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  1. 1. State Laws That Impact Clinical Research: What Investigator Sites Need to Know Paul Below, Clinical Research Consultant Janet Petrell, Independent Contract CRA Minnesota Chapter ACRP 10 March 2005
  2. 2. Presentation Topics <ul><li>Review the major legal areas where state laws impact clinical research </li></ul><ul><li>Highlight notable examples from a few areas </li></ul><ul><li>Provide resources for obtaining additional information </li></ul>
  3. 3. Disclaimer & Disclosure <ul><li>The presenters do not have a significant equity interest in any of the products or companies mentioned in this presentation </li></ul><ul><li>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 </li></ul>
  4. 4. Why are State Laws Important? <ul><li>Compliance with Good Clinical Practice includes not only adhering to the federal regulations but also all “applicable regulations” (21 CFR 312.60) </li></ul><ul><li>Federal regulations do not overrule those of the states </li></ul><ul><li>Health practitioners who conduct clinical trials practice under state licensure and must be compliant with state laws to maintain that licensure </li></ul>
  5. 5. What is State Law? <ul><li>“ State Law” consists of: </li></ul><ul><ul><ul><li>Laws – bills passed by State Legislature and signed by the governor </li></ul></ul></ul><ul><ul><ul><li>Statutes – codification of laws </li></ul></ul></ul><ul><ul><ul><li>Rules – orders created by an office of the state under authority granted by the Legislature. </li></ul></ul></ul><ul><ul><ul><li>Case Law – court opinions </li></ul></ul></ul>
  6. 6. Major Legal Areas <ul><li>Informed Consent </li></ul><ul><li>Clinical Research Conduct </li></ul><ul><li>Investigational Drug Handling </li></ul><ul><li>Laws Governing IRBs </li></ul><ul><li>Gene Research </li></ul><ul><li>Medical Record Privacy / STD Reporting </li></ul><ul><li>Gifts to Research Personnel </li></ul>
  7. 7. Informed Consent Issues <ul><li>Age of consent </li></ul><ul><li>Effective time period </li></ul><ul><li>Definition of “legally authorized representative” </li></ul><ul><li>Physician duty to obtain </li></ul><ul><li>Specific requirement for research consent </li></ul>
  8. 8. Age of Consent <ul><li>Many states outline the minimum age for health care consent but none specify for clinical research </li></ul><ul><li>In many states, can consent for health care when under 18 years old if emancipated minor, married, or have a child </li></ul><ul><li>Examples: </li></ul><ul><ul><ul><li>Oklahoma – married, emancipated, has child </li></ul></ul></ul><ul><ul><ul><li>Missouri – married minor 15 or have a child </li></ul></ul></ul><ul><ul><ul><li>Florida – married minor, pregnant minors </li></ul></ul></ul>
  9. 9. Age of Consent (cont) <ul><li>Some states specify an “age of majority” = age at which a person is legally entitled to manage their own affairs (usually 18) </li></ul><ul><li>Notable exception: Nebraska & Alabama = 19 </li></ul><ul><li>Some debate that age of consent for health care does not apply to clinical research </li></ul><ul><li>FDA states that consent to enroll in research is not the same as consent to provide medical treatment (FDA Information Sheets) </li></ul>
  10. 10. Effective Time Period of Consent <ul><li>Wisconsin law specifies that informed consent for treatment of mental illness, developmental disability, alcoholism or drug dependency is effective for only 15 months </li></ul>
  11. 11. Legally Authorized Representative <ul><li>Wide variation across states in definition </li></ul><ul><li>Most include parent (for minors), guardian, spouse, power of attorney </li></ul><ul><li>Notable examples: </li></ul><ul><ul><ul><li>Arkansas – guardian must obtain court approval before authorizing experimental medical procedures </li></ul></ul></ul><ul><ul><ul><li>Arizona – for unable adult, majority of adult children, domestic partner, brother or sister, close friend </li></ul></ul></ul>
