Huron Consulting Group Inc. · NASDAQ:HURN
Huron Consulting — Technical Presentation (December 2012)
29 slides from Huron Consulting's technical presentation, Dec 19, 2012
Slide 1: Regulatory Considerations for Biorepositories: Navigating HHS, FDA, HIPAA and Informed Consent
Clinical Research Management Webinar Series: Regulatory Considerations for Biorepositories: Navigating HHS, FDA, HIPAA and Informed Consent Wednesday, December 19, 2012 12:00 p.m. - 1:00 p.m. CT
Slide 2: Disclaimer
Disclaimer The views expressed in this presentation are the views of the speakers and do not necessarily reflect the views or policies of the companies they represent. This presentation is intended for educational purposes only and does not replace independent professional judgment. Neither Huron Co
Slide 3: A Bit About Our Speakers
A Bit About Our Speakers Madeleine Williams Director P 312. 479. 3374 mwilliams@huronconsultinggroup.com Maddie has over 10 years of research experience and assists clients with research biorepository design and development, institutional review board (IRB) assessments and operational support, regul
Slide 4: Agenda
Agenda Recommended biorepository model When DHHS, FDA and HIPAA regulations apply When informed consent is not required Pros and cons of different informed consent approaches Q&A / Wrap-up © 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 4
Slide 5: Regulatory Considerations
Regulatory Considerations Applicable research and privacy regulations • DHHS • FDA • HIPAA • Other state and local laws Goal should be to set up a biorepository that utilizes the flexibility in the regulations • Appropriate set up for collection and coding of samples and data • Governance model
Slide 6: Polling Question #1
Polling Question #1 What kind of biorepository activities are currently ongoing at your institution? a. We have a central biorepository “core” that supports all banking for the institution b. We have a central biorepository but also have decentralized individual investigator biorepositories c. We ju
Slide 7: Recommended Biorepository Model
Recommended Biorepository Model Step 2 Step 1 7
Slide 8: The Model is a Two-Step Process
The Model is a Two-Step Process Step 1: Procedures for collection and banking of specimens Step 2: Procedures for use of specimens Note that “specimens” may be: • Tissue • DNA • Images • Text © 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 8
Slide 9: The Model Separates the Known and Unknown Activities
The Model Separates the Known and Unknown Activities Oversight must be based on actual uses of specimens Step 1: • Known use: Specimens will be collected and banked for research Step 2: • Unknown uses: Specific research studies that specimens will be used for © 2012 Huron Consulting Group. All
Slide 10: Step 1: DHHS and OHRP
Step 1: DHHS and OHRP OHRP considers the collection of specimens or data for research purposes to be research and guidance recommends that human tissue repositories supported by HHS should be subject to oversight by an Institutional Review Board (IRB). The IRB should determine if: • The activity
Slide 11: Step 1: DHHS and OHRP
Step 1: DHHS and OHRP If the repository involves human research, the IRB should review: • Conditions under which data and samples are collected and shared • Provisions to protect privacy • Provisions to maintain confidentiality of data OHRP has guidance as to when coded private information or sa
Slide 12: Step 1: Other Considerations
Step 1: Other Considerations Use of an honest broker when collecting identifiable information • An individual, organization or system collects identifiable data and replaces identifiers with a code, and releases only coded information to the researcher or to be stored in the repository. • The hone
Slide 13: When is Collection/Storage in Step 1 Not Research?
When is Collection/Storage in Step 1 Not Research? Not all specimen or data collection/storage is research even if specimens are used for research • Pathologic lab archive • Radiology film library • Medical record © 2012 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. 13
Slide 14: When Does Collection/Storage in Step 1 Not Involve Human Subjects?
When Does Collection/Storage in Step 1 Not Involve Human Subjects? Not all research biorepository storage and collection involves human subjects • Collection of de-identified specimens • Collection of already coded specimens • Collection of autopsy specimens © 2012 Huron Consulting Group. All Righ
Slide 15: The Model Minimizes Regulatory Burden
The Model Minimizes Regulatory Burden Steps 1 and 2 may have different regulatory statuses Step 1: • Usually human research • Usually subject to HIPAA Step 2: (when properly designed) • Usually not human research • Usually not subject to HIPAA © 2012 Huron Consulting Group. All Rights Reserved
Slide 16: Step 2: Does the research involve human subjects?
