Research subjects, informed consent

The principle of autonomy entails that persons should be treated as inherently valuable individuals with the moral right to make decisions about their own lives. To the extent that one s actions and choices do not negatively affect others, individuals with the capacity to make their own decisions should be free to do as they wish, even if their choices are risky or harmful to themselves. The principle also entails that persons with diminished autonomy, such as those who are illiterate or retarded, deserve to have their interests protected. Many moral obligations for professionals engaged in scientific research or health care are derived from the principle of autonomy, such as the physician-researcher s obligation to fully inform potential research subjects and respect the individual s informed consent or informed refusal. This obligation is founded on the principle that individuals are the appropriate decision makers for choices that do not harm others. 

Institutional Review Board/ Independent Ethics Committee and Informed Consent Protecting Subjects Throughout the Clinical Research Process... 

Guarino, R.A. Institutional review board/independent ethics committee and informed consent. Protecting subjects throughout the clinical research process. In New Drug Approval Process, 3rd Ed. Marcel Dekker, Inc. New York, 2000 100, 271. 

Assuming that standard codes of conduct, for example, the Nuremburg Code (1947) and the World Medical Association s Declaration of Helsinki, are followed by researchers, the element of consent will already have been satisfied. In fact, as far as the element of consent to the intrusion into privacy goes, the medical community s doctrine of informed consent is a very strict application of the element of consent. We may note that the specific informed consent of an individual human subject of research may not be adequate to the decisions surrounding data mining. 

On the other hand, a topic such as the duty of honesty, although generally stated, holds a lot of interest for the philosopher for the particular manner in which the duty of honesty might appear in research using human subjects. The duty of honesty governs informed consent with regard to health risks, but it could also serve as a springboard to inform human subjects of the potential risks to privacy as well, even if those risks are not well understood. 

In the United States, as in most other countries, individual informed consent is generally required before research may be done with a living, identifiable human being. Informed consent for research generally has two different justifications. First, it allows the potential subject to weigh for himself or herself the balance of risks and benefits from his or her participation in the proposed research. Second, it embodies the individual s autonomy and control over interventions in or about his or her own body. 

Although there are several ethical concerns with biobanks and other large-scale research repositories (Rothstein, 2002), the most important issue is informed consent. Participants in research involving human subjects must be advised of the intended research to be performed with their specimens. With biobanks, however, the future research uses of the samples are unknown at the time of collection. It would be infeasible to contact each of the donors to obtain consent every time a new research use is contemplated, yet IRBs are reluctant to approve the use of blanket consent for unspecified uses. One way to avoid this problem is for prospective sample donors to be given a menu of possible uses of their samples. Such a list might include research in mental health, HIV/AIDS, cancer, cardiovascular disease, or other areas. The donors would then have the opportunity to approve the use of their specimens for all or some of the listed uses. Other disclosures necessary to obtain informed consent include the financial interests of the biobank and researchers, whether individuals may elect to be notified of research findings, and whether it is possible for an individual to withdraw his or her sample from the bank (Rothstein, 2002). 

Duties of IRBs. IRBs are required to review and have the authority to approve, require modifications in, or disapprove all research activities covered by the regulations [45 CFR 46.109(b)]. They must require that information given to subjects as part of informed consent is in accordance with the general requirements for informed consent that are set out in the regulations. Additionally, they may require that other information be given to subjects when they judge that such information would further protect the rights and welfare of the subjects [45 CFR 46.109(c)],... 

In addition to these basic elements of informed consent, IRBs shall also require that information shall be provided, where indicated, to the effect that (1) the particular treatment or procedure being tested may involve risks to the subject that are currently unforeseeable (2) foreseeable circumstances may exist under which continued participation by the subject may be terminated by the investigator without regard to the subject s consent (3) additional costs to the subject may results from participation in the research (4) the consequences of a decision to withdraw and (5) significant findings that may influence a subject s continued participation will be related to the subject. 

Regulations also exist to protect the confidentiality of the research participant. All information collected throughout the clinical trial remains with the study staff. For the purposes of data capture, each subject is identified by initials or study number only. In addition, the informed consent discusses who will have access to the trial documents. 

FDA, Protection of human subjects Exception from informed consent requirements for emergency research. Code of Federal Regulations, Title 21, Part 50, Subpart b 50.24, Rev. April 2004, pp. 313-314. 

When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in a dependent relationship with the physician or... 

Research on individuals from whom it is not possible to obtain consent, including proxy or advance consent, should be done only if the physical/mental condition that prevents obtaining informed consent is a necessary characteristic of the research population. The specific reasons for involving research subjects with a condition that renders them unable to give informed consent should be stated in the experimental protocol for consideration and approval of the review committee. The protocol should state that consent to remain in the research should be obtained as soon as possible from the individual or a legally authorized surrogate. 

The principle of justice states that individuals should be given what they deserve, be that benefit or burden. Cases that are alike should be treated similarly, and relevant distinctions should be drawn consistently. The principle of justice does not specifically state what distinctions are fair or which criteria are reasonable it simply requires that, once criteria are determined, they be applied fairly. Justice is important in many areas, such as recruitment of research subjects for pharmaceutical studies. For example, researchers must guard against distributing the burdens of participation disproportionately among populations that are poorly equipped to give informed consent, such as children or the mentally incompetent. 

C) Subjects are not asked to give informed consent, as they cannot understand the complexities of a research study. 

When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in a dependent relationship with the physician or may consent under duress. In that case the informed consent should be obtained by a well-informed physician who is not engaged m the investigation and who is completely independent of this relationship. 

In what follows, I will focus on the individual assumption operating in the "mainstream model." The Individual level also presupposes a reductive and idealized view of the research subject. It reduces her to a perfect contractor and centers the ethics of research on the informed consent process. Contractors follow the pattern of businessmen striking a bargain. As long as the contract process is fair, contractors are entitled only to what they bargained for. 

Hence, even if either model does not seem to be completely accurate at conceptualizing the research subject s situation, there might be something appealing in both characterizations as victim and as contractor. This is why 1 believe they should not be dismissed. What we can say is that, as a possible contractor, her autonomy and consent should be sought. And, as a possible victim, in addition to the adequacy of informed consent, she should be protected from unfair situations. We have to acknowledge both aspects of the situation. We cannot reduce the research subject to a rational contractor. 

Adult male subjects age 23-65 in good general health participated in this study while living in the Metabolic Unit of the Center. They gave consent after being informed of the purpose of the research and its potential hazards. This project was approved by the Human Studies Committees of the University of North Dakota School of Medicine and of the USDA Science and Education Administration. Informed consent and experimental procedures were consistent with the Declaration of Helsinki. 

Finding Biomonitoring research presents a number of ethical issues about informed consent and the interpretation of results. For example, biomonitoring research is conducted with anonymized samples that limit the communication of results and potential followup with study subjects. 

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