This webpage discusses genomics-relevant considerations for informed consent and provides guidance on how to approach them. It also provides sample language to help investigators think through important content to include in their consent forms and how to use clear and concise language to inform participants about the risks and benefits of participating in a research project.
For genomics research, it is particularly important to consider specific implications for the following issues:
- Broad Versus Specific Consent
- Considerations for Families
- Considerations for Identifiable Populations
- Studies Involving Children
- Studies Involving Participants Who Cannot Give Consent
- Data and Sample Sharing Through Data Repositories and Biobanks
- Return of Results and Incidental Findings to Participants
Broad Versus Specific Consent
The informed consent process and consent form should reflect the research uses for which samples, genomic data, and health information might be shared. Investigators should ensure that the consent approach for their study is consistent with program or funding agency data-sharing expectations. In general, broad consent is preferable whenever possible to facilitate future research and increase the scientific value of the data. For NIH-funded research, investigators are expected to obtain consent for future uses and broad sharing of genomic and phenotypic data. For more information on genomic data sharing expectations, see the NIH Genomic Data Sharing Policy. When considering the use of tiered or specific consent approaches, investigators should balance the responsibility of protecting participants' interests with the potential loss of opportunities for public benefit due to limitations on future research uses.
In addition to or in combination with obtaining specific consent for research in which genomics is the primary aim, and for some disease-specific research that considers genomics, participants can be asked to agree to storage of their samples and/or data and to the use of their samples/data in future unspecified research ("general research use"). Broad consent maximizes the utility of collected samples and/or data.
Sometimes, it may be appropriate to seek consent for more narrowly defined research uses of participant samples and data. In addition, a biobank or data repository could establish a dynamic consent process by which participants can change their consent preferences over time. These consent approaches may increase participation of people who have concerns about privacy or do not want their samples and data used for research on certain topics.
Researchers may include options for data use limitations in the consent form. Some potential limitations on samples and data include:
Use of the samples and data is limited to health/medical/biomedical purposes; does not include the study of population origins or ancestry.
Use of the samples and data must be related to a specified disease.
Use of samples and data must be for not-for-profit purposes or by non-commercial entities.
Under some consent and governance strategies, biobank or data repository coordinators may re-contact participants and seek specific consent for each new study using the samples and data. If researchers contact potential participants because they have a specific genotype (genotype-driven recruitment), they should be aware of participants' expectations about any such future contact and potential concerns and questions about whether they are being recruited because they have a disease risk, which could come as a surprise to them.
Writing consent forms that offer multiple options can be challenging: investigators should ensure that any choices participants can make are clearly described and consistent over time, and that the consent form does not allow participants to make conflicting choices or choices that will be difficult for researchers to interpret. If a study investigator provides research participants with a set of choices or levels of participation in the research project, it is important that the investigator and, as appropriate, the data repository and/or biobank, have the appropriate mechanisms in place to track the individual participant choices and to ensure that data use is consistent with those choices.
For genomic studies involving the use of previously collected samples, research data, and health information, investigators should consult with their IRBs to determine whether the informed consent for the primary research is consistent with the proposed genomic studies. If the original consent seems too narrow, or if it seems highly unlikely that genetic or genomic analyses would have been anticipated, the Institutional Review Boards (IRB) may determine that re-contact of research participants to seek their consent for the proposed genomics research (and likely subsequent data sharing) is appropriate. Therefore, some of the sample language below reflects wording that could be used when re-contacting participants about new uses of their previously collected specimens.
Overall, it is important that investigators inform participants of the primary and any anticipated secondary uses of data (including unspecified future uses) and their options for participation.
Sample Language: Broad versus Specific Consent
[Broad consent example]
Your samples, genomic data and health information will be stored and shared with other researchers. The samples and information will be available for any research question, such as research to understand what causes certain diseases (for example heart disease, cancer, or psychiatric disorders), development of new scientific methods, or the study of where different groups of people may have come from.
[Tiered consent example]
If you wish to participate, please check your answers to the following questions.
May we collect your tissue samples, health information, and genomic information to study [state specific research project]?
May we share your tissue samples, health information, and genomic information with other researchers to study [state specific disease or disorder]?
May we share your tissue samples, genomic data, and health information with other researchers for future research projects related to other topics?
