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The purpose of this IRB is to protect the rights, well-being, and personal privacy of individuals; to assure a favorable climate for the conduct of scientific inquiry; and to protect the interests of the University of Kansas.
All of the Institution's human subjects research activities, regardless of whether the research is subject to federal regulations, will be guided by the ethical principles in:
HSCL will ensure that all requirements of Title 45, Part 46, of the Code of Federal Regulations (45 CFR 46) will be met for all applicable Department of Health and Human Services (DHHS)-supported research, and all other human subject research, regardless of sponsorship. 45 CFR 46 is the set of regulations under which HSCL operates. Regardless of source, no funds for which this Assurance applies may be expended for research involving human subjects unless the requirements of this Assurance have been satisfied.
The involvement of human subjects in research covered by this Assurance will not be permitted until HSCL has reviewed and approved the research protocol and informed consent has either been obtained from the subject or the subject's legal representative or waived in accordance with 46.111, 46.116 and 46.117.
Before human subjects are involved in research covered by this Assurance, HSCL will give proper consideration to:
Expedited Review. This level of review requires that the proposed research procedures fall under at least one of the criteria designated by 45 CFR 46.110. No application may receive expedited review if any research procedure presents more than minimal risk, even if it would otherwise fall within the procedures described in 46.110. In addition, the procedures considered under Expedited review cannot involve vulnerable populations, that is, subjects who could be judged to have limited freedom of consent (e.g., minors, developmentally delayed persons, or those institutionalized). The exception to this rule is that Expedited review may be given for research conducted in established or commonly accepted educational settings, involving normal educational practices, such as research on regular and special education instructional strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Full Board Review. This level of review requires that the proposed research be reviewed by members of the committee, and be acted upon at a convened meeting.
Exempt designation. The regulations allow for some education research to be designated "Exempt" (see 46.101 (b) (1)). However, HSCL's agreement with the Office for Human Research Protections (OHRP) stipulates that HSCL must review all research to determine whether or not such research may be exempted from full board review. Research that falls under the definition of "Exempt" research receives Expedited review from HSCL.
Risks to subjects are minimized. This is the first and foremost concern in the review of application by HSCL. What potential risks, stresses, or discomforts (if any) will be incurred by participation in this project? Has the PI taken steps in the design or procedures of the study to reduce the possibility of these risks or discomforts?
Risks to subjects are reasonable in relation to anticipated benefits. Do the benefits, if any, to be derived from this research outweigh the risks posed by this research to the subjects?
Informed consent will be sought from each subject (or the subject's legal representative) and documented.Are subjects fully informed of the risks and benefits of participation in the research? Are subjects informed of their basic rights in participating (e.g., withdrawal without penalty)? Are all of the appropriate aspects of informed consent included? If not, have the omissions been adequately justified? (See especially the section “HSCL Policy on Experiments Involving the Deception of Subjects” that follows). If audio or video taping is part of the research procedure the participants must be given the option of not being taped or having taping stopped at any time. If the subjects themselves are unable to give informed consent, has consent been acquired from the appropriate responsible person(s), and has an assent procedure been provided? Is there adequate provision for the documentation of informed consent by the PI? The most common form of difficulty encountered by HSCL in granting approval of projects involves technical problems with informed consent forms (e.g., all the necessary aspects listed in Consent Form Requirements are not included).
Adequate provisions for monitoring data to insure the safety of subjects. Is the research monitored so that previously unforeseen risks come to the attention of the PI? This section also includes the monitoring of data in the case that individual subjects are identified as being at risk for medical or psychological problems. For example, in the course of research on exercise physiology, a PI might discover the presence of a heart murmur; in the course of psychological research on depression, a PI might discover a subject who is at some risk for suicide. What provisions, if any, are made for subjects who are identified as being at risk during the conduct of this research?
