Research participants

Department of Chemistry, University of Vermont, Burlington, Vermont. Supported by the National Science Foundation Undergraduate Research Participation Grant during the summer of 1964 and National Science Foundation Grant No. G-19490. 

Soldano, J. E., Report of ANL Student Research Participation Program, Fall, 1981. 

In an older and simpler model of research, samples are given by research participants to individual scientists, for use for a single purpose, by that scientist s own laboratory. This model was never entirely accurate. Among... 

In an industry where there is virtually full employment, it is difficult to find framed CRCs and CRAs. So, conflicts can arise from inferacfion befween unfrained or inexperienced personnel. Sometimes, however, personality conflicts are the main culprit. Although technology can eliminate some of the need for CRA-CRC inferacfion, all parties need to understand the roles and pressures on the other person. For example, many CRAs travel 4 days a week and see various levels of work qualify af differenf sifes. On the other hand, CRCs are often responsible for more fhan one sfudy and have requests from multiple CRAs on any given day. In addition, the CRA must respond to the needs of the research participant first, which can cause time delays in completing data queries. 

The principle of justice refers to the fairness or equity involved in the selection of research participants. The point is to ensure that risks or benefits incurred by research participants are not unfairly concentrated in one segment of fhe population. 

To ensure that the rights and welfare of human research participants are protected, the IRB takes on the task of performing a risk vs. benefit analysis. Before a clinical trial can be initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the trial participant and for society (Section 22.2). Risks associated with participation in research should be justified by the anticipated benefits only then, can the trial be initiated. Because this requirement is clearly stated in the federal regulations, it is, therefore, one of the major responsibilities of fhe IRB to assess fhe risks and benefits associated with proposed research. Definitions of fhe terms fhaf fhe IRB uses to assess risk include the following ... 

Risks to which research participants may be exposed have been grouped as physical, psychological, social, and economic harms. The description of each classification is as follows ... 

One of the most important pieces of a research trial is the informed consent of the research participant. However, a signature on an informed consent document does not constitute the end of the informed consent. It is very important, for the research community (the sponsor, the investigator, and the IRB), to remember that informed consent is not just a document, but is, instead, a continuing process that carries through to the end of the individual s participation in the trial. 

The governing rules and regulations require cerfain elemenfs (information) be included wifhin every informed consenf form fhaf is provided to a potential research participant. These required elements are outlined in Table 22.2. 

The anticipated prorated payment, if any, to the participant for participating in the trial A statement of dosage/frequency and the probability for random assignment to each treatment An explanation of whom to contact for answers to pertinent questions about the research and research participants rights and whom to contact in the event of a research-related injury to the participant A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled A place for signatures by the participant, physician, person obtaining consent, and witness (less signatures may be required) it depends on the policies and procedures of the particular IRB... 

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. 

Research participants are the true pioneers of medicine. Through their participation, novel therapeutic cures and treatments have been made possible. Furthermore, their participation also protects the public from approval of drugs that have a poor benefit-to-risk relationship. Thus, data obtained via research volunteers may be used to provide medical advances or to protect against insidious drugs entering the marketplace. 

Today, an ethical review is an essential part of the biomedical research process. lECs provide ethical guidance on research protocols and ensure the protection of research participants. In the United States, similar bodies called institutional review boards (IRBs) have a similar role to that undertaken by lECs in the rest of the world. 

The weighing of risks and benefits in research on pediatric psychopharmacology can be among the most complex to address. The primary premise is that risks and benefits should be viewed from the standpoint of the research participant, not that of the investigator or institution. No risk is considered acceptable if the research does not have the potential to benefit the participant or if it will not strengthen knowledge about the condition or treatment for that condition. The sci-... 

Because children s legal status is limited and because they cannot legally consent to research participation, children are often considered to be a vulnerable population. In addition, children with psychiatric disorders may have (but do not necessarily have) limitations with respect to understanding the conditions under which their participation is being solicited. Therefore, special efforts must be made to ensure that children s assent to participate is voluntary and that they understand fully the risks and benefits of participation. It is often prudent to ask whether a particular study s aims could be directed toward a less vulnerable population first. A clear rationale should be provided for targeting children with psychiatric disorders, as opposed to children or adolescents without these conditions, as the population of interest for a particular study. 

Incentives offered for research participation need to be considered with respect to two issues respect for participant s time and compensation for such and lack of coercion (Macklin, 1986 Roberts, 1998b). 

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. 

This role of the research participant as being actively engaged in the study, as a collaborator, contrasts with the passive stance that has typically described much medical research in the past. The role of research participant as a collaborator is an ideal that is never fully realized in any study—there are numerous obstacles to it (Atkisson et ah, 1996). 

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