[Permission to re-contact example]
Researchers might want to ask you to participate in additional studies. In some cases, you might be a particularly good candidate for a particular study because of your health history or genomic information.
May we contact you in the future to get your permission to use your samples, health information, and genomic information for additional studies?
May we contact you in the future to ask your permission for additional samples or follow-up information about your health or medical care?
Considerations for Families
Family perspectives are an important and complex topic to discuss during the informed consent process for genomics studies. If individual research results are returned as part of the study, an individual may effectively become the gatekeeper for information that could have both positive and negative implications for his or her biologically-related family members. Depending on the study design, genomics research results about an individual's current or future health risk may be relevant to family members. For example, learning about a relative's genomic results could influence someone's decision to get tested themselves, or it could impact reproductive decision-making. Genomics research results may also reveal unexpected information about family relationships, such as the presence of misattributed paternity or adoptive relationships where a biological relationship was previously assumed. When relevant, researchers should plan how to manage such information, and participants should be informed about the circumstances under which such information would and would not be disclosed to them or to family members. For more information on the return of results, see the Return of Results and Incidental Findings to Participants section.
For genomics research that requires recruiting multiple family members, researchers often ask participants to identify family members eligible for study participation (i.e., requesting family histories with names and contact information, and participants' help to initiate contact with relatives). This sort of family recruitment raises ethical issues about how to recruit families while minimizing unwelcome intrusions and undue pressure upon family members to enroll in genetic or genomic studies. The IRB should determine the appropriateness of the recruitment plan and decisions about the timing of informed consent for family members.
Although deceased individuals are not considered to be research subjects under the Common Rule, there are consent-relevant considerations related to the ongoing use of samples and data from deceased participants. Because the Health Insurance Portability and Accountability Act (HIPAA) protects confidentiality for 50 years after death, use of a deceased individual's identifiable data for research would require next-of-kin authorization for any information covered by HIPAA. The results of post-mortem genomics research analyses may be clinically relevant to surviving family members, raising questions about whether those family members should be informed that the research on their deceased relative's samples, genomic data, and health information is ongoing, whether they should be informed of these results, and when an individual's confidentiality should be protected after his or her death. If appropriate to the study, recruited participants can be asked explicitly at the time of informed consent whether, and with whom, their post-mortem results of clinical relevance should be shared, and any authorization to disclose protected health information should be documented according to HIPAA requirements.
Sample Language: Considerations for families
Before joining the study, you may want to consider discussing your plans and this study with your family members.
Because certain conditions and traits run in families and are inherited through genes, this study is recruiting biologically-related family members. This study will compare family members who have [disorder] and family members who do not have [disorder].
You may learn something about your genome that relates to the health of your relatives. If so, your relatives might want to know so that they can decide whether to get tested or follow up in other ways. It is also possible that they might not want to know.
It is possible that we will learn that assumed family relationships are incorrect (such as learning that a child is adopted or has a different father). [Possibly] We will not give you these results. [OR] We will tell you these results only if they are relevant to your health.
Considerations for Identifiable Populations
Identifiable populations, which include specific racial or ethnic groups, geographically defined communities, and members of ultra-rare disease groups, present particular concerns with regard to privacy, stigmatization, and discrimination. Researchers recruiting members of such groups should strive to understand and mitigate potential group risks, and communicate about such risks during the consent process, particularly regarding how groups will be identified when summary-level results are disseminated. It is also possible that members of populations that may be vulnerable to such risks nevertheless place high value on research progress and hence might agree to participate with the expectation of eventual benefit to individuals who share their group affiliation. Researchers may consider offering tiered consent options that limit some prospective sample or data uses (see Broad Versus Specific Consent). Researchers should also explain what will happen to stored samples or data when the study ends, participants withdraw from the study or the repository closes (see Data and sample sharing through data repositories and biobanksand Withdrawal from Research).
Potential participants should be made aware of (1) individual risks they might face because they are part of an identifiable population, and (2) potential risks to an identifiable population to which they belong. There is evidence that some individuals base, in part, decisions about their participation in genomics research on assessments of the risks and benefits of a given study for racial and ethnic groups with which they identify. This suggests that it is appropriate to incorporate discussions about the effect of genomics research on group risks and benefits in the consent process.
