INTRODUCTION

The collection, storage, and research use of samples from named populations is a shared responsibility of the investigator who collects the samples (the collector), the Repository staff, the NIGMS project officer, and the investigators who subsequently obtain the samples for their research (the investigators). Researchers considering the collection of this type of sample set for possible submission to the Repository must discuss their plans with the Repository staff and the NIGMS project officer before embarking on the collection of samples. Additional discussion of the rationale for this policy and guidelines for its implementation are contained in the NIH document Points to Consider When Planning a Genetic Study That Involves Members of Named Populations. For purposes of this policy, a "population" is defined as a group of people who share a common ethnic or geographic origin. A "community" is a social unit of organization within that population with which members of a named population may identify themselves as belonging. Individuals may consider themselves as belonging to multiple communities or as belonging both to a broader community and to smaller subset[s] of that community.

POLICY

This document describes the policy under which the NIGMS Human Genetic Cell Repository will obtain and distribute samples from groups of individuals from named populations with the objective of including the samples in the Human Variation Collection (in which samples are identified as coming from the members of a particular population). Such samples are typically used for research in which groups, rather than individuals, will be the fundamental unit of analysis and in which inter-group comparisons will be a primary goal (for example, population genetics or genetic epidemiological studies). Because studies of this type may raise concerns both for individuals and for the larger populations of which they are a part (such as risks of group stigmatization), the Repository has adopted a policy that sample collectors must consult with the communities where they propose to collect samples in advance of the sample collection and establish mechanisms for ongoing consultation with those communities thereafter. The policy also places certain restrictions on investigators proposing to use those samples.

Certain aspects of this policy may need to be modified for the collection of samples from populations in countries other than the United States out of respect for local cultural or political norms. Nevertheless, establishment of some form of meaningful community consultation is desirable for all samples from named populations submitted to the Repository, regardless of the country in which they are collected. This policy reflects an emerging international bioethics consensus, as reflected in the Declaration on the Human Genome from the International Bioethics Committee (IBC) of UNESCO. NIH-funded research involving non-U.S populations also requires the same assurances (e.g., human subjects, inclusiveness of women, members of minority groups, and children) as research involving U.S. citizens (See http://grants1.nih.gov/grants/policy/nihgps_2001/part_iib_7.htm for the NIH Grants Policy Statement on Awards to Foreign Institutions, International Organizations, and Domestic Grants with Foreign Components).

This policy is not applicable to the large majority of samples that are acquired by the Repository solely because the individual subject-donor has a particular genetic disorder or serves as a control.

ELEMENTS OF COMMUNITY CONSULTATION

In advance of collection, the collector of the samples must consult with members and leaders of the community where the consultation will occur. The collector must assure that those consulted are representative of the community. The broader the range of people consulted, the more likely they are to be representative of the community as a whole. The following points are included as guidance in determining starting points for identifying representatives of a community.

1. What is the total number of individuals (approximately) who are part of the named population from which sample donors will be recruited?
2. What communities exist within that population, and what is the total number of individuals (approximately) who are part of those communities?
3. Can a particular community or communities within the larger population be identified as an appropriate forum for the consultation?
4. Is this community politically organized in any way (i.e., tribe, municipality, etc.)? If so, that political organization, or community leaders, must be consulted. (Note that Native American tribes are sovereign nations and that formal intergovernmental negotiations must be undertaken to obtain tribal permission.)
5. If not, are segments of the community politically organized? If they are, will samples be collected from one or more of those organized segments? If so, each of these political units should be consulted.
6. If no local political organizations exist, then what cultural or other social organizations exist at the local level? If such cultural or social organizations do exist, they should be consulted.
7. If no organized groups exist at all, the collector must identify other effective ways to consult the community.

1. Make clear the range and the general goals of the research that will be conducted using the samples while they are in the Repository.
2. Make clear whether the community will be able to specify certain types of research for which samples may not be used. These exclusions must be established before the samples are collected.
3. Describe the types of investigators (i.e., academic, commercial, or other researchers, basic scientists, clinicians) who will use the samples.
4. Point out that information learned about the samples might be stored in a Web database.
5. Describe the risks and benefits to the community and what will be done to minimize the risks.
6. Discuss the length of time the samples will be stored in the Repository.
7. Describe the process that will be used to keep the community informed of how the samples are being used.
8. Discuss the option for the community to specify that all samples may be withdrawn from the Repository at any time if they are being used in a way inconsistent with the terms of the original informed consent.
9. Describe to the community in an understandable form the plans for disseminating results of future research using the samples.

