Research subjects, informed

Research subjects compensating, 73-74 protecting, 77-78 returning relevant information to, 72-73... 

The right of research subjects to safeguard their integrity must always be respected. Every precaution should be taken to respect the privacy of the subject, the confidentiality of the patient s information and to minimize the impact of the study on the subject s physical and mental integrity and on the personality of the subject. 

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 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. 

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. 

As Atkisson, and colleagues have pointed out (1996), research subjects are best seen as active collaborators in the research process. The relationship between investigator and research participant is most respectful when it is structured as a collaborative partnership. This stance requires that participants be fully informed about the risks and benefits of the study, that they understand that the partnership is voluntary, and that they can discontinue participation at any time. 

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. 

Factors may have associated values called levels of variations. Each state of a black box has a definite combination of factor levels. The more different states of the black box that exist, the more complex is the research subject. Formalization of preliminary information includes analysis of reference data, expert opinions and use of direct data, which enables correct selection of response, factors and null point or center of experiment. Factor limitations are also defined at this stage. If the research is linked with several following responses, then response limitations also have to be analyzed. The next phase refers to defining the research problem. When defining this problem one must keep in mind the research-subject model, and in a general case it is Eq. (2.1) that defines the link between the inlet and outlet of the black box. Defining the research problem is possible only now when its aim has been determined, the criteria established, the factors, limitations and null point defined. The problem is a simple one when only one response or optimization criterion is in... 

The construction of the general response is linked to defining one quantitative response to a research subject with several partial responses, each of which has its own physical interpretation and dimension. To form from such different partial responses a unique response, it is necessary to transform all partial responses into non dimensional values by a unique scale. It is therefore necessary when defining a general response first to choose the scale for doing the transformation. The scale must be unique for all partial responses to be transformed. The choice of the scale depends on preliminary information about partial responses and on the required precision of the general response. 

Factor space may be obtained from the matrix of random balance and analysis of variance. Information on number of replications of design points-trials in the basic experiment is obtained from analysis of variance, and some proofs about linear or nonlinear relationships between variables of the research subject from correlation analysis. 

To obtain information on the analyzed research subject, a basic FUFE, as demonstrated in Example 2.41 Table 2.135, has been set up. By processing experimental results, this linear model has been obtained ... 

Clinical protocols and investigator information—detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. Also, information on the qualifications of clinical investigators—professionals (generally physicians) who oversee the administration of the experimental compound—to assess whether they are qualified to fulfill their clinical trial duties finally, commitments to obtain informed consent from the research subjects, to obtain review of the study by an IRB, and to adhere to the IND regulations. 

See, for example, 21 C.F.R. 20.63(a), The names or other information which would identify patients or research subjects in any medical or similar report, test, study or other research project shall be deleted before the record is made available for public disclosure. ... 

From the scientific perspective, an inappropriate study design is generally incapable of answering a research question, no matter how careful the subsequent methodology and analysis. Additionally, the perfect design will not provide optimum information if the research methodology is flawed or an inappropriate statistical analysis is conducted. From the ethical perspective, research subjects voluntarily take part in clinical trials with the understanding that their participation... 

Informed consent is governed by both federal and state law [14],These laws generally require that before participating in clinical trials, human research subjects state in writing that they understand the risks of the trial and are participating voluntarily. Each informed consent document must contain several elements required by FDA regulations [15]. 

---