Association for Molecular Pathology comments on proposed changes to the common rule

October 26, 2011 in Other

Yesterday, the Association for Molecular Pathology (AMP) submitted comments on the Advanced Notice of Proposed Rulemaking (ANPRM) called, Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators. AMP commends the agency for its efforts to streamline the regulations to facilitate participation in research while maintaining the high level of protections research subjects deserve and expect. The Association also supports the creation of an excused category of studies and modifies the rule to allow a multi-site study to rely on a single institutional review board (IRB). However, AMP believes that this should not be mandatory and asks that the final rule deem this change to be optional.

Despite these positive changes in the proposed rule, AMP is very concerned about the sections addressing biospecimens and calls on the Department of Health and Human Services (DHHS) to modify the rule prior to being implemented. In , molecular and laboratory directors develop and validate testing for clinical use. Generally, laboratories use samples collected outside of a research study, e.g., leftover tissue following surgery, or share samples with other laboratories to use as controls. In these instances, all identifiers have been removed from the samples to protect the patient's confidentiality. "These practices are instrumental to and are necessary to ensure high quality, safe testing for patients," said Dr. Elaine Lyon, chair of AMP's Professional Relations Committee. Dr. Lyon stressed that, "the practice of using samples for validation and verification are part of conducting and quality assessment activities, and are not research."

As such, AMP calls on the DHHS to include language that identifies these activities to be part of clinical care and the practice of medicine, and not considered to be research, to clarify any confusion and prevent possible future misinterpretations.

AMP also believes the proposed rule oversimplifies the ability to link a de-identified biospecimen back to an individual based on the sample's extracted DNA. "This is practically impossible with current technologies," explained Dr. Lyon, "In fact, the few instances when this has occurred, investigators had access to samples from family members or information about a clinical presentation so rare that it was easy to identify who gave the sample." AMP views the proposed rule's reaction to this concern to be disproportionate to the risk and the conclusion that biospecimens cannot be de-identified to be far reaching. To address this remote concern, AMP shares the American Society for Investigative Pathology's view that enforcement of the current policy of the use and misuse of biospecimens coupled with stricter penalties for violations is the best way to ensure the best protection of human subjects who are involved in research.

Last, in regards to obtaining broad consent from research participants, AMP encourages the agency to address ways to obtain consent without needlessly creating mistrust or fear as potential participants review the consent form.

Provided by Association for Molecular Pathology

not rated yet  

Rank not rated yet
Relevant PhysicsForums posts

More news stories

ACP issues recommendations for management of high blood glucose in hospitalized patients

High blood glucose is associated with poor outcomes in hospitalized patients, and use of intensive insulin therapy (IIT) to control hyperglycemia is a common practice in hospitals. But the recent evidence does not show a ...

Other created 5 hours ago | popularity not rated yet | comments 0

Future doctors unaware of their obesity bias

Two out of five medical students have an unconscious bias against obese people, according to a new study by researchers at Wake Forest Baptist Medical Center. The study is published online ahead of print in the Journal of ...

Other created 11 hours ago | popularity not rated yet | comments 0

Plastic realistic: Medical students to use plastinated human bodies for anatomy learning

Nanyang Technological University's (NTU) new medical school will be pioneering the use of plastinated bodies for medical education in Singapore.

Other created 20 hours ago | popularity not rated yet | comments 0

Survey points out deficiencies in addictions training for medical residents

A 2012 survey of internal medicine residents at Massachusetts General Hospital (MGH) – one of the nation's leading teaching hospitals – found that more than half rated the training they had received in addiction and other ...

Other created May 22, 2013 | popularity 5 / 5 (1) | comments 0

Early use of tracheostomy for mechanically ventilated patients not associated with improved survival

For critically ill patients receiving mechanical ventilation, early tracheostomy (within the first 4 days after admission) was not associated with an improvement in the risk of death within 30 days compared to patients who ...

Other created May 21, 2013 | popularity not rated yet | comments 0


Hormone replacement therapy—clarity at last

The British Menopause Society and Women's Health Concern have today released updated guidelines on Hormone Replacement Therapy (HRT) to provide clarity around the role of HRT, the benefits and the risks. The new guidelines ...

Controlling mood through the motions of mitochondria

(Medical Xpress)—Regulating the distribution of power in neurons is done by a system that makes the national electric grid look simple by comparison. Each neuron has several thousand mitochondria confined ...

Motion quotient: IQ predicted by ability to filter motion (w/ video)

A brief visual task can predict IQ, according to a new study. This surprisingly simple exercise measures the brain's unconscious ability to filter out visual movement. The study shows that individuals whose ...

Multiple research teams unable to confirm high-profile Alzheimer's study

Teams of highly respected Alzheimer's researchers failed to replicate what appeared to be breakthrough results for the treatment of this brain disease when they were published last year in the journal Science.

Scientists discover molecule triggers sensation of itch

Scientists at the National Institutes of Health report they have discovered in mouse studies that a small molecule released in the spinal cord triggers a process that is later experienced in the brain as ...

Researchers find common childhood asthma unconnected to allergens or inflammation

Little is known about why asthma develops, how it constricts the airway or why response to treatments varies between patients. Now, a team of researchers at Weill Cornell Medical College, Columbia University Medical Center ...