informed consent and would have included in the broad consent as proposed in the NPRM. If Obtaining, additional requirements. a time limit should be required, is the NPRM proposal of Waiving, and up to 10 years a reasonable limitation? Would a limitation Documenting HHS will public templates for broad related to an identified clinical encounter better inform Informed Consent: consent. individuals of the clinical information and biospecimens Broad Consent to that would be covered by a broad consent document? the Storage, (Page 83) Maintenance and 62. Public comment is sought on whether all of the Secondary elements of consent proposed at § __.116(c) should be Research Use of required for the secondary use of biospecimens or Biospecimens and identifiable private information originally collected as part Identifiable Private of a research study that was conducted without consent Information because either the original research study met an exclusion or exempt category of research, or a waiver of consent was approved by an IRB. (Page 83) 63. Public comment is sought on whether oral consent should be permissible in limited circumstances as proposed under exemption § __.104(f)(1). (Page 83) 64. Would research subjects continue to be appropriately protected if the definition of authorized “legally were broadened to include individuals representative” authorized by accepted common practice to consent on behalf of another individual to participation in clinical procedures? If the definition of authorized “legally was broadened in this way, public representative” comment is sought on the interpretation of and “accepted” as these terms would be used in the revised “common” definition. (Page 83) New consideration and criteria when 65. Public comment is sought on how the waiver criterion Informed Consent approving waivers or alterations of regarding at § __.116(d)(3) could be “practicably” Found under informed consent when research explicitly defined or otherwise clarified (e.g., what term involves accessing or using should replace Section: (Page 89) “practicably”?). identifiable biospecimens or 66. Public comment is sought on the proposed differences II.B.3. Proposed identifiable information. between the criteria for waiving informed consent for the Changes to research use of biospecimens versus identifiable Obtaining, IRB cannot waive consent for information. (Page 89) Waiving, and storage/maintenance for secondary Public comment is sought on whether the proposal to Documenting 67.
Obtaining, Waiving, and Documenting Informed Consent: Broad Consent to the Storage, Maintenance and Secondary Research Use of Biospecimens and Identifiable Private Information informed consent and would have additional requirements. HHS will public templates for broad consent. included in the broad consent as proposed in the NPRM. If a time limit should be required, is the NPRM proposal of up to 10 years a reasonable limitation? Would a limitation related to an identified clinical encounter better inform individuals of the clinical information and biospecimens that would be covered by a broad consent document? (Page 83) 62. Public comment is sought on whether all of the elements of consent proposed at § __.116(c) should be required for the secondary use of biospecimens or identifiable private information originally collected as part of a research study that was conducted without consent because either the original research study met an exclusion or exempt category of research, or a waiver of consent was approved by an IRB. (Page 83) 63. Public comment is sought on whether oral consent should be permissible in limited circumstances as proposed under exemption § __.104(f)(1). (Page 83) 64. Would research subjects continue to be appropriately protected if the definition of “legally authorized representative” were broadened to include individuals authorized by accepted common practice to consent on behalf of another individual to participation in clinical procedures? If the definition of “legally authorized representative” was broadened in this way, public comment is sought on the interpretation of “accepted” and “common” as these terms would be used in the revised definition. (Page 83) Informed Consent Found under Section: II.B.3. Proposed Changes to Obtaining, Waiving, and Documenting New consideration and criteria when approving waivers or alterations of informed consent when research involves accessing or using identifiable biospecimens or identifiable information. IRB cannot waive consent for storage/maintenance for secondary 65. Public comment is sought on how the waiver criterion regarding “practicably” at § __.116(d)(3) could be explicitly defined or otherwise clarified (e.g., what term should replace “practicably”?). (Page 89) 66. Public comment is sought on the proposed differences between the criteria for waiving informed consent for the research use of biospecimens versus identifiable information. (Page 89) 67. Public comment is sought on whether the proposal to
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