Objective 3.3 Discuss ethical considerations in research into genetic influences on behavior?

Ethical considerations Things to consider…. Advances in human genetic research hit the headlines every day in our world. The Human Genome Project, cloning people, “gay” genes, genes for alcoholism and cancer are all daily fare for the media. We live in a “genetics world”. It is critical that genetic research is carefully guided by strict and specific ethical guidelines.

Ethical considerations The review of genetic research is becoming an increasingly important aspect of the work of human research ethics committees. An important thing to remember when considering genetic research is that genes themselves do not cause disease, but alterations to the usual gene sequence may lead to disease. Why is this important to consider when dealing with genetic behavioral research?

Things to consider….. It would be over-simplistic to assume that all disease is due purely to our genetic make-up. Some scientists, and the media, can polarize towards ‘genetic determinism’, assuming that a person is merely the sum of his or her genes. However, a person’s current and future health is the interaction of many factors, including environment and lifestyle, genes and interaction between the two. Thus, one cannot approach genetic research with the assumption that genes are 100% of any problem.

Ethical considerations Consent and recruitment of research subjects Confidentiality, privacy and security The potential benefits and harms of human research involving genetic testing The interface between research and clinical practice The future use of samples Vulnerable groups Note: This list is not compulsory and thus it should be noted that several other considerations exist.

Consent and recruitment of research subjects Researchers should always pay particular attention to ensuring that potential research subjects are adequately informed in an accessible and understandable way about the goals of the study, what their participation entails, and possible harms and benefits of participation. This should be the case in all research at any level of analysis. In a genetic study specifically, they should also know how their privacy and confidentiality will be protected, and what will happen to any genetic material or information obtained as part of the study. People have a right to know whether their access to insurance or employment could be compromised in any way by genetic data that are generated.

Consent and recruitment of research subjects Recruitment and enrollment of both affected and unaffected family members might in some cases pose a threat to the usual relationship between a clinician and patient. An example of this might be where a patient comes to suspect, rightly or wrongly, that a clinician is more concerned with a successful research outcome than with the patient’s care.

Recruitment of family members Most genetic research involves patients and family members. Thus, special consideration must be made for family members of patients. In a genetic study, researchers should pay particular attention to the method by which family members are to be approached and by whom a family member will be contacted. It is generally accepted by genetics researchers and clinicians that it is best for potential research subjects to be contacted by someone they know and are likely to trust. In many cases this will be a family member.

Recruitment of family members Sometimes this may make potential participants vulnerable to pressure to participate from other family members, and conversely, if there are family disputes it may be less likely that members will be recruited for valuable research. These considerations sometimes suggest that it may be better for research subjects to be recruited by health professionals or suitably qualified researchers. Whatever approach is adopted, it is important to confirm that researchers have considered possible difficulties and have thought about the issues. Subjects should be recruited as individuals in their own right rather than as a family group, and should consent as individuals.

Confidentiality, privacy and security Given the familial nature of genetic research, confidentiality, privacy and security are important considerations in ethical review of a genetic study. The seriousness of the consequences varies both between conditions and individuals. Genetics research can sometimes, either directly or by implication, reveal private information to one individual about other members of their family.

Confidentiality, privacy and security It might reveal information about health status either through discussion of the result of a genetic test or in the process of collecting information for the construction of a family pedigree. A research subject may read or deduce information provided by other family members. Such information may be disclosed by accident through questions asked by a researcher about the family history.

Confidentiality, privacy and security Accidental disclosure of such information can have consequences for the broader family and for one person’s relationships with other family members. It may be revealed later by one family member to another during a family conflict, or may itself become the subject of a dispute. Care should be taken to ensure that safeguards are in place to avoid this outcome.

The potential benefits and harms of human research involving genetic testing As in the review of all medical research, committees have to assess the potential benefits and harms of the project under consideration. Genetic research will, in all probability, bring great benefits to human health. One benefit that some genetic studies offer is information about susceptibility to disease, and precautions that can be taken to prevent disease. Another important benefit can be knowledge about risk of having a child with a genetic condition and strategies one can employ to avoid having a child with a genetic condition (adoption, prenatal testing or pre-implantation genetic diagnosis).

The potential benefits and harms of human research involving genetic testing Possible psychosocial harms might include fear of discrimination or stigmatization. Research subjects may also become anxious about the implications of test results for insurance, for their future relationships or for future reproductive choice. In other cases, such as genetic research in psychiatry, research subjects may come to feel that their involvement will lead to social stigmatization or family rejection. Even where the likelihood of such harms might appear to be minimal, consideration may need to be given to the need for advice and counseling to research participants. Many genetic studies should consider making the services of a genetic counselor available to participants who request this

The potential benefits and harms of human research involving genetic testing In addition to these psychosocial harms, participation in a study may leave subjects and their relatives open to stigmatization in a variety of ways. Discrimination may occur within the family itself, with affected family members rejected by other family members. In some cases genetic information will have the potential to affect a person’s future relationships, or their perceived suitability for marriage. What examples can you think of where this would happen?

The potential benefits and harms of human research involving genetic testing Genetic research can reveal unexpected information, that may be a source of harm to research subjects, particularly if this possibility is not discussed when obtaining consent. Examples include misattributed paternity or ‘secret’ adoptions within a family. Another example occurs when a family member offers to participate in a study believing s/he is unaffected, and discovers from the study that he or she carries the altered gene but has no signs of the disorder. A+ Info on IEC Manual http://www.uq.edu.au/oppe/PDFS/IEC_Manual.pdf

Ethical considerations of the Human Genome Project The Human Genome Project was completed in 2003. One of the key research areas was ethical, legal, and social issues research (ELSI). The U.S. Department of Energy (DOE) and the National Institutes of Health (NIH) devoted 3% to 5% of their annual Human Genome Project (HGP) budgets toward studying the ethical, legal, and social issues (ELSI) surrounding availability of genetic information. This represents the world's largest bioethics program, which has become a model for ELSI programs around the world.

Ethical considerations of the Human Genome Project The ethical issues raised by the human genome project can be grouped into two general categories: genetic engineering and genetic information. The first category consists of issues pertaining to genetic manipulation or what is sometimes called “genetic engineering.” The map of the human genome provides information that will allow us to diagnose and eventually treat many diseases. This map will also enable us to determine the genetic basis of numerous physical and psychological traits, which raises the possibility of altering those traits through genetic intervention.

Ethical considerations of the Human Genome Project Reflection on the ethical permissibility of genetic manipulation is typically structured around two relevant distinctions: The distinction between somatic cell and germ line intervention, and The distinction between therapeutic and enhancement engineering

Ethical considerations of the Human Genome Project Somatic cell manipulation alters body cells, which means that resulting changes are limited to an individual. In contrast, germ line manipulation alters reproductive cells, which means that changes are passed on to future generations. What ethical issues can rise from germ line manipulation?

Ethical considerations of the Human Genome Project Therapeutic engineering occurs when genetic interventions are used to rectify diseases or deficiencies. In contrast, enhancement engineering attempts extend traits or capacities beyond their normal levels. What ethical issues can rise from genetic engineering?

Ethical considerations of the Human Genome Project Germline interventions involve more significant ethical concerns, because risks will extend across generations, magnifying the impact of unforeseen consequences. While these greater risks call for added caution, most ethicists would not object to the use of germline interventions for the treatment of serious disease if we reach the point where such interventions could be performed safely and effectively.

Ethical considerations of the Human Genome Project Indeed, germline interventions would be a more efficient method for treating disease, since a single intervention would render both the patient and his or her offspring disease-free, thus removing the need for repeated somatic cell treatments across future generations. Enhancement engineering is widely regarded as both scientifically and ethically problematic. From a scientific standpoint, it is unlikely that we will soon be able to enhance normally functioning genes without risking grave side effects. Would the benefit of enhancement engineering to genes outweigh the cost? Why or why not?

Ethical considerations of the Human Genome Project Enhancing an individual’s height beyond his or her naturally ordained level may inadvertently cause stress to other parts of the organism, such as the heart. Moreover, many of the traits that might be targeted for enhancement (e.g., intelligence or memory) are genetically multifactorial, and have a strong environmental component. Thus, alteration of single genes would not likely achieve the desired outcome. These problems are magnified, and additional problems arise, when we move from somatic cell enhancements to germline enhancements.

Ethical considerations of the Human Genome Project In addition to the problem of disseminating unforeseen consequences across generations, we are faced with questions about whether future generations would share their predecessors’ views about the desirability of the traits that have been bequeathed to them. Future generations are not likely to be ungrateful if we deprive them of genes associated with horrible diseases, but they may well feel limited by choices we have made regarding their physical, cognitive, or emotional traits. In short, there is a danger that social-historical trends and biases could place genetic limitations on future generations. Do you agree or disagree with this assertion? A+ info on HGP ethical considerations http://www.actionbioscience.org/genomic/carroll_ciaffa.html