MSU HRPP Manual Section 2-3

State and Local Guidelines and Regulations

Investigators are responsible for complying with laws relevant to their human research activities, regardless of the location of the research. A summary of the current laws of the State of Michigan relevant to human subject research are included below. These laws are applied as appropriate, e.g., determination of age of majority and emancipation of a minor; confidentiality of HIV, general medical, mental health and child abuse records, and restrictions on use of state funds for human cloning. MSU’s Office of the General Counsel (OGC) will be consulted as needed if questions arise regarding applicability of laws to human research activities. For example, when research is conducted outside the jurisdiction of where MSU resides (i.e., outside the State of Michigan), OGC will be consulted as appropriate to determine whether any relevant laws apply to the conduct of the research. OGC will also be contacted to resolve potential conflicts of law (e.g., between federal / national law and other applicable laws).

Michigan has no statute that broadly addresses human subject research. However, both the Michigan Mental Health Code and the Michigan Public Health Code reference the protection of human subjects in research in specific contexts and state that such research should comply with the provisions of 45 CFR 46. The State Constitution of Michigan also includes a provision for human embryo and embryonic stem cell research.

The sections below describe legal standards under Michigan law that potentially pertain to Human Research. Human Research activities conducted at Michigan State University or other locations in Michigan are subject to these laws and regulations. These standards apply under Michigan law only. Investigators are responsible for determining other laws and standards applicable to their activities addressed in other sections of this Guide.

Confidentiality and Consent Rights of Mental Health Patients – Michigan Mental Health Code

MCL 330.1001 - 330.2106; 330.1748; 330.2004a

Mental Health Information

Under MCL 330.1748, information in the record of a mental health patient, and other information acquired in the course of providing mental health services to a mental health patient, must be kept confidential and is not open to public inspection. The information may be disclosed by the holder of the record only as necessary for the purpose of outside research, evaluation, accreditation, or statistical compilation. However, the individual who is the subject of the information shall not be identified in the disclosed information unless the identification is essential in order to achieve the purpose for which the information is sought or if preventing the identification would clearly be impractical, but not if the subject of the information is likely to be harmed by the identification.

Substance Use Disorder Services

MCL 330.1260 (Chapter 2A, Substance Use Disorder Services) also defines records for services provided under this chapter that are confidential (MCL 330.1261) and may only be disclosed for the purposes authorized under section 262 or 263. Under section 262 (MCL 330.1262), a person who is the subject of a record under section 261 may consent in writing for any purpose. Otherwise, the content of the record may only be disclosed under section 263 for scientific statistical research purposes without directly or indirectly identifying the individual.

Electroconvulsive Therapy

MCL 330.1717 (Electroconvulsive therapy (ECT) or other procedure; consent) provides that a recipient shall not be the subject of electroconvulsive therapy or a procedure intended to produce convulsions or coma unless consent is obtained from the following:

(a) The recipient, if he or she is 18 years of age or older and does not have a guardian for medical purposes.

(b) The recipient's parent who has legal and physical custody of the recipient, if the recipient is less than 18 years of age.

(d) The recipient's designated representative, if a durable power of attorney or other advance directive grants the representative authority to consent to procedures described in this section.

If a guardian consents to a procedure described in this section, the procedure shall not be initiated until 2 psychiatrists have examined the recipient and documented in the recipient's medical record their concurrence with the decision to administer the procedure. 330.1717(2)

A minor or an advocate designated by the minor may object to the administration of a procedure described in this section. The objection shall be made either orally or in writing to the probate court. The procedure shall not be initiated before a court hearing on the minor's or advocate's objection. 330.1717(4)

At least 72 hours, excluding Sundays or holidays, before the initiation of a procedure described in this section, a minor shall be informed that he or she has a right to object to the procedure. 330.1717(5)

If a procedure described in this section is considered advisable for a recipient and an individual eligible to give consent for the procedure is not located after diligent effort, a probate court may, upon petition and after a hearing, consent to administration of the procedure in lieu of the individual eligible to give consent. 330.1717(6)

Any individual contemplating human research involving ECT should consult with the MSU Human Research Protection Program (HRPP) and OGC prior to initiating to ensure compliance with applicable law.