When appropriate, researchers should work directly with members of identifiable populations before research commences and throughout the research study to help inform the study design and the informed consent process. Some communities may require the research to obtain community approval before seeking consent from potential participants. For example, the Indian Health Service (IHS) approval process requires formal, written approval by the tribal government(s) before even submitting any documents to IHS and tribal IRBs., The NIH Genomic Data Sharing Policy recognizes the importance of giving consideration to group or population risks, and of ensuring that data submission is consistent with local laws and policies, including any relevant tribal laws or regulations.
Sample Language: Considerations for Identifiable Populations
This study has been developed in consultation with [representatives of the community, describe]. These community representatives have been/are involved in [describe their involvement].
[For a biobank/data repository] Although we will not give researchers your name, we will give them basic information such as your race, ethnic group, geographic region, age range, and sex [specify demographic variables]. This information may help researchers study whether the factors that lead to health problems are the same in different groups of people. It is possible that such findings could one day help people in the same groups as you.
However, it is also possible that research findings could be used inappropriately to support negative stereotypes, stigmatize, or discriminate against members of the same groups as you.
Studies Involving Children
Children are vulnerable research participants because they are not legally or cognitively able to consent. For these reasons, parental permission is generally necessary for the participation of children in research. Children should be given age-appropriate information and included in the permission/assent process to the greatest extent possible. As with any research, assent (agreement to participate) is required from older children but they cannot provide consent for themselves. 
Genomics research that involves children can reveal information that might raise concerns for children and their families. Specifically, genomic analyses could reveal the presence of particular conditions, disease susceptibilities, or carrier statuses that are relevant for the enrolled children or their family members, including adult onset conditions. Some questions that may arise include whether it is appropriate to disclose the risk of adult-onset conditions to children; whether to honor future autonomy (and the right to an open future) when the child has a condition where he is unlikely to gain capacity; and whether researchers must honor a parental decision not to learn about a piece of information that has clinical significance for their child. Researchers should anticipate how such issues will be managed, including informing parents about the circumstances under which results will be disclosed to the parents and/or the child. ,,,,
Researchers should also consider whether minors enrolled in their studies will reach the legal age of consent during the study period and what, if any, re-contact should take place at that time. In many pediatric studies, samples, genomic data, and health information analyses continue after the direct involvement of the child in the research has ended. This is an important consideration for genomics research in which samples, genomic data, and health information are stored for future use. The initial informed consent process should communicate any plans for obtaining legal consent for research participants who reach the age of majority during the conduct of research with their samples, genomic data, and/or health information, including what will be done if research participants cannot be reached at the age of majority and the possibility of a waiver of consent being issued to continue research use of study data. When surveyed about a hypothetical situation, respondents in one study felt that researchers should attempt to obtain consent from children who reach the age of majority, but that it is acceptable to continue research when it is impossible to locate individuals. NHGRI-funded consortia have begun to distill some of the known challenges of consent in pediatric biobanking into concrete practical recommendations on topics including tailored educational materials, developmental level and assent, what will be done at the age of majority, and return of results.
Sample Language: Studies Involving Children
As a part of the study, your child'ssamples, genomic data,andhealthinformationwill be stored and used for future research. When your child reaches age 18, we will try to contact him or her to ask whether he or she wants to continue to participate in research. If we cannot find your child, we will remove identifying information, and continue to include his or her samples, genomic data and health information in research.
We may learn information relevant to your child's or your family's health. [Tailor based on the plans for returning results, for example:] If this happens, we will tell you only information directly related to diseases and disorders that affect children. Your child can request additional information when he or she is 18.
Studies Involving Participants Who Cannot Give Consent
Some developmental disorders and degenerative disorders that affect children and adults are characterized by reduced cognitive and decisional capacity. Additionally, people who have suffered an acute injury may be unable to consent. As with any research, when a potential adult research participant is unable to provide consent to participate in research, a surrogate decision maker may be able to provide permission on behalf of that adult. While an adult may be unable to make decisions about study participation, he or she may be capable of designating a surrogate. The procedures for surrogate consent should be reviewed by an IRB and be consistent with institutional and state policies. In obtaining surrogate consent, investigators should ensure that any legal requirements for assignment of power of attorney or legal guardianship are met. Because capacity to consent often is considered a basic entrance criterion, IRBs sometimes do not approve genetic studies that rely on consent from surrogates, which might result in selection bias or impede research in some fields. To help address this issue, the NIH has resources regarding research involving individuals who are unable to give consent., Because genomics research on stored samples and data might go on indefinitely, a participant's capacity to provide ongoing consent or re-consent may be impossible. Participants at high risk of losing the ability to consent (such as those with a degenerative disorder), should be encouraged to state how they wish the researchers to obtain future consent. Researchers should ensure that the consent form takes these contingencies into account, including the possibility of using a surrogate for ongoing consent or re-consent.
