Toggle navigation. Institutional Review Board IRB The primary purpose of the IRB is to protect the rights and welfare of human subjects involved in research activities being conducted under its authority.
The risks to human research subjects are reasonable in relation to the anticipated benefits if any to the individual, and the importance of the knowledge that may be expected to result.
For the purpose of IRB consideration, "benefit" is defined as a valued or desired outcome; an advantage. For the purpose of IRB consideration, "risk" is defined as the probability of harm or injury physical, psychological, social, or economic occurring as a result of participation in a research study.
In evaluating risk, the IRB is to consider the conditions that make the situation dangerous, per se i. Such arrangements should be documented in writing. Individuals conducting research in a non-institutional setting often use established IRBs independent or institutional rather than form their own IRBs.
May a hospital IRB review a study that will be conducted outside of the hospital? A hospital IRB may review outside studies on an individual basis when the minutes clearly show the members are aware of where the study is to be conducted and when the IRB possesses appropriate knowledge about the study site s. The FDA regulations do not preclude a member from being compensated for services rendered. Payment to IRB members should not be related to or dependent upon a favorable decision.
Expenses, such as travel costs, may also be reimbursed. FDA regulations do not address the question of IRB or institutional liability in the case of malpractice suits.
Is the purpose of the IRB review of informed consent to protect the institution or the subject? The fundamental purpose of IRB review of informed consent is to assure that the rights and welfare of subjects are protected. A signed informed consent document is evidence that the document has been provided to a prospective subject and presumably, explained and that the subject has agreed to participate in the research. IRB review of informed consent documents also ensures that the institution has complied with applicable regulations.
Does an IRB or institution have to compensate subjects if injury occurs as a result of participation in a research study? Institutional policy, not FDA regulation, determines whether compensation and medical treatment s will be offered and the conditions that might be placed on subject eligibility for compensation or treatment s. Any statement that compensation is not offered must avoid waiving or appearing to waive any of the subject's rights or releasing or appearing to release the investigator, sponsor, or institution from liability for negligence [21 CFR When selecting IRB members, the potential for conflicts of interest should be considered.
When members frequently have conflicts and must absent themselves from deliberation and abstain from voting, their contributions to the group review process may be diminished and could hinder the review procedure. Even greater disruptions may result if this person is chairperson of the IRB. May one member satisfy more than one membership category? For example, one member could be otherwise unaffiliated with the institution and have a primary concern in a non-scientific area.
This individual would satisfy two of the membership requirements of the regulations. IRBs should strive, however, for a membership that has a diversity of representative capacities and disciplines. When IRB members cannot attend a convened meeting, may they send someone from their department to vote for them?
Alternates who are formally appointed and listed in the membership roster may substitute, but ad hoc substitutes are not permissible as members of an IRB. However, a member who is unable to be present at the convened meeting may participate by video-conference or conference telephone call, when the member has received a copy of the documents that are to be reviewed at the meeting.
Such members may vote and be counted as part of the quorum. If allowed by IRB procedures, ad hoc substitutes may attend as consultants and gather information for the absent member, but they may not be counted toward the quorum or participate in either deliberation or voting with the board.
The IRB may, of course, ask questions of this representative just as they could of any non-member consultant. Opinions of the absent members that are transmitted by mail, telephone, telefax or e-mail may be considered by the attending IRB members but may not be counted as votes or the quorum for convened meetings. The use of formally appointed alternate IRB members is acceptable to the FDA, provided that the IRB's written procedures describe the appointment and function of alternate members.
The IRB roster should identify the primary member s for whom each alternate member may substitute. To ensure maintaining an appropriate quorum, the alternate's qualifications should be comparable to the primary member to be replaced.
The IRB minutes should document when an alternate member replaces a primary member. When alternates substitute for a primary member, the alternate member should have received and reviewed the same material that the primary member received or would have received. Although 21 CFR Therefore, frequent absence of all non-affiliated members is not acceptable to FDA. Acknowledging their important role, many IRBs have appointed more than one member who is not otherwise affiliated with the institution.
Most IRBs include physicians and Ph. Such members satisfy the requirement for at least one scientist. FDA believes the intent of the requirement for diversity of disciplines was to include members who had little or no scientific or medical training or experience.
