Informed Consent Research Paper

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‘Informed consent’ denotes a person’s autonomous agreement to a proposed course of action, usually in a treatment or research context. Consent is not considered to be informed unless the person: has received disclosure of the information that a reasonable person would consider material to the decision at hand; has the capacity to use that information in a rational process of decision making; and reaches a decision in the absence of coercive offers or threats (Appelbaum et al. 1987a). Broad agreement exists that informed consent is an indispensable requirement for the ethical conduct of research with human subjects, at least when the research renders them liable to more than minimal risks of harm. But considerable controversy remains regarding the precise contours of the doctrine and of the circumstances that might constitute exceptions to the general rule. And since the rules have been devised largely with biomedical research in mind, issues more characteristic of social and behavioral science research have been relatively neglected.

1. History Of Informed Consent To Research

The history of informed consent to research is usually traced back to the decision of the court in the Nazi doctors’ trial at Nuremberg after World War II, which declared, ‘The voluntary consent of the human subject is absolutely essential.’ It is clear, however, that the Nuremberg tribunal neither originated nor established the concept of consent to research. References to requirements for consent from research subjects can be found in the writings of physician experimenters and in governmental pronouncements dating back to the late nineteenth century, when experimental medicine grew out of its infancy. Indeed, George Bernard Shaw’s Pygmalion contains an explicit statement of the principle. Two of the leading instances, ironically, derive from Germany, where the advanced state of empirical medical science made consent an object of at least periodic concern (Grodin 1992). Nonetheless, however much the Nuremberg court desired to root the principle in contemporary practice, it appears that researchers in many countries, even after the Nazi atrocities came to light, frequently neglected to obtain consent from their subjects.

Nor did the Nuremberg decision immediately change these practices. Investigators using human subjects apparently saw the Nuremberg Code, as the ten principles embodied in the court’s decision came to be known, as applying only to the anomalous situation of concentration camp inmates. Thus, the history of the postwar decades is marked by repeated revelations of questionable ethical practices, including studies in which persons were subject to clear harms without their knowledge or consent (for one of the most influential reports of problematic studies, see Beecher 1966). Pressure built for clearer rules and mechanisms of enforcement.

The World Medical Association responded to these concerns with its Declaration of Helsinki in 1964 (World Medical Association 1964), the first attempt to forge an international professional consensus on the ethics of research. The Declaration endorsed a requirement for informed consent, albeit in less sweeping terms than the Nuremberg Code. National professional organizations developed similar documents, but their nonbinding character left research subjects with few certain protections. A move to legally enforceable rules came in the USA in 1974, with the adoption of regulations governing federally funded research. Most of the industrialized countries in the world have since followed suit, by way of legislative or regulatory enactments, or binding guidelines (for a summary of the status of research regulation internationally, see Brody (1998). The general principle that research should not be conducted without the informed consent of participants has been accepted around the world.

2. Current Contours Of Informed Consent To Research

The requirements for informed consent are rooted in the ethical principle of autonomy, which demands respect for the free, informed choice of a competent person (Faden and Beauchamp 1986). Valid informed consent requires three elements to be present: disclosure, decision-making capacity, and voluntariness.

2.1 Disclosure

The Nuremberg Code (1948) declared that the research subject ‘should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.’ Brody (1998) summarizes the international consensus regarding those items that need to be disclosed to achieve this end as follows:

‘(a) the purpose and the research nature of the project;

(b) the duration of the subject’s participation, the treatment and procedures that the subject will undergo (with a clear specification of which are experimental), and the subject’s responsibilities;

(c) the risks of harms and discomforts that might result from participating in the research;

(d) the possible benefits to the subject or to society from the research;

(e) the alternatives to participating in the research;

(f) the right not to participate and to stop participating at any time without penalty or loss of benefits to which the subject is otherwise entitled;

(g) the measures to protect confidentiality;

(h) the anticipated payments, if any, to the subjects and the anticipated expenses, if any, that will be borne by the subject;

(i) the compensation and treatment available for injuries sustained in the research;

(j) the identity of a contact person to discuss questions about the research;

(k) the circumstances under which the subject’s participation will be terminated;

(l) the assurance that new information relevant to participation that becomes available during the research will be provided to the subject;

(m) the names of the sponsors of the research and the ownership of any commercial results.’

This information is generally provided in written form, though often supplemented by verbal disclosures. Frequently, the result is a lengthy form (12–14 page, single-spaced forms are not uncommon in clinical research) that is difficult for potential subjects to read and assimilate. Provision of a mass of detailed information means, moreover, that important data, such as those dealing with significant risks, are frequently neglected by subjects. A common resulting problem is the so-called ‘therapeutic misconception’— a belief on the part of subjects that procedures are being undertaken for their benefit (including randomization and use of placebos), when they are actually designed solely to advance the research effort (Appelbaum et al. 1987b). Though investigators are often urged to provide additional disclosures in more understandable formats (e.g., illustrated brochures that subjects can read at their leisure), this still represents the exception rather than the rule.

