Many individuals may already have had the experience of signing consent forms for other medical procedures, such as surgery or for cancer treatments. However informed consent for a clinical trial involves more than just reading and signing a piece of paper.3 It actually involves two parts: “a document and a process.”2 Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a “continuing process throughout the study in order to provide new information for participants.”2 In order to help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the explicit details of the study.2 Consequently if the participants native language is not English, translation assistance is provided. Then the research team provides an “informed consent document that includes details about the study such as: its purpose, duration, required procedures and key contacts.”2 The risks and potential benefits are explained in the informed consent document.5 The participant then decides whether or not to sign the document. If the patient decides to participate then the clinical research team will continue to update any new information that may affect the individual’s situation.5 Before, during and the trial participants will have the opportunity to ask questions and raise concerns as informed consent is an ongoing, interactive process, rather than an information session. Informed consent is “not a contract, and the participant may withdraw from the trial at any time.”2
Participants of clinical trials need to be fully aware that there are risks involved when consenting to taking part. The risks may be unpleasant, serious or even life-threatening side-effects to experimental treatment.6 From studies carried on informed consent the question whether healthy volunteers participating in clinical trials are sufficiently informed of the risks is debateable. In a paper by Griffin7 on how much information do participants retain from the informed consent process it examined how previous studies had reported mixed information about how much information study participants actually can read, understand and retain after completing the informed consent process. It examined how fewer studies “had examined disparities in the retention and recall of information by patient factors, such as age, education and race.”7 Not “retaining or being able to recall information from the informed consent process has potentially important ethical and legal implications and consequences for research quality and integrity especially when found in populations that commonly are underserved or underrepresented in clinical trials.”7
In this paper by Griffin a study7 was carried out in order to determine how much basic knowledge participants finishing a “five year, multi-centre, double-blinded randomized, placebo controlled clinical trial had about the study.”7 The participants were asked at their final follow-up visit three multiple-choice questions which were: the “study’s purpose; the name of the medication under investigation and the main side effect of the medication.”7 The associations between knowledge of these fundamental details and participant social and demographic factors were investigated. A majority of participants correctly recalled the study’s purpose (64.7%) and medication (79.6%), but few correctly reported the main side effect (31.1%). In “spite of relatively high recall for study purpose and medication, disparities by age, education and race existed.”7 Increasing age was significantly associated with higher odds of incorrectly recalling both the study purpose and the name of the study medication. Black and other non-white race or ethnic groups were more than two and a half times as likely to incorrectly identify the study’s purpose. Even though all of this was extrapolated from the study it did however conclude that on the whole patients participating in clinical trials are sufficiently well informed of the risks prior to giving to consent.
In another paper by Lavori8 on improving informed consent in clinical trials: a duty to experiment it examines how investigators and practitioners of the trials have a sole duty to fully inform patients participating in research about the risks and benefits before giving consent and also that it should be totally voluntary. The study involved the development of a preliminary proposal to improve the quality of informed consent, based on experimentation with informed consent in ongoing clinical trials. It described a “conceptual paradigm for research in informed consent and linked it to measurement of outcomes.”8 It ultimately concluded that participants of the trial where fully made aware of the risks prior to giving their consent but the amount of information they retained in regards to this varied between individuals.
The majority of clinical trials provide an incentive for individuals to participate in them in order to compensate for their time and consequently try to reimburse the participants for any inconvenience they have incurred in the process. They may also reimburse them for travel costs, parking, meals, and accommodation as well as possibly for loss of work time.9 On the whole generally only Phase I clinical trials which involve the use of healthy volunteers will pay you for participating whereas phase II and III may not. A healthy volunteer is usually compensated approximately £80 to £150 daily for their inconvenience but this is all dependent on the trial and the pharmaceutical company undertaking the trial.10 Every trial has its own scheme in which participants are paid. Payment is usually given by two bank cheques in which, “50% of the study compensation fee is usually given to you at the end of a study, and the remaining 50% at post study medical”. If the clinical trial is of a longer duration then it is possible that an additional payment may be made at a specified time.10
The amount individuals are paid for participating in trials is decided by both the trial sponsor and investigator.10 Essentially an ethics committee reviews the level of payment in order to make sure that is appropriate. The amount a participant will be paid is usually directly proportional to the amount of time that is required by them to be present for the trial. In some cases a trial may require the individual to visit the clinical trial unit for just a few hours or even be admitted for up to a couple of weeks. Therefore the amount a healthy individual can receive could be as small as £20 to well over £2000.10 Consequently from this stems the statement “financial reimbursement is appropriate” and this is debateable. As ultimately it is dependent on the individual and whether they are satisfied with the amount they are being paid to participate in the trial.
As mentioned earlier clinical trials are beneficial as they provide access to promising new treatments that are widely available and many individuals who participate in these trials want to become part of this and do feel they are adequately financially reimbursed. One healthy volunteer who was remained unnamed in the news stated he had participated in clinical trials for over 9 years and felt that he was reimbursed suitably as the money had helped him to pay off his debts yearly. Also he did not feel anxious about participating as a healthy volunteer in any clinical trial after the disastrous effects of the TGN1412 trial. But what is also surprising is in a journal article by Moberly11 he states that despite this catastrophe that occurred “clinical trial recruiters saw surges of interest from would-be volunteers.” Although this was mainly from individuals who were unaware that they could get paid for participating in phase I trials as healthy volunteers. It was questioned whether this surge that was seen would “lead to increased recruitment”11 in clinical trials. It should be noted that those six individual men who suffered multiple organ failure after participating in the TGN1412 trial feel that no amount of money can compensate for the severe effects they have incurred. Therefore the £2,000 they were each paid to take one dose of the drug is not financially adequate.11
The findings from many papers such as that from Griffin7 and Lavori8 suggest that even the most basic information may not be understood or retained by important subgroups of patients enrolled in clinical trials but participants in most cases are fully informed about the risks involved in the trial. By implementing effective strategies, such as “additional time and effort for consent or repetition of study information, may be necessary in order to assure ethical and valid consent.”7 In relation to whether financial reimbursement is appropriate in my eyes is debateable. I feel that even though on the whole the majority of clinical trials are safe and ultimately result in the production of new safe and efficacious medicines they can have disastrous effects as seen with the TGN1412 trial therefore I feel that no amount of money can reimburse the cost of the effects to ones life!
REFERENCES
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Shein Chung Chow, The Design and analysis of clinical trial concepts and methodologies (1998), 1st Edition, John Wiley & Sons, Chapter 1.
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Ignazio Di Giovanna, Gareth Hayes, Principles of clinical research (2001), 1st Edition, Institute of clinical research, Pg 93 -117.
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- Joan M. Griffin, James K. Struve, Dorothea Collins, An Liu, David B. Nelson, Hanna E. Bloomfield. Long Term Clinical Trials: How much information do participants retain from the informed consent process? Contemporary Clinical Trials 27 (2006) 441 -448.
- Philip W. Lavori, PhD, Jeremy Sugarman, MD, MPH, Marguerite T. Hays, MD, and John R. Feussner, MD. Improving Informed Consent in Clinical Trials: A duty to experiment. Controlled Clinical Trials 20: 1987-193 (1999).
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accessed on 22/02/2007.
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- Tom Moberly. Will Volunteers still want to take part in research after the TGN1412 trial? The Pharmaceutical Journal (Vol 277) 387-388.
