News & Press: General News

Common Rule Final Response

Tuesday, January 5, 2016  
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COMMON RULE FINAL RESPONSE

Jerry Menikoff, M.D., J.D.

Office of Human Research Protections

1101 Wootton Parkway, Suite 200

Rockville, MD 20852

 

 Dear Dr. Menikoff,

Thank you for the opportunity to submit comments in response to the Notice of Proposed Rulemaking (NPRM) entitled, Federal Policy for the Protection of Human Subjects (HHS-OPHS-2015-0008). Updating the “Common Rule” is an overdue activity of tremendous importance that should be undertaken with the utmost care and thoroughness.

 

The Coalition for Clinical and Translational Science (CCTS) is led by the Association for Clinical and Translational Science and The Clinical Research Forum and serves as the unified voice of the clinical and translational research community. We act as a nationwide, grassroots network of scientists and academic and healthcare leaders who work together to educate Congress and the administration about the value and importance of federal clinical and translational research and of research training and career development activities. Our goals are to ensure that the full spectrum of medical research is adequately funded, translating from the bench, to the bedside, to practice, to public benefit and policy, with real impact on health. We also support a regulatory and public policy environment that facilitates ongoing expansion and advancement of the field of clinical and translational science.

 

We applaud the decision to extend the comment period for community feedback in response to this NPRM by 30 days. In this regard, CCTS joins the larger public health and medical research community in encouraging the Office of Human Research Protections (OHRP) to conduct any modernization of the Common Rule with extensive diligence. We have overriding concerns that, given the breadth and depth of the current effort, a hurried crafting of a Final Rule will lead to less protections for patients, administratively burdensome research activities, and arbitrarily increased costs; all of which undermine health and wellness for both the individual and society.

 

It appears that many of the issues raised by the community during the Advanced Notice of Propose Rulemaking (ANPRM) that was published in July of 2011 have been misconstrued or disregard. Moreover, the current NPRM poses more (often thoughtful) questions than the previous ANPRM, which indicates the complex nature of finalizing a rule in this area and speaks to the need for ongoing dialogue and prolonged consensus building through collaboration with the community and leading experts in the field. Individuals within the administration have certainly done yeoman’s work to get us to this point, but there is no reason to minimize their efforts by moving expeditiously to implement a Final Rule. Many of the questions put forward through the NPRM do not lend themselves neatly to a one-size-fits-all solution and subsequent conversations are required to craft more precise tools. While we hope this NPRM is the start of a timely and substantive dialogue moving forward we ask that the administration not proceed with issuing a final rule later this year. Rather, we encourage the administration to issue a second NPRM that simplifies and clarifies the potential regulation, answers valid questions raised by the scientific and patient communities, and acknowledges input on complex topics from leading experts in biomedical research. In this regard (and when applicable to specific questions posed by the NPRM), CCTS strongly endorses the comments submitted by the Association of American Medical Colleges.

 

To follow, please find items of specific concern to the clinical and translational research community. In a more general sense though, CCTS disagrees with the seeming overarching assumption that current protocols are failing to protect human subjects and are in need of a drastic overhaul that will rely, in large part, on codifying the reliance on a burdensome and potentially harmful system of paperwork and tracking that expands into new and confusing areas.

 

Biospecimens

 

Evidencing the need for an ongoing dialogue on core issues raised by the NPRM are proposed changes pertaining to biospecimens. The treatment of biospecimens is heavily intertwined with the newly-introduced concept of “Broad Consent”. Neither the general language nor the consent procedure itself is laid out through the NPRM. Rather, this area will be developed at a later time through a loosely identified process, which makes it nearly impossible to provide meaningful feedback. There is real potential here to increase administrative burden, drive up costs, jeopardize patient anonymity and safety, and undermine the research enterprise. At this time though, it is simply too difficult to understand how the proposed regulation would be applied and impossible to divine if new tools (including the proposed web-based tool) that do not exist yet would be helpful or a hindrance.

 

Much new attention is given to de-identified biospecimens. In regards, to secondary use of non-identified clinical biospecimens we do not believe written consent is necessary and ask that these specimens continue to fall outside the scope of the Common Rule. OHRP has current rules and guidance in this area that are more than adequate.

Most notably, incorporating biospecimens into the definition of a human subject has significant potential for negative consequence and limited potential for any benefits. For patients, such action will not enhance privacy or security and actually make it more likely that they are identifiable. The most pressing concern in this area would be the ongoing threat of data-breaches and the inadequacy of cyber security. When a discoverable record must be created and preserved the threat to patient privacy in this area is significant when weighed against perceived, minimal benefits of this new paradigm.

 

Broad Consent

 

As noted previously, a mandate for broad consent would jeopardize patient safety and data security rather than improve their autonomy in a meaningful way. Moreover, this proposals enters into murky ethical territory and would certainly drive up research costs and increase administrative burden. The requirement that an identifiable consent record be maintained on file for at least 10 years (and re-consented every 10years) for research and auditing purposes represents a tremendous burden. Such a process is even more illogical when considering the importance of anonymized tissue. Under the new proposal, such tissue would have to be identified, stored, consent would need to be verified, then de-identification for use. Arbitrarily, a broad consent approach will require expensive recordkeeping of little value by staff that will now have to learn new processes and protocols. Whenever, a specimen is needed for research, a second costly effort would need to be made to determine if the specimen was obtained under the broad consent requirement. Only after fulfilling these administrative requirements (that more closely tie the patient to their previously anonymized tissue) can research activities begin.

