1. Are the risks reasonable in relation to the benefits?
Consideration of this criterion ensures that the generally accepted canons of good scientific research are fulfilled and that there is evidence of scientific propriety. The IRB should consider the entire protocol from the participant's point of view and decide if the information gained is worthwhile.
The IRB must determine whether every possible precaution been taken to minimize pain, discomfort, or harm. Are there adequate safeguards to the participant against anticipated risks?
3. Is the selection of participants equitable?
The IRB must insure that care has been taken to avoid discrimination or the overselection of vulnerable participants. Who are the participants and do they come from a specific population? Selection of particularly vulnerable participants requires specific consideration of the protection of those participants.
4. Has informed consent been obtained?
Informed consent means that the participant has full disclosure of the procedures involved as well as the risks and benefits of these procedures. Does the participant understand what will be done, why it is being done, what risks are involved, the kind and possibility of discomfort, and the anticipated duration of the procedures? All of the circumstances of being a participant must be understood by a competent individual, either the participant or the legally authorized representative of the participant. Incomplete disclosure is justified only when 1) complete disclosure would invalidate the research, 2) risks to subjects are no more than minimal, and 3) debriefing is eventually carried out. The decision to participate must be the individual's own decision on the basis of his or her values and should be free of coercion. The IRB attempts to insure that the rights of the participant as a person are respected.
5. Has informed consent been adequately documented?
One of the major goals of the IRB is to insure that participants are provided with a form explaining the purpose of the research and supplying a description of procedures sufficient to obtain informed consent. Individuals should be informed that they have the right to refuse to participate and that they also have the right to withdraw from the procedures at any time without being penalized. (See specific requirements for informed consent.)
6. Are the privacy and confidentiality of the participant protected?
Any information obtained from the participant must be kept confidential and those individuals who have access to the information must be specified. The privacy of the individuals and their capacity to control their way of life must be respected.
7. Are the data monitored and the risk-assessment reevaluated during the course of the study?
The IRB expects each investigator to be aware of the preceding seven criteria not only while designing research projects, but also while data collection is progressing. The results should be assessed for effectiveness -- is the information sought being obtained? The risks involved in obtaining the information should be reevaluated. Is the information worth the risk to the participant? The IRB requests notification at the conclusion of data collection, and also in the event of any unexpected negative consequences (e.g., unforeseen discomforts or harmful repercussions of the research).
Last
updated: August, 2006
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This site was authored by Dr. Catherine Pittman and Zhou Zhu as the product of a faculty / student special project.