By Cinead Kubiak 2010 Annual IRB Board Member Training Legal Issues in Human Subject Research.

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  • Slide 1
  • By Cinead Kubiak 2010 Annual IRB Board Member Training Legal Issues in Human Subject Research
  • Slide 2
  • Disease Reporting Reporting AIDS and HIV Testing Mandatory Disease Reporting Mandatory Reporting of Cancer
  • Slide 3
  • Reporting AIDS and HIV Testing Health Care Providers must report AIDS or HIV infection to the Utah Dept. of Health. Guidelines provide details of reporting and details of IRB authority to grant exemption from reporting requirement. Investigators complete the HIV Testing Checklist and disclose mandatory reporting in the consent document. Board Members verify that disclosure of mandatory reporting is made in the consent document. In rare cases, Board Members may grant exemption from reporting requirements. Language from IRBs consent template: If HIV testing is performed as a result of study participation, state that additional consent will be required for the University of Utah Hospitals and Clinics or PCMC (as applicable) which describes how results will be given to the participant and the methods or opportunities participants will be given for appropriate counseling and medical care.
  • Slide 4
  • Mandatory Disease Reporting Health care providers are required to report communicable diseases within 24 hours of concluding that a report is required (refer to http://health.utah.gov/epi/report.html for a current list of Utahs reportable diseases).http://health.utah.gov/epi/report.html If testing is performed for any communicable or infectious diseases reportable by Utah State law as a result of study participation, Investigators disclose mandatory reporting in the consent document. Board Members verify disclosure of mandatory reporting that is made in the consent document. Language from IRBs consent template: If testing is performed as a result of study participation for any communicable or infectious diseases reportable by Utah State law, the following must be addressed in this section (refer to http://health.utah.gov/epi/report.html for a current list of Utahs reportable diseases): http://health.utah.gov/epi/report.html Tell the participant about the state reporting. Describe how results will be given to the participant to comply with state reporting requirements. Describe the methods or opportunities participants will be given for appropriate counseling and medical care.
  • Slide 5
  • Mandatory Reporting of Cancer All hospitals, radiation therapy centers, and other facilities and health care providers are required to report to the Department of Health new cases of cancer within six months of diagnosis. If an Investigator is a health care provider who diagnoses cancer in a patient, he/she is responsible for the mandatory reporting of cancer as described. No verification necessary by Board Members.
  • Slide 6
  • Criminal Reporting Mandatory Reporting of Injury as a Result of Criminal Conduct Mandatory Reporting of Child Abuse Mandatory Reporting of Abuse of Vulnerable Adult
  • Slide 7
  • Mandatory Reporting of Injury as a Result of Criminal Conduct Any health care provider who cares for any person who suffers from an injury resulting from criminal conduct (including as gunshot wounds, stabbings, explosive devices), shall immediately report to a law enforcement agency the facts regarding the injury. It is not possible to predict when a health care provider will care for a person who suffers from an injury resulting from criminal conduct. If an Investigator is a health care provider, he/she is subject to mandatory reporting of injury as a result of criminal conduct as described. No verification necessary by Board Members.
  • Slide 8
  • Mandatory Reporting of Child Abuse Any person that has reason to believe that a child has been subjected abuse, or neglect, or who observes a child being subjected to conditions or circumstances which would reasonably result in sexual abuse, physical abuse, or neglect, shall immediately notify the nearest law enforcement agency, or office of the Division of Child and Family Services. If an Investigator has reason to believe a child has been abused, neglected or observes a child being subjected to conditions which would reasonably result in abuse or neglect, he/she must report such observations as described. Since it is not possible to predict the observation of abuse or neglect, if a study involves the possibility of the disclosure of abusive situations, Investigators should include language regarding the reporting of abuse in the consent document. Board Members verify language regarding the reporting of abuse is in the consent document, if applicable. Language from IRBs consent template: In some cases this section must include a statement about mandatory reporting of confidential information such as when the researcher is legally obligated to reveal instances of child abuse, elder abuse, or abuse of the disabled. If your study involves the possibility of disclosure of abusive situations, the following mandatory language from the Department of Health and Human Services must be inserted: However, if you disclose actual or suspected abuse, neglect, or exploitation of a child, or disabled or elderly adult, the researcher or any member of the study staff must, and will, report this to Child Protective Services (CPS), Adult Protective Services (APS) or the nearest law enforcement agency.
  • Slide 9
  • Mandatory Reporting of Abuse of Vulnerable Adult Any person who has reason to believe that any vulnerable adult has been the subject of abuse, neglect, or exploitation shall immediately notify Adult Protective Services intake or the nearest law enforcement agency. If an Investigator has reason to believe a vulnerable adult has been abused, neglected or exploited, he/she must report such observations as described. Since it is not possible to predict the observation of abuse or neglect, if a study involves the possibility of the disclosure of abusive situations, Investigators should include language regarding the reporting of abuse in the consent document. Board Members verify language regarding the reporting of abuse is in the consent document, if applicable. Language from IRBs consent template: In some cases this section must include a statement about mandatory reporting of confidential information such as when the researcher is legally obligated to reveal instances of child abuse, elder abuse, or abuse of the disabled. If your study involves the possibility of disclosure of abusive situations, the following mandatory language from the Department of Health and Human Services must be inserted: However, if you disclose actual or suspected abuse, neglect, or exploitation of a child, or disabled or elderly adult, the researcher or any member of the study staff must, and will, report this to Child Protective Services (CPS), Adult Protective Services (APS) or the nearest law enforcement agency.
