Proposed Rulemaking on Federal Policy for Human Subjects Data Use
Explore the Notice of Proposed Rulemaking from August 2015 regarding secondary research use of data, aiming to facilitate research while ensuring privacy protections and reducing unnecessary reviews. The document discusses goals, exclusions, exemptions, and achieving the NPRM objectives related to data collection and analysis for research purposes, including federal regulations and HIPAA-regulated health information.
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Presentation Transcript
Secondary Research Use of Data Notice of Proposed Rulemaking on Federal Policy for the Protection of Human Subjects August 2015
Goals of the NPRM Facilitate secondary research use of data Assure privacy protections against informational risk Reduce unnecessary reviews 2
Achieving the NPRM Goals Four exclusions (no requirements) Three exemptions (recorded as exempt, and meeting various conditions) 4
Achieving the NPRM Goals (2) Research with non-identified data remains outside the regulations Full/Expedited IRB review, with informed consent or waiver; continuing review replaced by confirmation of research status 5
Exclusions 1. Research involving the collection or study of information that has been or will be collected (Revised version of the current Rule s exemption category 4) Does not include secondary research use of biospecimens Includes data that do not exist at the time the study commences 2. Use of protected health information regulated by HIPAA as health care operations, research or public health activities 6
Exclusions 3. Data collection and analysis for an institution s own internal operational monitoring and program improvement purposes -- if limited to the use of data or biospecimens originally collected for another purpose, or obtained through oral or written communications (e.g., surveys or interviews) 7
Exclusions 4. Federally-conducted research using government-generated or government-collected data 8
Exemptions Research use of identifiable private information that has been or will be acquired for non-research purposes, with the following conditions: prior notice has been given privacy safeguards will be observed the recipient investigators use the information only for the purposes of the specific research proposed 9
The Two Stage Broad Consent Exemptions 1. Storage or maintenance for secondary research use of biospecimens or identifiable private information that have been or will be acquired for other research studies or for non- research purposes 2. Specific research projects involving the use of biospecimens or identifiable private information that have been stored or maintained for secondary research use 10
The Two Stage Broad Consent Exemptions Exemption for Specific Secondary Research Use 104(f)(2) Conditions: 105 Privacy Safeguards No plan to return individual results Broad Consent was obtained Exemption to Label & Track 104(f)(1) Conditions: 105 Privacy Safeguards Limited IRB Review of Consent Procedures and Adequacy of Privacy Safeguards 11
Enquiring Minds Want to Know Scope of Exclusions and Exemptions Exemption Provisions IRB Review Conditions 12
Exemption Provisions Recording Exemptions Exemption Determination Tool Privacy Safeguard Options A list of specific measures published by the Secretary The HIPAA standards Federal government requirements for government research Notice Broad Consent Templates 13
New IRB Review Provisions Limited IRB review of consent procedures and adequacy of privacy safeguards Confirmation of research status replacing continuing review Waiver of informed consent provision regarding whether the research could not practicably be carried out without accessing or using identifiers, see 116(f)(1) 14
Submit Comments! See OHRP Website: http://www.hhs.gov/ohrp 15
OHRP Contact Information Phone: 866-447-4777 Fax: 240-453-6909 E-mail: ohrp@hhs.gov Website: http://www.hhs.gov/ohrp 240-453-6900 16
