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Subcommittee on Harmonization (SOH) Update. Mark Barnes David Forster July 21, 2010. Membership. Mark Barnes, J.D., LL.M. - Co-Chair Jeff Botkin, M.D., MPH David Forster, J.D., MA, CIP Dean Gallant, A.B. Karen N. Hale, RPh, MPH, CIP Justin P. McCarthy, JD Marjorie A. Speers, Ph.D.

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Subcommittee on Harmonization (SOH) Update

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Subcommittee on Harmonization (SOH) Update

Mark Barnes

David Forster

July 21, 2010


  • Mark Barnes, J.D., LL.M. - Co-Chair

  • Jeff Botkin, M.D., MPH

  • David Forster, J.D., MA, CIP

  • Dean Gallant, A.B.

  • Karen N. Hale, RPh, MPH, CIP

  • Justin P. McCarthy, JD

  • Marjorie A. Speers, Ph.D.

  • Susan Stayn, J.D.


  • Initial convened meeting, April 15-16, 2010

  • Monthly teleconferences

Approach Adopted

  • At initial meeting the subcommittee identified “constellations” of issues where harmonization among the agencies could benefit the regulated community

  • Then prioritized initial constellations to work on

FDA Related Issues

  • Definition of “clinical investigation” and “human subject” under FDA regulations, and relation to OHRP and OCR. When do the FDA regulations apply?

  • Does FDA definition of “human subject” include dead people?

  • Post marketing registries, pregnancy registries, Risk Evaluation and Mitigation strategy (REMS). Is IRB review of these required by FDA regulations?

Standard Practice vs. Innovative Care vs. Research vs. Clinical Investigation

  • QA/QI activities, especially QA/QI activities involving FDA regulated products or products that may or may not be FDA regulated (example, skin cleaner on wash cloth versus a marketed product for cleaning skin.)

  • CDC definition of research vs. QI vs. epidemiology

  • Individual patient case studies, as OCR may designate them as research

Definition of a Non-Scientist

  • OHRP versus FDA

Tissue Research

  • Testing on tissue samples and biological sample banking

  • Unspecified future research

  • Identifiable versus non-identifiable

  • Extension of IVD assay consent waiver to IND assays

  • Most potential overlap with Subpart A Subcommittee (SAS) is in this area

Conflicts of Interest

  • Conflict of interest standards across HHS

  • New proposed NIH standards increase timeliness of a SACHRP recommendation


  • HITECH breach laws and reporting requirements

  • How do these correlate to reporting requirements under Common rule/FDA?

  • Limited data sets - subset of PHI under Privacy rule, not identifiable under IRB regulations, but still under HIPAA breach requirements. What would required reporting mean to subjects?

Recruitment of Research Subjects

  • When does research begin? Different guidance from OHRP, FDA, and OCR. Looking at records, contacting subjects, doing clinically indicated diagnostic tests and using them for recruitment analysis.

  • Paying subjects for referrals – social behavioral, phase I, studies of illegal drugs

  • Use of social media to recruit – Facebook, Twitter, etc.

Engagement of Community in Research

  • How and when should community be engaged in research?

  • No clear protocol or method, subjects are involved in design

  • HPTN, HVTN, NIADA CAB utilize community participation

  • Community consultations under 50.24

Consent Issues

  • Use of partially translated short form for non-English speakers. OHRP versus FDA. OCR silent

  • Documentation of consent/signature requirements. HHS signature v. FDA signature and date v. ICH signed copy and witness signature for illiterate subjects

  • Waivers of consent across regulations

Application of Subparts B, C, D

  • Unequal application of the subparts across agencies


  • Common Rule vs. FDA vs. ICH vs. OCR

  • Also European laws, other laws around the world

  • Preemption issues

State Laws, Non-HHS Agencies

  • Broadest issue, outside current focus of SOH

Incapacitated Adults

  • SIIIDR report

  • VA guidance

  • New FDA information sheets

  • ICH


  • NIH Points to Consider

  • Could and should all these be harmonized?

Safety Issues

  • Unanticipated problems and overall protocol safety assessment by sponsors and others

  • FDA guidance on DSMBs and NIH requirements for DSPs

  • Continuing difference between FDA and OHRP UP guidances. Mostly issue of seriousness. Could it be a single guidance?

Local Attitudes

  • FDA versus OHRP guidance

Exculpatory Language

  • What is exculpatory language?

  • Issue mostly focused on property rights in tissues

  • FDA and OHRP working on guidance

  • ESCRO standards, state laws, DOD differ

Procedural Issues

  • Creation of a single new agency to oversee all human subjects research in the US

  • Procedural changes in the way that the common rule agencies establish guidance in order to promote harmonized guidance

  • Procedural changes to require or promote joint regulations and/or guidance from OHRP and FDA and other HHS agencies

Prioritized List of Issues

  • Draft Request For Information (RFI) to get public opinion on harmonization issues

  • Draft finished, provided to agencies for review

  • Inventory of differences between FDA and Common Rule

  • Done. Lots of prior work to draw from.

Prioritized List of Issues

  • FDA Issues

  • What is FDA regulated?

  • Also, at FDA’s request, attention to issue of definition of a minor change in research and planned protocol deviations

  • Work group established

  • Conflict of Interest

  • Work group established

Prioritized List of Issues

  • Unspecified future research /secondary use.

  • Work group established.


  • Work group established.

  • List of potential FAQ issues provided to OCR.

  • International

  • Work group established.

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