Sample Language: Studies Involving Participants Who Cannot Give Consent
[If the study includes participants who lack the capacity to consent but are capable of designating a surrogate]
I designate ____________________ [OR a previously designated legal guardian/named power of attorney] to make decisions about my participation in this research project.
[If participants are at high risk of losing capacity to consent]
If my [e.g. dementia, illness, etc.] progresses to the point that I cannot answer questions about whether to participate in the study:
You may continue to use the samples and data you have already collected from me [Yes] or [No]
You may collect new samples or data from me, just as described in this consent form [Yes] or [No]
I designate ____________________ [OR a previously designated legal guardian/named power of attorney] to make decisions about my participation, consistent with what I have agreed to here.
Data and Sample Sharing Through Data Repositories and Biobanks
Samples collected from research participants or patients, the genomic information generated from these samples, and participants' associated health information are often stored for future research use. It is increasingly common for samples and/or data to be stored in repositories where they can be used by other researchers for purposes beyond those of the primary investigation (secondary research use) or for samples and health information to be collected solely for deposition in a biobank. Sharing samples/data for secondary research use maximizes their scientific utility and promotes the achievement of public benefit. We define biorepositories or biobanks as repositories that store and distribute biospecimens and associated data. Repositories that store and distribute only data are referred to as databases or data repositories.
It is important to note that for NIH-funded genomic studies initiated after January 25, 2015 (the effective date of the NIH Genomic Data Sharing (GDS) Policy), NIH expects investigators to obtain explicit consent for participants' genomic and phenotypic data (which may include some clinical information) to be used for future research purposes and to be shared broadly through databases repositories. In general, secondary investigators can access de-identified individual-level participant data through NIH-designated data repositories via controlled-access procedures that enable research use for specific purposes defined by the submitting institutions based upon the participants' informed consent. Only if participants explicitly consent to allow unrestricted access to and use of their data for any purpose should individual-level genomic data be provided via open data repositories. These expectations for informed consent to include discussion of future use and any data sharing plans also applies to NIH-funded studies that generate large-scale genomic data also include studies using genomic data from de-identified cell lines or clinical specimens that were created or collected after the effective date of the NIH GDS policy.
See http://gds.nih.gov/ for more information.
Researchers who plan to deposit share samples and/or genomic data in through biobanks or data repositories bases should disclose these plans, and related considerations, prospectively during the informed consent process. The informed consent process should include information on the following:
What samples, data, or other information and/or data will be shared: The informed consent process should specify what samples, and/or data, or summary results will be shared (e.g., deposited in a repository) and available for use by investigators outside of the study team. Expectations about control over future use of data and confidentiality of identifiable information can affect participants' willingness to participate in research, so explaining the extent to which identifiable information will be shared is critical. Implications for the protection of participants' privacy and confidentiality also should be addressed in the consent process (see Confidentiality).
How the samples, data, or other information and/or data will be shared: Biobanks and data repositories bases may be generally accessible to the public (unrestricted access) or accessible only with the permission of governance committees or other processes (controlled access) depending on the nature of the data, local policies, qualifications of the user, and other factors.
As of November 1, 2018, NIH does enable unrestricted access to genomic summary results (GSR) from most genomic studies to advance health or scientific research. The GSR shared may be generated by a study investigator or by an NIH-designated data repository where the data are deposited. GSR are defined for these purposes to include any systematically computed statistics such as, but not limited to, genotype counts and frequencies and allele counts and frequencies. In some cases, however, institutions can choose to keep GSR under controlled-access by designating this information as "sensitive." Institutions may determine this to be appropriate for GSR from studies that may include potentially stigmatizing traits or vulnerable populations because of heightened privacy or confidentiality risks for these groups. NIH expects that the informed consent process and consent forms for NIH-funded studies generating large-scale genomic data will clearly state the access plans for data and other information generated through the study, including GSR. This should include that summary results may be shared through public scientific resources, such as data repositories that provide unrestricted access to the information (for non-sensitive studies), or controlled-access to the information (for sensitive studies). For all studies, consent processes should note that summary results may be shared through the scientific literature.