  12. 12. Legally Authorized Representative (cont.) <ul><li>More notable examples: </li></ul><ul><ul><ul><li>Florida – adult child, adult sibling, adult relative, close friend (can consent for experimental treatments) </li></ul></ul></ul><ul><ul><ul><li>Georgia – grandparent, minor spouse, adult sibling </li></ul></ul></ul><ul><ul><ul><li>New Jersey – “special medical guardian” </li></ul></ul></ul><ul><ul><ul><li>Indiana – for incompetent adult, religious superior </li></ul></ul></ul>
  13. 13. Duty to Obtain Consent <ul><li>Many states have case law decisions outlining physician duty to obtain consent </li></ul><ul><li>Some states even specify malpractice risk for failure to obtain consent: </li></ul><ul><ul><ul><li>Louisiana </li></ul></ul></ul><ul><ul><ul><li>Arizona </li></ul></ul></ul><ul><ul><ul><li>Georgia </li></ul></ul></ul><ul><ul><ul><li>New Hampshire </li></ul></ul></ul>
  14. 14. Research Consent <ul><li>Some states have a general requirement that consent be obtained for research (Arizona, California, Illinois, Kansas) </li></ul><ul><li>California requires that subjects be given a copy of California's Experimental Subject’s Bill of Rights </li></ul>
  15. 15. Research Consent (cont) <ul><li>Some state specify additional consent requirements for special populations: </li></ul><ul><ul><ul><li>Connecticut – mental health disorders </li></ul></ul></ul><ul><ul><ul><li>Delaware – prisoners with mental illness </li></ul></ul></ul><ul><ul><ul><li>Florida – youth in detention centers </li></ul></ul></ul><ul><ul><ul><li>Missouri – pediatric nursing facilities </li></ul></ul></ul><ul><ul><ul><li>North Carolina – nursing home patients </li></ul></ul></ul><ul><ul><ul><li>New York – disabled persons </li></ul></ul></ul>
  16. 16. Minnesota Consent Laws <ul><li>Consent age for health care: 18 years, married, who has borne a child, who is living separate from parents </li></ul><ul><li>Written informed consent is required prior to genetic testing </li></ul><ul><li>Informed consent for health care at state hospitals must contain certification from treating physician that patient understands document & is competent to give consent </li></ul>
  17. 17. Minnesota Consent Laws (cont) <ul><li>Legally authorized representatives: </li></ul><ul><ul><li>parents (for minors) </li></ul></ul><ul><ul><li>health care directive/power of attorney agents </li></ul></ul><ul><ul><li>guardian for incapacitated persons (experimental research requires a court order) </li></ul></ul><ul><ul><li>guardian for mentally retarded persons (experimental research must be court-approved) </li></ul></ul>
  18. 18. Minnesota Consent Laws (cont) <ul><li>For mentally retarded persons: informed consent required for participation in research or experimental treatment </li></ul><ul><li>For experimental research in mental health institutions: no guardian can give consent unless procedure is first approved by the court </li></ul>
  19. 19. Clinical Research Topics <ul><li>Submission to state health authorities </li></ul><ul><li>Insurance reimbursement for standard of care items done during a clinical trial </li></ul><ul><li>Duties of site personnel </li></ul><ul><li>Investigator registration/licensure for research with controlled substances (Massachusetts, Georgia, Kansas, Tennessee) </li></ul>
  20. 20. State Submissions <ul><li>The following states have laws requiring research proposal submissions prior to starting the trial: </li></ul><ul><ul><ul><li>Arizona, Illinois – prisoners </li></ul></ul></ul><ul><ul><ul><li>California – drugs not subject to FDA regulation, developmentally disabled in state hospitals </li></ul></ul></ul><ul><ul><ul><li>Delaware – mental health patients, clients of Del. Health & Social Services </li></ul></ul></ul><ul><ul><ul><li>Florida – investigational drugs not covered by a federal IND </li></ul></ul></ul><ul><ul><ul><li>Indiana – can request pre-clinical tests, investigator notarized statement </li></ul></ul></ul>
  21. 21. State Submissions (cont.) <ul><li>States requiring research proposal submissions: </li></ul><ul><ul><ul><li>South Dakota – mental retardation patients </li></ul></ul></ul><ul><ul><ul><li>Missouri – patients in a Dept. of Mental Health facility </li></ul></ul></ul><ul><ul><ul><li>North Carolina – institutionalized mental health patients, prisoners </li></ul></ul></ul><ul><ul><ul><li>Oklahoma, South Carolina – controlled substances </li></ul></ul></ul>
