days after the trial is closed to Documenting recruitment. Informed Consent: Posting of Consent Forms Biospecimens Investigators conducting non-exempt 71. Public comment is sought regarding whether particular research involving the collection, information security measures should be required for storage, or use of biospecimens or certain types of information or research activities and, if Found under Section: identifiable private information will so, what measures and for what types of information or need to implement: research. Specifically, should the safeguards be calibrated II.C. Proposed to the sensitivity of the information to be collected? (Page List of specific safeguards that Changes to Protect 95) would be identified by the Information and 72. Are the proposed limitations on re-disclosure more or Biospecimens Secretary less restrictive than necessary? Are there additional If an institution or investigator is purposes for which re-disclosure of biospecimens or required to comply with HIPAA, identifiable private information should be permitted? then NPRM specific safeguards (Page 95) 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. Harmonization Common Rule agencies must consult, 73. Will the proposed language at § __.101(j) be effective to the extent possible, before issuing in achieving greater harmonization of agency guidance, federal guidance on the Common and if not, how should it be modified? (Page 97) Found under Section: Rule. II.D. Harmonization of Agency Guidance U.S. institutions engaged in 74. Is mandated single IRB review for all cooperative Cooperative cooperative research must rely upon research a realistic option at this time? Please provide Research approval by a single IRB. The information about the likely costs and benefits 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
Table%20of%20NPRM%20Posed%20Public%20Comments.docx