Mandatory Reporting and Human Subjects Research Studies

Researchers should protect the privacy of participants and maintain the confidentiality of research data, per the regulations. However, Maine law requires that certain professionals who suspect child abuse and neglect or who suspect abuse, neglect, or exploitation of an incapacitated or dependent adult report to the Maine Department of Health and Human Services (DHHS). Student researchers (who are not considered employees) are not required to report, but the Faculty Sponsor overseeing the project must comply with the law.

What Needs to be Reported?

Abuse

This includes physical, mental, emotional or sexual abuse of children, elderly adults, and disabled individuals. Mandatory reporters under Maine law must report to DHHS. See the Maine law for reporting suspected abuse or neglect (external link) and more information regarding Maine’s mandatory reporting (external link).

Please note that Maine law requires that abuse or neglect be immediately reported by phone and should be followed up within 48 hours with a written report. More information on reporting procedures (external link).

All researchers, regardless of status as mandatory reporters, shall report abuse to the Institutional Review Board (IRB) as an unanticipated or adverse event in accordance with the UMaine IRB reporting guidance.

Sexual Misconduct and Discrimination

All incidents of sexual misconduct (sexual assault, sexual harassment, dating violence, or stalking) or sexual discrimination involving the university community (UMaine student or UMaine employee) must be reported; see Mandatory Reporting Guidelines from the UMaine Office of Equal Opportunity. The report must be made to the Title IX Coordinator. Reports of sexual misconduct or discrimination may constitute an unanticipated or adverse event that must be reported in accordance with the UMaine IRB reporting guidance.

The University IRB may approve an exception to the requirement to report for certain human subjects research activities that may result in a participant disclosing alleged sexual violence, harassment, or stalking involving the UMaine community. In all instances, however, researchers should offer participants information on resources.

For researchers conducting studies at other institutions, researchers must follow the sexual misconduct and discrimination policies at that institution.

Threat to Self or Others

If a participant discloses that they may harm themselves or others, the researchers will need to report this.

If researchers have questions about reporting, whether they are mandatory reporters, or the process of reporting, they should reach out to the Office of Research Compliance or the University of Maine System (UMS) Office of General Counsel.

Role of the Institutional Review Board (IRB)

The IRB may require that the informed consent includes a warning of when confidentiality may not be maintained. The participants should be notified that the researcher has an obligation to report known or suspected incidents of abuse or neglect to appropriate authorities, which may include law enforcement.

The IRB will review and assist with the language used to inform subjects about the possibility of mandatory reporting.

The IRB will ensure that the consent form requirements do not override state reporting requirements.

Role of the Researcher

The researcher should assess if they think that mandatory reporting events may be encountered in the study.

Any personnel that are a mandatory reporter should be identified by the research team. Personnel who are mandatory reporters under state law should have completed State of Maine Mandated Reporter Training (external link) (available for free online).

The researcher must provide participants with information about the possibility of mandatory reporting, as applicable.

Points to Address in IRB Application

Resources

If applicable, the participants should be provided with appropriate resources for counseling and care.

Consent Form & Assent

A statement must be added to the Confidentiality section of the Consent Form and/or Assent that lets participants know that there are instances when breach of confidentiality is required by law or University policy.

Consent Form Sample Language

We need to make you aware of two exceptions when we will need to break confidentiality. It is our responsibility to report to the appropriate authorities knowledge or suspicion of abuse or neglect of a child or vulnerable adult, or if we learn that you or someone else is at high risk of imminent risk of harm.

If applicable, add: However, we are not seeking this type of information in our study, nor will you be asked questions about this.

Assent Sample Language

In general, we will not tell anyone what you tell us without your permission. However, if you tell us something that could harm you or someone else, we [will/may] have to tell your parent and/or someone else (guidance counselor or doctor) to make sure you are safe.

Office of Research Compliance