Mental Health Patients Who Are Prisoners

This statute further references the confidentiality rights of mental health patients who are prisoners, whose information is used in outside research. Under MCL 330.2004a, information in the medical record of a prisoner receiving services from the corrections mental health program and other information acquired in the course of the prisoner's treatment in the program is confidential and shall not be open to public inspection.

The corrections mental health program is the holder of the record and may disclose the information only as necessary for the purpose of outside research, evaluation, accreditation, or statistical compilation, provided that if the prisoner can be identified from the disclosure only if that identification is essential in order to achieve the purpose for which the information is sought or if preventing that identification would clearly be impractical, but in no event if the prisoner is likely to be harmed by the identification.
See also, 45 CFR 46.301(b): Nothing in this subpart shall be construed as indicating that compliance with the procedures set forth herein will authorize research involving prisoners as subjects, to the extent such research is limited or barred by applicable State or local law.

Michigan Correctional Facilities

In addition, the Michigan Administrative Code (administrative rules and regulations promulgated by Michigan State Government agencies) includes Mich. Admin. Code R. 791.733, which requires correctional facilities to establish and maintain a written policy and practice that prohibits the use of inmates for medical, pharmaceutical, or cosmetic experiments.

This rule does not preclude individual treatment of an inmate for a specific medical procedure that is not generally available outside of research.
While this rule applies to Michigan correctional facilities, individuals contemplating human research involving prisoners or other detained persons should not approve or perform research prohibited under this rule regardless of whether a particular correctional facility has implemented the required policies and practices under the rule.

Confidentiality, Consent, and Restrictions on Medical Research – Michigan Public Health Code

MCL 333.1101 - 333.25211

The information below is related to the statute and provided for purposes pertaining to research.

Information Shared with Michigan Department of Health and Human Services

Information shared with the Michigan Department of Health and Human Services in the conduct of a medical research project (including projects involving birth defects) is confidential. MCL 333.2631 and 333.5721.

Genetic Testing and Informed Consent

MCL 333.17020—Genetic Testing; Informed Consent (Public Health Code)

MCL 333.17020 (1) requires that a physician or an individual to whom the physician has delegated authority to perform a selected act, task, or function under section 16215 shall not order a presymptomatic or predictive genetic test without first obtaining the written, informed consent of the test subject, pursuant to this section.

MCL 333.17020 (2) provides for purposes of subsection (1), written, informed consent consists of a signed writing executed by the test subject or the legally authorized representative of the test subject that confirms that the physician or the individual acting under the delegatory authority of the physician has explained, and the test subject or the legally authorized representative of the test subject understands, at a minimum, all of the following:

(a) The nature and purpose of the presymptomatic or predictive genetic test.

(b) The effectiveness and limitations of the presymptomatic or predictive genetic test.

(c) The implications of taking the presymptomatic or predictive genetic test, including, but not limited to, the medical risks and benefits.

(d) The future uses of the sample taken from the test subject in order to conduct the presymptomatic or predictive genetic test and the information obtained from the presymptomatic or predictive genetic test.

(e) The meaning of the presymptomatic or predictive genetic test results and the procedure for providing notice of the results to the test subject.

(f) Who will have access to the sample taken from the test subject in order to conduct the presymptomatic or predictive genetic test and the information obtained from the presymptomatic or predictive genetic test, and the test subject's right to confidential treatment of the sample and the information.

Under (9) of MCL 333.17020, “[f]or purposes of subsection (8)(b), the term genetic test’ does not include a procedure performed as a component of biomedical research that is conducted pursuant to federal common rule under 21 C.F.R. parts 50 and 56 and 45 C.F.R. part 46. However, under section (1) a physician or an individual to whom the physician has delegated authority to perform a selected act, task, or function under section 16215 shall not order a presymptomatic or predictive genetic test without first obtaining the written, informed consent of the test subject, pursuant to this section. Section 16215 provides selected acts, tasks, or functions include “[s]urgically removing only bone, skin, blood vessels, cartilage, dura mater, ligaments, tendons, pericardial tissue, or heart values only from deceased individuals for . . . scientific purposes.”