Step 2: Does the research involving human subjects? Both DHHS and FDA regulations may apply. • Systematically consider both. First consider: • Is there “research” as defined by DHHS? • Is there “research” as defined by FDA? If NO to both, stop. (If no research, no human subjects) Then consid
Slide 17: Human Research Flowchart
Human Research Flowchart START Is activity “Human Research” Yes No as defined by DHHS? Is activity “Human Research” Is activity “Human Research” Yes as defined by FDA? No Yes as defined by FDA? No “Human Research” “Human Research” “Human Research” NOT under DHHS and FDA under DHHS only under FDA onl
Slide 18: Step 2: Readily Identifiable Information
Step 2: Readily Identifiable Information OHRP guidance on biologic specimens and OHRP guidance on engagement provides examples where OHRP considers information to be NOT “readily identifiable”: • The investigators and the holder of the key enter into an agreement prohibiting the release of the key
Slide 19: Step 2: Coded Samples and Data
Step 2: Coded Samples and Data If the biorepository releases coded samples and data to investigators for specific research studies, in most cases this will not meet the definition of human subjects research Should have appropriate governance structure in place • Scientific committee to review an
Slide 20: Scenario and Polling Question #2
Scenario and Polling Question #2 An investigator is conducting research on diabetes. She wants to develop an assay to screen for the presence of a biomarker than is linked with type 2 diabetes. She will obtain blood samples and data from a diabetes repository with no identifying information. She w
Slide 21: Follow Up For Polling Question #2
Follow Up For Polling Question #2 Yes FDA considers data regarding the use of a device on human specimens (identified or unidentified) to be a clinical investigation if it will be submitted to or held for inspection by FDA as part of an application for a research or marketing permit Relevant t
Slide 22: HIPAA
HIPAA Applies if samples and data are collected within or received by a covered entity Most likely scenarios for repository data, sample labeling: • Identifiable – Authorization from the patient OR – Waiver of authorization from IRB/Privacy Board • Limited Data Set – Data Use Agreement is in pla
Slide 23: "De-identified" versus "not readily identifiable"
“De-identified” versus “not readily identifiable” HIPAA defines identifiers that need to be stripped from data to make protected health information de- identified. However, an investigator cannot readily identify the individual from whom the following was obtained: • Zip code • Fingerprints • De
Slide 24: Informed Consent
Informed Consent Human Subject Research Regulations (HHS and FDA) • Informed consent is not required if : 1) the research does not meet the definition of human subjects research under HHS; 2) is exempt from the HHS regulations; 3) the research has been granted a waiver of consent by the IRB; or 4)
Slide 25: Informed Consent
Informed Consent NCI and ISBER Best Practices • Informed consent information describing the future research should be as specific as possible • Obtain informed consent whenever possible • Consent may be obtained for unspecified future research; mechanisms should be in place to assure that future r
Slide 26: Informed Consent Approaches
Informed Consent Approaches General consent for biorepository • Can get consent from subjects to bank specimens (Step 1) and indicate that for future research (Step 2) either their specimens will not be identified, an IRB will waive consent, or their consent will be obtained • Cannot get “blanket”
Slide 27: HIPAA Authorization
HIPAA Authorization A HIPAA authorization may not seek permission to use or disclose PHI for future unspecified research uses of health information. Authorization can be obtained to create a repository (Step 1) but that authorization does not cover subsequent research uses of identifiable data.
Slide 28: Questions?
Questions?
Slide 29: Thank you!
Thank you! For further information, please contact: Madeleine Williams Scott Jewell Director, Huron Consulting Group Van Andel Research Institute P 312. 479. 3374 P 616. 234. 5435 mwilliams@huronconsultinggroup.com scott.jewell@vai.org
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