The core bibliography covering research published through December 1997 was compiled by Jeremy Sugarman, Douglas C. McCrory, Donald Powell, Alex Krasny, Betsy Adams, Eric Ball, and Cynthia Cassell, and published as a Special Supplement to the January-February 1999 issue of the Hastings Center Report. An addendum covering publications through 2001 was compiled by Marguerite Strobel, under the direction of the Hastings Center.

Compiling the bibliography

Sugarman and colleagues developed eight content categories to identify appropriate research questions addressed in the articles, drawing on theoretical work on informed consent as well as the types of empirical studies that might be available – those categories form the core keywords noted below.

To compile the original bibliography, Sugarman et al. identified appropriate electronic bibliographic databases using the Gale Directory of Databases (1995) and with guidance from experts in information retrieval. Nine databases were selected and searched from their inception through December 1997:bioethicsline (inaugurated in 1973);cancerlit (1983); EthicsIndex (1994, 1996 update); Healthstar (1975), LegalTrac (1980), medline (1966), pais International (1972), Psychinfo (1967), and Sociofile (1974).

Search strategies were designed using the thesauruses of each database. In addition, articles were identified by reviewing the text and reference sections of articles that met initial inclusion criteria, that is, reported primary data or provided systematic review of articles reporting primary data, dealt with one or more aspects of informed consent, and reported studies conducted with adults. Finally, all articles identified in a previous systematic review of the literature on research with older persons were incorporated.

To determine each article’s relevance for the bibliography, Sugarman and colleagues initially assessed title and, when available, abstract. Where titles and abstracts did not give sufficient information to evaluate articles against inclusion criteria the articles were reviewed in their entirety. Those that met inclusion criteria were retained. To avoid over-representing data from a single study, if multiple articles reported on the same study using similar analytic approaches, the article that provided the most information for purposes of annotation was retained and the other(s) removed from the data set.

The addendum was developed as an outgrowth of a State of the Art (SOTA) conference on informed consent, held in March 2001 and sponsored by the Department of Veterans Affairs Office of Research and Development. The addendum is limited to articles relevant to the goals of the SOTA conference itself, to inform researchers of more recent work in the study of informed consent.Medline (which now includesbioethicsline, cancerlit, and Healthstar) was searched using “informed consent” as a major MESH heading and “informed consent/statistics & numerical data” as a MESH heading to capture empirical studies. In addition,medline was searched using names of investigators known to be participating in informed consent research. Although not in the original bibliography, pediatric studies are included in the addendum. Studies not applicable to U.S. populations or U.S. investigators, or studies relevant only to clinical and not research encounters were not selected. The addendum also incorporates articles from the supplement to Medical Care that was an end product of the SOTA conference. Cited references from the articles identified were often selected for inclusion as well. Descriptions of articles have been written based on information in the abstracts and, if easily available, the full text of the articles. In general, articles included are available in full text in English; in some cases topically relevant articles published in languages other than English have been included when English abstracts are available.

Due to the differences in search strategies and selection criteria, the articles have been tagged to indicate whether they are from the original bibliography created by Sugarman and colleagues (Sugarman, J) or from the addendum (SOTA). Users may limit their searches to either set of data if they wish.

Using the bibliography

To assist readers in identifying articles that address specific aspects of informed consent, the finding aids originally prepared by Sugarman and colleagues (see print bibliography) have here been restructured as searchable keywords: