Research Ethics

Alzheimer’s disease among the U.S. population: A national review. Gerontologist 49(suppl. 1): S3–S11. Available at: http://dx. doi.org/10.1093/geront/gnp088

protection for human research subjects. American Journal of Bioethics 4(3): 44–49. Available at: http://dx.doi.org/10.1080/ 15265160490497083

Blay, S. L.. and E. Toledo Piza Peluso. 2010. Public stigma: The community’s tolerance of Alzheimer disease. American Journal of Geriatric Psychiatry 18(2): 163–171. Available at: http://dx.doi. org/10.1097/JGP.0b013e3181bea900

Nelson, T. D. 2005. Ageism: Prejudice against our feared future self. Journal of Social Issues 61(2): 207–221. Available at: http://dx. doi.org/10.1111/j.1540-4560.2005.00402.x

Coleman, C. H. 2009. Vulnerability as a regulatory category in human subject research. Journal of Law Medicine and Ethics 37(1): 12–18. Available at: http://dx.doi.org/10.1111/j.1748720X.2009.00346.x Council for International Organizations of Medical Sciences (CIOMS). 2002. Available at: http://www.cioms.ch/publications/ layout_guide2002.pdf p. 64ff. Finder, S. 2004. Vulnerability in human subject research: Existential state, not category designation. American Journal of Bioethics 4(3): 68–70. Available at: http://dx.doi.org/10.1080/ 15265160490497344 Hooper, M., J. D. Grill, Y. Rodriguez-Agudelo, et al. 2013. The impact of the availability of prevention studies on the desire to undergo predictive testing in persons at risk for autosomal dominant Alzheimer’s disease. Contemporary Clinical Trials 36(1): 256– 262. Available at: http://dx.doi.org/10.1016/j.cct.2013.07.006

Organization for Economic Cooperation and Development. 2013. Available at: http://skills.oecd.org/informationbycountry/mex ico.html. Piver, L. C., P. Nubukpo, A. Faure, N. Dumoitier, P. Couratier, and J. P. Clement. 2013. Describing perceived stigma against Alzheimer’s disease in a general population in France: The STIGMA survey. International Journal of Geriatric Psychiatry 28(9): 933– 938. Available at: http://dx.doi.org/10.1002/gps.3903 U.S. Department of Health and Human Services. 2009. Final rule 45 CFR 46 Sections A,B,C, and D. Protection of human subjects. Revised January 15. Available at: http://www.hhs. gov/ohrp/humansubjects/guidance/45cfr46.html (accessed 7 January 2015). Werner, P., M. S. Mittelman, D. Goldstein, and J. Heinik. 2012. Family stigma and caregiver burden in Alzheimer’s disease. Gerontologist 52(1): 89–97. Available at: http://dx.doi.org/10.1093/ geront/gnr117

Levine, C., R. Faden, C. Grady, D. Hammerschmidt, L. Eckenwiler, and J. Sugarman. 2004. The limitation of “vulnerability” as a

Barriers and Facilitators to the Consent Process in a Study of Complex Genetic Factors Anne R. Simpson, University of New Mexico Alzheimer’s disease and other dementias have an enormous impact on patient, family, and the community. Studying and developing curative interventions will be of benefit to society as a whole. The proposed study in this case is focused on a specific variant of Alzheimer’s disease that is of significant relevance to the research subject cohort. Many principles, such as those presented in the World Medical Association (WMA) Declaration of Helsinki (WMA 2013), guide the ethical practice of research and the process of informing potential research subjects. In consideration of the diverse makeup of the cohort to be studied,

ensuring that each member of the cohort is informed is essential but might prove challenging, given the complexity of issues inherent in the study. The burden of ensuring the subject’s capacity for understanding and delivering a noncoerced agreement rests on the investigator. The focus of this commentary is on the key concepts those eligible for enrollment will need to understand, as well as some barriers and facilitators to understanding. The subjects approached to consider enrollment in the study described need to understand that they are being asked to enroll in a research study and not being offered medical treatment. According to the study protocol,

Address correspondence to Anne R. Simpson, MD, CMD, Associate Vice Chancellor for African American Health, Professor of Medicine & Geriatrics, Rust Professor of Ethics, Director, University of New Mexico School of Medicine Institute for Ethics, Exec. Director for UNMHSC Black Health Resource Center, MSC11 6095, One University of New Mexico, Albuquerque, NM 87131-0001, USA. E-mail: [email protected]