How the samples, data, or other information and/or data might be used: Participants may provide broad consent for unrestricted future research uses of their samples and/or data or they may provide specific consent that limits future research uses of their samples and/or data (see Broad Versus Specific Consent). If the study involves depositing samples into a biobank, it is important to consider the derivatives (such as cell lines or other products that could be propagated and used for many years) and data (including genomic data, epigenetic data, and other unanticipated types of data) that may be generated from those samples, and to include this information in the informed consent process. Some of these derivatives and data types may raise unique ethics concerns, ,  for example, creating induced pluripotent stem cells (iPSCs) from donated samples for regenerative medicine. Because some participants will be uncomfortable with some potential uses, the consent process should explain for what purposes cell lines might be used, including those uses related to genomic information. Research participants should also be informed about whether there may be any future commercial use of their data (or samples), and whether or not there is any potential that they will receive financial benefit from these activities.
If participants may be contacted in the future: The informed consent process should include discussion of any potential re-contact of the participant for additional information collection or requests to participate in other studies. In particular, an explanation of any planned genotype-based recruitment to subsequent studies should be included. Asymptomatic biobank participants may be surprised to learn that their genotype may link them to a disease or disorder, so this should be considered within the informed consent process for the primary and the secondary studies. Similarly, plans or any potential for returning results from future research using stored samples and data should be discussed (see Return of Results and Incidental Findings to Participants).
What will happen to a participant's samples, data, or other information and/or data following a change in participation status: The informed consent process should include discussion about what will happen to stored samples and/or data if the participant withdraws from the study, (if relevant) reaches the age of majority, has some other change in status that might affect his or her willingness to participate, or dies. This discussion should include whether the investigators and/or secondary investigators might continue to use the participants' stored samples or genomic data after participants have withdrawn from the study (see Withdrawal from Researchfor more information).
What will happen to samples, data, or other information and/or data if the repository closes: Participants should understand whether samples and/or genomic data will be destroyed or transferred if the repository closes.
For information specific to consent in pediatric biobanking, see Studies Involving Children.
Sample Language: Data and Sample Sharing Through Data Repositories and Biobanks
Storage and release of samples, genomic data, and health information
Portions of your samples, genomic data, and health information will be stored for an unlimited period of time to be used in future research.
[If appropriate] As part of this project, your samples will be used to create cell lines that will keep reproducing and can be used for many purposes. We will store the cell lines and other samples and data in a "cell bank," so that other researchers and companies can apply to use the cell lines in their own research. The cell bank will only release cell lines to researchers and others under certain conditions. [Specify the terms of release established by the repositories, such as IRB approval or approval by a governance committee.]
Unrestricted access databases:
The information from this study will be freely available in a public, unrestricted database that anyone can use. [For example], the public database will include information on hundreds of thousands of genetic variations in your DNA code, as well as your ethnic group and sex. The only health information included will be whether you had [disease X] or not. This public information will not be labeled with your name or other information that could be used to easily identify you. However, it is possible that the information from your genome, when combined with information from other public sources could be used to identify you, though we believe it is unlikely that this will happen.
Controlled access databases:
Your individual genomic data and health information will be put in a controlled-access database. This means that only researchers who apply for and get permission to use the information for a specific research project will be able to access the information. Your genomic data and health information will not be labeled with your name or other information that could be used to identify you. Researchers approved to access information in the database will agree not to attempt to identify you.
[For GSR under unrestricted access]
Although researchers will not be able to access information specific to you without permission, it will be generally possible to access some summary-level information about all the participants included in a dataset (including you), or across multiple datasets, without applying for permission. This information may be shared through the scientific literature or through other public scientific resources, such as data repositories that provide unrestricted access to the information. Some examples of information that may be shared includes how different genes are associated with different traits or diseases across the many participants in a dataset, or how often certain gene changes are seen across participants from many studies. The risk of anyone identifying you with this information is very low.
