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
Documenting Informed Consent: Posting of Consent Forms days after the trial is closed to recruitment. Biospecimens Found under Section: II.C. Proposed Changes to Protect Information and Biospecimens Investigators conducting non-exempt research involving the collection, storage, or use of biospecimens or identifiable private information will need to implement: List of specific safeguards that would be identified by the Secretary If an institution or investigator is required to comply with HIPAA, then NPRM specific safeguards would be satisfied IRBs would not be required to review the individual plans for safeguarding information and biospecimens for each research study. Specific list of limitations on use, release, and disclosure is proposed for the use and disclosure of identifiable private information and biospecimens maintained for research. 71. Public comment is sought regarding whether particular information security measures should be required for certain types of information or research activities and, if so, what measures and for what types of information or research. Specifically, should the safeguards be calibrated to the sensitivity of the information to be collected? (Page 95) 72. Are the proposed limitations on re-disclosure more or less restrictive than necessary? Are there additional purposes for which re-disclosure of biospecimens or identifiable private information should be permitted? (Page 95) Harmonization Found under Section: II.D. Harmonization of Agency Guidance Common Rule agencies must consult, to the extent possible, before issuing federal guidance on the Common Rule. 73. Will the proposed language at § __.101(j) be effective in achieving greater harmonization of agency guidance, and if not, how should it be modified? (Page 97) Cooperative Research U.S. institutions engaged in cooperative research must rely upon approval by a single IRB. The 74. Is mandated single IRB review for all cooperative research a realistic option at this time? Please provide information about the likely costs and benefits to
Found under Section: Cooperative Research and Proposal to Cover Unaffiliated IRBS Not Operated by an Institution Holding a Federal-wide Assurance reviewing IRB will be selected by the federal department/agency supporting the research, or if no funding agency, by the lead institution conducting the research. IRBs not affiliated with an assured institution that review research covered by the Common Rule would be subject to direct compliance oversight regarding IRB regulatory requirements. institutions. Will additional resources be necessary to meet this requirement in the short term? Should savings be anticipated in the long run? (Page 103) 75. What areas of guidance would be needed for institutions to comply with this requirement? Is there something that OHRP could do to address concerns about institutional liability, such as the development of model written agreements? (Page 103) 76. Would it be useful for this requirement to include criteria that Federal departments or agencies would need to apply in determining whether to make exceptions to the use of a single IRB requirement? If so, what should these criteria be? (Page 103) 77. Are the exceptions proposed appropriate and sufficient, or should there be additional exceptions to this mandate for single IRB review than those proposed in the NPRM? If additional exceptions should be included, please provide a justification for each additional exception recommended. (Page 103) 78. Is three years appropriate timing to establish compliance with this provision? (Page 103) IRB Operations Found under Section: II.F. Changes to Promote Effectiveness and Efficiency in IRB Operations Continuing review would be eliminated for all studies that undergo expedited review, unless the reviewer explicitly justifies why continuing review would enhance protection of research subjects. Expedited review can occur for studies on the Secretary's list unless the reviewer(s) determine(s) that the study involves more than minimal risk. IRBs will be required to document rationale when they override that studies on the Secretary's expedited review list involve greater than minimal risk. 79. How often should the Secretary's list of minimal risk activities be updated? Should advice be solicited from outside parties when updating the list? (Page 108) 80. Is this Secretarial list of minimal research activities a useful tool for the research community, or does it represent a loss of IRB flexibility in risk determination? (Page 108)