Under (5) of MCL 333.17020, a copy of the informed consent document should be provided to the person who signed it. The original form, signed by the patient or his legally authorized representative, must be placed in the patient’s medical record. The Michigan Department of Health and Human Services has developed a patient information brochure and model informed consent document that it recommends for use with genetic testing. See https://www.michigan.gov/mdhhs/-/media/Project/Websites/mdhhs/Public-Health-Genomics/Informed-Consent-Brochure-2021_FINAL.pdf?rev=35a9bdc9e7dd41cd920afe85063c2819&hash=3A7A0A98B0FDF0125D742E7DD8E54C1F

Therefore, in Michigan, Section (1) and (2) should be followed when appropriate in the context of a human research project.

Genetic Testing and Informed Consent

MCL 333.17520—Genetic Testing; Informed Consent (Public Health Code)

Under (1) a physician or an individual to whom the physician has delegated authority to perform a selected act, task, or function under section 16215 shall not order a presymptomatic or predictive genetic test without first obtaining the written, informed consent of the test subject, pursuant to this section. Section 16215 provides selected acts, tasks, or functions include “[s]urgically removing only bone, skin, blood vessels, cartilage, dura mater, ligaments, tendons, pericardial tissue, or heart values only from deceased individuals for . . . scientific purposes.”

Under (2) written, informed consent consists of a signed writing executed by the test subject or the legally authorized representative of the test subject that confirms that the physician or the individual acting under the delegatory authority of the physician has explained, and the test subject or the legally authorized representative of the test subject understands, at a minimum, all of the following:

(a) The nature and purpose of the presymptomatic or predictive genetic test.

(b) The effectiveness and limitations of the presymptomatic or predictive genetic test.

(c) The implications of taking the presymptomatic or predictive genetic test, including, but not limited to, the medical risks and benefits.

(e) The meaning of the presymptomatic or predictive genetic test results and the procedure for providing notice of the results to the test subject.

For purposes of subsection (8)(b), the term "genetic test" does not include a procedure performed as a component of biomedical research that is conducted pursuant to federal common rule under 21 C.F.R. parts 50 and 56 and 45 C.F.R. part 46.

Under (5), a copy of the informed consent document should be provided to the person who signed it. The original form, signed by the patient or his legally authorized representative, must be placed in the patient’s medical record. The Michigan Department of Health and Human Services has developed a patient information brochure and model informed consent document that it recommends for use with genetic testing.

See https://www.michigan.gov/mdhhs/-/media/Project/Websites/mdhhs/Public-Health-Genomics/Informed-Consent-Brochure-2021_FINAL.pdf?rev=35a9bdc9e7dd41cd920afe85063c2819&hash=3A7A0A98B0FDF0125D742E7DD8E54C1F

Therefore, in Michigan, Section (1) and (2) should be followed when appropriate in the context of any human research project.

Use of live human embryo, fetus, or neonate for nontherapeutic research

The use of a live human embryo, fetus or neonate is prohibited for nontherapeutic research if the life of the live human embryo, fetus or neonate is jeopardized by the research. MCL 333.2685.

Research on dead embryo, fetus, or neonate

A dead embryo, fetus, or neonate is not considered a “human subject” for purposes of HRPP oversight.

Research on a dead embryo, fetus, or neonate may not knowingly be performed unless the consent of the mother has first been obtained. An exception to the consent requirement applies in cases of a routine pathological study. Consent is presumed by written statement signed by the mother that she consents to the use of her dead embryo, fetus, or neonate for research. Research must be performed in accordance with the same standards applicable to research conducted Part 101 (Revised Uniform Anatomical Gift Law). MCL 333.2688

Pregnancy Termination, Informed Consent

A physician shall not perform an abortion without the patient’s informed written consent given freely and without coercion. Abortion is defined as the intentional use of an instrument, drug, or other substance or device (other than drug or device intended as contraceptive) to terminate a woman’s pregnancy for a purpose other than to increase the probability of a live birth, preserve life or health of child after birth, or remove a fetus that has died of natural causes, accidental trauma, or criminal assault on the pregnant woman. MCL 333.17015 Section (1) (Pregnancy Termination, Informed consent)

Further, consent to abortion on a minor requires written consent of the minor and 1 of the parents or the legal guardian of the minor. If a parent or legal guardian is not available or refuses to give consent, or if the minor elects not to seek parental/guardian consent, the minor may petition the probate court pursuant to MCL 722.904 for a waiver of the parental consent requirement. MCL 722.903 (Parental Rights Restoration Act)

Any individual contemplating human research involving clinical research that involves pregnancy termination should consult with HRPP and OGC prior to initiating to ensure compliance with applicable law.