The outcome of these discussions must be documented and made available to the Repository, to the Repository's IRB, and to the project officer. As part of the documentation, the collector should describe the methods that were used in the consultations (i.e., interviews, forums) and the rationale for the choice of community representatives to consult, and provide a summary of the views of the individuals and groups that were consulted.

The information in the individual informed consent document that research participants will sign must be consistent with information provided, and promises made, to the communities during the community consultation process.

The collector of the samples (in consultation with the Repository director) must establish a community advisory group to serve as a liaison between the Repository and the community once the samples are acquired by the Repository and throughout the period agreed upon by the community advisory group when it is established. Ideally, some of the members of this community advisory group would have been involved in the initial consultations. It is expected that the community advisory group would consist of approximately 6-8 members, depending on the size and diversity of the community. A separate community advisory group will generally be established for each collection.

It will be the shared responsibility of the collector (or, if the collector does not reside near the community where the samples are collected, a local collaborator) and the Repository director to maintain contact with the community advisory group for a period of time to be agreed upon by the community advisory group and the Repository. Contact may occur through meetings, telephone conferences, e-mail, or other means that should be determined by the community advisory group when it is established. The production of reports for the community advisory groups will be handled by the Repository, by the collector, or by a third party, as determined at the time of collection of the samples. The source of the funds for producing and distributing reports to the community will be negotiated prior to submission of the samples.

The Repository will provide limited funds to defray the costs of community advisory group activities for as long as the advisory group continues to exist. The proposed budget for running the community advisory group must be agreed upon with the Repository staff at the time the community advisory group is established. Appropriate costs could include compensation to community advisory group members and to collectors (or to their designated local collaborators, in cases where the collector does not reside in the community) for local travel expenses to attend yearly group meetings, payment for facility rental costs, and dissemination of written information. Currently, the total amount will not exceed $1,000 per year (additional information).

The community advisory group should be consulted by the Repository director if any changes involving the research use of these samples are proposed that would alter the originally agreed upon policies or research goals.

Since the community advisory group could exist for an extended period of time, there is likelihood of turnover in membership. At the time the community advisory group is established the members should decide upon the term of an individual's membership and develop a plan for replacing members. The community advisory committee should notify the collector and the Repository director of changes in membership so that communication can be maintained.

Communications between the Repository director and the community advisory group should be documented by the Repository director and a copy provided to the project officer and to the Repository's IRB.

The IRB that reviews the collection protocol must be informed of the community consultation process and the efforts that will be put in place to minimize group harm.

Individual informed consents must state explicitly that samples will be deposited in a Repository and will be identified as to the individual's ethnic or geographic group (although the individual himself or herself will not be identified). The consent should also state clearly the possible benefits and risks both to the individual and to his/her community, what will be done to minimize the risks, the length of time the samples will be retained in the Repository and the possible research uses of the samples during the time they will be maintained in the repository.

Investigators who wish to use these samples for research will be subject to all the Repository's policies, including submission of a Statement of Research Intent (which must be approved by the Repository's IRB) and approval by their own IRB. As in the case of all other human specimens in the Repository, the Repository's IRB is responsible for determining whether the research intent is consistent with the informed consent signed by the individual from whom the sample was derived. The IRB will also ascertain that the research is consistent with the community's views as determined by the initial and ongoing consultations.

The community advisory group should be generally informed of how the samples will be used. This information should be disseminated to the community in an understandable way.

If naming the population from which the samples were derived is not scientifically relevant, the results of research on these samples should not identify the community, unless the community (through the community advisory group) wants to be identified.

Policy for use of biomaterials from the International HapMap Project

The Coriell Institute for Medical Research will produce and distribute periodic newsletters and quarterly reports for the Community Advisory Groups (CAGs) in each community where new samples were collected for the International HapMap Project, These materials will be produced and distributed for as long as the CAGs remain in existence and are interested in receiving them.

The newsletters will include general information about the Project, the participating communities, and how the HapMap and the stored samples are being used. Each issue of the newsletter will be available in English and the primary languages of the participating communities.

A separate quarterly report will be prepared for each participating community. Each quarterly report will provide a list of all orders received for the community's samples for the preceding quarter. The list will include, for each order: the date of the order; the name of the investigator and institution ordering the samples; the number of samples ordered; and a brief description of the research (written in lay language). The quarterly report will also list publications about the HapMap Project, publications from studies that have used the HapMap, and publications from other studies that have used the community's samples.

