LISBON, JUNE 13, 2019

Rose M Carter - Canada
Bennett Jones

Ethical and Legal Obligations in Stem Cell Research

Partner, Adjunct Professor, Faculty of Medicine and Dentistry, University of Alberta
Bennett Jones LLP

Stem cell research as with any other research involving human participation must be governed by medical ethics and the law. Protection of participant donors and recipients is paramount.  Researchers and institutions must gain and maintain the confidence of the scientific community and the public.  Historically, this standard has not always occurred resulting in harm to human subjects and serious damage to the reputations of researchers and institutions.

Prevention of such behaviour requires the adoption of strict protocols, openness, a rigid reporting structure, researcher accountability, peer review done by those inside and outside the institution, sharing of information in the scientific community, and review by arms-length regulatory bodies.  Prior to testing on human subjects, research must be verified to demonstrate it is safe for exposure to human subjects.  Informed consent must be obtained from human subjects who are fully informed of the purpose of the research, the hope for benefits either to the subjects or to the broader community and all risks have been disclosed.  Others must not be allowed to give consent on behalf of the human subject.  Ethically and legally, only the prospective
participant can provide an informed consent. 
Failure to act appropriately, aside from being unethical, exposes researchers and institutions to legal consequences and loss of reputation.

Stem cell research is an invasive technique whereby the process of approval requires similar checks and balances as for existing procedure standards such as blood drawn, biopsies, radiographic processes to name but a few examples.  Examples of results of unethical/illegal behaviour by researchers abound as a result of uninformed and/or pressured subjects which has led to physical/emotional harm to subjects.  Other instances have occurred whereby
researchers have benefitted financially from using tissue samples from subjects either without their knowledge or with the knowledge the tissue would be taken but not being advised of its intended use or possible financial benefit to the researcher and institution.  This behaviour has been harshly dealt with by the law.  To meet acceptable standards, the following must be in place, monitored and maintained:

· Strict institutional reporting structures (authorities must be aware of the type and extent of research);
· Standardized research in laboratories;
· Trained personnel who also understand ethical/legal responsibilities;
· Independent ethics committee with strict reporting requirements;
· External reviewers;
· Protocols following international standards;
· Documented informed consent from subjects including the understanding that the subject may leave the study at any point;
· Written agreements between researchers and their institution of the ramifications of failing to follow institutional research policies.

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