State Laws that Impact Good Clinical Practice: Focus on Informed Consent

Paul Below, CCRADirector, GCP Training Specialists

May 14th, 2015

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Speaker Bio – Paul Below

• Director for GCP Training Specialists

• Clinical Project Manager for American Medical Systems

• Adjunct Instructor for St. Cloud State University Master’s Degree Program in Applied Clinical Research

• Former President Minnesota Chapter ACRP (2004, 2010)

• ACRP Professional Development Committee (2013-2014)

• CCRA certified since 2001

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Disclosure

• I have relevant financial relationships with respect to this educational activity with the following organizations:

» American Medical Systems: Employee and Shareholder

» GCP Training Specialists: Owner and Director

• I do not have a vested interestin any commercial productsmentioned here

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Disclaimer

• This presentation deals with legal topics but I am not a lawyer

• The information provided here is for training purposes only and should not be construed as legal advice

• You should contact your attorney to obtain advice with respect to specific state law issuesor problems

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Learning Objectives

• Define what state is and why it is important to understand

• Review the major areas that state law impacts informed consent including:

» Minimum age of consent

» Who can function as a legally authorized representative

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Learning Objectives (cont.)

• Cite examples of unique state laws for informed consent such as:

» Special requirements for content

» Penalties for failure to obtain consent

» Expiration of consent for certain kinds of studies

• Critique resources for obtaining additional information

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What is State Law?

• Laws: bills passed by state legislature and signed by the governor

• Statutes: codification of laws

• Rules: orders created by a state office under authority granted by the state legislature

• Case Law: court opinions

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Why is this Important?

• Compliance with Good Clinical Practice includes adhering to the federal regulations and all applicable regulations (21 CFR 312.60)

• Federal regulations do not overrule state laws

• Health practitioners who conduct clinical trials under a state licensure must be compliant with state law to maintain that licensure

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What is Informed Consent?

Informed consent is more than just a signature on a form, it is a process of information exchange that may include, in addition to reading and signing the informed consent document, subject recruitment materials, verbal instructions, question/answer sessions and measures of subject understanding.

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“

From the FDA Information Sheets: A Guide

to Informed Consent (1998)

Minimum Age of Informed Consent

Minimum Age for Consent

• All states specify an “age of majority” or minimum age by which legal decisions can be made

• Usually 18 years old except in Alabama and Nebraska = 19 years old

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Minimum Age for Healthcare

• Many states outline the minimum age for healthcare consent but none specify a minimum age for clinical research consent

• There is some debate about the age of consent for health care applying to clinical research

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Healthcare Consent Debate

• However, most lawyers agree that healthcare consent law does apply to clinical research since studies are conducted in a healthcare setting and involve medical procedures

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Age for Healthcare Consent

Notable examples of health care consent age other than 18 years old:

• Oregon: 15 years old

• Rhode Island: 16

• South Carolina: 16 unless an operation is involved

• Texas: 16

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Healthcare Consent (cont.)

Many states allow minors to consent for health care on their own behalf if they are:

• Married

• Emancipated

• Living independently

• Pregnant

• Parent

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Emancipated Minors

• The exact laws and protocols for obtaining emancipation vary from state to state

• In most states, minors must file a petition with the family court, formally requesting emancipation and citing reasons it is in their best interest to be emancipated an must prove financial self-sufficiency

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Healthcare Consent (cont.)

Special state laws for consent for health care if:

• In Military (Maine, Massachusetts, South Dakota, Virginia, Wyoming)

• Graduated from High School (Montana, Pennsylvania)

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Age for Mental Health Consent

Some states specify a different minimum age of consent for mental health treatment:

• California: 12 years old (if deemed mature and danger to themselves/others)

• Michigan: 14 (except for psychotropic drugs or pregnancy termination)

• Connecticut: 14 (if parents arenotified within 5 days)

• Ohio: 14

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Minn. Law - Age of Consent

• Age of majority = 18

• Following minors may consent to healthcare on their own behalf if:

» Married (16 years old)

» Parent

» Living independently from parents

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California Law - Age of Consent

• Age of majority = 18

• Following minors may consent to healthcare on their own behalf:

» 15 years old or older, and

» Living separately and apart from parents or guardians, and

» Managing own financial affairs, regardless of the source of income

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Cal. Family Code §6922

California Law - Age of Consent

• If patient is a minor, treating medical professional may (with or without patient consent) notify parents or guardian of the treatment1

• Minor may consent to mental health treatment if they are 12 or older if deemed mature enough to “participate intelligently” and they present a danger to self / others (or victim of abuse, incent)2

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1 Cal. Family Code §69222 Cal. Family Code §6924

Legally Authorized Representatives

Legally Authorized Rep.

