______
NEBRASKA’S HEALTH SCIENCE CENTER OFFICE OF REGULATORY AFFAIRS (ORA)
Institutional Review Board (IRB)
Addendum J
Waiver or Alteration of Informed Consent and HIPAA Authorization
In Biomedical Research Involving Adult Subjects
DATE:
IRB #:
TITLE OF PROTOCOL:
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
PRINCIPAL INVESTIGATOR:
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
Instructions: In accordance with HHS regulations at 45 CFR 46.116(d), the equivalent section of the Common Rule adopted by other federal departments or agencies, and the HIPAA Privacy Rule, 45 CFR 164.514(b)(2)(i) as applicable, the IRB may waive the requirements to obtain informed consent/authorization, or approve a consent procedure which does not include or which alters some or all of the elements of informed consent/authorization, provided certain conditions are met. FDA regulations have no similar provision for waiver or alteration of consent.
If the research involves children, the IRB may waive the requirement for obtainment of parental permission (consent) in research involving children under the provisions of 45 CFR 46.116(d) or 45CFR46.408(c). FDA regulations, however, have no similar provision for waiver of parental permission. Requests for waivers of parental permission or child assent must be addressed by completing Addendum L Waiver or Alteration of Parental/Guardian Permission/Child Assent and HIPAA Authorization.
Submit this addendum with the IRB application. To determine if a waiver/alteration of consent/authorization is allowable under the applicable regulations, the investigator must provide thorough and complete responses to the attached questions. This addendum must be completed in order for the IRB to review the research protocol. Information should be provided by site for all studies involving more than one site for which the UNMC IRB or PedsIRB is the only IRB of record.
1. Does the study require a complete waiver of the requirements for informed consent or HIPAA authorization?
Yes
No
2. Does the study require an alteration or waiver of one or more of the elements of informed consent or HIPAA authorization?
No
Yes. Specify the element(s) that will be altered or waived.
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
3. Does the study require a waiver or alteration of the process of consent or HIPAA authorization?
No
Yes. Describe the proposed altered process of consent.
Note: In some research projects it may be appropriate to only obtain verbal consent via the telephone because prospective subjects do not live close to the study and transmittal of a consent form via fax, e-mail or mail is not feasible or necessary to protect human subjects.
Another example might be the situation where a clearly competent patient entering the ER for treatment is asked to verbally consent to provide a extra blood sample for research because it would not be in the patient’s best interests to either obtain written consent or use an unsigned consent form either before or during the treatment.
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
4. Will informed consent/authorization be waived or altered for all subjects or just a subset of subjects?
All subjects
A subset of subjects. Describe the characteristics of these subjects.
Note: In some research projects, the waiver of the requirement to obtain informed consent is only applicable to a subset of subjects.
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
5. Do any of the research-related tests and procedures involve more than minimal risk to the subject?
No
Yes
Note: Minimal risk means "The probability (of occurrence) and magnitude (seriousness) of harm or discomfort (e.g., psychological, social, legal, economic) associated with the research are not greater than those ordinarily encountered in daily life (of the average person in the general population) or during the performance of routine physical or psychological examinations or tests."
Minimal risk is used to define a threshold of anticipated harm or discomfort associated with the research that is low. The evaluation of whether or not research involves minimal risk must take into consideration not only the risk associated with interventions (e.g., a blood draw), but also the risk of violating the privacy of subjects in the case of unauthorized use or disclosure of PHI. In this case, the determination of whether the research involves more than minimal risk is also based upon a) the adequacy of the plan to protect subject identifiers from improper use and disclosure and b) the adequacy of the plan to destroy the identifiers at the earliest opportunity. A waiver of consent/authorization is not permitted if the research is more than minimal risk.