Frequently Asked Questions

1. What samples are subject to this policy? This requirement for community consultation applies to the collection of samples from populations (groups of people who share a common ethnic or geographic origin) when the intention is to make the resulting set of samples available as a "named population" in the Repository's Human Variation Collection. Certain aspects of this policy may need to be substantially modified for the collection of samples from populations in countries other than the United States in respect for local cultural or political norms. Nevertheless, the establishment of some form of meaningful involvement is recommended for all samples from named populations submitted to the Repository, regardless of the country in which they are collected. It is important to be aware of historical or current political issues that might affect how the research using the samples will be perceived and how it might potentially affect the community. Knowledge of local laws or other constraints while planning the research is necessary to prevent complications during the research process. Regardless of how the community consultation is done, NIH-funded research involving foreign subjects requires the same assurances (e.g., human subjects, inclusiveness of women, members of minority groups, and children) as research involving U.S. citizens. (See http://grants1.nih.gov/grants/policy/nihgps_2001/part_iib_7.htm for the NIH Grants Policy Statement on Awards to Foreign Institutions, International Organizations, and Domestic Grants with Foreign Components). This policy is not meant to be applied to the collections of samples that are acquired by the Repository solely because the donors have a particular genetic disorder or serve as controls.
2. What are the responsibilities of the collector? The collector is responsible for (1) determining what constitutes the population and the most appropriate communities to consult within that population, (2) making the initial contact with the appropriate community to determine the appropriate social structures through which to identify representatives of the community, (3) engaging in substantive consultations with representatives of the community, (4) documenting the consultations and their outcomes, and (5) establishing a community advisory group. The collector is also responsible for obtaining IRB approval from his/her institution for the sample collection protocol. Following approval by the NIGMS project officer and the Repository director, the collector may contact potential sample donors, obtain their individual informed consents, and collect and send the samples to the Repository. Once the samples become part of the Repository collection, the collector, in cooperation with the Repository director, is responsible for maintaining contact with the community advisory group and for facilitating communication between the group and the Repository.
3. What can be done if collectors do not reside near the community where the samples are collected? The collector should designate a local collaborator in the community to maintain contact with the group and to facilitate communication between the group and the Repository after the samples are collected.
4. What are the responsibilities of the Repository director? The Repository director will notify any potential collectors of the policy for the collection of samples from named populations. The Repository director will work closely with the collector and the project officer to assure that appropriate community consultation is conducted in advance of the collection. The Repository director shares the responsibility with the collector (or the designated local collaborator) for communicating and consulting with the community advisory group, for documenting the consultations with the group, and for notifying the project officer and the Repository's IRB of the consultations. The Repository will provide limited funds to compensate community advisory group members and collectors for local travel expenses to attend yearly group meetings and to pay for expenses such as meeting facility rental. Reimbursement of travel expenses for the collector to meet with the community advisory groups within the United States will be considered by the Repository if other sources of support for research activities involving the community are not available to the collector.
5. What are the responsibilities of the community advisory group? The community advisory group serves as the liaison between the community and the Repository. This group is responsible for staying informed about the research uses of the samples, advising the Repository director of concerns about the research use of the samples, and disseminating back to the community information on the research use of the samples. The community advisory group is also responsible for appointing new members to replace members who might no longer be able to serve and notifying the collector and the Repository director of the changes.
6. What are the responsibilities of the NIGMS project officer? The project officer is responsible for discussing with and advising prospective collectors about the policies for the collection of samples from named populations and for giving final approval for the submission of such samples following the consultations with the community and the submission of documentation by the collector. The project officer is also responsible for arbitrating any disagreements between the community advisory group, the Repository, and investigators who obtain samples for their research.
7. What are the responsibilities of the investigator who obtains the samples? The investigator must obtain approval from his/her IRB for the studies that will use the samples. The investigator must submit a Statement of Research Intent to the Repository. In addition to the standard assurance form that users of Repository samples must sign, the investigator must agree to abide by any restrictions placed on the use of the samples by the community. The investigator must also agree not to disclose the identity of the population from which the samples were obtained if this information is not scientifically relevant, unless the community requests that its identity be revealed.
8. What are the responsibilities of the collector's IRB? The collector's IRB must approve the protocol for the collection of samples from the named population and their subsequent storage in the Repository.
