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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

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
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
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
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
Definition of a Non-Scientist Clinical Investigation

  • OHRP versus FDA

Tissue research
Tissue Research Clinical Investigation

  • 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
Conflicts of Interest Clinical Investigation

  • Conflict of interest standards across HHS

  • New proposed NIH standards increase timeliness of a SACHRP recommendation

HITECH Clinical Investigation

  • 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
Recruitment of Research Subjects Clinical Investigation

  • 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
Engagement of Community in Research Clinical Investigation

  • 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
Consent Issues Clinical Investigation

  • 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
Application of Subparts B, C, D Clinical Investigation

  • Unequal application of the subparts across agencies

International Clinical Investigation

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

  • Also European laws, other laws around the world

  • Preemption issues

State laws non hhs agencies
State Laws, Non-HHS Agencies Clinical Investigation

  • Broadest issue, outside current focus of SOH

Incapacitated adults
Incapacitated Adults Clinical Investigation

  • SIIIDR report

  • VA guidance

  • New FDA information sheets

  • ICH


  • NIH Points to Consider

  • Could and should all these be harmonized?

Safety issues
Safety Issues Clinical Investigation

  • 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
Local Attitudes Clinical Investigation

  • FDA versus OHRP guidance

Exculpatory language
Exculpatory Language Clinical Investigation

  • 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
Procedural Issues Clinical Investigation

  • 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
Prioritized List of Issues Clinical Investigation

  • 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 issues1
Prioritized List of Issues Clinical Investigation

  • 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 issues2
Prioritized List of Issues Clinical Investigation

  • Unspecified future research /secondary use.

  • Work group established.


  • Work group established.

  • List of potential FAQ issues provided to OCR.

  • International

  • Work group established.

Feedback or Questions? Clinical Investigation