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Am J Public Health. 2007 January; 97(1): 25–30.
PMCID: PMC1716233

Informed Consent: An International Researchers’ Perspective


We reported 164 researchers’ recommendations for information that should be included in the informed consent process. These recommendations were obtained during training workshops conducted in Africa, Europe, and the United States.

The 8 elements of informed consent of the US Code of Federal Regulations were used to identify 95 items of information (“points”), most related to benefits and research description. Limited consensus was found among the 3 workshops: of the 95 points, only 27 (28%) were identified as useful by all groups.

These points serve as a springboard for identifying information applicable in different geographic areas and indicate the need for involving a variety of individuals and stakeholders, with different research and cultural perspectives, in the development of informed consent, particularly for research undertaken in international settings.

INFORMED CONSENT IS AN important resource for protecting participants in research studies. All major national and international organizations require that “effective informed consent”1 or “voluntary informed consent”2 be obtained before a prospective participant is enrolled in a research study. The Council for International Organizations of Medical Sciences (CIOMS) defines informed consent as (1) receiving information necessary to make an informed choice about study participation, (2) understanding that information, and (3) making a voluntary decision on whether to participate.2 Determining how much detail should be provided and balancing this with the potential participants’ need for information and capabilities to understand it is a major challenge for researchers and institutional review boards. To facilitate these efforts, the US Code of Federal Regulations (CFR)1 requires that the following 8 basic elements be presented to participants to ensure informed consent: (1) research description, (2) risks, (3) benefits, (4) alternatives to study participation, (5) confidentiality, (6) compensation, (7) contacts, and (8) voluntary participation. The CFR also provides a brief elucidation of what type of information should be provided under each element. This limited clarification of the CFR creates the potential for different interpretations; more detailed specifications should be considered.

Information deemed essential for CFR-required elements is presented here, gathered from experienced researchers who participated in international research ethics training workshops. The need to involve a variety of individuals with different field experiences when developing informed consent documents was evident from our analysis of these researchers’ opinions.


From July 2002 to July 2003, the Office of International Research Ethics of Family Health International conducted 8 1-day training workshops on basic research ethics at 3 sites in Africa, Europe, and North America. Family Health International is a not-for-profit organization, based in the United States, that conducts biomedical and social research worldwide. A total of 164 researchers participated in these workshops. In July 2002, 63 researchers participated in 4 workshops conducted at the headquarters of a major international organization in Geneva, Switzerland. They came from various developed and developing countries, and all resided in Europe at the time the workshops were held. During June and July 2003, 68 Family Health International research staff attended 3 workshops held at Family Health International offices, 2 in Research Triangle Park, NC, and 1 in Arlington, Va. The large majority of the participants were US-born. In August 2003, 33 researchers from Ethiopia, Ghana, Kenya, Malawi, Rwanda, South Africa, Tanzania, Zambia, and Zimbabwe attended a regional workshop held in Nairobi, Kenya, organized by the Family Health International regional Africa office.

All workshops were conducted with the Research Ethics Training Curriculum developed by Family Health International3 (available at: http://www.fhi.org/en/RH/Training/trainmat/ethicscurr/index.htm). The participants were highly educated in the biomedical and social sciences. They were responsible for designing, conducting, or monitoring health research projects, including research on ethics-related responsibilities, mostly related to international research.

The workshops focused on principles and foundations of research ethics, functions of research ethics committees, informed consent, and roles and responsibilities of researchers and sponsors. As part of a training exercise designed to identify the information that should be included in the informed consent process, participants were divided into 4 to 8 working subgroups (depending on the number of participants at a given workshop) and each subgroup was assigned 1 or 2 of the 8 CFR-required elements of informed consent. Each subgroup was given 30 minutes to list the information it considered relevant to the assigned element. Participants were asked to provide items of information applicable to participants in all types of health research studies. Each subgroup presented its list, fielding suggestions for additional items from the other subgroups. Participants were not required to classify the information in order of importance, and the workshop facilitators did not attempt to influence this process in any way. The exercise lasted approximately 90 minutes. A report including all suggested information points was issued for each training site. Care was taken to make only minor editorial corrections to the reports to maintain the original meaning of the participants’ input.

Each information item identified by the subgroups is referred to hereafter as a point. Participants from each workshop site are referred to hereafter as a group. We used the workshop reports to prepare a list of points for each of the 8 elements. This information was then integrated into 3 lists, 1 for each of the workshop sites described earlier. The items were then listed according to the workshop site from which they originated. When the same point was identified in more than 1 workshop at a particular site (because 3 and 4 workshops were conducted in the US and Swiss sites, respectively), we included it as only 1 point, incorporating the main characteristics suggested by all subgroups at the site.

