Ethical issues informed consent

Even if research ethics has ignored justice issues until recently, justice is an important aspect of any serious bioethical proposal. There are many challenges around it but because of the difficulties of the issues, this does not indicate that we should ignore them. Mere procedural mechanisms or reducing ethics to informed consent and... 

Several other chapters in this book address ethical issues, which are essential for the educational programs. Pharmacogenomic analyses will multiply the challenges of explaining available tests and gaining informed consent to perform each test. In some cases, patients or relatives will be asked... 

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). 

Ethical issues surrounding the design and conduct of genetic research with people, including the process of informed consent. 

This volume contains frank discussion of the ethical compass that guided our work, particularly with respect to informed consent. Some chapters describe, and occasionally take issue with comments appearing in both military and civilian publications, particularly between 1965 and 1982, when public concern about the Army s testing of drugs in human volunteers dramatically escalated. 

For discussions concerning informed consent and medical experimentation on prison populations, see Mark, Vernon H, Neville, Robert, (1977) Brain Surgery in Aggressive Epileptics Social and Ethical Implications. Ethical Issues in Modern Medicine, (eds, Robert Hunt John Arras). Veatch, Robert M, (1977). Case Studies In Medical Ethics, pp, 267-71 Bernier, Barbara L, (1994) Class, Race, And Poverty Medical Technologies And Socio-Political Choices. 11 Harv. BlackLetter J. 115,... 

Stabel S, Parker PJ Protein kinase C. Pharmacol Ther 51 71-95, 1991 Stagno SJ, Smith ML, Hassenbusch SJ Reconsidering psychosurgery issues of informed consent and physician responsibility. J Clin Ethics 5 217-223, 1994 Stahl SM Is serotonin receptor down regulation linked to the mechanism of action of antidepressant drugs Psychopharmacol Bull 30 39-43, 1994 Stahl SM Mixed anxiety and depression serotonin 1A receptors as a common pharmacological link. J Chn Psychiatry (in press)... 

A basic ethical issue in several areas of psychiatric research is whether participants are able to provide informed consent, particularly for protocols entailing medication washout and/or placebo treatment. The majority of psychiatric patients who are asked to participate in clinical trials have adequate capacity to provide consent. Thus, in a study specifically designed to examine the capacity of schizophrenic patients to give informed consent, cognitive dysfunction and negative symptoms (apathy and avolition). but not psychotic symptoms (hallucinations, delusions), were found to be associated with impaired decisional capacity (Moser et al., 2002). These features are probably not unique to schizophrenia but are likely to apply to many other forms of illness. 

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. 

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. 

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). 

As the pediatric subgroup represents a vulnerable population, studies in children are endowed with specific challenges such as additional ethical (e.g., informed consent be obtained from the legal guardian) or clinical-technical (e.g., minimize the amount of blood drawn and the number of venipunctures) issues. 

The issue of (informed) consent looms large in discussions of the ethics of research involving human subjects and is a principal concern of the Research Ethics Committees that are now the norm in medical research. 

Undeniably, genomics and pharmacogenomics opens up a whole host of legal, ethical, and societal issues that will have implications in patient confidentiality, discrimination, malpractice, and informed consent (135-137). However, as clinicians, scientists, and health care practitioners, we must always remember the unquestionable power of an individual s right to choose, and prospectively fight to ensure patients rights and prevent genomic discrimination. 

The Durham Humphrey Amendment (1951) defined the kinds of drugs that required medical supervision for safe use and restricted them to sale by prescription. Two years later, in 1953, the US Public Health Service issued a policy document entitled Group Consideration of Clinical Research Procedures Deviating from Accepted Medical Practice or Involving Unusual Hazard. This policy stated that the potential risks of clinical studies must be carefully assessed and that informed consent was essential. Ethical review of research proposals was also suggested. In this same year, the Factory Inspection Amendment was passed, requiring the FDA to give written inspection reports to manufacturers. 

Children and prisoners are considered to be vulnerable populations because of issues of potential ethical issues related to informed consent and coercion. Participation in clinical trials is permitted for vulnerable populations, but only if the risks of the trial are minimal. Finally, cancer patients in general can be considered vulnerable because many subjects are terminally ill by the time they enroll in clinical trials [23]. It is important to be aware of the potential ethical issues and similar to other vulnerable populations, minimize the risks and ensure proper informed consent. 

The sharing of patient data between health care professionals, departments, and other information systems could affect the confidentiality of a patient s data or it could compromise the integrity and timeliness of the treatment of the data (Whitehouse and Duquenoy, 2011). These threats are extremely difficult to address technologically and enforce internationally (Duquenoy and Whitehouse, 2010). Patient confidentiality must be preserved and the users informed consent must be given to use these data. Given that a user may have little knowledge and lack of control of the information system handling the data, we need to ask to what extent and in what way, the particular user is informed of the system (Duquenoy and Whitehouse, 2010). Another potential ethical impact on users is compatibility—if the user is tied in to one particular system platform and its applications, this raises issues of affordability and opportunity for equal access. Reliability is another concern, particularly where systems are life critical. Users need to be made aware of how reliable the systems are. 

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