Belmont Report (basic principles underlying the ethical challenges):

Autonomy
respect for persons
beneficence
justice

“[AS1]What should participants understand to understand they are participants in research?” (Wendler et al. 2008).
In order for a participant to give valid consent, the PIL at minimum should include 20 elements as detailed out in section 4.8.10 of ICH GCP guidelines so that comprehensive information is provided to them. The CIOMS guideline lists 26 essential elements to informed consent. Hence, this question encompasses one of the major ethical challenges faced during the consenting process.

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According to participant’s perspective, is all the information included in the PIL relevant to their decision-making? It is often noticed in practice that participants feel overwhelmed by the information provided to them, and as a consequence they skim over information which they feel is not applicable or relevant to them. But then the next question arises, what about the elements that are considered non-relevant by the patient? Does it contain important information which the patients would otherwise be missing out on? As result it is unclear as to what should be the adequate content of the PIL’s to satisfy the needs of the patient and delivering the minimum sufficient (encompassing all perspectives) information at the same time. Failure to find a balance in this respect might undermine the validity of potential participants’ consent – is it as informed consent or not?
Fortun et al. 2008 noted that participant recall and understanding of clinical trial information was poor despite a comprehensive 13 page PIL. A systematic review also highlighted that providing patients with more information results in lower participation rates (Edwards et al. 1998)
To determine what information potential participants need to understand in order to give valid informed consent, it is useful to identify the purpose or justification for requiring consent in the first place. Once we answer this question, we can then determine what information individuals need to realize this purpose or goal (Wendler et al. 2008).
Informed consent serves at least two purposes. First, the requirement for informed consent allows competent individuals to understand whether participation in research is consistent with their interests. Second, informed consent allows individuals to decide for themselves whether they will enrol in the study in question. For this purpose, potential participants should be provided with the information they want to decide whether to enrol in the study, which goes back to our earlier challenge of the content of consent.
Not[AS2] just the content of PIL, but the quality of its content should also come under ethical scrutiny. Both – the content and its quality – together will help the patient to make a reasoned choice. In order to truly understand something, one must exercise two capacities (which together constitute the meaning of ‘decisional capacity’ in healthcare) – the capacity to understand the meaning of the information provided, and the capacity to appreciate the relevance of this information to one’s own situation and come to a decision [Iltis, 2006, 181].
In terms of the actual words used in PIL, the complexity of the technical language in which consent forms are written remains a problem, though this can easily be remedied. (Macklin). But it’s not just that. It’s even the simple terms like describing ‘research’ using other terms, for example, explaining that the project involves a ‘study’ or a ‘clinical trial’, seems unlikely to help those who do not already understand research. For example, a potential participant understands the study’s risks, potential benefits, procedures, and alternatives. What else should the patient understand to understand that the project in which they are being invited to participate ‘involves research?’ And what additional information should investigators disclose to help them understand this fact?
Another facet to this linguistic challenge is when considering translation to local (or regional language). For example, some languages do not include a word for research. Does it follow, as some commentators speculate, that these individuals cannot understand that a study involves research, hence, may not be able to provide valid informed consent?
At the other extreme, explaining every aspect of clinical ‘research’ seems impractical, if not impossible. Understanding the history of clinical research and its abuses alone might require a lifetime of study. Between the insufficiently minimalist and impossibly maximalist extremes lie many questions, and the need for guidance. Must investigators disclose and must potential participants understand the scientific design of the study? Do they need to understand that the study is phase I, and how that differs from phase II and phase III studies? Too much information can be as bad as too little; both tend to interfere with the ability of research participants to grasp what is relevant Macklin et al.
After the information has been provided, the next question is, has the information been received? As Nijhawan et al. states, it is very difficult to evaluate a participant’s viewpoint about trial since there is no established method to measure the level of understanding that a participant has about the information given. There are various factors involved in this. A participant’s level of understanding would be affected by a degree of misunderstanding that can occur because of incorrect or inadequate language translations as well as their level of education. (Ferguson, 2002) The national and international guidelines state that the comprehension of PIL should be accessible to a 12 year old. However, only 50% of patients feel that the provided information is clear and concise, with many patients having to read the document numerous times to gain a grasp of the medical terms contained within the PIL.
There is also considerable debate about patient’s perception of the goal of research, which is termed as “Therapeutic Misconception” in an article by Appelbaum et al. It states that a further difficulty arises from the failure to distinguish between experimental research and therapeutic medicine in the context of clinical research. Surveys have shown that many patients who are enrolled as subjects develop the misconception that the goal of the research is a therapeutic one, and they agree to be enrolled in the often unrealistic hope that they will benefit directly from participation in the study which yet again undermines the validity of informed consent.
Another [AS3]related difficulty involves the widespread variation in subjects’ comprehension and appreciation of the nature of risk. The Belmont Report reminds investigators that they have responsibility for ensuring that the subject has comprehended the information provided to them, and that the obligation to ascertain that the subject has adequately understood the nature of the risk entailed by the research increases in proportion to the seriousness of the risk (Section C).
Studies have shown that most adults have a limited ability to think in terms of probabilities and to appreciate risk, even when steps are taken to enhance their understanding [Iltis, 2006, 181, 185]. It is generally agreed that the amount of information provided should be based on the ‘typical’ reasonable adult’s understanding of risk, although there is much disagreement about how to define this, given that interpretations of both linguistic and numerical ways of expressing the possibility of risk vary considerably, as does the amount of risk different people are willing to assume. Moreover, what might be risky for one person, it necessarily won’t be the same for another. While the investigator can provide the prospective participant with scientific data relating to types and probability of risk in order to assist her in making a decision, it is the value they attach to risk which will ultimately determine whether or not they chooses to participate. Thus great care has to be taken to ensure that research risks and potential adverse events are presented to prospective participants as unambiguously as possible.
Then [AS4]again there are problems relating to research involving ‘vulnerable populations’, some of whom may have diminished or impaired mental capacity and may not be capable of providing consent at all. (Macklin)
A balance needs to be established between the obligation to protect more vulnerable – or less autonomous – research participants, on one hand, and, on the other, the need to conduct research involving minors and persons with reduced mental capacity in order to provide these populations with access to results or interventions which may benefit them clinically. Persons with diminished mental capacity and children who have not yet reached decisional maturity should not be automatically denied the benefits of medical research, but neither should they be excluded without justification from decisions made about whether or not they become involved in research. What is crucial is that additional safeguards be put in place to ensure that these groups are protected from exploitation, in particular while explaining the nature of the research when obtaining their consent. Where this is not possible, and it is felt that the research has sufficient clinical value to proceed, stringent requirements for obtaining proxy or surrogate consent should be put in place. Consent forms should reflect this need for additional protection.