2.2 Decision-Making Capacity

The subject’s capacity (in legal terms referred to as competence) to give a meaningful consent was considered a sine qua non in the Nuremberg Code. Although formulations of the requirements differ somewhat across jurisdictions, decision-making capacity generally involves the abilities to understand the information relevant to a decision, to appreciate its implications for one’s own situation, to reason in a rational fashion, and to evidence a choice (Appelbaum and Roth 1982).

Capacity is generally presumed to be present, unless there is reason to believe otherwise. When studies involve populations at elevated risk of incapacity, however, including persons with severe mental disorders, mild dementia, head injury, and the like, particularly when the research may present significant risks to participants, investigators are increasingly assessing capacity prospectively. This can be done by means of clinical evaluations or formal screening instruments. Identification of a potential subject as having impaired capacities does not necessarily mean that the person must be excluded from research participation. Many such persons can be brought up to acceptable levels of functioning with extra educational efforts.

Were capacity to be an absolute requirement, as the Nuremberg Code suggested, no research could be conducted with children—who lack capacity as a matter of law—or with many patient groups, including potential subjects who are comatose, suffering from moderate to severe dementia or mental retardation, or severely psychotic and disorganized. The desirability of allowing research to be conducted with these groups, so that progress might be made on the disorders from which they suffer, led the drafters of the Declaration of Helsinki, and most subsequent compilers of codes, regulations, and statutes, to make some provision for the entry of incapable subjects into research projects. Rules governing their recruitment differ, but common limits include that the research be directly applicable to their conditions, not able to be performed with capable subjects, hold out the prospect of some therapeutic gain, or present no more than minimal risks of harm. Innovative proposals that would allow persons to make advance decisions while competent about whether to enter research projects should they later become incompetent have been much discussed, but rarely implemented.

2.3 Voluntariness

Overt coercion—the application of threats or unfair offers to a prospective research subject—is universally recognized as vitiating that person’s decision and thus rendering consent invalid. The effects of more subtle influences on the legitimacy of subjects’ consent to research is a matter of greater controversy. Some environments may be considered so intrinsically coercive—prisons, for example—that research with the persons detained therein has been severely restricted in many countries. Whether hospitals, institutions for the mentally ill or retarded, schools and colleges, places of employment, and other entities fall into that category is more difficult to say. Paradoxically, efforts to protect inmates, patients, workers, and others by prohibiting their participation in research deprive them of their residual decision-making power, and may increase their feelings of helplessness and their perceptions of being coerced.

Research subjects are often compensated for their participation with money or its equivalent. Fair compensation for the time expended in a study is generally considered acceptable. To the extent that payment is so substantial as to lead subjects to give insufficient attention to the risks they may run by participating, however, it may be considered an undue influence on their decisions, which renders their choices substantially involuntary.

3. Special Considerations In Behavioral And Social Science Research

Rules governing informed consent to research, from the Nuremberg Code to most contemporary governmental regulations, typically have been formulated with biomedical research in mind. Issues more characteristic of social and behavioral research have been relatively neglected. Indeed, the federal regulations in the USA categorically exempt many types of behavioral and social research from their purview, including: educational research; studies designed to evaluate governmentally provided benefits or services; and testing, surveys, interviews, or observations of public behavior, unless information is recorded in a manner that would render subjects identifiable, and subjects would be likely to suffer harm if the information were released (Code of Federal Regulations 1991).

Yet, many behavioral and social science studies involving human subjects raise important issues related to informed consent. One of the major questions is when, if ever, it is appropriate to deceive subjects about the purpose of a research study, a frequent technique in psychological research. Other issues concern consent for access to records, consent in observational and field work studies, and the appropriateness of seeking consent—or some equivalent—from entire communities that may be affected by an intervention that is part of a research project.

3.1 Consent In Studies Based On Review Of Records

Analysis of existing records, often aggregated into large databases, is a frequent technique used by behavioral and social scientists. These records may have been collected originally with subjects’ consent but for nonresearch purposes (e.g., medical records) or without subjects’ consent (e.g., national birth registries, educational testing results, or census information). When individual subjects are not reasonably identifiable in the database, it is generally agreed that consent need not be obtained prior to granting researchers access. Even with identifiable data, researchers have usually been allowed to utilize such records as long as they agree to protect the confidentiality of those persons whose information they are reviewing (e.g., by publishing data only in aggregate form).

This practice has been criticized as insufficiently protective of subjects’ interests in both autonomy and privacy. The autonomy argument is predicated on the belief that persons should have the right to control access to information about them, preventing its use, for example, for research purposes of which they may disapprove. Privacy concerns have been given greater weight of late with the growing ability of researchers to correlate information obtained from different databases about the same individuals, thus accumulating large amounts of information that, were it to be used or accessed for unauthorized purposes, could prove embarrassing or harmful to the people involved. Strong arguments have been made for obtaining consent from the subjects of these records prior to their release for research purposes.

