Request for Alteration or Waiver of Informed Consent
Purpose:
- This form is to request an alteration or waiver of informed consent outlined in
45 CFR 46.116 (d).
- Informed consent can be altered or waived only for research that is not regulated as a clinical trial by the FDA or EPA.
- If a waiver of informed consent is granted by the IRB, documentation of informed consent (i.e. a signed informed consent document) is also waived.
- If an alteration or waiver of informed consent is granted by the IRB, the committee may still require other conditions, such as providing subjects with a written statement regarding the research.
What is being requested? Choose one:
Full waiver of informed consent
Alteration of informed consent>Please specify what elements of informed consent are to be altered:
Please respond to the following questions:
- This research involves no more than minimal risk to subjects because:
Points to consider:
- To satisfy the definition of minimal risk, the anticipated harms and discomforts of the proposed research should not be greater than an estimate of the harms and discomforts ordinarily encountered in daily life or during the performance of routine medical or psychological exams or tests.
- The evaluation of the harms and discomforts of the research should consider the nature of the study procedures, subjectcharacteristics, type of data collected, and steps taken to minimize risk.
- Will the data collected be de-identified, encrypted, and/or password-protected? How will privacy be maintained?
- A waiver of consent will not adversely affect the rights and welfare of the subjects because:
Points to consider:
- Whether other federal, state or local laws require informed consent
-E.g. federal law protects the privacy of student educational records, so a waiver of informed consent for research into these records would violate federal law.
- Whether the subject population, in general, would object if they knew of the waiver and its intent to facilitate research. Please consider the reaction of minority and vulnerable populations.
- The research could not practicably be carried out without waiver or alterationof consent because (please note that convenience, cost, and speed are notacceptablecriteria):
Points to consider:
- Scientific validity would be compromised if consent was required
-E.g. Sample size is so large that including only samples for which consent could be obtained would prohibit conclusions to be drawn or bias the sample.
-E.g. Subjects for whom records would be reviewed are no longer followed and may be lost to follow-up, such that the research results may not be meaningful.
- Ethical concerns would be raised if consent was required.
-E.g. Additional threats to privacy would be created by having to link otherwise de-identified data with identifiers in order to contact individuals to seek consent.
-E.g. Risks of inflicting psychological, social or other harm by contacting individuals or families.
- Where appropriate, how will subjects be provided with additional pertinent information after participation?
Points to consider:
- This criterion is intended to refer to the need to consider debriefing after research is conducted. In some situations, it may be ethically required or determined to be respectful to provide the subject with pertinent information after the research is complete.
- Under most circumstances, this criterion does not apply to retrospective research conducted under a waiver. However, it is helpful to note how subjects will be informed of the study results once the research is completed.