[For 'Sensitive' GSR under controlled-access]
Although researchers will not be able to access information specific to you without permission, some summary-level information about all the participants included in a dataset (including you) may be shared through the scientific literature. Some examples of information that may be shared includes how different genes are associated with different traits or diseases across the many participants in a dataset, or how often certain gene changes are seen across participants.The risk of anyone identifying you with this information is very low.
The plan for offering research results to participants should be carefully articulated at the outset of any study and made clear to potential research participants.
The following topics should be covered in the informed consent process:
Whether individual results will be returned, and if so, what types of findings may be returned
Whether summary-level study results will be given to participants
When and how results will be returned to participants
Whether results may be returned by secondary investigators if samples or data are deposited in a biobank or data repository
Whether any applicable state or local laws require the return of specific test results to participants (e.g., the diagnosis of particular communicable diseases)
Whether participants may receive unanticipated incidental findings, including lifesaving incidental findings
Sharing primary research results or incidental findings with family members should also be discussed (see Considerations for Familiesfor more information).
It should be made clear in the informed consent process that the clinical significance of some results may be unknown, that the absence of a result does not equate with absent or reduced disease risk, that future research may change the clinical significance attributed to results at the time of the investigation, and whether the study team will be responsible for providing updates to participants regarding the significance of individual results.
There is little consensus on whether results should be returned, and if so, what types of results should be returned to research participants, though some groups have issued recommendations for returning incidental findings in clinical care  and in research settings.I nvestigators who plan to return individual research results should also consider the possibility that participants might wish to opt out of receiving individual results during the consent process, and whether that is appropriate with respect to the study design. Investigators may find it helpful to provide participants with various examples of results they might receive in order to establish expectations about the breadth of results that could be received, and to give participants a framework for deciding which type of results they might be interested in receiving. If researchers provide multiple options for the types of results to receive, there must be a robust mechanism for tracking these choices.
Some types of results to consider when developing any plans for return include:
Medically preventable conditions
Medically relevant results with unclear treatment implications
Results without personal health implications, but which may be useful for reproductive planning
Results of uncertain significance
In studies that do return results, it should be considered up front whether or not to return results for adult-onset disorders to children (or the parents of minor participants). If there are study participants under the age of 18, the consent process should describe whether return of results is dependent on the age of the participants and whether participants will be given the opportunity to provide consent for return of results when they reach the age of majority. For more information on informed consent for children in genomics research see Studies Involving Children.
For men and women of reproductive age and for women known to be pregnant at the time of enrollment, the informed consent process should include information about the relevance to reproductive planning of any results that are returned. Considerations of reproductive planning may also be relevant to parents of children involved in research.
Any plan to offer research results must be IRB approved, and a CLIA-certified lab must confirm all individual results that will be returned to participants. For more information on return of genetic results and incidental findings, see Return of Research Results.
Sample Language: Return of Results and Incidental Findings to Participants
[No results returned to participants]
In general, we will not give you any individual results from the study of the samples you give us. If we find something of urgent medical importance to you, we will inform you, although we expect that this will be a very rare occurrence.
[Participants will receive aggregate results]
Once the study has been completed, we will send you a summary of all of the results of the study and what they mean. We will not send you your individual results from this study.
[Participants have option to receive individual results]
As they become available, do you want us to contact you and ask whether you want to receive your genetic results?
What types of results would you like to receive?
Results about my genetic risks that I can do something about, like start a new medication or have preventive screening.
Results about my genetic risks that I cannot do anything about but that might affect my future health.
Results that might be important for my family members or for my plans to have future children (if relevant).
Do you want to be contacted by other researchers with results from studies using your samples, genomic data, and health information?
Some things you should know about results:
Any results we return to you will first be verified in a clinical lab.
The results will be explained to you by a genetic counselor, a health professional who has training in genetics and counseling. [if applicable]
Sometimes the meaning of the results will be uncertain. It is important to know that our understanding of genetics is changing quickly, and in many cases, we will not know for sure what the results mean for your future health.
Sometimes, even if you learn of a clear diagnosis, there will be no clear treatment.
For many participants, only certain genes will be analyzed, so we will not find all gene variants that cause disease. You should not assume that if you are not contacted, that you do not have any gene variants that might be related to a disease.
It is possible that we will discover that you have a gene variant that is unrelated to the purpose of this study. If we believe that the information is of urgent medical importance, we will share this information with you. You should not assume that if you are not contacted, that you do not have any gene variants that might be related to a disease.