Our primary objective was to present site-specific lists of points, noting both the common and the unique points that each group contributed. A secondary objective was to assess the extent of agreement among the groups in citing various points within each of the 8 informed consent elements by calculating a κ statistic for each group’s lists with Stata, Release 7.0 (Stata Corp, College Station, Tex). We also calculated the difference between the number of groups that could have cited a particular point and the number of groups that actually cited the point to identify which groups did not report certain points. If the difference was significant, the associated κ statistic was likely to be close to zero.


The points of informed consent identified for research description, risks, and benefits are presented in Tables 1 [triangle] through 3 [triangle] [triangle], according to which groups cited them. The points are not listed in order of importance because ranking was not required of the participants. To maintain the anonymity of the groups, they are presented as Groups 1, 2, and 3, which does not correlate with the order of appearance of the workshops described in the Methods section.

Information Points for Research Description Identified by Workshop Participants: Geneva, Switzerland; Research Triangle Park, NC; Arlington, VA; Nairobi, Kenya; July 2002–2003
Information Points for Risks Identified by Workshop Participants: Geneva, Switzerland; Research Triangle Park, NC; Arlington, VA; Nairobi, Kenya; July 2002–2003
Information Points for Benefits Identified by Workshop Participants: Geneva, Switzerland; Research Triangle Park, NC; Arlington, VA; Nairobi, Kenya; July 2002–2003

The 3 groups combined cited 95 unique points. The number of points cited for any individual element ranged from 5 to 22. Under the element of research description, points mentioned by all 3 groups included study purpose, goals, and objectives; justification or rationale for the study; a detailed description of the procedures, tests, or questionnaires required by the study; study duration; the number of participants and study sites; and how results of the study will be used (Table 1 [triangle]). Under the element of risks, the consideration of physical, mental, and social risks was among the 4 points common to all groups. Particular reference was made to possible risks associated with stigma, discrimination, loss of respect, or public ridicule as a result of participating in a study (Table 2 [triangle]). Of the 22 points identified for the element of benefits, helping others and compensation or other incentives for participation were the 2 points mentioned by all 3 groups (Table 3 [triangle]).

Two points of consensus were identified under the element of alternatives to study participation: explanation of alternative treatments and standards of care and notification of the right to discontinue a study at any time without penalties. Four points were mentioned by all groups for the element of confidentiality: defining the limits of confidentiality, who will have access to the information, how the information will be kept confidential, and how long the information will be retained after the study ends. For the element of compensation, all groups agreed that appropriateness of monetary compensation from culture to culture must be discussed among researchers to find the appropriate monetary reimbursement or other types of nonmonetary reimbursement when preferred. Four points of consensus were identified for the element of contacts. All 4 points centered around the need to provide potential participants with a comprehensive list of contacts, including the names of community advisory board members or community representatives. Under the final element, voluntary participation, the points mentioned by all groups included information on choosing not to participate, the right to withdraw at any time without loss of benefits, and health care not being dependent on participation.

Table 4 [triangle] summarizes the information collected by the groups for all 8 elements, including the number of points cited for each element and how many points were identified by 1, 2, or all 3 groups. The 2 elements with the most points were benefits and research description: 21 and 16 points, respectively. The elements of risks and compensation had the next highest, each with 14 points. The fewest points—only 5—were cited for the element of contacts. For 5 of the elements, most points were cited by only 1 group. A relatively small number of points were common to all 3 groups: only 27 of 95 points (28%). Only 12 of the 95 points (13%) were common to 2 groups, and 56 (59%) were mentioned by only 1 group.

Number of Unique Informed Consent Points Reported by All Groups, by Number of Groups, and by Each Separate Group: Geneva, Switzerland; Research Triangle Park, NC; Arlington, VA; Nairobi, Kenya; July 2002–2003

Table 4 [triangle] also shows the number of points identified by each of the 3 groups. Group 1 cited the most points for all the informed consent elements, including 12 (75%) of the 16 research description points and 9 (64%) of the 14 risks points. The extent of agreement among the groups was poor for points under all of the elements except contacts, for which 4 of the 5 points were reported by all 3 groups. Also, the values of the κ statistics for all elements except contacts were close to zero. Therefore, despite the presence of commonly cited points, we found a general lack of consensus among the groups with respect to what the contents of the informed consent elements should be.