HIV infection and acquired immunodeficiency syndrome

Research records, and information pertaining to partner notification (under section 5114a) that are associated with HIV infection and acquired immunodeficiency syndrome are confidential. A person shall release reports, records, data, and information described in the subsection pursuant to the section. MCL 333.5131.

HIV Testing Performed for Research Purposes

While MCL 333.5131 pertains to testing, care, treatment, reporting, and research pertaining to partner notification that are associated with HIV infection in general, in addition, MCL 333.5133 specifically pertains to HIV testing performed for the purpose of research.

Where HIV testing is performed solely for research, only where the test results are performed in such a manner that identification of the test subject is not revealed to the researcher and not made known to the test subject do the requirements under MCL 333.5133 not apply.

Otherwise, the researcher has the obligation to obtain informed consent as follows:

The subject or his/her legally authorized representative who provides a general informed consent for medical care is considered to have consented to an HIV test under subsection (2). A separate HIV test consent form is not required.
However, the healthcare provider must inform the test subject or authorized representative that an HIV test will be performed unless the test subject/authorized representative declines.
The provider must also offer the subject/representative the opportunity to ask questions and decline the HIV test.
Further, if a test subject consents/undergoes an HIV test, partner notification requirements under section 5114a(3) to (5) apply in the case of a test subject being HIV infected. Unless the identity of the test subject is not revealed to the researcher and the test results are not made known to the test subject as outlined above. Otherwise facility shall inform the patient of the positive test results and shall provide the patient with appropriate counseling regarding HIV infection and acquired immunodeficiency syndrome and referrals to expedite HIV treatment and service.

The Human Cloning Funding Prohibition Act

MCL 333.26401 - 333.26406

This Act prohibits the expenditure of state funds for the purpose of human cloning. It does not prohibit the use of state funds for scientific research that does not involve the use of human somatic cell nuclear transfer technology to produce a human embryo. See also MCL 333.16274 and 333.16275.

See also MCL 750.430(a) of the Michigan Penal Code which states that a person who intentionally engages or attempts to engage in human cloning is guilty of a felony and faces imprisonment of up to 10 years and/or a fine of up to $10,000,000.

Confidential Research and Investment Information Act

MCL 390.1551-1557

The Confidential Research and Investment Information Act (MCL 390.1551 et seq.) provides that intellectual property created by individuals employed or contracted by MSU for research, education, and related activities is exempt from disclosure under the Michigan Freedom of Information Act (FOIA) until a reasonable opportunity is provided for the information to be published. The same applies to copyrightable and patentable information. In addition, subject to certain exceptions the Act protects from disclosure as a public record under FOIA any information received from a private external source that is used exclusively for research, testing, evaluation, and related activities as long as the information is designated as confidential, and MSU enters into an agreement with the private external source to keep the information confidential.

Status of Minors and Child Support; Adults with Cognitive Impairments/Impaired Decision-Making

MCL 722.1 - 722.6

This statute defines minors as persons under 18 years of age. It also sets forth the circumstances that lead to the emancipation of a minor and states that emancipated minors have the right to consent to their own preventive healthcare.

For Minors, MCL 722.1 defines age of majority as eighteen or older. Parental or legal guardian consent is generally required subject to various restrictions such as emancipated minors (MCL 722.4) or children seeking certain treatment/care.

For an adult, individuals who constitute a legally authorized representative may include a patient advocate under an advanced health care directive or Durable Power of Attorney as well as a Guardian, Conservator, Spouse, or other family member. Consult OGC and HRPP for guidance to ensure the appropriate informed consent is appropriate, possible, and obtained.