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[task article] Given the current socio-legal research environment, it is difficult to know whether, in practice, researchers and research review bodies err in overestimating or underestimating the decisional capacities of persons with mental illness. Either type of systematic error can be costly. Allowing persons with mental illness to participate on the basis of defective consent would violate the most basic ethical tenets governing human research and can amount to exploitation. Yet, by erring too much in the other direction-that is, by overemphasizing the vulnerabilities of persons with mental illness-researchers and review bodies could unfairly exclude competent individuals with mental illness from opportunities to participate in research. The ethical costs of excluding willing individuals with mental illness from participating in research are not sufficiently emphasized. Unjustified exclusion from research, however well intended, is a form of discrimination. Moreover, in the absence of adequate research on the most severe forms of mental illness, individuals with these illnesses are relegated to receiving treatments for which there is only inferential evidence of efficacy. For these reasons, a major ethical challenge for psychiatrists and other professionals engaged in mental illness research is to develop ethical principles and practices for selecting research participants that ensure proper respect and protection without reinforcing incorrect assumptions about individuals with mental disorders.
Another major ethical challenge faced during obtaining consent is assessing the patient’s voluntariness. Macklin et al. paper questions, can the complete voluntariness of patients’ decisions to participate in research always be guaranteed, especially when the person conducting the research is the patient’s own physician?
Objective of a researcher is to perform systematic investigations involving human beings to develop generalizable knowledge whereas as a practitioner their focus is on diagnosing and treating the illness in individual or group to meet their health needs. So an interesting, albeit ethical, dilemma arises. Should the physician fulfil their sole obligation of focusing on the well-being of the patient, yet in the context of trial conduct, the physician (now an investigator) has competing obligation to generate high quality data. The trial distracts from “good personal care”.
Declaration of Helsinki 2000 Article 28 says:
“The physician may combine medical research with medical care, only to the extent that the research is justified by its potential prophylactic, diagnostic or therapeutic value. When medical research is combined with medical care, additional standards apply to protect the patients who are research subjects.”
[macklin] There are problems concerning the way research is presented to patients who are potential subjects when the investigator is faced with such a dual role. When researchers are also clinicians caring for their patients, they face a conflict of interest that is non-financial. The need to accrue a sufficient number of patients in a study could affect the way a researcher conducts the informed consent process. Patients tend to trust their doctors, even when the intervention is research rather than a treatment proven to be effective. Practically in such a situation, patients often rely on the responsible doctor for decisions about whether to take part in a research study, the treatment available and its associated risks, despite the information available in the PIL [Bjorn et. Al, 1999]
Hence, a sense of patience and training as a researcher is required from the investigator’s end. Investigators should receive education in research ethics that addresses rules and norms governing research; sensitivity to ethical implications of decisions and actions; and skills in ethical problem solving, including ascertainment and disclosure of conflicts of interest. [task article]
Conclusion: Informed Consent is not enough. There are multi-factorial challenges to this single concept.
With subject populations that are mostly medically naive and for whom the whole concept of clinical research and the umpteen terms and concepts associated with it are alien; the true essence of an “informed” and “autonomous” decision is fundamentally lost. The consent process thus gets reduced to mainly a “narration-followed-by-signature” process. Over the last few years, this gap in principles and practices of ethics and consent has been acknowledged and innovative concepts and attempts are being fostered, to make the informed consent process more “ethical”. Pranati et al.