In the News: Proposed Changes to Common Rule Guidelines
What is the NLMSF’s position on the proposed revisions to the current Common Rule guidelines? And how might this affect the LMS Community?
Dr. Jerry Menikoff, MD, JD, OHRP
1101 Wootton Parkway, Suite 200
Rockville, Maryland 20852
Dear Dr. Menikoff,
The mission of the National Leiomyosarcoma Sarcoma Foundation is to provide patient and family advocacy through education, as well as fund Leiomyosarcoma medical research.
The National Leiomyosarcoma Foundation has evaluated the proposed revisions to the current Common Rule guidelines. We understand and agree that an update to the Common Rule is needed due to the medical and scientific advances that have occurred since the implementation of the Common Rule in 1991. The intent of the proposed changes are well intended. However, one aspect of the proposed changes could have undesirable and devastating consequences for patients.
The proposed Common Rule change regarding restricting the ability to use archived biospecimens for new research studies without new patient consent would potentially be detrimental to rare disease patients and research.
To obtain consent from patients, years after their biospecimens were acquired, in order to use their anonyomized archived biospecimens for use in new research represents a burdensome process. It would be time consuming and costly, requiring additional staff to handle the new consent requirements that might be difficult if not impossible to obtain because of the difficulty in finding the patients.
Due to the rarity of Leiomyosarcoma, obtaining useful biospecimens for research is difficult in the best of times. To invoke additional unnecessary administrative roadblocks to the access and use of these valuable biospecimens only results in a critical loss of time and the wasteful use of already limited resources. This extra burden disrupts and derails potential life saving research advancements and breakthrough treatment opportunities.
The Foundation understands and supports the need for the protection of patients’ privacy. However, patients with rare, and aggressive cancers, such as Leiomyosarcoma, do not have the luxury of time for administrative barriers that are attempting to address privacy issues that have so far not been shown to be problematic.
Prolonging patient survival is of critical importance to Leiomyosarcoma patients, who currently have poor long-term survival rates. Focusing efforts on the immediate advancement of research is the key to any hope of potential improvement in treatment. To impede research puts these patients at great risk.
Federal regulatory guidelines should facilitate the SUPPORT and PROMOTION of cancer research advancement, NOT diminish or impede it.
In summary, the National Leiomyosrcoma Foundation’s position is: the use of archived biospecimens for cancer research for which there is no existing signed “general” consent, should remain exempt from the Common Rule proposed change, provided that biospecimens have no accompanying personal identifying information. We are opposed to the proposed change in the Common Rule regarding the current ability for researchers to use archived patient biospecimens without obtaining a new patient consent.
If a continued complete exemption is not acceptable then we would agree with the waiver/ exemption outlined in Proposal A which allows for the use of biospecimens, that contain no patient identifying information without a patient signed consent, except when the biospecimens are to be used for whole genome testing.
We hope for re-evaluation and reconsideration of the proposed rule change for the reasons mentioned above.
Thank you for your consideration of our concerns.
The National Leiomyosarcoma Foundation
Deadline to Respond has been extended to
January 6, 2016
From: The National Leiomyosarcoma Foundation
To: Affected Rare Disease / Rare Cancer Patients
SUBJECT: A proposed change to the “Common Rule” regarding patient privacy and consent for the handling of tissue samples(biospecimens) for research purposes – negative ramifications.
The Federal Government recently issued a proposal for considering changes to Federal Policy regarding Protection of Human Subjects, with the goal of updating and strengthening the policy known as the Common Rule, last revised in 1991.
There are several proposed changes to this Policy, which is pages long; links to the Federal Registry and the U.S. Department of Health & Human Services are provided at the end of this alert is you wish to learn in more detail about the Common Rule and the proposed changes.
This ALERT is to inform you about only one of the proposed changes to the current Common Rule that could potentially prevent or delay vital future medical research. This is important for the development of improved treatments of rare diseases/cancers including Leiomyosarcomas.
The National Leiomyosarcoma Foundation has submitted its position paper on this matter. Our response is listed above. We are hopeful that after reading this alert that you as patients, family members of patients or caregivers of patients with leiomyosarcoma will also voice your opposition to the proposed change to the Common Rule regarding the use patients’ archived biospecimens in future research.
Summary of opposition to the change to the Common Rule:
- Before stored patient tissue or other types of material (biospecimens) for which there is no exisiting “general” consent from the patient to allow the use of their biospecimens for any future research, new consent from the patient would be required. This rule change applies to biospecimens even if all identifiable patient information has been removed prior to the biospecimens being used for the new research.
- This new requirement would be extremely detrimental to future medical research. To attempt to locate patients, in many instances many years after their biospecimens were stored, in order to obtain their consent for use of their biospecimens in research would prove to be a monumental task at best and in many cases impossible. The loss of precious time and the costly administrative burden of such a proposal would adversely affect if not completely prevent the start of some research endeavors. Accelerated research efforts are our only hope for the development of new treatment options to improve our survival.
The Foundation, therefore, strongly encourages you to find your voice, and immediately send a letter of objection to the change proposed to the Common Rule which is not in the best interest of patients and researchers — lives are at stake.
Patients are the “stakeholders.” Individual researchers, scientific organizations are “stakeholders” as well. The Waiver of Informed Consent should continue to be permitted for archival biospecimens under the current consent criteria as set forth in the Common Rule. Federal Regulations should facilitate the support and promotion of cancer research advancements, not diminish and impede them.
If you are willing to stand up and be counted and play a major role for the sake of preserving life saving research, please act immediately.
The DEADLINE TO SEND IN YOUR COMMENTS IS: JANUARY 6, 2016.
A sample patient comment letter is offered to assist you (See PDF, below)
Your comments can be submitted in two ways:
- Through the Federal eRulemaking Portal (http://www.regulations.gov). Instructions once you access this portal are as follows:
- Enter the docket number: Doc HHS-OPHS-2015-008 in the SEARCH for: Rules, Comments, Adjudications or Supporting Documents” field and click on “Search.”
- After the Search, the proposed Rule by HHS on 09/08/2015 will display. Click on “Comment Now!” and follow the prompts/instructions.
- Mail your response to the following address:
Dr. Jerry Menikoff, MD, JD,OHRP
1101 Wootton Parkway, Suite 200
Rockville, MD 20852
Want to learn more about the Common Rule and the proposed changes? Here’s some helpful links:
- U.S. Department of Health & Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP). [cited 2011 Oct 13]. Available from:http://www.hhs.gov/ohrp/sachrp/commsec/index.html
- Federal Register, Vol. 80, No. 173, Federal Policy for the Protection of Human Subjects; Proposed Rules, September 8, 2015. [cited 2015 Oct 10]. Available from:http://www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-21756.pdf
Download this to use this as your sample letter.
Common Rule Final Patient Sample Letter.[…]
Microsoft Word document [16.1 KB]