Adequate provisions to protect the privacy of subjects and maintain confidentiality. To what degree are subjects' responses protected with respect to confidentiality and anonymity? Will subjects' names be associated with their data? Who will have access to materials (e.g., data sheets, audio recordings or videotapes) through which subjects might be identified? Will response sheets be kept in a safe place? What are the plans for disposition of materials through which subjects might be identified when the study is finished?
Appropriate additional safeguards for subjects who are especially vulnerable. Have adequate additional provisions been made to protect the rights of those subjects who might be especially vulnerable to coercion or undue influence? Federal law specifically mentions children, those with physical illness or psychological disorders, or those who are economically or educationally disadvantaged, as being members of this class. Are there any circumstances in the proposed research under which subjects might feel coerced to participate?
HSCL acknowledges that it is occasionally necessary to use deception in a research design in order to protect or strengthen the scientific integrity of an investigation. However, because participants are deliberately misinformed concerning the actual purposes or procedures of the research in such cases, HSCL considers such research to not meet the general requirement for informed consent as stated in the Code of Federal Regulations (45 CFR 46.116.a.1). This part of the law delineates the basic elements of informed consent, and states that in seeking informed consent, the following information shall be provided to each subject:
an explanation of the purposes of the research and a description of the procedures to be followed
Please note that federal law does not necessarily restrict the concept of "informed consent" to the consent form that subjects sign at the start of a study.
The Code of Federal Regulations, however, does provide for instances in which informed consent can be altered or waived. Under this federal law (45 CFR 46.116.d.1-4), this can occur only if all of the following conditions are met:
Therefore, investigators proposing research to HSCL in which participants are misinformed concerning the study's procedures or purposes during the course of data collection must address how their applications meet these conditions. This requirement may be met in a number of ways. However, in order to address these issues and facilitate review of such applications, HSCL recommends that applications for research involving deception include the following elements:
Justification for the Deception. The justification should address the third condition listed above. Investigators should provide specific and cogent reasons why fully informed consent is not appropriate for this study, and/or the manner in which fully informed consent threatens the integrity of the research.Explicit Statement of No Risk/Minimal Risk. This statement should address conditions 1 and 2 listed above. Investigators should provide a statement affirming that the proposed research presents no more than minimal risk to the participants.
Federal law (45 CFR 46.102.g) defines "minimal risk" as follows:
"Minimal risk" means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Description of Debriefing. Procedures for debriefing should address condition 4, listed above. Subjects should be informed that deception took place, and should be appropriately informed as to the actual purpose of the research, and the role of the deception in protecting the integrity of the research. Finally, subjects should also be reminded of their right to withdraw from the study at this time; this can be accomplished through a range of various procedures, extending from the inclusion of a simple statement to that effect in the debriefing, to having the participant sign a second informed consent form at the end of the study.
It is noted that the text of the Code of Federal Regulations allows for the possibility that circumstances may arise in which debriefing may not be judged to be "appropriate." HSCL allows for this possibility, but PIs should note that requests to omit such debriefing in research involving deception should be strongly justified.
Although applications involving deception must meet the conditions for alteration of informed consent, signed informed consent is still required to meet the requirements described in 45 CFR 46.116.a.2-8. Note that the informed consent form may not contain misinformation, may not be used as part of the deception, and may not be used as a means for manipulating subjects' behavior.
HSCL will certify all federally sponsored research involving human subjects and submit the certification to the Office of Contract Negotiations and Research Compliance for forwarding to the appropriate federal department or agency as needed. Compliance will occur within the time and in the manner prescribed for forwarding certifications of HSCL review to DHHS or other federal departments or agencies for which this Assurance applies. As required under Section 119, the HSCL will review and recommend approval for involvement of human subjects in federal research activities for which there was no prior intent for such involvement, but will not permit such involvement until certification of the HSCL's review and approval is received by the appropriate federal department or agency.
Questions? Please contact:
Mary Denning
785-864-7429 | mdenning@ku.edu
Coordinator |Human Subjects Committee of
Lawrence (HSCL)
