1. Informed Choices in Biobanking: An Examination of Participants' Understanding and Congruence between Knowledge, Values, and Decisions
- Author
-
Eisenhauer, Elizabeth
- Subjects
- Biobanking, Biological specimen banks, Informed consent, Understanding, Newborns' residual dried blood spots, Moral risk
- Abstract
The ethical foundation of clinical research is informed consent. Biobanking has added to the complexity of the informed consent process. Biomedical research with human biospecimens often occurs without any consent or with inadequately understood consent information. Yet, the use of biospecimens in research is not without controversy. One abundant source of biospecimens for research is residual dried blood spots (rDBS) from newborn screenings. Approximately 4 million infants are born annually in the United States (U.S.) and most have mandatory newborn screening. In 2010, the state of Michigan implemented a process of written parental consent for donating newborns’ residual dried blood spots to the Michigan BioTrust for research. Thus, biobanking of newborn rDBS in Michigan presented a prime opportunity to study mothers’ level of knowledge, attitudes, values, and decision-making after a broad consent process for donating their newborn’s rDBS for research. Therefore, the purposes of this dissertation research are to a) describe the current state of the science regarding participants’ understanding of informed consent for biobanking; b) describe the influence of mothers’ knowledge (understanding of biobanking), values (personal and religious), and perceptions of the informed consent process (content and context) on their decisions to donate their newborn’s rDBS for research purposes; c) compare and contrast mothers’ knowledge of and attitudes towards biobanking, socio-demographics, and personal and religious values with their decisions (yes or no) to donate their newborn’s rDBs for research purposes and determine the proportion of informed choices. A qualitative descriptive design, a non-experimental survey, and methodological triangulation are used in this three-paper style dissertation. The first of the three papers (Chapter 2) is a systematic review to evaluate participants’ level of understanding of the information presented during the consent process for donation of biological specimens for research purposes (i.e., for biobanking or genetic epidemiological studies). Results indicated many elements of informed consent unique to biobanking were inadequately understood by potential participants. Next, semi-structured interviews (Chapter 3) were used to describe mothers’ understanding of biobanking, attitudes about rDBS research, and the influence of personal values on the decision-making process. Findings indicated that while most mothers agreed (14/20; 70%) to donate the rDBS and expressed favorable attitudes about research, most decisions (16/20; 80%) were determined to be uniformed choices due to inadequate knowledge of the Michigan BioTrust and biobanking. A non-experimental, descriptive and correlational survey was randomly distributed to 500 mothers in the state of Michigan with a newborn age 0-3 months (Chapter 4) to examine knowledge, attitudes and values, and the proportion of informed choices in a larger sample using standardized instruments. Just over half of the mothers (55%) in this study were deemed to have made an informed choice; however, knowledge scores were still low. On average, respondents were only able to correctly answer approximately 8/16 biobanking questions. With 4 million American newborns having blood spots each year there are significant policy implications to this research (Chapter 5). Three recommendations are put forth: include the ethical implications of biobanking in educational materials, enhance consenters’ knowledge about rDBS research and their communication skills for conducting informed consent processes, and move the educational content about rDBS research to the prenatal setting (Chapter 5).
- Published
- 2018