Community consent

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. 

Communication with the potential volunteers prior to the study is essential. Prior to the initiation of the field phase of the study, a meeting should be held with the potential volunteers to explain the details of the procedures of the study, present the consent form, and inform the potential volunteers of the risks and benefits (including any monetary compensation to the worker) of participating in the study. At this meeting, consent in writing should be obtained from the worker. If there is any language barrier between the researcher and the potential volunteers, an interpreter should be present at the meeting. 

Council, 1998 Juengst, 1998a, 1998b Reilly, 1998 Reilly and Page, 1998) and few supporters (Freeman, 1998). It has, however, spawned substantial discussion of an intermediate position, sometimes called "community consultation," which would require researchers to discuss their proposed research broadly with the affected group, although not to seek or obtain their formal consent (Foster et al., 1999 Foster and Sharp, 2000 Foster et al., 1998). 

Besides the intake interview, which can help gather information, there are a number of assessment measures for determining the quality of an important interpersonal relationship. The questions on these measures generally ask about things like communication styles, satisfaction in the relationship, joint decision making, and in some cases, abusive behavior. Two of the most well-known measures are the Dyadic Adjustment Scale (Spanier, 1976) and the Marital Satisfaction Inventory (Snyder, 1979). Therapists and counselors also may choose to interview couples together (with the consent of client and partner), and some therapists may recommend couples therapy (see Chapter 5) as part of the overall approach to treatment if deemed appropriate to help the client. Relationship assessments can yield important information that may be useful when working with couples. 

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 IG report criticizes this consent form for not guaranteeing adequate discussion of the nature and hazards of the experiment. This was particularly true for the early volunteer records. Establishment of trust, however, was always a priority. No one can predict all the symptoms or mishaps that might conceivably occur. Ultimately, the volunteer s confidence in the physician s integrity and concern for his well-being is paramount. The concept of informed consenf remains as slippery today as it was in the sixties. Honest communication remains more important than fine print in a contract. 

Rosenthal JP, Politics, cultute, governance in the development of prior informed consent in indigenous communities, Curr Anthropol4S7. 3— A2, 2006. 

Members of this team jointly meet with the EPA to facilitate these goals. This working group has been a success in improving communications with all parties to implement the consent decrees and meet the stated objectives. 

A variety of features may be included in protocols to improve the process of obtaining informed consent. These include repeated exposure to the information in the protocol multiple avenues of communication (verbal, written, etc.) language use that is simple, in small units, and comprehensible use of patient educators who can review relevant information with the potential subject, explain the study s purpose and process, and answer any questions and attention to personal aspects of consent, including motivation, cultural and developmental issues, expectations, and investigator-participant relationship issues (Applebaum and Grisso, 1988 1995 Sutherland, et al. 1994 Bonnie, 1997 Roberts, 1998a,b). 

Ability to Communicate. The mental status exam is critical to the determination of a patient s capacity to consent, and the ability to communicate is an absolute prerequisite (see the section Diagnostic Assessment in Chapter 1). Psychomotor impairments such as mutism or catatonia (withdrawn type) would severely affect an individual s fundamental ability to communicate any appreciation of the issues involved and their ramifications. Although an individual may actually be well oriented and may intellectually appreciate and even later remember events that occurred and the issues involved, that person is not capable of consenting if unable to demonstrate these faculties. 

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. 

Communication and ethical challenges Personal and complex biomonitoring data require careful planning, informed consent, information sharing, and evaluation to continue to move science of biomonitoring forward... 

The third research recommendation is to conduct empirical research on the mental models of the general population about biomonitoring, as also recommended in Chapter 6 for the purpose of communication results, interpretations, and uses. One ethical reason for this research would be to understand the population s concerns about participating in biomonitoring studies, since participation rates in some countries have been depressed to the extent that the apparent need for incentives could compromise ethics if incentives are too high. Research on biomonitoring concerns can address these issues, as well as help ensure that better informed consent will be obtained from biomonitoring study participants. 

Because of the challenges posed by informed consent for studies that use high-output, high-throughput technologies, the committee recommends research that develops, evaluates, and disseminates methods that ethically and practically inform study subjects during recruitment and during later communication of study results. 

An essential element of any medical program is informed patient consent prior to the performance of any test or procedure. Although informed consent is not specifically mentioned in the ACOEM components of occupational and environmental health programs, it is inherent in the ethical practice of medicine. The ACOEM Code of Ethical Conduct (adopted October 25,1993) states that physicians should relate honestly and ethically in all professional relationships. Also, the Association of Occupational and Environmental Clinics has issued guidance relative to patient consent, confidentiality of medical records, and communication of the results of tests and procedures (AOEC, 1987). 

Investigator s qualifications and agreements Communication with IRB/IEC Compliance with protocol Randomization procedures and unblinding Informed consent of trial sutbjects Safety reporting... 

Disclosure of Information to Foreign Regulators—Final Rule, Federal Register, March 7,2000. Public Information Communications with State and Foreign Government Officials. The rule states that the FDA may disclose confidential commercial information to international organizations only with the consent of the person who submitted the information to the FDA. 

Having classihed the IMBP based on its effects on immune function, the next and hnal step would be to make a risk assessment and to communicate the risk to physicians and to the patients receiving therapeutic doses of the IMBP. This can be accomplished through the existing mechanisms of the Investigator s Brochure, Informed Consent documents, and ultimately, the product label. 

---