 

Transition Provisions

 

We appreciate the spirit of this rule and the need to bridge effectively between the current system and new regulations. In this regard, any transition provisions should honor respect for persons by allowing samples to be used that were previously authorized. This should extend to allowing the use of identifiable samples when consent was initially obtained and such activities permitted. Such action would ensure that ongoing research can continue during a transition phase.

 

Limitations on Excluded Quality Assurance/Quality Improvement Activities

 

It is important to clarify exclusions from the Common Rule as the NPRM seeks to. However, the scope of current quality assurance and quality improvement activities is inadequate and falls short of capturing key activities that should not be considered research. It is anti-innovation and contrary to public health and patient care improvement efforts to limit such activities to the areas of utilization and accepted practice. This section must be broadened and improved moving forward or we will lose meaningful healthcare improvement activities at leading healthcare facilities geared towards enhancing patient safety and improving public health.

 

Mandate for a Cooperative Review by a Single IRB

 

Consistent with the mainstream view of the research community in general, we support migrating to a single IRB for domestic multi-site studies. Meaningful models currently exist, including the National Cancer Institute (NCI) central IRB. The concept put forward through the NPRM though is ill-defined and has the potential to create a myriad of problems. As proposed, what is being discussed is a constantly varying and unpredictable patchwork of rotating IRBs (often on a sporadic or one-time only basis). There is real potential for IRB shopping under this framework that could proliferate a race-to-the-bottom for less rigorous review. Such an approach neither streamlines the IRB process nor improves patient protections.

The “single IRB” must perform as a truly central IRB through a single IRB review process. In this regard, NIH is currently studying this very topic through a recent RFP entitled, “Empirical Research on Ethical Issues Related to Central IRBs and Consent for Research Using Clinical Records and Data.” While NCI has a strong model, any rule-making effort could be better- informed by the outcomes of the ongoing NIH project. This study is essential to determining the best ways to design and implement a single IRB review system for multi-site research and a Final Rule in this area should be delayed until the new information can be evaluated.

 

Exemptions

 

Similar to the amorphous process for “Broad Consent” determing when a study is exempt will rely on a yet-to-be-determined online decision tool. Once again, since such a tool exists in concept only, it is nearly impossible to comment on whether it would be a positive or a negative for advancing research. There is much complexity in this area and negative outcomes through a poorly-designed tool are just as likely as positive outcomes from a well-designed tool. More information is needed on how such a tool would be designed, collaborated on, and implemented and more information is needed through a subsequent NPRM that more fully-realizes this concept. Most seriously, the government cannot limit liability through misuse of a confusing or inadequate tool for determining exemptions, thus any subsequent effort must be conducted diligently and thoroughly.

 

Protection of Biospecimens and Identifiable Private Information

 

There seems to be much confusion and potential conflict regarding how the Common Rule treats biospecimens and how HIPAA rules will apply, and harmonization must be achieved to move forward. Currently, HIPAA does not cover de-identified biospecimens. A subsequent NPRM would need to address if HIPAA compliance is sufficient for protecting biospecimens and identifiable data or if an expanded framework is required. Additionally, if the NPRM is implemented as written, the limits on the use and disclosure of now identifiable biospecimens will also conflict with HIPAA. Finally, the NPRM does not allow for sharing data or biospecimens without consent, which is highly burdensome and also inconsistent with HIPAA (which facilitates sharing for treatment purposes). Most pressingly though, once again the proposed system is difficult to comment on due to persistent questions and inconsistencies, and there is no justification or evidence to suggest why moving in this newly proposed direction is necessary or essential.

 

Conclusion

 

Clinical and translational medical research has reached a tipping point where tremendous progress can be delivered through further advancements. With the advent of the president’s Precision Medicine Initiative, meaningful congressional efforts such as the Senate’s “Innovation” legislation, and a real democratization of science through collaboration with patient stakeholders, the opportunities have never been greater. Many of the proposals put forward through the current NPRM would undermine these important efforts.

 

Our colleagues at major research coalitions and leading academic institutions have provided thoughtful and detailed analysis of the NPRM. We ask that the administration acknowledge that there is consensus within the public health community’s comments and emerging themes through a pattern of specific concerns. This is an important dialogue, and the robust and passionate nature of the feedback lends itself to the need for further discussion. Rather that absorbing input and moving forward with the issuance of a Final Rule, we ask that the administration issue a second NPRM that address and responds to the common concerns raised by the medical research and public health communities so the conversation can continue to move in a positive and productive direction. Further, CCTS fully endorses the comments submitted by the Association of American Medical Colleges in response to this NPRM.

 

Thank you for your time and your consideration of these comments.

 

Sincerely,

 

 


____________________________

Rebecca D. Jackson, MD                
President

Association for Clinical and Translational Science

 

 


____________________________

Harry Selker, M.D., MSPH

Chair
The Clinical Research Forum
President-Elect
Association for Clinical and Translational Science

 

To view the official AAMC response click here: www.regulations.gov/#!documentDetail;D=HHS-OPHS-2015-0008-1325.