Researchers object to these proposals on the grounds that they would materially increase the costs of research and, insofar as subjects’ refusal of consent would bias the resulting data, decrease the validity of their findings. In many cases, it will simply be infeasible to track down and obtain consents from the persons whose data is in question. No reasonable argument can be made for precluding researchers’ access in these circumstances, so long as the study is of some significant value and appropriate safeguards are in place. When smaller and more recent repositories of data are involved, and obtaining consent would not involve unreasonable expenditures of resources, it is clearly more respectful of subjects’ interests to seek their agreement. When records are being compiled prospectively with the intent of using them in the future for research purposes, there is no ethical justification for failing to obtain subjects’ consent at the time.

3.2 Consent In Observational Studies And Field Work

Many of the behavioral sciences have a long tradition of sending researchers into the field to study the behaviors of persons in their natural environments. This often involves requesting access from those to be observed to otherwise private interactions and territory (e.g., discussions between spouses in the subjects’ home). Considerable controversy exists over whether and how truly informed consent should be obtained in such cases. Insofar as researchers may observe and/or report embarrassing of frankly criminal behavior, subjects may be placed at risk of psychological or tangible harm. Thus, the case for obtaining consent in such studies would seem strong, bolstered by the discomfort some investigators report in withholding this information from their subjects.

On the other hand, researchers have an understandable concern that informing subjects clearly of the goals of their studies may lead subjects to alter their behaviors, thus obscuring the very phenomena that are under study. Though many subjects appear remarkably prone to ignore such information, especially once they become accustomed to the observer’s presence, this concern needs to be taken seriously. It should usually be possible to accommodate both parties’ interests by disclosing the intent of the study in general terms, along with the likely risks to which subjects’ may be exposed. If some modification of subjects’ behavior occurs, this is an unavoidable price to pay for acquiring a meaningful consent.

3.3 Consent In Community Intervention Projects

Social science research increasingly involves large-scale interventions directed at particular communities or segments of a community. These may include interventions designed to avoid undesirable outcomes (e.g., juvenile delinquency, teenage pregnancy, illegal drug use) or to promote what are generally seen as salutary ends (e.g., moving persons off welfare and into paying jobs). When such interventions occur at the level of the community as a whole—such as broad-based educational programs concerning drug abuse— it is impossible to obtain informed consent as it is usually conceptualized. Moreover, when studies are based on changes to entitlement programs that have been enacted through the political process, the consent of individual persons may be seen as irrelevant.

There may, nonetheless, be a role in such instances for a modified form of consent interactions with the relevant community. Although each person’s consent cannot be obtained, disclosure of the nature and purpose of the study and its risks and benefits can still take place. Consultation with the community at large and its designated representatives may result in suggestions for modifications in the study culminating in a general consensus concerning its desirability (Trickett 1998).

4. Research On Informed Consent

The last decades of the twentieth century have seen a flowering of empirical studies on informed consent to research that promises to shape for the better a debate that has frequently been waged on theoretical grounds alone. Among the areas of investigation have been: the adequacy of investigators’ disclosures and how they can be improved; the prevalence of incapacity among various groups of research subjects; subjects’ understanding of the information they have received and their appreciation of its implications for their situation; and subjects’ retention of information over time (Sieber 1996).

Naturalistic research on the consent process involves overcoming the reluctance of investigators to grant access to the research setting, and of subjects to consent to yet another research project. Subject recruitment can be both difficult and time-consuming. The willingness of funding agencies to sponsor such research is often related to the degree of public scrutiny of and concern about the agencies’ research portfolio. But such research is likely to increase over time and to play a greater role in helping to shape investigators’ practices and official policies governing informed consent.

Bibliography:

  1. Appelbaum P S, Lidz C W, Meisel A 1987a Informed Consent: Legal Theory and Clinical Practice. Oxford University Press, New York
  2. Appelbaum P S, Roth L H 1982 Competency to consent to research. Archives of General Psychiatry 39: 951–8
  3. Appelbaum P S, Roth L H, Lidz C W, Benson P, Winslade W 1987b False hopes and best data: consent to research and the therapeutic misconception. Hastings Center Report 17(2): 20–4
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  11. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1978 The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. US Government Printing Office, Washington, DC
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  14. Trickett E J 1998 Toward a framework for defining and resolving ethical issues in the protection of communities involved in primary prevention projects. Ethics and Behavior 8: 321–37
  15. World Medical Association 1964, last revised 1989 Declaration of Helsinki. In: Vanderpool H Y (ed.) The Ethics of Research Involving Human Subjects: Facing the 21st Century. University Publishing Group, Frederick, MD
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