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Points to Consider When Planning a Genetic Study
That Involves Members of Named Populations


The National Institutes of Health supports a broad range of genetic research aimed at improving the diagnosis, treatment, and prevention of many human illnesses. This research is designed to understand normal genetic processes, the consequences of genetic errors in those processes, genomic structure and function, the effects of genetic variation and the environment on the development of disease, and the effects of interventions on the disease process. Genetic research employs many different approaches, including observational studies, epidemiological studies, collection of biological samples for analysis or storage, and clinical trials. NIH-supported genetic research has already yielded important insights into diagnosing and treating several hereditary diseases and conditions.


The research participant is the individual who consents to participate in the study.

The population is the pool from which the research participants are drawn.

A population is considered a named population when the investigators intend to refer to it specifically in publications, presentations, and other venues.

The community is the broader ethnic, racial, geographic, or other group that may be affected by the research.

While the potential benefits of genetic research may seem obvious to the scientific community, it is important for researchers to realize that non-scientists may not be aware of these benefits. Furthermore, individuals and the communities to which they belong may fear that participating in genetic studies involving named populations may end up stereotyping that particular named population, potentially putting the entire community at risk of discrimination by insurers or other third parties. By being open with communities about the goals and process of their research before it is conducted, scientists can better design studies to yield meaningful data while working within distinct social and cultural contexts. By sharing results with a community after a study has been completed, research participants are more likely to know what to do to seek treatment or how to implement preventive measures to improve their health. In general, well-informed communities, which have a window into the research process, are likely to maintain a more positive attitude about scientific research--not only about how research is conducted but about what great benefits science can offer for humankind.

Important safeguards such as the Regulations for the Protection of Human Subjects (45 CFR 46), implemented through Institutional Review Boards (IRBs) and the informed consent process, protect individuals who participate in genetic research studies. (See Researchers' adherence to these Federal mandates is high. Taking into account the cultural context of populations of interest for genetic studies can enhance participation in population-based genetic research, a scientific endeavor poised to improve human health through the development of diagnostics and therapies.

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What is Community Consultation?

Community consultation takes many forms, and researchers consult communities in many ways. NIH has a longstanding and productive experience in establishing dialogues with communities that participate in research studies. Whether the research project involves genetics, epidemiology, or clinical trials, many investigators find that community consultation is a helpful tool for blending good science, protection of participants, and public health needs. The process is mutually beneficial to researchers and community members who are potential study participants.

Many researchers hold open houses in a community setting to explain their research project and to inform potential participants about the possible risks and benefits of participation in the study. Such a forum also invites participants to ask questions about things they don't understand. With these new insights, researchers can then do a better job of fully informing participants in lay language about the benefits and risks of participating in their study, as well as indicate what protections are already in place to guard against foreseeable risks. This open exchange with the community can identify and correct needless barriers to recruitment and retention, as well as align expectations about what a participant is later told of his or her clinical findings or of the overall research results.

NIH supports and encourages community consultation in many research areas and believes that investigators planning genetic research projects involving members of named populations should consider whether and how the community should be consulted. Ideally, investigators should initiate discussions with communities as early as possible in the course of their proposed research, although the dialogue can and should continue throughout the research project. Genetics researchers may wish to seek the advice of investigators from other fields who have more experience with conducting community consultations.

How is a community defined? Characteristics such as biological relatedness, geographic dispersion, social interactions, cultural values, and past experiences can all impact the nature of the potential benefits and risks associated with participating in genetic research. Because there is great diversity in the kinds of genetic research projects as well as in the types of affected communities, NIH recognizes that it is not possible to provide specific guidelines for community consultation. Rather, this document provides guidance to help investigators decide whether they should consult community members in planning and carrying out their research. Where possible, practical approaches that are likely to be helpful have been provided.

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Points to Consider

No two research projects are alike, and decisions about conducting a community consultation in connection with a research project are best made on a case-by-case basis. Investigators should consider the following points in making their decisions:

Should I conduct a community consultation?