9. What are the responsibilities of the Repository's IRB? The Repository's IRB must obtain the documentation provided by the collector about the community consultations, an unsigned copy of the informed consent form that individual donors signed, and reports of communications that take place between the Repository director and the community advisory group. The Repository's IRB is responsible for assuring that the Statement of Research Intent submitted by investigators who wish to use the samples is consistent with the community's and the individual sample donor's intent as reflected in the signed consent forms.
10. What are the responsibilities of the investigator's IRB? The investigator's IRB is responsible for evaluating the research protocol that would involve these samples and approving the protocol if it meets the appropriate criteria for importance and for the protection of human subjects.
11. How will differences of opinion regarding the participation in sample collection between members of the community be resolved? It is the responsibility of the collector to demonstrate that the community was appropriately consulted and that the community feels comfortable with the collection of samples from its members. It is expected that in any community there will be some differences of opinion. However, if a significant portion of the members of a community has serious reservations about the advisability of collecting samples from the community, the collection should probably not be done.
12. How will differences of opinion among members of a community advisory group be resolved? Again, it is expected that some differences of opinion will occur. It is suggested that, at the time the community advisory group is established, the group will develop its own plans for addressing and resolving potential disagreements.
13. This policy addresses only the bioethical issues related to samples from named populations. Does the Repository conduct any scientific review or quality control on these samples? Like all samples that are available in the Repository, the inclusion of these samples in the collection must be approved by the Working Group of the Human Genetic Cell Repository, a group composed of individuals with expertise in medical, molecular, and population genetics, cytogenetics, bioethics, and bioinformatics. In addition, like all samples, these will undergo rigorous quality control procedures as described on the Repository's Web site at (Quality Control Procedures for the Repository).
14. What are the Repository's policies about redistribution of samples and the on commercial use of samples? The secondary distribution and sharing of samples between investigators is permitted in certain specific circumstances if it can be established that protection of human subjects and quality control can be assured. Sharing of the same cell lines or DNA samples permitted under this policy includes use by two or more investigators for a common research purpose, use by the staff of a multi-user core facility to perform assays for investigators at the same or collaborating institutions, or distribution of samples for use as standards. These activities are permitted only after review by the Repository's IRB. The complete policy can be found in the Policy on Secondary Distribution and Shared Use of Cell Cultures and DNA Samples. The Repository does not allow commercial products to be developed from its human cell lines or DNA samples.
15. Can an investigator who obtains a sample for use in one research project use it for other projects? No. In order to obtain a cell line or DNA sample from the Repository, an investigator must submit a Statement of Research Intent. The Repository's IRB assures that the proposed research use of the sample is consistent with the informed consent that the individual signed and, in the case of samples from members of named populations, that the proposed research use is consistent with the community's views, as expressed in the initial community consultations and by the community advisory group. If an investigator wishes to use the sample for a different research project, he or she must submit a new Statement of Research Intent to the Repository.
16. What will happen if a community, acting through its community advisory group, decides to withdraw the community's samples from the Repository? Following a thorough community consultation process, it is unlikely that a community would wish to withdraw its stored samples from the Repository. However, if the community advisory group, reflecting the views of a substantial portion of the community and after careful consideration, wishes to withdraw the community's stored samples from the Repository, the Repository will respect the community's wishes. The Repository will either destroy the stored samples or return them to a designated community representative, whichever the community prefers. However, the Repository staff will be unable to return samples that have already been sent out to investigators. In addition, since individual sample donors cannot be identified, it will be impossible for an individual member of the population to withdraw his/her sample.
17. What will happen if the community advisory group dissolves itself and ceases to exist? It is possible that, over the period of time that samples are stored in the Repository, the community advisory group may lose interest. If this occurs, the community should be assured that the Repository will continue to respect the wishes of the community, as expressed during the initial community consultation and during the course of the community advisory group's existence. The Repository's IRB will continue to assure that the Statement of Research Intent submitted by investigators who wish to use the samples is consistent with the community's and the individual sample donor's intent as reflected in the signed informed consent forms, and the investigator will continue to be required to agree to abide by any restrictions placed on the use of the samples by the community.
18. Are there additional considerations when using samples from the International HapMap Project? The Repository will distribute quarterly reports to each community advisory group listing the names and institutions of investigators who have ordered the samples from that community. A brief description of the proposed projects will be included. The reports will list publications resulting from use of the samples as they become available. Periodic newsletters will also be provided to all of the communities describing general developments with the HapMap and how the samples are being used.