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Ethical Principles |
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Institutional Responsibilities |
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What is "Minimal Risk?" |
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Exemptions |
Kinds of Research Requiring Review
Categories of Review
III. Continuing Review
IV. Informed Consent
V. Required Education of Human Research Participants
VI. What Are Researcher's Responsibilities After Protocol Approval?
VII. Student Research
Institutional Review Board
Forms/Additional Info.
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UDC Home
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General Guidelines for the Protection of Human Research Participants |
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IRB Application Procedures |
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All research protocols involving human participants should be forwarded to the Institutional Review Board electronically through the IRBnet for review and approval. You must first -register. Go to www.irbnet.org and click new user registration on the left side of the screen. We ask that you use your first initial and last name as your User ID. For specific instructions please click the link for IRB Login Registration Tips. |
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Applications must include the research protocol, informed consent form, any recruitment notices, research survey instruments, psychological tests, interview forms, or scripts to be used. (The Sample Informed Consent Form and Checklist attached to the application form provides a useful guide.) Federal regulations also mandate applicants to submit a certificate of completion of training in the protection of human research participants, within the last three years. Recommended on-line sources for investigator education appear in Section IV of this document. |
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Although applications may be submitted at any time, submission of a complete application not later than 10 business days prior to a regularly scheduled meeting of the IRB will ensure that the Board can consider it at its next meeting. IRB Meetings are held monthly on the first Friday of the month during the months of September, October, November, and February, March, April.
Once the application arrives in the IRB Office, please allow two or three weeks for processing. Exempt applications tend to require less time, while non-exempt applications which require review by Board members tend to take longer.
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Upon receipt of application the Chairperson of the IRB, or a designee, in consultation with at least one member of the Board designated on a rotating basis by the Chairperson shall determine, within five (5) working days, whether the proposal is exempt from review, meets the criteria necessary for an expedited review, or requires a full review. |
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Exempt Review. If the IRB Chairperson declares an application exempt, no further review beyond the IRB Chair is required, and a certificate of exemption will be sent to the principal investigator. |
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Expedited Review. The expedited review procedure may be used to review either or both of the following: (a) Research that involves no more than minimal risk to participants and where the only involvement of participants will be in one or more of the Expedited Review Categories of research appearing in the attached list; (b) Minor changes in previously approved research during the period (of one year or less) for which approval is authorized. |
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Full IRB Review. If a full review is warranted the Chairperson shall convene the Board meeting within 10 working days from the date when the proposal is received.
(a) Research protocols scheduled for review shall be distributed to all members of the IRB prior to the meeting.
(b) The IRB may invite consultants or experts to advise the IRB in its review of a protocol.
(c) A majority of the membership of the IRB constitutes a quorum and is required in order to convene a meeting for the review.
(d) For a research protocol to be approved, it must receive the approval of a majority of those members present at the convened meeting.
(e) An IRB member will not participate in the IRB’s review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
(f) In cases where research protocols were initially approved under expedited procedures and subsequently reviewed by non-expedited procedures, the decisions reached at the convened meeting shall supercede any decisions made through the expedited review.
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IRB Notification to research investigators and the Vice President of Academic Affairs of its decision.
(a) The IRB shall immediately notify the research investigators in writing of the IRB’s decision, conditions, and requirements. In case of disapproval, the IRB shall provide to the research investigator reasons for disapproval and an opportunity for the research investigator to respond.
(b) The IRB shall submit a copy of its decision through the Director of the Office of Sponsored Research and Programs to the Vice President for Academic Affairs (VPAA) or his/her designee for final approval. The VPAA may not approve protocols that have been disapproved by the IRB.
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The researcher may not begin the project prior to the approval of the IRB and the signatory approval of the VPAA. |
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Prepared by the University of the District of Columbia Institutional Review Board (UDC IRB) with reference to the Institutional Review Board Guidebook (http://www.hhs.gov/ohrp/irb/irb_guidebook.htm). The UDC IRB acknowledges the assistance of the College of Charleston, which shared its web materials, on which UDC’s materials are based. The UDC IRB is also indebted to many other fine university web sites which it has visited in the course of preparing these materials, and in particular commends the design and content of the University of Maryland Baltimore Campus website. |
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