  • Consider whether your study population and the potentially affected communities have interests as stakeholders in your research project and consider how those interests arise. By stakeholder interests we mean the ways in which your population and broader communities may benefit from, be harmed by, or otherwise be affected by the research project and its findings. The potentially affected communities may also include groups with characteristics similar to your study population. They might also include racial, ethnic, cultural, or religious communities, as well as other individuals who identify with the population under study in the research project.
  • Consider the potential risk of the research project to the population and to the potentially affected community of which it is a part. Is there any possibility that the outcome of the research could have a negative effect on the population or the community?
  • Consider the distinctive cultural and normative traditions that should be respected in the design and conduct of the project.
  • Consider the past experience of the study population or the potentially affected community in research and whether this experience has created concerns that require specific attention.
  • Consider the social structure of the population and of the potentially affected communities. Is the population or the community well-defined? Are there clear governance structures and leaders? Are there organizations or institutions that play key roles within the community? Are there informal community leaders or individuals with positions in the social structure who would be suitable as key contacts? What ability, if any, would each of these individuals or organizations have to represent the views of the community?

How should I conduct a community consultation?

  • Define the goals of the community consultation.
  • Identify the individuals and groups to be included in community consultation activities. Choose individuals and groups that can reasonably be expected to represent the range of views of stakeholders. Consider mechanisms (e.g., town meetings) for open discussion of the research project.
  • Define the consultation activities you will undertake and the timing of those activities. Don't consult the community on study design after the design has already been finalized. If you plan to share research findings with the community, do so in a timely fashion.
  • In designing the consultation, consider the balance between individual autonomy (the right of individuals to decide whether to participate in research) and the ethical concerns of groups that may be affected by the research.
  • In designing the consultation, consider harms, either to the community or to the integrity of the research project, which could be caused by the process of consultation.

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Frequently Asked Questions (FAQ)

  1. Does this document represent a new NIH requirement or a new policy?
  2. Will reviewers be looking for a community consultation plan in my application?
  3. Is an investigator ever legally required to consult communities in genetic research?
  4. Is community consultation required for IRB approval of my protocol?
  5. How does the informed consent process relate to community consultation?
  6. Why should I consult the community if the individuals in my study provide informed consent?
  7. How does the community consultation process help the community?
  8. Can consulting the community strengthen my research plan?
  9. What will happen if I don't consult the community?
  10. NIH requires that I include women, children, and minorities in my clinical trials (unless their exclusion is scientifically justified). Does this mean I have to consult members of all these communities as I plan my clinical trials?
  11. Do I need to consider community consultation if I plan to study foreign communities?
  12. Does community consultation mean that the community must give its consent or approval before I can conduct my research project?
  13. I am planning to conduct a community consultation--how do I get started?
  14. When should I conduct a community consultation?
  15. How do I determine which members of a community I should consult and how many?
  16. What if I propose to study a named population that is part of a nationwide community?
  17. For some communities numerous groups that represent the community have widely divergent perspectives and goals. How can I consult with such groups?
  18. May I request funds in my NIH grant application for activities related to community consultation?

1. Does this document represent a new NIH requirement or a new policy?          [Back to FAQ List]

No. NIH does not require researchers to conduct consultations with communities. NIH recognizes that researchers in some scientific areas, such as genetics, are just beginning to work with named populations. Thus, the concept of community consultation may be new to researchers in this area. This document has been prepared to help inform the scientific community that such efforts can be helpful to all parties involved in the research.

2. Will reviewers be looking for a community consultation plan in my application?          [Back to FAQ List]

Not necessarily. The review criteria for NIH research applications have not changed. NIH does not require consultations with communities. However, community consultation is already the norm in some scientific areas, such as the social sciences.

