Mandatory Reporting

Version: December 16, 2025

Guidance

This guidance outlines information that should be shared with participants during the informed consent process relating to the 1) disclosure of confidential information of reportable diseases; 2) disclosure of abusive situations; and 3) disclosure of information about harming others or themselves. In some cases, the disclosure of confidential information is mandatory (by law or University policy) and in other cases, the researcher may have a professional duty to make such disclosures. For the citations of applicable laws, please see the University of Utah Board Member Guidance Series: Applicable State Laws.

Reportable Diseases

Local and state health departments require certain diseases to be reported in the interest of public health. These diseases are called “reportable diseases”. Cases of reportable diseases are required to be reported to local and state health departments by health care providers, hospitals or laboratories. By complying with reporting requirements, state and local health departments can improve public health through prevention services, treatment and care, and disease control. Each state has its own laws and regulations defining reportable diseases. The list of reportable diseases may vary over time.

Investigators should be familiar with the local reporting requirements because reporting requirements will vary based on location. You may refer to Utah Department of Health & Human Services website for a current list (rev. 3/2023) of Utah’s reportable diseases, including the reporting time frame and how to report.

If a reportable disease may be detected, diagnosed or treated during the course of a research study at the University of Utah, the IRB may request the following:

The informed consent document states the intent to test for the reportable disease.
The informed consent document states the investigator’s responsibility to report to the appropriate agency and how the reporting will affect confidentiality.
If a positive result and the notification to the appropriate health department may result in partner notification activities, this should be stated in the confidentiality section.
The informed consent document describes opportunities for follow-up counseling or medical care, as applicable.

Sample consent language can be found in the Points to Consider section below.

Please see Appendix A of this document for more information regarding requests for exemption of mandatory reporting of AIDS and HIV infection in Utah.

Abuse

In some cases, mandatory reporting of confidential information may be required. If researcher is legally obligated to reveal instances of child abuse, elder abuse, or abuse of the disabled, a disclosure should be given during the informed consent process. If your study involves the possibility of disclosure of abusive situations, mandatory language must be included in the consent document. Sample consent language can be found in the Points to Consider section below.

Sexual Misconduct and Discrimination

Under University of Utah policy, most University employees (including researchers) are required to report situations involving sexual misconduct and discrimination to the Office of Equal Opportunity and Affirmative Action (OEO/AA). This includes research activities that may result in a participant who is a University of Utah student disclosing alleged sexual violence. The PI/study team member to whom incidents of this alleged sexual violence is disclosed is considered a “mandatory reporter” and has an obligation to report these incidents to the University of Utah Office of Equal Opportunity, Affirmative Action, and Title IX (OEO). If the research is such that participants may divulge experiences with sexual violence and participants are adult students (18+) at the University of Utah, the consent document should include language that outlines this required reporting. Sample consent language can be found in the Points to Consider section below.

Threat to Self or Others

In some cases, a researcher may have a duty to disclose information necessary to prevent a serious and imminent threat to the health or safety of the patient or others. If a study involves the possibility that participants may disclose information about harming themselves or others, investigators should include a statement about the potential breach of confidentiality. Sample consent language can be found in the Points to Consider section below.

Documents and References

BMGS: Applicable State Laws

University of Utah Consent Document Checklist – Supplemental Elements Tab

University of Utah Office of Equal Opportunity (OEO/AA)

Utah Department of Health and Human Services Office of Communicable Diseases

Utah Department of Health and Human Services Reportable Disease List (Rev. 3/2023)

Points to Consider

New Study Application

Resources and Responsibilities page (question 4): If applicable, describe plans to refer participants for follow-up care or counseling.

