2006D-0331

Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research

FDA Comment Number :

EC67

Submitter :

Dr. Robert Dunne

Date & Time:

11/28/2006 08:11:31

Organization :

Wayne State University SOM

Category :

Health Professional

Issue Areas/Comments

A. Scientific Aspects of Emergency Research and Human Subject Protection

4. Are there challenges that have not been explicitly addressed in the regulation in designing scientifically rigorous and ethically sound emergency research protocols (e.g., pediatric protocols)?

Pediatrics should be specifically included.

Pre-Hospital (EMS) issues shouls be spelled out. Most EMS systems are not run by the hospital and IRB's are variable in how they approve EMS related research. Some require city council approval some only need medical control approval. Since much more EMS research is needed, the regulations should spell out a method for approval and designate some guidleines as well as request to add to the DOT EMT curriculum.

Additional Challenges

20. Are there any additional challenges to the conduct of emergency research that have not been identified in the preceding questions?

Simple no risk diagnostic studies (Ultrasound in the EMS community etc) should be specifically exempt from the process, or this research will never get done.

B. Additional Human Subject Protections

10. Are there others besides the IRB (e.g., sponsors, clinical investigators, community leaders, advisory committees, ethicist) who should play a role in determining the adequacy of the plan for community consultation and the material to be publicly

A state official should be designated for each state to help guide the process.

11. The community consultation process typically includes meetings and discussions about the study with the community.

All trial info should be on clinicaltrials.gov

5. What are the costs, benefits, and feasibility of community consultation as currently required under 50.24?

The costs are prohibitive for small studies or pilot research, however without pilot data one cannot obtain the grants needed to do large scale research. I have participated in 3 research projects involving community consent and I do not think that the process did what was intentended.

6. What aspects of community consultation as currently practiced are effective mechanisms for human subject protection?

There needs to be ongoing discussions in communities regarding this process, not a one off per project. EMS projects are of particular interest. When a citizen dials 911 they expect quality, evidence based care. Without active research this will not happen. EMS research needs to be a specific expectation of the social contract implicit in activating the system. Radio and TV ads should be considered PSA's and not charged exhorbitant rates.

7. Are there elements of community consultation, both procedural and substantive, that should, at a minimum, be required (e.g., types of information presented, number and types of meetings or interactions, number of people reached)?

The focus needs to be on the potential subjects, if victims of penetrating trauma will be the subject, then meeting with older members of the community at churches or community centers is not helpful. Radio information on stations that do not cater to the demographic is not helpful. Identifying the potential subjects should be part of the study design.

8. Would opt-out mechanism (e.g., advanced directives, jewelry similar to medical alert bracelet/necklace, and driver's license indicators to identify individuals who do not wish to be included as subjects in particular emergency research studies pr

I do not think opt-out strategies for lifesaving techniques are feasible or desirable. Advanced directives in the prehospital community are often not found or available.

9. Who should use the information obtained from the community consulttion process and how should they use it?

If an opt out is offered it should be the same throughout the US and use the same mechanism

GENERAL

Overall the process is frustrating, very vocal, very small minorities can derail projects. Oversight appeal is needed on a more formal basis either at the state or federal level. IRB interpretation of the rules is wildly and unpredictably variable, more guidance on this in the form of education and/or materials is needed. Minimal to no risk research needs a fast track for approval without community consultation. EMS research needs to be specifically addressed (see other comments). Thank you

Public Disclosure Following Completion

14. Is there information regarding study results that, at a minmum, should always be disclosed after the clinical investigation is completed?

All results should be on clinicaltrials.gov within 6months of final analysis.