Essay Example on Proposed Rule Disqualification of a Clinical Investigator









The Federal Register is an official journal of the United States government that consists of new regulations proposed rules and notices It is compiled by the Office of the Federal Register and published by the Government Publishing Office The Federal Register has a comment period during which the public can submit their views and comments about the Proposed Rules The FDA carefully scrutinizes these public comments and based on their analysis the FDA can either declare the rule or abandon its intention to declare a rule Disqualification of a Clinical Investigator is a rule proposed by the Food and Drug Administration on April 13 2011 1 The provision for disqualification of a Clinical Investigator is already a part of regulations 21 CFR Part 312 511 and 812 2 3 4 When disqualified an Investigator is ineligible to receive for the purpose of research any FDA regulated products such as drugs medical devices biologics foods animal drugs infant formulas tobacco products and food and color additives An investigator who is declared to be ineligible to receive these test articles under 21 CFR parts 312 511 or 812 will be ineligible to perform any clinical investigation or research The given Proposed Rule expands upon the scope of Clinical Investigator disqualification Its main intent is to ensure the integrity and dependability of clinical trial data The mission of the FDA is to protect public health The given rule if enforced will support the FDA in protection of subjects participating in clinical investigations The basis of this proposal is a study conducted by U S Government Accountability Office GAO that studied the FDA's oversight of Clinical Investigators who conducted research consisting of new devices biologics and drugs 5 On conducting the study GAO found that clinical investigators who were disqualified from receiving one type of investigational test product were able to serve as investigators for other kinds of test products According to current regulations the FDA can disqualify a clinical investigator if he is found to be engaged in misconduct that puts the safety of the study subjects at risk 

The procedure to disqualify an investigator is initiated when a clinical investigator repeatedly or deliberately defies regulations of the FDA However due to regulatory language this disqualification of an investigator applies to the study of only one type of medical test product Thus the GAO recommended an amendment to FDA regulations such that clinical investigators who have been found to be involved in misconduct in one study be disqualified from serving as clinical investigators in any other types of products regulated by FDA According to this Proposed Rule modifications were proposed to the provisions currently in 21 CFR 312 511 and 812 One of the revisions proposed was to harmonize the provisions for investigator disqualification in these regulations It includes the addition of an explicit provision that states that a clinical investigator also includes a sponsor investigator If it is found that a clinical investigator has repeatedly or deliberately not complied with the regulations or if he is involved in scientific misconduct then the applicable FDA Center should send a written notice to the investigator This notice gives the investigator a chance to justify himself in writing or at an informal hearing If the investigator s explanation is acceptable to the FDA then the disqualification proceedings will discontinue If not then the clinical investigator is given an opportunity to ask for an informal regulatory hearing under 21 CFR part 16 6 As per the old rules investigator was ineligible to receive test articles only under the category in which they were disqualified However under the provisions of the proposed rule if an investigator is disqualified he would be ineligible to receive test articles under any category of products regulated by the FDA The purpose of disqualifying a clinical investigator is to ensure the integrity of the study data as well as to protect the safety and welfare of study subjects Clinical investigator disqualification is a remedial step

The comment period for this Proposed Rule is till July 12 2011 The submissions can be either electronic or written to the Division of Dockets Management There are some modifications that can be made to the proposal The proceedings for disqualification of an investigator go on for a long time The investigator can still conduct the study and will continue receiving test materials as long as he is not disqualified Thus there should be a provision for implementing a Clinical hold on the clinical investigator in order to prevent him from conducting any studies while the trial is ongoing The development of veterinary biologics does not come under FDA jurisdiction They are regulated by United States Department of Agriculture USDA Clinical investigators performing studies on animal drugs who are disqualified by the FDA might switch to veterinary biologics Thus the FDA should consider notifying the USDA about disqualified investigators and the USDA should bring out a companion rule to disqualify such investigators from performing studies on veterinary biologics as well 7 The Proposed Rule is an improvement to the preexisting regulations and it should be implemented to enable the FDA in fulfilling its mission of protecting public welfare

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