Therefore, nurses, pharmacists and other biomedical health professionals should not be regarded to have "primary concerns in the non-scientific area. Some members have training in both scientific and non-scientific disciplines, such as a J. While such members are of great value to an IRB, other members who are unambiguously non-scientific should be appointed to satisfy the non-scientist requirement. FDA regulations allow for one emergency use of a test article in an institution without prospective IRB review, provided that such emergency use is reported to the IRB within five working days after such use.
An emergency use is defined as a single use or single course of treatment, e. In its review of the emergency use, if it is anticipated that the test article may be used again, the IRB should request a protocol and consent document s be developed so that an approved protocol would be in place when the next need arises.
In spite of the best efforts of the clinical investigator and the IRB, a situation may occur where a second emergency use needs to be considered.
FDA believes it is inappropriate to deny emergency treatment to an individual when the only obstacle is lack of time for the IRB to convene, review the use and give approval. Are there any regulations that require clinical investigators to report to the IRB when a study has been completed?
IRBs are required to function under written procedures. One of these procedural requirements [21 CFR Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. The IRB may also use the expedited review procedure to review minor changes in previously approved research during the period covered by the original approval.
Under an expedited review procedure, review of research may be carried out by the IRB chairperson or by one or more experienced members of the IRB designated by the chairperson. The reviewer s may exercise all the authorities of the IRB, except disapproval.
Research may only be disapproved following review by the full committee. The IRB is required to adopt a method of keeping all members advised of research studies that have been approved by expedited review.
The number of studies we review has increased, and the size of the package of review materials we send to IRB members is becoming formidable. Must we send the full package to all IRB members? While it is preferable for every IRB member to have personal copies of all study materials, each member must be provided with sufficient information to be able to actively and constructively participate. Some institutions have developed a "primary reviewer" system to promote a thorough review.
Under this system, studies are assigned to one or more IRB members for a full review of all materials. Then, at the convened IRB meeting the study is presented by the primary reviewer s and, after discussion by IRB members, a vote for an action is taken.
The "primary reviewer" procedure is acceptable to the FDA if each member receives, at a minimum; a copy of consent documents and a summary of the protocol in sufficient detail to determine the appropriateness of the study-specific statements in the consent documents. In addition, the complete documentation should be available to all members for their review, both before and at the meeting.
The materials for review should be received by the membership sufficiently in advance of the meeting to allow for adequate review of the materials. Whatever system the IRB develops and uses, it must ensure that each study receives an adequate review and that the rights and welfare of the subjects are protected. Are sponsors allowed access to IRB written procedures, minutes and membership rosters? The IRB and the institution may establish a policy on whether minutes or a pertinent portion of the minutes are provided to sponsors.
Must an investigator's brochure be included in the documentation when an IRB reviews an investigational drug study? For studies conducted under an investigational new drug application, an investigator's brochure is usually required by FDA [21 CFR Even though 21 CFR part 56 does not mention the investigator's brochure by name, much of the information contained in such brochures is clearly required to be reviewed by the IRB. The regulations do outline the criteria for IRB approval of research.
The risks cannot be adequately evaluated without review of the results of previous animal and human studies, which are summarized in the investigator's brochure. There is no specific regulatory requirement that the Investigator's Brochure be submitted to the IRB. There are regulatory requirements for submission of information which normally is included in the Investigator's Brochure.
Investigator's Brochures may be part of the investigational plan that the IRB reviews when reviewing medical device studies. To what extent is the IRB expected to actively audit and monitor the performance of the investigator with respect to human subject protection issues? FDA does not expect IRBs to routinely observe consent interviews, observe the conduct of the study or review study records.
However, 21 CFR When and if the IRB is concerned about the conduct of the study or the process for obtaining consent, the IRB may consider whether, as part of providing adequate oversight of the study, an active audit is warranted. The Division of Scientific Investigations, Center for Drug Evaluation and Research, maintains an inventory of the IRBs that have been inspected, including dates of inspection and classification. The Division recently began including the results of inspections assigned by the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health.
When an IRB disapproves a study, it must provide a written statement of the reasons for its decision to the investigator and the institution [21 CFR The IRB is concerned with protecting the welfare, rights, and privacy of human subjects.
The IRB has the authority to approve, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy. The IRB shall have at least five members of varying backgrounds in order to provide complete and adequate review of human research and its institutional, legal, scientific, and social implications.
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