconference, to conduct business of the IRB, except for expedited or exempt reviews, and among this majority at least one member must be a non-scientist (45CFR Sec 46.107). No proxy votes will be accepted, all votes must be cast during the convened meeting. The final approval or disapproval of any research project application will require a majority vote of IRB members present and voting, with at least one member of a non-scientific area voting. If a quorum is lost at any time during the meeting, the meeting shall be adjourned and no further action taken until a quorum is attained.

IRB members with a conflict of interest in a particular research project cannot participate in the board’s deliberations and voting concerning that project and shall not be present during IRB initial or continuing review of that project.  Should conflicted IRB members leave during the meeting, the total needed to calculate quorum would be reduced by the numbers who leave the meeting. Those with a conflict of interest may provide information requested by the IRB.

2.6.3 Attendance

Members are expected to attend a majority of convened IRB meetings. IRB Adminstration will maintain records of attendance and members who attend less than 50% of meetings per year will be contacted and encouraged to increase their attendance. Anticipated absence from an IRB meeting should be communicated to the IRB Chair at least 24 hours prior to the meeting.

If requested, research investigators are required to attend IRB meetings at the date and time scheduled for full IRB review and discussion of their initial submission or of changes to a previously approved or disapproved research project if requested. Once scheduled, the Principal Investigator should contact the IRB Chair to request a scheduling change if such a change is necessary.

Confidentiality
All members are expected to hold in confidence all matters coming before the IRB.

2.6.4 Minutes

Minutes of meetings shall include (45CFR Sec 46.115) the following information:

• Attendance of members and guests
• Actions taken by the IRB on each research project reviewed including the level of risk as determined by the IRB, the approval period and any required modifications for IRB approval
• Votes on these actions including the number of members voting for, against, and abstaining, and record of members who were not present during deliberations and voting when review involved projects on which they have a conflict of interest
• The basis for requiring modifications or disapproving research
• A written summary of the discussion and resolution of debated issues

2.7 EDUCATION OF IRB MEMBERS

All new members appointed to the IRB must complete Drake University’s human subjects research tutorial and certification requirement.  Initial certification fulfillment requires the following:

• A copy of the most recent Drake University's Federal-Wide Assurance of Protection for Human Subjects
• Completion of the web-based tutorial on human subjects research and its associated testing

2.8 IRB RECORDS

All research protocols submitted to the IRB for review will receive an identifying number.  The proposals received beginning at the onset of the academic year will be sequentially identified using the following method:

Example: 2003-04001
2003-04 designates the academic year submitted
001 representing the first protocol submitted, 002 to follow, etc.

The IRB shall retain and have accessible in a central location (45CFR Sec 46.115) the following records for at least three years after the completion of the research:

• All research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, required yearly, or other progress reports submitted by investigators, correspondence between the IRB and the investigators, and adverse event reports
• Minutes of IRB meetings, detailed appropriately
• Records of continuing review of previously approved research projects
• List of IRB members, identified by name, earned degrees, representative capacity, indications of experience sufficient to describe each member's chief anticipated contributions and employment relationship (if any) with the institution and dates of service on the IRB
• Statements of significant new findings provided to subjects as required by either FDA or DHHS
• Written procedures for the IRB.

IRB records, as outlined above, shall be available for inspection and copying by the Institutional Official or his/her designees, affiliated entities, and designated federal and other agencies.

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