State Laws That Impact Clinical Research: What Investigator Sites Need to Know

Paul Below, Clinical Research ConsultantJanet Petrell, Independent Contract CRA

Minnesota Chapter ACRP10 March 2005

Presentation Topics

• Review the major legal areas where state laws impact clinical research

• Highlight notable examples from a few areas

• Provide resources for obtaining additional information

Disclaimer & Disclosure

• The presenters do not have a significant equity interest in any of the products or companies mentioned in this presentation

• The information presented here is provided for training purposes only. It does not constitute legal advice and should not be used as a substitute for the advice of competent counsel

Why are State Laws Important?

• Compliance with Good Clinical Practice includes not only adhering to the federal regulations but also all “applicable regulations” (21 CFR 312.60)

• Federal regulations do not overrule those of the states

• Health practitioners who conduct clinical trials practice under state licensure and must be compliant with state laws to maintain that licensure

What is State Law?

• “State Law” consists of:

• Laws – bills passed by State Legislature and signed by the governor

• Statutes – codification of laws

• Rules – orders created by an office of the state under authority granted by the Legislature.

• Case Law – court opinions

Major Legal Areas

• Informed Consent

• Clinical Research Conduct

• Investigational Drug Handling

• Laws Governing IRBs

• Gene Research

• Medical Record Privacy / STD Reporting

• Gifts to Research Personnel

Informed Consent Issues

• Age of consent

• Effective time period

• Definition of “legally authorized representative”

• Physician duty to obtain

• Specific requirement for research consent

Age of Consent

• Many states outline the minimum age for health care consent but none specify for clinical research

• In many states, can consent for health care when under 18 years old if emancipated minor, married, or have a child

• Examples:

• Oklahoma – married, emancipated, has child

• Missouri – married minor 15 or have a child

• Florida – married minor, pregnant minors

Age of Consent (cont)

• Some states specify an “age of majority” = age at which a person is legally entitled to manage their own affairs (usually 18)

• Notable exception: Nebraska & Alabama = 19

• Some debate that age of consent for health care does not apply to clinical research

• FDA states that consent to enroll in research is not the same as consent to provide medical treatment (FDA Information Sheets)

Effective Time Period of Consent

• Wisconsin law specifies that informed consent for treatment of mental illness, developmental disability, alcoholism or drug dependency is effective for only 15 months

Legally Authorized Representative

• Wide variation across states in definition

• Most include parent (for minors), guardian, spouse, power of attorney

• Notable examples:

• Arkansas – guardian must obtain court approval before authorizing experimental medical procedures

• Arizona – for unable adult, majority of adult children, domestic partner, brother or sister, close friend

Legally Authorized Representative (cont.)

More notable examples:

• Florida – adult child, adult sibling, adult relative, close friend (can consent for experimental treatments)

• Georgia – grandparent, minor spouse, adult sibling

• New Jersey – “special medical guardian”

• Indiana – for incompetent adult, religious superior

Duty to Obtain Consent

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

• Some states even specify malpractice risk for failure to obtain consent:

• Louisiana

• Arizona

• Georgia

• New Hampshire

Research Consent

• Some states have a general requirement that consent be obtained for research (Arizona, California, Illinois, Kansas)

• California requires that subjects be given a copy of California's Experimental Subject’s Bill of Rights

Research Consent (cont)

• Some state specify additional consent requirements for special populations:

• Connecticut – mental health disorders

• Delaware – prisoners with mental illness

• Florida – youth in detention centers

• Missouri – pediatric nursing facilities

• North Carolina – nursing home patients

• New York – disabled persons

Minnesota Consent Laws

• Consent age for health care: 18 years, married, who has borne a child, who is living separate from parents

• Written informed consent is required prior to genetic testing

• Informed consent for health care at state hospitals must contain certification from treating physician that patient understands document & is competent to give consent

Minnesota Consent Laws (cont)

• Legally authorized representatives:

• parents (for minors)

• health care directive/power of attorney agents

• guardian for incapacitated persons (experimental research requires a court order)

• guardian for mentally retarded persons (experimental research must be court-approved)

