Rights in Published Reports of Genetic Studies
5.8.3 Rights in Published Reports of Genetic Studies
The rules for ethical approval of studies and for obtaining informed consent also apply to genetic studies of family pedigrees and population-based samples. However, obtaining written informed consent from all members of a large pedigree (many of whom may be deceased or unaware of the collection of family data) may be difficult or impossible. Proposals for obtaining some form of group consent and for avoiding the publication of information about identifiable family members who will not give their permission have been considered. All such studies must be reviewed by an independent ethics review committee or IRB, and if the individual members of the family or population-based sample are considered to be “human subjects” and identifiable, informed consent may be required; otherwise a waiver may be granted.39,40 (See also 5.8.1, Ethical Review of Studies and Informed Consent.) The “Methods” section of all reports of genetic studies should include statements about ethics committee/IRB review and approval or waiver and information about informed consent procedures or waivers.
As with reports of other types of studies, nonessential identifying information should be removed from reports of genetic studies. However, data should not be altered in an attempt to protect the identities of individuals or family members, although relevant information may be masked. For example, in pedigree charts, diamonds or another sex-neutral symbol can be used instead of squares and circles if the sex of family members is not essential to the report (eg, if the disease is known not to be sex-linked), or sections of pedigrees may be excluded from pedigree charts or not described in detail if appropriate consent could not be obtained as long as such omissions are noted. (See also “Pedigree” in 4.2.2, Visual Presentation of Data, Figures, Diagrams, and 15.6.6, Nomenclature, Genetics, Pedigrees.)