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
6. Explain how the waiver or alteration will not adversely affect the rights and welfare of the subjects.
Note: This justification should take into consideration the “reasonable person” standard; that is, whether or not a reasonable person in the subject’s position would consider the waiver as adversely affecting his/her rights and welfare. For example, a “reasonable person” would probably not object to innocuous identifiable medical information such as height or weight being entered into a database without their knowledge or consent. The same reasonable person might, however, object if the identifiable information was sensitive (e.g., previous psychiatric treatment, HIV status, age at first pregnancy). It should also be recognized that in some cultures any waiving of consent may well be interpreted by the community as adversely affecting the rights and welfare of members of that community. A waiver of consent/authorization is not permitted if the waiver will adversely affect the rights and welfare of the subjects.
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
7. Explain why the research could not be practicably carried out without the waiver or alteration of consent.
Note: In some research projects it would not be practicable to perform the research (as it has been defined in the application by its specific aims and objectives) if informed consent was required. For example:
1) The sample size required is so large (epidemiological studies) that including only those samples/records/data for which consent could be obtained would prohibit conclusions to be drawn or bias the sample such that conclusions would be skewed.
2) The subjects for whom records would be reviewed may be lost to follow-up. Individuals likely to have relocated or died may be a significant percentage of the proposed subject population, thus decreasing the statistical power of the study if informed consent was required.
3) There is a risk of creating additional threats to privacy by having to link otherwise de-identified data with nominal identifiers in order to contact individuals to seek consent, or
4) There is a risk of inflicting psychological, social, or other harm by contacting individuals or families with particular conditions.
5) Because of the nature of the research and/or circumstances of the prospective subject, there is not sufficient time to obtain consent. For example, a study involves interviewing emergency room patients. The interview consists of sensitive questions. There is not enough time to obtain written consent in this case. Verbal consent may be acceptable.
Finally, it should be noted that, in general, investigator inconvenience or cost does not determine "impracticality" and there should be a clear rationale why the research could not be conducted with a population from whom consent could be obtained. A waiver of consent/authorization is not permitted if the research could practicably be conducted without a waiver.
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
8. Explain why the research could not be practicably carried out without access to and use of the protected health information (PHI). Note: Biomedical Research involving the collection and use of PHI is subject to HIPAA requirements. In order for a waiver to be granted, it must be clear that the research could not be practicably conducted without access to PHI. A waiver of consent/ authorization is not permitted if the research could be practicably conducted without access to the PHI.
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
9. Describe the plan to protect subject identifiers from improper use and disclosure.
Note: In order for a waiver to be granted, there must be an adequate plan to protect confidentiality of research data which contains PHI. It is important that the data contain as few of the 18 HIPAA-specified subject identifiers as possible. This section may be answered by referencing the information in Section II.15 of the Biomedical Application or Sections II.10-18 of the Medical Records Research application. A waiver of consent/authorization requires an adequate plan to protect data which contains subject identifiers from improper use and disclosure as a result of a breach of confidentiality.
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
10. Provide written assurance that the PHI collected and used in this research will not be reused or disclosed to any other person or entity, except as required by law or for authorized oversight of the research.
Note: This section should include a brief assurance attesting to compliance with the above-specified HIPAA requirement for a waiver. A waiver of consent/authorization cannot be granted without this assurance.
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
11. Will subjects be provided with additional pertinent information after participation?
Yes. Describe what information will be shared, and when and how subjects will be informed.
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
No. Provide justification.
Note: In general, this criterion is designed to address de-briefing after the research is completed. In this situation, it may be ethically required or determined to be respectful to provide the subject with pertinent information pertaining to their participation in research under the waiver of consent/authorization granted by the IRB. When this is the case, the subject must be presented with an informed consent form (ICF) for continued participation in the research. The ICF must include a provision for the subject to withdraw their data and/or samples from use in research should they choose not to participate.. Use of the reasonable person standard can help assess when and how this criteria should be satisfied. A waiver of consent/authorization can be granted only if the subject is provided with additional pertinent information whenever appropriate.
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4
Addendum J- Waiver/Alteration of Informed Consent & HIPAA
Biomed (adults) (07-27-10) Page 1 of 4