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The Brody School of Medicine Office of Compliance
Compliance Wise-Fall 2007



Research Compliance Corner


CMS Issues a New Proposed Decision Memo on the Clinical Research Policy (formerly the Clinical Trials Policy).


On July 19, 2007, the Center for Medicare and Medicaid Services issued proposed revisions to the Clinical Trials Policy which currently governs how CMS pays for items or services billed when the beneficiary is a participant in a clinical trial.  The Proposed Decision Memo on the Clinical Research Policy makes a number of changes including (i) what is considered a “qualifying clinical trial;” (ii) the definition of “research;” (iii) what is considered “usual patient care” as part of the clinical trial (replacing the prior “routine cost” definition; (iv) creation of a new self-certification process for sponsors and principal investigators as a means of notification to CMS that the trial meets these new requirements; and (v) requirements for new modifiers for claims submitted in connection with clinical trials.


Based on various comments and advice from various industry groups, it is expected that CMS will continue to revise the new Clinical Research Policy (the “CRP”).  Of the many concerns expressed by industry over the CRP, one major concern is that CMS has indicated that clinical trials already enrolling subjects as of the final CRP release date (scheduled for October 17, 2007) will be subject to the requirements of the old Clinical Trials Policy, while clinical trials that begin enrolling patients after the CRP release date will be subject to the new requirements.  This could create two different sets of billing requirements for clinical trials which institutions would potentially need to follow for at least the next several years. 


We will be providing educational sessions with respect to the CRP to principal investigators, study coordinators, and others involved in billing for clinical trials once it is released in final form. You may access the full text of the CRP directly at https://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=210.



OHRP Posts a Series of 35 Questions and Answers about Informed Consent


The Office of Human Research Protections recently posted a series of 35 questions and answers (Q&As) regarding informed consent.  In addition to the more basic questions regarding informed consent (such as basic elements of informed consent), the Q&As also address more complex issues such as coercion and undue influence in informed consent, the role of compensation in undermining informed consent and parental permission, electronic signatures, legally authorized representatives, and the definition of guardian in the contest of obtaining consent for research involving children.  The full text of the Q&As can be accessed at




FDA Issues Proposed Guidance Prohibiting Complete Reliance by a Principal Investigator on his or her Study Coordinator for the Proper Conduct of a Study.


Recently, the FDA released draft guidance (the “Guidance”) outlining investigator responsibilities with respect to clinical trials.  Among other issues, the Guidance addressed (i) appropriate delegation of study-related tasks; (ii) adequate training of research staff; (iii) adequate supervision of the conduct of the study; and (iv) the investigator’s responsibilities with respect to oversight of study staff who may not be employed by the investigator (or investigator’s institution).  The Guidance stated that an investigator should have a detailed plan for the supervision and oversight of a clinical trial, even when such trial is conducted by “highly qualified and experienced” personnel.  The Guidance also provided recommendations for what might be included in such an oversight plan.  You can access this Guidance document at http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0173-gdl0001.pdf.  This link will also be available on the BSOM Office of Compliance website at http://www.ecu.edu/cs-dhs/bsomcompliance/recent-news.cfm.


The FDA has cited many investigators for failure to personally conduct or supervise clinical trials (see example FDA warning letter http://www.fda.gov/foi/warning_letters/g6135d.pdf)  Federal regulation requires that the investigator ensures that the investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations.  Reliance by an investigator on his or her study coordinator alone, regardless of such coordinator’s level of expertise, to supervise, conduct, and ensure compliance of trials with applicable law and regulation is unacceptable.  Investigators themselves are ultimately responsible and liable for the proper conduct of research studies.