• Wide variation across states in definition of who can function as a “legally authorized representative” (LAR)

• Impacts informed consent for minors and incapacitated/incompetent adults

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LAR for Incapacitated Adults

For incapacitated/incompetent adults, most states allow following to be a LAR:

• Guardian (some states require court order)

• Health Care Power of Attorney

• Appointee by Advanced Health Care Directive

• Parent

• Spouse (some states specify not separated)

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LAR for Incapacitated Adults

Some states also allow the following to act as a LAR:

• Adult Children

• Adult Sibling

• Grandparents

• Adult Grandchild

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LAR for Incapacitated Adults

Unusual examples of LARs:

• Relative by Marriage (Missouri, Oklahoma, South Carolina)

• Close Friend (Florida, Colorado, Maryland, West Virginia)

• Domestic Partner (Arizona, California)

• Attending Physician (Arizona)

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Order of Priority for LARs

• Several states have an “order of priority” for who can act as the legal representative

• Those states usually have laws about dealing with conflicts when equal legal representatives conflict

• Virginia and California: if 2 or more individuals who qualify as legal representatives disagree on trial participation, subject will not be allowed to participate in the research

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Order of Priority Example

Florida: Order of priority for who can give consent for incapacitated adults:

• Surrogate designated in an advanced directive

• Judicially-appointed guardian

• Spouse

• Adult child, or majority of adult siblings

• Parents

• Adult sibling

• Adult relative

• Close friend

• State-licensed clinical social worker

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Case of Terri Schiavo

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California Law - LARs

• For medical experiments in life-threatening emergencies, treatment can be given without consent if a number of rules are satisfied

• Investigator attempts to contact LAR within time period defined by the protocol before treatment

• These kinds of studies may require establishment of an Independent Data Monitoring Committee and disclosure to the community

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Cal. Health & Safety Code §24177.5

California Law - LARs

• For non-emergency research, rules established for treatment of cognitive impairment, lack of capacity, or serious or life-threatening diseases and conditions

• Surrogate informed consent can be obtained from persons unable to consent and who do not express dissent or resist participation

• Does not applies if the subject is voluntarily or involuntarily committed to a Mental Health Institution

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Cal. Health & Safety Code §24178

California Law - LARs

Surrogate with “reasonable knowledge” of the subject can include the following (in order of priority):

• Agent – advanced health care directive

• Conservator or guardian

• Spouse

• Domestic partner

• Adult son or daughter

• Custodial parent

• Adult sibling

• Adult grandchild

• Any available adult relative with closest degree of kinship

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Cal. Health & Safety Code §24178

California Law - LARs

• When two or more persons of equal priority are available, refusal to consent by one person is final

• Surrogate shall exercise judgment about participation in accordance with the person's individual health care instructions (if known) or best estimation of what the person would have chosen if capable

• Surrogates may not be financially compensated for providing informed consent

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Cal. Health & Safety Code §24178

Special Requirements for Informed Consent

Special Consent Requirements

• Many states have laws that specify requirements for obtaining consent for research that are consistent with the HHS or FDA regulations

• California requires that all subjects be given a copy of California’s Experimental Subject Bill of Rights(Cal. Health & Safety Code §24172)

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Special Consent Requirements

• In North Dakota and Pennsylvania, copies of federal regulations on human subject protection must be made available to individuals considering participation in a clinical trial

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Special Consent Requirements

• Indiana: A patient who has given informed consent for the administration of an experimental treatment may receive the treatment only if a licensed physician has “personally examined” the patient and agreed to treat them

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Special Consent Requirements

• Maine: Human subjects between the ages of 12 and 18 must provide consent unless they are unable to do so; the subject’s parents or guardians must also consent

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Special Consent Requirements

• Texas: Informed consent can be withdrawn by a patient and in any form, including non-compliance, active resistance or verbal or other expression of unwillingness to continue to participate

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Mental Health Patients

• Delaware: Subjects in state mental health facility shall not be approached to participate in any pharmaceutical trials if the most recent psychiatrist evaluation states the patient is unable to give consent for medical treatment