3. Is an investigator ever legally required to consult communities in genetic research?          [Back to FAQ List]

There are no laws or regulations that explicitly govern the conduct of genetic research involving members of a named population. However, Native American and Alaskan Native tribal governments have legal jurisdiction to govern and regulate activities that occur within the geographical boundaries of their territory. This authority of tribal governments, which predates the U.S. Constitution, has been recognized by the U.S. Supreme Court, Congress, and the Executive Branch. Research involving members of the tribe living within the tribe's territory is considered to be an activity over which the tribe has jurisdiction. Therefore, investigators must obtain approval from the government of the tribe (e.g., its tribal council) and from any applicable IRB that serves the tribe in order to conduct such research. A Native American tribe is treated as a sovereign Nation, and the same is true for Alaska Native tribal governments. Since 1968 it has been the policy of the Federal Indian Health Service not to authorize any research involving a tribe unless the tribal government approves the proposed research in its community.

4. Is community consultation required for IRB approval of my protocol?          [Back to FAQ List]

No. Community consultation is not a required part of the IRB approval process, although IRBs often consider the implications of the research project on the participants' community. Community consultation is a vehicle for hearing about the community's interests and concerns, addressing ethical issues, and communicating information about the research to the community.

5. How does the informed consent process relate to community consultation?          [Back to FAQ List]

Informed consent is a process required by Federal regulations that pertains to individuals who are considered human subjects in research. The informed consent process must occur before subjects begin participation in a research project. The content and process of informed consent is carefully stipulated by relevant regulations and monitored by IRBs and other entities that form a web of protection for human research subjects. Community consultation pertains to the population from which the subjects are recruited and is a process not expressly required by Federal regulations. Community consultations are often informal activities. While the information provided in a community consultation may be similar to that provided in the informed consent process, the goals of these two activities may be very different.

6. Why should I consult the community if the individuals in my study provide informed consent?          [Back to FAQ List]

Initiating a dialogue with a community makes sense. The community consultation process promotes the two-way communication between investigators and the community. Investigators can inform the community about the research and its outcomes, and the community can tell investigators about their interests and concerns. The more the public knows about the process of scientific research, the less afraid they will be about asking questions, and the better informed they will be about interpreting results.

Genetic Research: Working with Tribal Communities

A group of researchers investigating the genetics of alcoholism in American Indians and Alaska Natives have established long-term relationships with these communities. Such liaisons have proven to be a useful component in implementing genetic research studies centered on prevention and treatment of alcoholism and other chronic health problems. At the outset, the researchers interacted informally with the communities, through meetings with both concerned individuals and tribal health committees. These meetings helped to guide the design of study plans and instruments. In these studies, community members recruited and trained by the study team played key roles in performing the research, both in tracking subjects and in collecting preliminary data. Formal agreements were developed between the researchers and the tribal leadership. Forging working relationships with tribal communities helped to spread the word about the benefits of research and bridged communication and cultural gaps between the scientists and the communities. In some cases, community members have benefited professionally--one community member in particular went on to earn an advanced degree in genetics and is now actively involved in broader efforts to inform tribal communities about research, as well as to voice the concerns of the Native American community about genetics and research.

7. How does the community consultation process help the community?          [Back to FAQ List]

By seeking the views and input of community members, consultations before, during, or after a research project show respect for the participants. Community members benefit from learning about the study and by understanding the scientific questions it seeks to answer, improving public scientific literacy. The consultation may also help to identify pitfalls in the design or plan for a study, which may improve the study's ability to address issues of importance to the community. As partners in, rather than simply as subjects of, the research activity, this process increases the likelihood that community members will feel empowered rather than exploited.

There are no guarantees that holding a community consultation will prevent stigmatization and stereotyping of a community on the basis of research findings. However, being available for discussion creates a forum for members to learn what to do with scientific conclusions and how to deal with potential outcomes of the research. Such forums can identify for community members the best places where they can obtain more information about their health.

8. Can consulting the community strengthen my research plan?          [Back to FAQ List]

Yes. Conducting a dialogue with the community may uncover weaknesses in the research plan. For example, the investigator may learn new information about language barriers, beliefs, or concerns that would threaten the feasibility of the research or undermine the validity of measures if they were not considered. A consultation may reveal strategies for more effectively identifying study participants. Community-wide "buy-in" to the goals of the research project may improve the ability to recruit study participants. However, community consultation is not a substitute for careful, systematic preliminary studies that provide the foundation for choosing the study population, developing sampling or recruitment plans, designing protocols and measurement tools, and planning analytic strategies. A wide variety of social science methods and statistical data are available for assessing the characteristics of communities. Investigators must be cautious about relying on anecdotal information gained in the course of community consultation to guide the development of their research plans.