Minnesota Consent Laws (cont)

• For mentally retarded persons: informed consent required for participation in research or experimental treatment

• For experimental research in mental health institutions: no guardian can give consent unless procedure is first approved by the court

Clinical Research Topics

• Submission to state health authorities

• Insurance reimbursement for standard of care items done during a clinical trial

• Duties of site personnel

• Investigator registration/licensure for research with controlled substances (Massachusetts, Georgia, Kansas, Tennessee)

State Submissions

The following states have laws requiring research proposal submissions prior to starting the trial:

• Arizona, Illinois – prisoners

• California – drugs not subject to FDA regulation, developmentally disabled in state hospitals

• Delaware – mental health patients, clients of Del. Health & Social Services

• Florida – investigational drugs not covered by a federal IND

• Indiana – can request pre-clinical tests, investigator notarized statement

State Submissions (cont.)

States requiring research proposal submissions:

• South Dakota – mental retardation patients

• Missouri – patients in a Dept. of Mental Health facility

• North Carolina – institutionalized mental health patients, prisoners

• Oklahoma, South Carolina – controlled substances

Reimbursement

The following states have laws ensuring coverage for the routine health care costs for all clinical trials:

• Delaware

• Maryland

• Massachusetts (cancer patients)

• New Hampshire

• New Mexico

• Nevada

Duties of Site Personnel

Every state has it owns definitions of scope of practice. Check with the nursing board and medical board of each state to determine the scope of practice for:

• Registered nurses

• Nurse Practitioners

• Physicians Assistant

• Foreign trained / unlicensed / allied health personnel

• Medical students, interns, fellows

Investigational Drug Handling

• Most states require that an investigational drug must be labeled with the statement, “For Investigational Use Only”

• California requires a special label for cancer drugs

• Illinois and Oregon requires the investigational product’s name, strength, expiration date, reference code, lot number and name and location of the patient

• Many states have laws dictating who and where the drug can be stored, prepared and dispensed

Investigational Drug Handling (cont.)

• Florida requires that the pharmacy must maintain information (investigational brochure) regarding the investigational product.

• Maryland and North Carolina requires a signed agreement from each investigator prior to administration and distribution.

• Tennessee requires that reports of investigations must be furnished to the Commissioner of Agriculture upon request.

• Texas requires that the IND be sent to the Commissioner of Public Health prior to administering the drug

Minnesota Privacy Laws

• A provider, or one who receives health records from a provider, may not release a patient's health records without a signed and dated consent from the patient or the patient's representative unless such release is specifically authorized by law

• Consent is valid for one year or for a lesser period as specified in the consent

Minnesota Privacy Laws (cont)

• Health records may be released for medical research if:

• patient is told of the release

• has opportunity to object (or the authorization is mailed twice with a postage prepaid return envelope and patient does not respond)

• the disclosure is necessary to accomplish the research

• the researcher employs confidentiality safeguards and will not further release the records without patient consent

California HIPAA Law

In California, an authorization for the release of medical information by a provider of health care, health care service plan, pharmaceutical company, or contractor shall be valid if:

• It is handwritten by the person who signs it or is in a typeface no smaller than 14-point type

• Is clearly separate from any other language present on the same page and is executed by a signature which serves no other purpose than to execute the authorization

Minnesota Gifts to Practitioners Law

• Minnesota passed legislation in 1993 prohibiting drug manufacturers from providing gifts to healthcare “practitioners” valued greater than $50.00 in any calendar year.

• Exceptions: drug samples, educational program registration, educational publications, reasonable honoraria for conference faculty, compensation for consulting services in connection with research projects

State Law References

Websites:• www.findlaw.com (Thomson Group)

• www.healthprivacy.org (Health Privacy Project)

Books:• State-by-State Clinical Trial Requirements

Reference Guide, Barnett International, September 2004

• Compilation of State and Federal Privacy Laws, Privacy Journal, March 2002

Contact Information

Paul Below

• Phone: (952) 882-4083• Email: paul@pbelow-consulting.com

Janet Petrell

• Phone: (715) 377-0160• Email: katvell@juno.com