Informed Consent and Other Ethical Issues in Human Population Genetics

Greely, Henry T.

doi:10.1146/annurev.genet.35.102401.091453

Cited by 53 publications

(24 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In the Indian context, any attempt to define a 'community' or a 'group' is problematic, since there are many population categories that overlap in their cultural, social, political, economic and other characteristics. On top of that, it is very difficult to recognise a 'culturally' or 'politically' appropriate authority 25 having the right to speak for all members of a specified community or group under study.…”

Section: ' 22mentioning

confidence: 99%

Informed consent in genetic research and biobanking in India: some common impediments

Patra

Sleeboom-Faulkner²

2009

Life Sci Soc Policy

View full text Add to dashboard Cite

The principle of informed consent, codified in the Declaration of Helsinki, has been widely seen as fundamental to bio-medical and research ethics. The importance of informed consent is increasing in procedures regulating the acquisition, possession and use of personal information, including genetic and medical information. Informed consent, it is believed, ensures that patients and research subjects can decide autonomously whether to permit or refuse actions that affect them. In response to this assurance, there are numerous guidelines at local, national and international levels that recognise the importance of informed consent, especially in research related to healthcare in developing countries. However, complications arise in applying these guidelines to a particular situation, especially under conditions that are prevalent in developing societies, for instance in India. This article discusses common forms of impediments or hindrances encountered while exercising the principles of informed consent in the context of genetic and genomics related research among the tribal and rural caste communities in India. These hindrances include: illiteracy, poverty, paternalistic attitudes, socio-cultural barriers, ineffective regulatory mechanism and procedural inconsistency among others. The data used in this article is based on an ethnographic study conducted between December 2006 and May 2007 using socialscience qualitative research techniques. We observe that three areas require attention: first, the ways in which informed public debate on bioethical issues can be held, and how the application of genetics and genomics in Indian society can be discussed; second, the readiness with which researchers, IRB members and the state appreciate and wish to map the genetic diversity in Indian society; and, third, the risks associated with the application of bioethical principles at a micro-level.

show abstract

Section: ' 22mentioning

confidence: 99%

Informed consent in genetic research and biobanking in India: some common impediments

Patra

Sleeboom-Faulkner²

2009

Life Sci Soc Policy

View full text Add to dashboard Cite

show abstract

“…Or community consent or group consent (if genetic material is shared, should it be groups or families consenting?) (Greely, 2001;Weldon, 2004;Whong-Barr, 2004)?…”

Section: Informed Consent As An Organizationally Useful Battlegroundmentioning

confidence: 99%

The Ethics of Research Biobanking: A Critical Review of the Literature

Hoeyer

2008

Biotechnology and Genetic Engineering Reviews

104

View full text Add to dashboard Cite

Human tissue has been stored and used for research on a regular basis for more than 80 years. During the 1990s, collections of human tissue suddenly became framed as ethical problems in a process reflecting developments in genetic research intertwined with developments in patient rights and steps towards increased commercialization of research. This review describes the process of framing tissue storage as an ethical problem and the solutions proposed in the process. It gives an overview of the academic debate and relates this debate to empirical studies of donor attitudes and interests. It points to the clear discrepancy between the concerns of donors, legislators and ethicists. The academic debate and legislatory action tend to focus on informed consent, and most of the concerns that donors have remain unattended to.

show abstract

“…41 This requirement has been recognized by the Tri-Council of Canada 42 and by the Human Genome Diversity Project, 43 which supports the principle that population consent, as well as individual consent, should be sought for genetic research. Researchers should obtain the informed consent of the population, through its culturally appropriate authorities, before they begin sampling.…”

Section: Issuesmentioning

confidence: 99%

“…41,59 Simultaneously, while some policies aim to encourage the commercial exploitation of publicly funded research, there is also a recognition that this must be matched by a suitable social return, either in the form of technology transfer, local training, joint ventures, provision of health care or information infrastructures, reimbursement of costs, or the possible use of a percentage of royalties for humanitarian purposes. 13,25,60 As we noted it, some consider that research teams, whether they be situated in academe or industry, should disclose that they may someday benefit economically from the research and that the subjects will not.…”

Section: Ownership Of Banked Samplesmentioning

confidence: 99%

Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A professional perspective

Godard

Schmidtke

Cassiman³

et al. 2003

Eur J Hum Genet

148

107

View full text Add to dashboard Cite

The purpose of this paper is to formulate a professional and scientific view on the social, ethical, and legal issues that impact on data storage and DNA banking practices for biomedical research in Europe. Many aspects have been considered, such as the requirements for data storage and DNA banking in the public and private sectors in Europe and the issues relating to DNA banking, that is to say the consent requirements for the banking and further uses of DNA samples, their control and ownership, and the return of benefit derived from DNA exploitation to the community. The methods comprise primarily the review of the existing professional guidelines, legal frameworks and other documents related to the data storage and DNA banking practices in public and private sectors in Europe. Then, the issues related to DNA banking were examined during an international workshop organized by the European Society of Human Genetics Public and Professional Policy Committee in Paris, France, 07 -08, April, 2000. A total of 50 experts from 12 European countries attended this workshop. It came out that DNA banking for medical and research purposes is indispensable. It facilitates the constitution of large collections, sharing of samples, multiple testing on the same samples, and repeating testing over the years. However, banking organization is complex, requires multiple actors, and concerns are expressed in various countries. International standardization of ethical requirements and policies with regard to DNA banking has been recommended. Such standardization would facilitate a greater protection of individuals as well as future international cooperation in biomedical research.

show abstract

Informed Consent and Other Ethical Issues in Human Population Genetics

Cited by 53 publications

References 15 publications

Informed consent in genetic research and biobanking in India: some common impediments

Informed consent in genetic research and biobanking in India: some common impediments

The Ethics of Research Biobanking: A Critical Review of the Literature

Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A professional perspective

Contact Info

Product

Resources

About