  22. 22. Reimbursement <ul><li>The following states have laws ensuring coverage for the routine health care costs for all clinical trials: </li></ul><ul><ul><ul><li>Delaware </li></ul></ul></ul><ul><ul><ul><li>Maryland </li></ul></ul></ul><ul><ul><ul><li>Massachusetts (cancer patients) </li></ul></ul></ul><ul><ul><ul><li>New Hampshire </li></ul></ul></ul><ul><ul><ul><li>New Mexico </li></ul></ul></ul><ul><ul><ul><li>Nevada </li></ul></ul></ul>
  23. 23. Duties of Site Personnel <ul><li>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: </li></ul><ul><ul><li>Registered nurses </li></ul></ul><ul><ul><li>Nurse Practitioners </li></ul></ul><ul><ul><li>Physicians Assistant </li></ul></ul><ul><ul><li>Foreign trained / unlicensed / allied health personnel </li></ul></ul><ul><ul><li>Medical students, interns, fellows </li></ul></ul>
  24. 24. Investigational Drug Handling <ul><li>Most states require that an investigational drug must be labeled with the statement, “For Investigational Use Only” </li></ul><ul><li>California requires a special label for cancer drugs </li></ul><ul><li>Illinois and Oregon requires the investigational product’s name, strength, expiration date, reference code, lot number and name and location of the patient </li></ul><ul><li>Many states have laws dictating who and where the drug can be stored, prepared and dispensed </li></ul>
  25. 25. Investigational Drug Handling (cont.) <ul><li>Florida requires that the pharmacy must maintain information (investigational brochure) regarding the investigational product. </li></ul><ul><li>Maryland and North Carolina requires a signed agreement from each investigator prior to administration and distribution. </li></ul><ul><li>Tennessee requires that reports of investigations must be furnished to the Commissioner of Agriculture upon request. </li></ul><ul><li>Texas requires that the IND be sent to the Commissioner of Public Health prior to administering the drug </li></ul>
  26. 26. Minnesota Privacy Laws <ul><li>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 </li></ul><ul><li>Consent is valid for one year or for a lesser period as specified in the consent </li></ul>
  27. 27. Minnesota Privacy Laws (cont) <ul><li>Health records may be released for medical research if: </li></ul><ul><ul><ul><li>patient is told of the release </li></ul></ul></ul><ul><ul><ul><li>has opportunity to object (or the authorization is mailed twice with a postage prepaid return envelope and patient does not respond) </li></ul></ul></ul><ul><ul><ul><li>the disclosure is necessary to accomplish the research </li></ul></ul></ul><ul><ul><ul><li>the researcher employs confidentiality safeguards and will not further release the records without patient consent </li></ul></ul></ul>
  28. 28. California HIPAA Law <ul><li>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: </li></ul><ul><ul><ul><li>It is handwritten by the person who signs it or is in a typeface no smaller than 14-point type </li></ul></ul></ul><ul><ul><ul><li>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 </li></ul></ul></ul>
  29. 29. Minnesota Gifts to Practitioners Law <ul><li>Minnesota passed legislation in 1993 prohibiting drug manufacturers from providing gifts to healthcare “practitioners” valued greater than $50.00 in any calendar year. </li></ul><ul><li>Exceptions: drug samples, educational program registration, educational publications, reasonable honoraria for conference faculty, compensation for consulting services in connection with research projects </li></ul>
  30. 30. State Law References <ul><li>Websites: </li></ul><ul><ul><li> (Thomson Group) </li></ul></ul><ul><ul><li> (Health Privacy Project) </li></ul></ul><ul><li>Books: </li></ul><ul><ul><li>State-by-State Clinical Trial Requirements Reference Guide , Barnett International, September 2004 </li></ul></ul><ul><ul><li>Compilation of State and Federal Privacy Laws , Privacy Journal, March 2002 </li></ul></ul>
  31. 38. Contact Information <ul><li>Paul Below </li></ul><ul><ul><ul><li>Phone: (952) 882-4083 </li></ul></ul></ul><ul><ul><ul><li>Email: [email_address] </li></ul></ul></ul><ul><li>Janet Petrell </li></ul><ul><ul><ul><li>Phone: (715) 377-0160 </li></ul></ul></ul><ul><ul><ul><li>Email: [email_address] </li></ul></ul></ul>