Town Meetings: Obesity in African Americans

Depending on the nature and goals of a study, researchers may wish to pursue town meetings as an approach to communicating with communities. This was an effective strategy used by researchers conducting a study on the genetic and environmental influences of obesity in African Americans. Before the study was implemented, the researchers invited neighborhood leaders in the study's local area to hear about and discuss the project. A town meeting was held one evening at a site with convenient access to a diverse group of community members. The casual gathering provided a useful information exchange, benefiting both the community and the researchers. After hearing about the nature and scope of the study, how it would be conducted, and what protections were in place for guarding confidentiality, community members became better informed about the specific study goals. They also learned how genetic research could lead to improved detection and treatment for chronic conditions like obesity, diabetes, high blood pressure, and some forms of cancer. The scientific team, in turn, heard useful feedback from the community about a range of issues related to implementing the study, such as door-to-door recruitment strategies. In response to these suggestions, adjustments to the research protocol were put into place. In a comfortable setting like a town meeting, community members often find it easier to ask questions about specific concerns they may have about the research. Investigators can respond to such questions and concerns directly, and in an understandable way.

9. What will happen if I don't consult the community?          [Back to FAQ List]

While it is not required by law, talking with communities about research that may impact their health and/or social standing is the respectful thing to do. Failure to consult with the community can erode trust in scientists and in the scientific research enterprise in general, which may affect the ability of investigators to conduct future research with that community or other communities. For example, many African Americans still harbor deep-seated mistrust of genetic research following the experiences of this population with the sickle cell screening programs of the 1970s. These programs were put into place without meaningful discussions with the African American community, resulting in group stigmatization and discrimination in insurance and employment among people carrying the sickle cell trait. Many American Indians and Alaska Natives similarly mistrust genetic research because they perceive that they are subjected to so-called "helicopter research." That is, many community members perceive that investigators "swoop down" without appropriate prior discussion to gather biological samples or conduct other types of research, then leave without providing any benefits or explanation to the study population.

10. NIH requires that I include women, children, and minorities in my clinical trials (unless their exclusion is scientifically justified). Does this mean I have to consult members of all these communities as I plan my clinical trials?          [Back to FAQ List]

No. NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research ( and the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects ( do not require community consultation. To recruit and retain subjects in a study, however, investigators are urged "to establish a relationship between the investigator(s) and staff(s) and populations and community(ies) of interest such that mutual benefit is derived for participants in the study." Experience shows that talking with community representatives to plan effective outreach increases the likelihood that the study will be implemented successfully.

11. Do I need to consider community consultation if I plan to study foreign communities?          [Back to FAQ List]

NIH-funded research with foreign communities generally requires the same assurances (e.g., human subjects, inclusiveness of women, members of minority groups, and children) as research with U.S. citizens. (See for the NIH Grants Policy Statement on Awards to Foreign Institutions, International Organizations, and Domestic Grants with Foreign Components.) Although community consultation is not generally required, establishing a relationship with communities of interest is desirable.

Planning genetic research studies involving communities outside the United States may be particularly suited to community consultation activities due to differences in language, culture, and political climate. Scientists may be much more familiar with the science than with the historical or current political issues affecting how the research is perceived or the potential implications that the research might have on the community. It is important to explore these issues and local laws or other constraints while planning the research. Investigators may contact either the NIH Fogarty International Center or the international office within the sponsoring NIH Institute to request assistance with the appropriate approach to conducting consultations with foreign communities.