April, Volume 15, Number 4, 2015

ajob 89

The American Journal of Bioethics

“Subjects found to carry the mutated gene would be randomized such that two-thirds would receive active treatment and one-third would receive placebo for the duration of the study.” If the “active treatment” referenced is the drug under study, then it needs to be clearly articulated during the process of informed decision making to avoid therapeutic misconception. In addition, the drug under study has been approved only for use in research, it has never before been used in humans, and therefore side effects for humans are not known. Potential subjects should be told of side effects that were observed in animal studies. They also need to understand that the study drug is not an approved treatment, that the drug may be of no benefit to them, and that some of the subjects will not receive the study drug. Research has shown that a person’s level of education plays a role in how well a potential subject can answer questions about the study they are considering participating in (Shafiq and Malhotra 2011). Those with lower education levels are less able to answer questions correctly. For all subjects, there are key research concepts such as randomization and placebo that are hard to understand (Ndebele et al. 2014). While some suggest approaches to simplifying the language used in consent forms and attending to the format in which the information is presented, others suggest that the best way to help subjects understand is to provide potential research subjects the opportunity to discuss their decision to enroll with someone other than the principal investigator (Naanyu, Some, and Siika 2014). A study team member other than the principal investigator may be better able to convey complex concepts in ways the average subject can best understand. It has also been shown that low-income and minority women overwhelming prefer (97%) the opportunity to discuss the consent form with a member of the study team when compared to reading the form on their own (Jallo et al. 2013). And relatedly, it has been recommended that those tasked with reviewing the consent form with the potential subject be adequately trained, and preferably be a member of that cultural community (Ndebele et al. 2014). One way to assure that potential subjects understand the information conveyed is to administer a quiz of understanding (Shafiq and Malhotra 2011). This summary of recent findings has implications. Explaining concepts such as randomization, double-blind study design, and placebo to a group with diverse education, culture, and literacy will require time and one-on-one engagement to ensure understanding, but participant comprehension and competency are required. For true informed decision making, all has to be divulged to the participants using language and terminology they understand. Members of the research team who are bilingual and have a detailed understanding of the study should engage in an ongoing dialogue between participants

90 ajob

and investigator to attend to the participant’s knowledge and understanding throughout. Understanding the cultural values of the cohort members is important. For example, the eligible population or subpopulation of the group may subscribe to a notion of community consent. If so, it will be important to make sure that each individual understands what the group may or may not be consenting for and that as an individual the person continues to have a right to not participate even if the majority chooses to participate. How do participants understand the disease under study and how it relates to them as family and each as an individual? This may help to ascertain their understanding of the genetic relevance of the study; in addition, it offers an opportunity to gain insight into cultural beliefs that might be associated with the disease and ways to tread with respect. To ensure subject understanding, the investigator can use the Informed Consent Comprehension Questionnaire, have bilingual/bicultural team members hold group and individual meetings with subjects, and reiterate the subjects’ right to voluntary participation in the study. & REFERENCES Jallo N., D. E. Lyon, P. A. Kinser, D. L. Kelly, V. Menzies, and C. Jackson-Cook. 2013. Recruiting for epigenetic research: Facilitating the informed consent process. Nursing Research and Practice 2013: 935740. PMID:23840949. Available at: http://dx.doi.org/10.1155/ 2013/935740 Naanyu, V., F. F. Some, and A. M. Siika. 2014. “I understood . . . but some parts were confusing and hard to grasp”: Patients’ perception of informed consent forms and clinical trials in Eldoret, Kenya. Perspectives in Clinical Research 5(1): 20–24. Available at: http://dx.doi.org/10.4103/2229-3485.124563 Ndebele, P., D. Wassenaar, F. Masiye, and E. MunalulaNkandu. 2014. Trial participants’ understanding of randomization, double-blinding, and placebo use in low literacy populations: Findings from a study conducted within a microbicide trial in Malawi. Journal of Empirical Research on Human Research Ethics 9(3): 2–10. Available at: http://dx.doi.org/10.1177/ 1556264614540592 Shafiq, N., and S. Malhotra. 2011. Ethics in clinical research: Need for assessing comprehension of informed consent form. Contemporary Clinical Trials 32(2): 169–172. Available at: http://dx.doi.org/ 10.1016/j.cct.2010.12.002 World Medical Association. 2013. WMA Declaration of Helsinki—Ethical Principles for Medical Research Involving Human Subjects; 64th General Assembly, Fortaleza, Brazil, October 2013. Journal of the American Medical Association 310 (20): 2191–2194. Available at: http://www.wma.net/en/ 30publications/10policies/b3/index.html (accessed 7 January 2015). Available at: http://dx.doi.org/10.1001/ jama.2013.281053

April, Volume 15, Number 4, 2015

Copyright of American Journal of Bioethics is the property of Routledge and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.

Barriers and facilitators to the consent process in a study of complex genetic factors.

Barriers and facilitators to the consent process in a study of complex genetic factors. - PDF Download Free
49KB Sizes 2 Downloads 8 Views