Possible explanations for the limited agreement among the groups are that the information was obtained from individuals with experience in different types of research, from a variety of professional disciplines, who hold different cultural perceptions of informed consent (from Africa, Europe, and North America). At least for the groups of researchers in our study and for the type of research they conduct, the 27 common points they identified could be used as the core information points addressed in the informed consent process. Our findings indicate that a variety of stakeholders with different research and cultural backgrounds must be involved in developing informed consent procedures.

Results indicated that the groups’ top priority was ensuring that potential study subjects receive sufficient information about possible benefits of participating in a study and how it will be conducted. We also observed consensus among all 3 groups that names of community advisory board members or community representatives should be included under contacts.

Information on country of origin was not collected for participants of 2 of the groups but was an administrative requirement for the participants of the workshop in Africa. Therefore, we were not able to analyze the participants’ responses by developed versus developing countries. Our analysis did not detect any points reflecting a unique concern of the participants from Africa. A common characteristic of all participants was their experience in international research, particularly in developing countries. The participants in the European and North American workshops were largely involved in international collaborative research in developing countries.

An informed consent process containing 95 points is unlikely to be needed for any study, and some of the points identified here may be applicable to only certain types of studies. Some experts have proposed that information overload may actually hinder understanding and that the amount of detail provided in the informed consent process should not be excessively comprehensive.4,5 Macklin,5 for instance, proposed providing “adequate information,” defined as “the amount and kind of information necessary for the individual to make a reasoned decision about whether to participate in the research.” The need to develop a participatory method inclusive of all relevant stakeholders (local and international researchers, sponsors, and community representatives) for improving the informed consent process, including identification of the information needed for each specific study, has been recognized.6 The points cited in our study could be a useful reference for identifying such information.

The information in our study was collected on the basis of the 8 elements of informed consent required by the CFR. In contrast to the CFR, CIOMS Guideline 5 proposes including 27 elements in informed consent. The guideline also includes an explanation of the intention of each element. Most of the 27 elements of CIOMS are an extension of the 8 elements of the CFR. However, some CIOMS elements are not explicitly considered in the CFR.

In our study, 17 (63%) of the 27 CIOMS elements were cited by all 3 groups, and 6 (22%) were cited by 1 or 2 of the groups. Only 4 CIOMS elements were not mentioned by any of the groups. The contents of CIOMS element 22, which recommends discussing “whether the investigator is serving only as an investigator or as both investigator and the subject’s physician,” was not mentioned, although the groups did mention the related point of distinguishing between a research study and health care provision. Also, although the 3 groups were emphatic about the necessity of discussing how study results will be used, participants did not directly mention that “subjects have the right of access to their data on demand” or that subjects have the right of access to the “use of results of genetic tests,” as proposed in CIOMS elements 8, 16, and 17.

Conversely, the groups in our study identified several points that are not directly mentioned in the CIOMS guidelines. These results suggest that the use of the 8 elements of the CFR continues to be an appropriate starting point for the development of informed consent processes and that the more detailed information provided by CIOMS may be a valuable additional resource.


The training workshops were conducted with funds provided by the National Institutes of Health, the US Agency for International Development, and the World Health Organization. This article was prepared with funds provided by Family Health International, Research Triangle Park, NC.

Human Participant Protection
No protocol approval was required for this study.


Peer Reviewed

R. Rivera was a facilitator in some of the training workshops and was responsible for the origination of the study, analysis and interpretation of the data, and preparation of the article. D. Borasky, R. Rice, and F. Carayon were facilitators in some of the training workshops. E. Wong conducted the statistical analysis of the data. All authors contributed to the interpretation of the data and preparation and review of the article.


1. Office for Protection from Research Risks. Protection of human subjects, 45 CFR 46. Office for Protection from Research Risks Reports, Federal Register (1996).
2. Council for International Organizations of Medical Sciences. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva, Switzerland: Council for International Organizations of Medical Sciences; 2002. [PubMed]
3. Family Health International. Research Ethics Training Curriculum. Research Triangle Park, NC: Family Health International; 2001. Available at: http://www.fhi.org/en/RH/Training/trainmat/ethicscurr/index.htm. Accessed December 6, 2006.
4. Brody BA. Making informed consent meaningful. IRB. 2001;23:1–5. [PubMed]
5. Macklin R. Understanding informed consent. Acta Oncol. 1999;38: 83–87. [PubMed]
6. Mariner WK. Taking informed consent seriously in global HIV vaccine research. J Acquir Immune Defic Syndr. 2003;32:117–123. [PubMed]

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