12. Does community consultation mean that the community must give its consent or approval before I can conduct my research project?          [Back to FAQ List]

No. Community consultation is not the same as consent. In the majority of cases, communities in the United States are not required to give consent or approval for research in which its members participate, nor is it reasonable to attempt to obtain community consent or approval. One exception is research that involves members of American Indian or Alaska Native tribes, which are sovereign nations with defined political organizations. Most tribes have established procedures that require researchers to seek approval to conduct research that involves members of the tribe. Such research requires both the approval of the tribal leadership and review by one of the Indian Health Service's IRBs or by the applicable tribal IRB. For studies conducted outside the United States, researchers are strongly encouraged, in the planning stages of the research, to contact appropriate individuals in the host government to find out about any special requirements for community consent or consultation.

13. I am planning to conduct a community consultation--how do I get started?          [Back to FAQ List]

Community consultation can take many forms, and these will vary depending on the political and social structure of the community, the degree to which its members are biologically related, the degree of geographic dispersion, religious and cultural characteristics, and past experiences of community members as research participants. How you conduct your consultation will also depend upon the goals you wish to achieve and the stage in the research at which you wish to consult the community. Useful approaches include informal dialogues with leaders and/or members of the potentially affected community, town meetings, or more focused community forums. For geographically dispersed communities, different strategies may be needed, such as small group meetings or distribution of written information inviting community members to ask questions and provide feedback through calls to telephone hotlines. Some investigators find a combination of approaches to be helpful to assure that members of the community understand the goals and possible outcomes of the proposed research, the potential risks and benefits, and also have an opportunity to ask questions and express their concerns. Contacting investigators with prior experience in conducting consultations may also be helpful.

DNA Banking Studies: Mexican Americans

As part of one research effort, an investigator wished to collect DNA samples from 100 Mexican Americans and deposit the samples into a national cell repository. The samples, which would be anonymized, could then be made available for future research use by investigators with IRB-approved protocols. Even though individual consent would be provided for use of the samples, the investigator sought the input of the Mexican American community, since the repository collection would represent a named population. The goal of the consultation efforts was to facilitate in-depth discussions of the potential impact of any findings that might associate certain genetic traits with the Mexican American community at large. The investigators first met with a large number of community leaders. Based on what the researchers learned from these meetings, they planned several larger community gatherings at different times of day and at various convenient locations, and distributed brochures publicizing the events. In some cases, child care and refreshments were provided. The investigators set up a full-time consultation program office, staffed by bilingual personnel, to field questions from the community. In addition to helping the investigators forge a connection with the local community and begin the sample recruitment process, the consultations were a valuable forum in which community members could learn how genetic research can improve health through the development of better treatment and prevention strategies. The consultations also led to the formation of a community advisory group, which will serve to facilitate ongoing dialogue between the community and the cell repository.

14. When should I conduct a community consultation?          [Back to FAQ List]

While any discussions you have with the community you plan to study are likely to be useful to both parties, it is helpful to think about the community consultation process as early as possible in the planning stages of your research. Talking with community members before you submit your grant application and weaving into your proposal any learned insights shows reviewers you thought carefully about the study's design and implementation. As your research proceeds, assembling a formal or informal group of community members may help to keep them informed about the progress of your study. In some cases, investigators have also conducted community consultations after the study has been completed to provide information on results that might impact the community.

15. How do I determine which members of a community I should consult and how many?          [Back to FAQ List]

There isn't a simple answer to this question, since many types of communities exist. Also keep in mind that any input you get can be useful both to you and to the community. Some research studies focus on very narrow local populations while others target large, heterogeneous, or national populations. The point is to get information to, and input from, any members of the community that may be affected by the study. Community consultations will be most effective when the individuals or organizations consulted represent a broad range of views from the potentially affected community or communities.

16. What if I propose to study a named population that is part of a nationwide community?          [Back to FAQ List]

For studies that involve a national population, conducting a consultation in a structured environment may not be practical. One factor to consider is whether the populations under study actually function as communities at the national level. For example, are there national organizations focused on the issues of these communities and do these organizations concern themselves with issues relevant to the research? For studies that recruit participants from national samples, solicit input from several national organizations that focus on issues related to specific communities at a national level or from several organizations or individuals with expertise from different regions.