• If capable, these patients must be monitored by a psychiatrist with no financial interest in the study

• Consent discussions must be witnessed by at least one independent healthcare professional

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Mental Health Patients

• Indiana: Mental health patients must be informed of the investigator’s credentials, the risks and benefits of participating in the clinical study and their ability to revoke consent

• Minnesota: Subjects in state hospitals, Minnesota requires that investigators provide a certification that the subject was competent to consent

• Missouri: Research is prohibited with involuntarily committed mental health patients

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Mental Health Patients

• Montana: If subject is a resident of a mental health facility, investigator must send a “notice of intent” to enroll to the subject, next of kin, and attorney

• Texas: Consent of subjects in state Department of Mental Health and Mental Retardation facilities must include discussion of receiving the experimental treatment after the conclusion of the study

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Mental Health & Drug Dep.

• Wisconsin: For patients being treated for mental illness, developmental disability, alcohol abuse or other drug abuse or dependency:

• Informed consent for clinical trial participation must be confirmed by the institution’s “consent monitor”

• If hospitalized, these patients must have an opportunity to consult with independent specialists and their legal counsel before providing clinical trial consent

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Prisoners

• Oregon: Inmates are prohibited from participating in research as human subjects

• Michigan: Inmates may not participate in medical or pharmaceutical research except in cases in which an inmate needs a specific procedure that is not otherwise available

• New Hampshire: All inmates must be provided with informed consent in a language understood by them (NH Department of Corrections Policy)

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Prisoners - Special Approvals

Several states require special approvals for research with prisoners:

» New York: Approval required by Commissioner of Department of Health

» Illinois: Approval by Illinois Department of Corrections

» Delaware: Prisoners who are mental health patients require court approval and Prison Medical Director

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Juveniles

• Alabama: Juveniles held in residential facilities are not permitted to be subjects in “medical or pharmaceutical experiments”

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Duty to Obtain Consent

Duty to Obtain Consent

• Many states have case law decisions outlining duty to obtain consent

• Nevada and Utah have laws that specify disciplinary action and malpractice risk for failure to obtain consent

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California Law - Duty to Obtain

• Any person primarily responsible for a study who negligently allows its conduct without a subject’s informed consent shall be liable to the subject in an amount of $500-10,000)

• Any person primarily responsible for a study who willfully fails to obtain a subject’s consent shall be liable to the subject in an amount of $1,000-25,000)

• Each and every medical experiment performed in violation is a separate and actionable offense

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Cal. Health & Safety Code §24176

California Law - Duty to Disclose

Any representative of a pharmaceutical company, who is directly responsible for contracting with another person for the conduct of a medical experiment, and who has knowledge of risks or hazards with respect to the experiment, and who willfully withholds information of the risks and hazards from the person contracting for the conduct of the medical experiment, and thereby exposes a subject to substantial risk of serious injury, either bodily harm or psychological harm, shall be guilty of a misdemeanor punishable by imprisonment in the county jail for a period not to exceed one year or a fine of fifty thousand dollars ($50,000), or both.

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Cal. Health & Safety Code §24176

“

Expiration of Consent

Expiration of Consent

• Wisconsin: Consent for treatment of mental illness, developmental disability, alcoholism or drug dependency is effective for only 15 months

• North Carolina: Consent of subjects who are clients of the state Division of Mental Health is effective for only 6 months

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Additional Resources

Additional Resources

• Order from Barnett International

• Available in print ($90) and electronic form ($100)

• I have no vested interest in Barnett International and recommend this product simply because I think it is good

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Additional Resources

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Thomson Reuters http://statelaws.

findlaw.com/

Additional Resources

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Thomson Reuters http://statelaws.

findlaw.com/http://leginfo.legislature.ca.gov

/faces/codes.xhtml

In Conclusion

• Defined what state is and its importance in clinical research

• Reviewed minimum age of consent and who can function as a legally authorized representative

• Cited examples of special requirements for content, penalties for failure to obtain consent, expiration for certain kinds of studies

• Critiqued resources for obtaining additional information

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Contact Information

Paul Below, CCRA

• Phone: (612) 643-5598

• Email: paul.below@gcp-specialists.com

• LinkedIn: www.linkedin.com/pub/paulbelow/12/339/b4b/

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