MSU HRPP Manual Section 2-3

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 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), the MSU Office of the General Counsel will be consulted as appropriate to determine whether any relevant laws apply to the conduct of the research. MSU’s Office of the General Counsel 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.

Mental Health Code
MCL 330.1116 - 330.2004(a)

This statute references the confidentiality rights of mental health patients, including mental health patients who are prisoners, whose information is used in outside research. See 45 CFR 46.301(b).


Public Health Code
MCL 333.1101 - 333.25211

This broad statute is intended to protect and promote the public health. For purposes pertaining to research, the statute:

  • States that information shared with the Department of Community Health in the conduct of a medical research project (including projects involving birth defects) is confidential. MCL 333.2631 and 333.5721.
  • Prohibits the use of a fetus or neonate for nontherapeutic research if the life of the fetus or neonate is jeopardized by the research. MCL 333.2685.
  • States that research records pertaining to patients with HIV are confidential. MCL 333.5131.

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.


Status of Minors and Child Support
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.

 

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 states 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 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 neglect”:

  • Physician
  • Dentist
  • Physician’s assistant
  • Registered dental hygienist
  • Medical examiner
  • Nurse
  • Person licensed to provide emergency medical care
  • Audiologist
  • Psychologist
  • 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
  • School administrator
  • School counselor or teacher
  • Law enforcement officer
  • Member of the clergy
  • Regulated child care provider

The statute requires the individual to “make immediately, by telephone or otherwise, an oral report or cause an oral report to be made . . . to the department.” The statute requires that “[w]ithin 72 hours after making the oral report, the reporting person shall file a written report as required by this act.”

Michigan Constitution
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.

Related HRPP Manual Sections

None

Approved PDF Version

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