17. For some communities numerous groups that represent the community have widely divergent perspectives and goals. How can I consult with such groups?          [Back to FAQ List]

Obtaining input from diverse groups calls for a plan to listen to them to the extent that is possible. Any input will likely be helpful to you and to the potential community participants. You may want to solicit input from each group separately, perhaps through individual meetings with community leaders. However, it is important to note that community leaders and organizations may or may not speak for the entire community.

18. May I request funds in my NIH grant application for activities related to community consultation?          [Back to FAQ List]

In circumstances where community consultation is identified as a useful part of a research project, investigators may request funds to support costs for community consultation. All requests must conform to the guidelines of the grant mechanism being used.

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For more information about how you can implement community consultation into your research project, contact:

Judith H. Greenberg, Ph.D.
Director, Division of Genetics and Developmental Biology
National Institute of General Medical Sciences
National Institutes of Health
Natcher Building, Room 2As25
45 Center Drive, MSC 6200
Bethesda, Maryland 20892-6200
Phone: (301) 594-0943
Fax: (301) 480-2228

Judith D. Auerbach, Ph.D.
Director, Behavioral and Social Science Program
Office of AIDS Research
Office of the Director
National Institutes of Health
2 Center Drive, Room 4E30, MSC 0255
Bethesda, MD 20892
Phone: (301) 402-3555

Virginia Cain, Ph.D.
Office of Behavioral and Social Sciences Research
Office of the Director
National Institutes of Health
Bldg. 1 Room 256
Bethesda, MD 20892
Phone: (301) 402-1146

Richard R. Fabsitz, M.A.
Leader, Genetic Epidemiology Scientific Research Group
National Heart, Lung and Blood Institute
Rockledge 2, Room 8152
Rockville, MD 20892
Phone: (301) 435-0444

Katrina Gwinn-Hardy
National Institute of Neurological Disorders and Stroke
National Institutes of Health
6001 Executive Boulevard
Rockville, MD 20892
Phone: (301) 496 5745

Jan Howard, Ph.D.
Chief, Prevention Research Branch
National Institute of Alcohol Abuse and Alcoholism
6000 Executive Blvd, Room 505
Bethesda, MD 20892
Phone: (301) 443-1678

Morgan N. Jackson, M.D., M.P.H.
Director, Office of Special Populations
Division of Extramural Research and Training
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475
Phone: (301) 402-1278

Lisa Kaeser
Office of the Director
National Institute of Child Health and Human Development
National Institutes of Health
Building 31, Room 2A10
31 Center Drive
Bethesda, MD 20892
Phone: (301) 496-0536

Mary S. McCabe, R.N., M.A.
Acting Director of Communications
National Cancer Institute
Building 31, Room 3A44
31 Center Drive
Bethesda, MD 20892
Phone: (301) 496-6404

Jean E. McEwen, J.D., Ph.D.
Program Director
Ethical, Legal, and Social Implications Program
National Human Genome Research Institute
National Institutes of Health
31 Center Drive, Room B2B07
Bethesda, MD 20892-2033
Phone: (301) 402-4997

Steven O. Moldin, Ph.D.
Chief, Genetics Research Branch
Division of Neuroscience & Basic Behavioral Science
National Institute of Mental Health
6001 Executive Blvd., Room 7189, MSC 9643
Bethesda, MD 20892-9643
Rockville, MD 20852 (for courier/express mail service)
Phone: (301) 443-2037

Rona Siskind
Program Analyst
Office of Program Operations and Scientific Information
Division of AIDS
National Institute of Allergy and Infectious Diseases
6700 B Rockledge Drive, Room 4139
MSC 7620
Bethesda, MD 20892
Phone: (301) 435-3732

Shobha Srinivasan, Ph.D.
Program Administrator
Chemical Exposures and Molecular Biology Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-21
111 T.W. Alexander Drive
RTP, NC 27709
Phone: (919) 541-2506

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Last updated: 02/21/08