  • Slide 10
  • Privacy Genetic Testing Privacy Act
  • Slide 11
  • According to Utah law, special protection applies with regard to genetic information. The law places restrictions on the use/disclosure of private genetic information to employers and to health insurers. Issues regarding privacy and confidentiality constitute a large portion of the potential risks in genetic research. Such risks include Discovery of non-paternity Negative impact on the participants insurability or employability Social discrimination
  • Slide 12
  • Genetic Testing Privacy Act (cont.) The investigator must provide a plan to protect privacy and confidentiality in the new study application and the consent document, addressing the following considerations: Investigators must establish a method to secure information related to genetic testing in a highly secure and confidential manner, and communicate this method in a manner satisfactory to the IRB and the participant. The investigator must specify who will have access to genetic results, limiting access only to those who will need the results to appropriately conduct the research. For studies that may discover non-paternity, a plan must be described for protecting the rights and privacy of the participants and their family members. The investigator may choose to withhold all knowledge of non-paternity from the participant. This should be adequately conveyed in the consent document. Genetic results obtained through the study may be required by the IRB to be excluded from the participants medical records, in order to prevent inadvertent disclosure to insurance companies or employers. If genetic results will be included in the medical record, participants must be informed of this in the consent document. Genetic studies which involve the long-term storage of specimens, genetic material, or data in tissue banks must follow the Tissue Banking Guidelines to ensure confidentiality. Investigators may want to consider acquiring a Certificate of Confidentiality, if appropriate (see IRB guidance on Certificates of Confidentiality). Results must be sufficiently anonymized to ensure privacy to participants (and family members) when the time comes for the investigator to publish the results of the study.
  • Slide 13
  • Genetic Testing Privacy Act (cont.) Disclosing Results to Participants: Information developed in the course of genetic studies may vary considerably with respect to its impact and value to subjects. Investigators should not disclose genetic results to participants or their physicians if the results are not clinically relevant (i.e., the claimed association between marker or gene and disease is generally accepted by the medical genetics community). The purpose of the study should be conveyed to the participants appropriately in the consent document and genetic results must not be indicated as medically important if the value and reliability of the results has not been established. If the investigator intends to disclose results to participants, the method should be described in the protocol summary and consent document. Written information in conjunction with other methods of disclosure is preferred by the IRB when disclosing results. Keep in mind that when participants are informed about the results of their genetic testing, complete anonymity is virtually impossible to accomplish, and additional protections for privacy and confidentiality may be needed. See: http://www.research.utah.edu/irb/guidelines/pdf/Genetic_Research_A1509.pdfhttp://www.research.utah.edu/irb/guidelines/pdf/Genetic_Research_A1509.pdf Investigators should consider the protections provided by law regarding the disclosure of genetic information when writing the risks and confidentiality sections of the informed consent document. Board Members review the consent document to ensure the genetic guidelines are met.
  • Slide 14
  • Consent for Medical Treatment HIPAA Consent to Health Care Advanced Health Care Directive Act Emancipation Consent of Minors
  • Slide 15
  • HIPAA To protect patient privacy, covered entities (all health plans, health care clearinghouses, and health care providers) must obtain specific, written authorization from a patient to use or disclose PHI. Patients must also be notified about their right to restrict the use and disclosure of such information. Covered entities must make reasonable efforts to limit the health information disclosed to the minimum necessary to accomplish the intended purposes. Options for Conducting HIPAA-Compliant Research: Obtain HIPAA authorization from individuals to use their protected health information (PHI) Use a de-identified Data Set that contains no PHI Use a Limited Data Set with an effective Data Use Agreement in place as applicable Obtain an IRB Waiver of (HIPAA) Authorization
  • Slide 16
  • HIPAA (cont.) PHI Identifiers: 1. Names 2. Geographic subdivisions smaller than a state if it contains less than 20,000 people (the initial three digits of the zip code are allowed). This includes street address, city, county, precinct, and zip code (or equivalent geocodes). The initial three digits of a zip code may be included if, according to the currently publicly available data from the Bureau of Census the geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people, and the initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000 3. Dates - All elements of dates (except year) for dates directly related to an individual (including birth date, admission date, discharge date, date of death), and all ages over 89 (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older 4. Telephone numbers 5. Fax numbers 6. E-mail addresses 7. Social security numbers 8. Medical record numbers 9. Health plan beneficiary numbers 10. Account numbers 11. Certificate or license numbers 12. Vehicle identifiers, serial numbers, and license plate numbers 13. Device identifiers and serial numbers 14. Internet Universal Resource Locators (URLs) 15. Computer Internet Protocol (IP) addresses 16. Biometric identifiers 17. Full-face photographs and comparable images 18. Any other unique identifying number, characteristic, or code, except as permitted for re-identification of the de-identified data
  • Slide 17
  • HIPAA (cont.) Language from IRBs consent template: AUTHORIZATION FOR USE OF YOUR PROTECTED HEALTH INFORMATION Include the Authorization section as outlined: Signing this document means you allow us, the researchers in this study, and others working with us to use information about your health for this research study. You can choose whether or not you will participate in this research study. However, in order to participate you have to sign this consent and authorization form. This is the information we will use: Modify the following list as appropriate delete or add items as necessary. > Others who will have access to your information for this research project are the Universitys Institutional Review Board (the committee that oversees research studying people) and authorized members of the > who need the information to perform their duties (for example: to provide treatment, to ensure integrity of the research, and for accounting or billing matters).
  • Slide 18
  • HIPAA (cont.) Use one of the following 2 disclosure options, as applicable: Disclosure Option 1: If you might disclose PHI to anyone outside the University, Primary Childrens Medical Center and/or Shriners use the following language: In conducting this study, we may share your information with groups outside the >. The information we share may include information that directly identifies you. These are the groups: Modify this list as appr...

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