Consent Document

Procedures: If testing for a reportable disease, describe the intent to test and the responsibility to report.
1. Sample Language: The tests that may be performed include <<type of test>>. Positive <<communicable or infections disease>> test results are required to be reported to local health authorities.
Confidentiality: Please state which reportable disease the participant will be tested for and that a positive result must be reported to the local or State Health Department where the participant resides. State that if a participant does not want to be tested, they can choose not to participate in the study.
1. Sample Language: You may be tested for <<communicable or infections disease>>. You will have appropriate counseling regarding this testing if the results are positive for <<communicable or infections disease>>. The results of your tests will be confidential but will appear in your medical records. Utah State law requires the test results to be reported to the Utah Department of Health and Human Services (UDHHS). In this instance the Study Doctor will offer you information relevant to your health and advise you on the next steps regarding your medical care and appropriate counseling. Confidentiality of your data will be respected at all times.
Confidentiality: If a positive result and the subsequent notification to the appropriate health department may result in partner notification activities, please inform participants that the Utah Department of Health or local health department shall conduct partner notification activities and counseling as per their own policies.
Confidentiality: If mandatory reporting is required of the investigator considering the scope of the research, ensure that the participants are informed of such potential disclosures.
1. Use the following statement verbatim if your study involves the possibility of disclosure of abuse situations: If you disclose information that gives study staff a reason to believe that a child or disabled or elderly adult has been subjected to abuse or neglect, study staff will report that information to Child Protective Services, Adult Protective Services, or the nearest law enforcement agency to the extent required by law.
2. Sample language: There are some cases in which a researcher is obligated or authorized by law to report issues, such as serious threats to public health or safety.
3. Sample language: It is important to note that should you disclose certain conduct (e.g., child abuse) during this research, the study team would be required to report it to law enforcement officials consistent with requirements under state and/or federal law.
Confidentiality: For research conducted at the University of Utah with participants who are adult students (18+ years of age) and the research is such that participants may divulge experiences with sexual violence, include the following language:
1. Sample Language: During this research, you may be asked about your experiences with sexual violence. University of Utah policy requires its employees to report situations involving sexual misconduct and discrimination to its Office of Equal Opportunity and Affirmative Action (OEO/AA). OEO/AA can provide support for your safety and ensure you have information about your options. It is important to note that should you disclose certain conduct (e.g., child abuse) during this research, the study team would be required to report it to law enforcement officials consistent with requirements under state and/or federal law.

Appendices

Appendix A: Requests for Exemption of Mandatory Reporting of AIDS and HIV Infection in Utah

Because of the nature and consequences of Acquired Immunodeficiency Syndrome (AIDS) and Human Immunodeficiency Virus infection (HIV), the reporting of those conditions is required in Utah (see Utah Code 26-6-3.5). Health care providers are required to report all positive results, presence of antibodies, and repeatedly reactive tests of AIDS or HIV infection to the Utah Department of Health and Human Services or the local health department where the patient resides (see Utah Administrative Code R386-702-3). For details on how to report, please refer to the Utah Department of Health and Human Services website. Investigators can find extensive provider resources in the event a research participant tests positive for HIV on the Utah AIDS Education and Training Center (UAETC) Website.

In rare cases, the Utah Department of Health and Human Services may grant an exemption from the required reporting (see Utah Code 26-6-3.5(2)(b); Utah Administrative Code R386-702-3(9)). In the course of University of Utah IRB approval, the University of Utah IRB may indicate institutional support for an investigator’s exemption application to the Utah Department of Health and Human Services. The exemption is permitted in research conducted by universities or hospitals under the authority of Institutional Review Boards if the study is funded in whole or in part by research grants; and if anonymity (anonymity means the patient’s personal information would not be reported to the Department of Health and Human Services) is required in order to obtain the research grant or to carry out the research. Researchers must apply to the Utah Department of Health and Human Services for approval of a reporting exemption prior to beginning the study. When applying for an exemption from reporting, the following should be submitted to the Utah Department of Health and Human Services:

A summary of the research protocol;
A written approval of the University of Utah Institutional Review Board; and
A letter showing funding sources and the justification for requiring anonymity.

Studies granted an exemption must provide the Utah Department of Health and Human Services with an annual report of the number of individuals informed of their HIV-positive status and receiving extensive counseling, as well as a report of compliance with state-mandated partner notification.

Please contact the IRB Office at (801) 581-3655 or irb@hsc.utah.edu for additional guidance.