October 24, 2011

Jerry Menikoff, M.D.
Director
Office of Human Research Protections
1101 Wooten Parkway, Suite 200
Rockville, MD 20852

Dear Dr. Menikoff:

Thank you for the opportunity to comment on the Office of Human Research Protections (OHRP) advanced notice of proposed rulemaking (ANPRM) on revisions to the Common Rule on human subject research protections. The American Thoracic Society (ATS) is an 15,000 member scientific multi-disciplinary organization dedicated to the prevention, treatment, cure and research of pulmonary, critical care and sleep related illnesses through research, education, and patient advocacy.

The ATS supports the OHRP’s efforts to update and improve human subject research regulations to enhance the system for both patients and researchers. We have the following comments on the specific questions/issues outlined in the ANPRM:

1. Revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk.
The ATS supports this proposed change. We believe that more accurate information about the level of risk for subject participants will better inform participants, providing them with greater comfort and ease with their participation in these important studies. An improved risk-based review process will enable more efficient categorization of studies as either "minimal risk" or "higher risk." Those designated as minimal risk can be reviewed more expeditiously while the higher risk studies receive more time and attention. This more streamlined process will serve to remove time delays and administrative requirements for minimal risk studies, enabling timely progress of important research.

2. Using a single Institutional Review Board (IRB)  review for all domestic sites of multi-site studies.
The ATS strongly supports single IRB review of multi-site studies. The current multi-site review process frequently results in delayed timelines and excessive administrative demands for studies while various individual reviews are completed and results are collated and disseminated. We believe that single IRB review is an important change from the current requirements that will enhance the timely progress of research. However, we request clarification regarding the specific implementation of this goal. Specifically, should a single set of federal guidelines apply to the stream-lining of institutional review of multi-institutional studies?  Additionally, what governing body would define the rules and how would arbitration be carried out should there be disagreements between IRBs regarding protocol, consent process, legal considerations, or contracts?

3. Updating the forms and processes used for informed consent.
The ATS strongly supports the concept of this change to simplify and streamline the patient informed consent process. We agree with the justification outlined in issue 2 concerning informed consent forms. The current informed consent process requires patients to complete multiple forms that are excessive in length and difficult to comprehend. The ATS asks that in the upcoming NPRM, the OHRP clarifies precisely how the process will be changed, including details on new patient informed consent forms. In order to reduce the burden on patients, the ATS recommends that the OHRP  reduce the overall number of consent forms required and ensure that new forms are shorter in length by limiting the forms to covering each study's research protocol, rather than the full standard of care in a study. In addition, we would ask for more clarification of the changes in Issue 19, concerning consent in exempt categories. We are concerned that the change in this area may require informed consent from additional subsets of patients than is currently required, which would amount to a significant administrative burden with the potential for hindering secondary data analysis, including comparative effectiveness research using large data sets.

The ATS strongly supports the proposed process outlined in the ANPRM for certain study participants to provide oral rather than written consent in some types of research including surveys. An oral consent process would significantly reduce the burden on patients.

Finally, in order to provide patients with more specific and easily accessible information on research studies, we recommend the creation of a website for patient participants displaying information on the risks to patients involved in studies and specific populations that may benefit from participation in studies.

4. Establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data.

The ATS supports the appropriate standardization of data security and information protection standards, which are critical to ensuring patient confidentiality. We would, however, urge the OHRP to ensure that such new protections do not result in an increased administrative burden for investigators and more onerous procedures for patients. In fact, the OHRP should develop ways of streamlining data security measures that currently hinder the movement of data between institutions for approved clinical trials at another site. Ideally, the language regarding data security would be simplified and incorporated into a single consent form so that patients no longer have a bewildering array of signatures to provide – consenting for the study and then consenting to have their data used for the study.

5. Implementing a systematic approach to the collection and analysis of data on unanticipated problems and adverse events across all trials to harmonize the complicated array of definitions and reporting requirements, and to make the collection of data more efficient.

The ATS supports this change to standardize and improve the efficiency of adverse events reporting systems. The current system for reporting adverse events is onerous for investigators, requiring completion of multiple administrative forms. The ATS recommends that the adverse events reporting system appropriately calibrate the level of patient risk with the level of reporting and ensure that the updated system is not overly burdensome or time-consuming for investigators.

6. Extending federal regulatory protections to apply to all research conducted at U.S. institutions receiving funding from the Common Rule agencies.

The ATS supports the OHRP's intent to ensure that human participants in biomedical research in the U.S. are afforded appropriate protections. We are concerned, however, that the increase of federal government requirements  including reporting systems and paperwork requirements for institutions that have been exempt from such requirements may serve to increase the cost of biomedical research and result in some institutions curtailing their support for research. The ATS recommends a flexible and incremental approach to these regulations being broadly applied to other institutions in order to prevent a detrimental effect on research. 

7. Providing uniform guidance on federal regulations.

The ATS supports the OHRP's intent to standardize guidance on federal regulations governing the protection of human subjects to eliminate conflicting guidance and requirements from multiple federal agencies. We urge the OHRP to maintain strong protections for human subjects while ensuring that new requirements and processes do not hinder the progress of critical biomedical research.  

We thank the OHRP for this opportunity to provide comment and look forward to continued dialogue with the Office as new regulations on human research subjects are developed.

Sincerely,

Nicholas Hill, M.D.
President
American Thoracic Society