Ethical Issues and Concerns of a Clinical Investigator

A s i a n B i o e t h i c s R e v i e w D e c e m b e r 2 0 0 8 i n a u g u r a l e d i t i o n 64 Ethical Issues and Concerns of a Clinical Investigator This article highlights the common questions that a clinical investigator is confronted with that may be potential ethical issues or concerns. Let me delve into the individual issues that I consider potential areas of concern. The first issue is the potential occurrence of undue inducement of both the investigator and the participant. The pharmaceutical company sponsoring the trial promised in the contract a bonus payment of $5,000 to the investigator if he is able to achieve the pre-set target of 40 participants. Inducement has always been an area of concern, particularly by ethics board reviewers when reviewing clinical trial protocols, especially those sponsored by multinational pharmaceutical companies. In an effort to accelerate participant recruitment, sponsors may offer financial and other incentives to sites. In addition they may offer additional incentives to the investigators when they meet the target sample size within a specified period of time. There is, however, a possibility that the integrity of the study may be compromised. Moreover, there is also the possibility that these incentives may unduly influence the course of action to be taken by investigators to meet the set targets. These may violate professional ethics codes, national laws and existing or institutional or administrative directives. Most ethical guidelines will prohibit the following incentives: 1. Finder’s fees. Payment for referring potential participants to investigators. There is no mention of this in the case or the presence of locators or people who recruit patients for the investigator. What is specified is the amount of $800 for each participant eventually included in the study. What is reasonable is payment to cover expenses directly related to the conduct of the study such as printing of information material for patients or transportation of required equipment and personnel. C A S E C O M M E N T A R Y 64–66 Asian Bioethics Review December 2008 inaugural edition 65 E t h i c a l I s s u e s a n d C o n c e r n s o f a C l i n i c a l I n v e s t i g a t o r J a i m e C . M o n t o y a 2. Bonus payments. Additional payments to the investigator, study coordinator, enroller or the institution for increased recruitment, especially when the payments are not related to increased trial costs. This was mentioned in the case. Payment to cover for site and institutional expenses based upon cost of enrollment not originally anticipated are usually permissible. Any costs other than these should be mentioned or included in the study contract with the study sponsor. This is for transparency and to avoid opportunities on either side (sponsor or investigator) to make inappropriate demands or obligations. Patients should be informed of potential conflicts of interest of investigators and sponsors and patients made to decide whether to participate or not, based on this information.1 Patients value being informed even if they are willing to defer decisions to their physicians.2 In designing recruitment strategies, investigators and sponsors must balance their enthusiasm for the research with the need to maintain an atmosphere that minimises the possibility of coercion or undue influence. Physicians may be motivated by financial interests other than what is best for their patient in the study. Communicating an excessive or unrealistic enthusiasm about the possible benefits of the research to potential subjects, either consciously or unconsciously, may unduly influence subjects’ enrollment decisions.3 Physicians should be aware of their own emotions and motivations and how these may affect their actions so that they will be in a better position to make rational decisions.4 Both the atmosphere of the consent conference and the language of the consent document must enhance the prospective subject’s ability to make a true, informed and...