Age of Majority Act of 1971

MCL 722.51 - 722.55

This Act defines the age of majority and defines the duties, liabilities, responsibilities, rights and legal capacity of persons 18 or more years of age.

Child Protection Law

MCL 722.621 - 722.638

With respect to research, this statute allows the Family Independence Agency to provide a person engaging in research pertaining to child abuse with information contained in the state’s central registry, on the understanding that the person receiving such information will not disclose identifying information without a family’s prior consent.

Mental Health and Substance Abuse Services - Rules

R330.1001-330.1059

In these rules, the Michigan Department of Community Health (now Michigan Department of Health and Human Services) states that research initiated, conducted, or supported by the Department must be subject to the administrative rules, department policies, and must follow federal guidelines.

Required Reporting Statutes

Michigan law requires certain licensed professionals to report abuse or suspected abuse of adults and children. These laws do not distinguish between information gained through the role required to report and information gained as a researcher. It is the license, registration, or certification that drives the requirement.

Required Reporting (Adult Abuse)

MCL 400.11(a)

This statute defines the reporting requirements for suspected adult abuse, neglect, or exploitation. The statute applies to the following persons who “suspect or ha[ve] reasonable cause to believe that an adult has been abused, neglected, or exploited:”

“[a] person who is employed, licensed, registered, or certified to provide health care, education, social welfare, mental health, or other human services”
“[a]n employee of any agency licensed to provide health care, education, social welfare, mental health, or other human services”
“a law enforcement officer” or
“[a]n employee of the office of the county medical examiner.”

The statute requires the individual to “make immediately, by telephone or otherwise, an oral report to the county department of social services of the county in which the abuse, neglect, or exploitation is suspected of having or believed to have occurred.” See MCL 400.11(a) for other specific reporting requirements.

Required Reporting (Child Abuse)

MCL 722.623

This statute defines the reporting requirements for suspected child abuse or neglect. The statute applies to the following persons who have “reasonable cause to suspect child abuse or child neglect”:

Physician
Dentist
Physician’s assistant
Registered dental hygienist
Medical examiner
Nurse
Person licensed to provide emergency medical care
Audiologist
Psychologist
Physical therapist
Physical therapist assistant
Occupational therapist
Athletic trainer
Marriage and family therapist
Licensed professional counselor
Social worker
Licensed master’s social worker
Licensed bachelor’s social worker
Registered social service technician
Social service technician
A person employed in a professional capacity in any office of the friend of the court,
School administrator
School counselor or teacher
Law enforcement officer
Member of the clergy
Regulated child care provider
A department employee who is 1 of the following:
- Eligibility specialist.
- Family independence manager.
- Family independence specialist.
- Social services specialist.
- Social work specialist.
- Social work specialist manager.
- Welfare services specialist.
Any employee of an organization or entity that, as a result of federal funding statutes, regulations, or contracts, would be prohibited from reporting in the absence of a state mandate or court order.

The statute requires the individual to “make an immediate report to centralized intake by telephone, or, if available, through the online reporting system. . .” The statute requires that “[w]ithin 72 hours after making an oral report by telephone to centralized intake, the reporting person shall file a written report as required in this act . . .” See MCL 722.623 for additional specific reporting requirements.

Michigan Constitution

Article I, Section 27, Human Embryo and Embryonic Stem Cell Research

This provision provides the criteria under which research involving human embryos may be permitted in Michigan. The provision permits all research permitted under federal law on human embryos to be conducted in Michigan (subject to additional requirements).

Additional requirements include:

Limit on amount of time stem cells may be taken from human embryo
Human embryos must have been created for purpose of fertility treatment, would otherwise have been discarded, and either were in excess of clinical need or were not suitable for implantation
Voluntary informed consent required of the person seeking fertility treatment to donate embryo to research
May not for valuable consideration purchase or sell embryos for research

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 3-3-2005. Revision 1 approved by VP Research & Graduate Studies on 3-9-2008. Revision 2 approved by the VP Research & Graduate Studies on 7-21-2011. Revision 3 approved by Assistant VP Regulatory Affairs on 12-6-2021. Revision 4 approved by Associate VP Research Regulatory Support on 11-28-2025.

Related HRPP Manual Sections

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