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Informed Consent Processes for Vulnerable Populations

2. Informed Consent - Vulnerable Populations . BackgroundGeneral considerations for vulnerable subjectsConsideration for specific categories of vulnerable subjects Resources. 3. Regulation for Protection of Human Subjects . HHS Regulations: Title 45 CFR part 46Subpart A basic HHS Policy Bas

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Informed Consent Processes for Vulnerable Populations

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    1. 1 Informed Consent Processes for Vulnerable Populations Pregnant Women/Fetuses/Neonates, Prisoners, and Children Freda E. Yoder Division of Education & Development Office for Human Research Protections (OHRP) Department of Health and Human Services (HHS) RCF - Richmond, VA September, 16, 2008

    2. 2 Informed Consent - Vulnerable Populations Background General considerations for vulnerable subjects Consideration for specific categories of vulnerable subjects Resources

    3. 3 Regulation for Protection of Human Subjects

    4. 4 Regulation for Protection of Human Subjects, cont’d

    5. 5 Regulations protecting human subjects apply to all non-exempt human subject research conducted or supported by HHS OR covered by an Assurance

    6. 6 Basic HHS Regulatory Protections

    7. 7 General Informed Consent Considerations

    8. 8 No investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative §46.116

    9. 9 Legally Effective - Informed Consent Adults with impaired decision making capacity –generally unable to give legally effective consent Minors cannot give consent, in most cases Human fetuses and neonates – cannot give consent Others

    10. 10 When informed consent is required, informed consent must be documented by the use of a written consent form approved by the IRB and signed by the subject or their legally authorized representative – unless waived under §46.117(c) A copy shall be given to the person signing the form §46.111(a)(5)

    11. 11 Provisions for Alteration or Waiver- Informed Consent and Documentation Provisions for Alteration or waiver of informed consent: §46.116(c) or (d), §46.408, and §46.101(i) Waiver of documentation of informed consent: §46.117(c), and 46.101(i) Note – may not apply to research with some categories of vulnerable subjects

    12. 12 Considerations for Specific Categories of Vulnerable Subjects

    13. 13

    14. 14 Subpart B: Pregnant Women, Human Fetuses and Neonates

    15. 15

    16. 16

    17. 17 Informed Consent – Research with Pregnant Women or Human Fetuses Categories of research Prospect of direct benefit for woman Prospect of direct benefit to both woman & fetus No prospect of direct benefit for woman or fetus -risk to fetus no greater than minimal -development of important biomedical knowledge Consent of pregnant woman in accordance with subpart A

    18. 18 Informed Consent - Research with Pregnant Women or Fetuses, cont’d Categories of research, cont’d Prospect of direct benefit to fetus only -- Consent of both the pregnant woman and father of fetus in accord with subpart A Exception if father unable to consent because of - unavailability, incompetence, or temporary incapacity - OR pregnancy resulted from rape or incest Pregnant children - assent and permission per subpart D

    19. 19 Informed Consent - Research with Neonates Uncertain viability - Consent from either parent Exceptions if neither parent able to consent …, then IC of either parent’s LAR under subpart A consent of father not required if pregnancy result of rape or incest

    20. 20 Informed Consent - Research with Neonates Nonviable neonate - Consent from both parents in accordance with subpart A – Exceptions only one parent’s consent required if one not able to give consent … no waiver or alteration of informed consent at §46.116(c) and (d) allowed no LAR Viable neonate – under subpart D

    21. 21 Subpart B - Other Research Research not otherwise approvable - §46.207 Secretarial Panel process informed consent - under subpart A and other applicable subparts Research involving placenta, dead fetus, or fetal material - §46.206 conducted under applicable Federal, State, or local laws and regulations informed consent - third party considerations

    22. 22 Other Considerations Documentation of informed consent in accordance with and to the extent required by §46.117 Secretarial waiver of §46.116 and §46.117 requirements under §46.101(i) for emergency research is not applicable

    23. 23 Subpart C: Prisoners

    24. 24 General Considerations Among others Controlled conditions of prison – concerns re: equitable selection of subjects voluntariness of consent Freedom to volunteer for research

    25. 25 Informed Consent Considerations, cont’d In general Informed consent in accord with subpart A, and if applicable, other subparts Participation must be voluntary advantages from research not coercive subject selection without coercion from authorities no affect on parole – must be so informed, if relevant

    26. 26 Informed Consent Considerations, cont’d Waiver or alteration of informed consent consistent with §46.116(c) or (d) and §46.408 but must be informed that no effect on parole, if relevant Waiver of documentation under §46.117(c) Secretarial waiver of §46.116 and §46.117 requirements under §46.101(i) for emergency research is not applicable Other subpart considerations may apply

    27. 27 Subpart D: Children

    28. 28 Definition "Children" are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted - §46.402(a)

    29. 29 General Considerations Among others Not reached full intellectual and emotional capacities Not able to give legally effective informed consent Therefore, provisions for permission of parents and assent of subjects

    30. 30 Assent “Assent” means a child’s affirmative agreement to participate in research - §46.402(b) Required when … children are capable of providing assent. §46.408(a) Not required if research provides prospect of direct benefits to health or well-being of child & only available in the research context §46.408(b) May be waived in accordance with §46.116

    31. 31 Permission of Parent(s) or Guardian(s) "Permission" means the agreement of parent(s) or guardian to the participation of their child or ward in research. §46.402(c)

    32. 32 Parental or Guardian Permission To extent consent is required by §46.116. Permission of one parent for research no greater than minimal risk §46.404 greater than minimal risk but prospect of direct benefit - §46.405 Permission both parents for research greater than minimal risk without direct benefit – but generalizable knowledge about disorder or condition likely - §46.406 Research not otherwise approvable per §46.407. §46.408(b)

    33. 33 Waiver of Parental Permission In accordance with §46.116 or If parental permission is not a reasonable requirement to protect the children, provided that: an appropriate mechanism for protecting the children is substituted, and the waiver is not inconsistent with Federal, state or local law §46.408(c)

    34. 34 Wards Appointment of advocate for each child required, in addition to any other individual acting on behalf of the child. §46.409(a)

    35. 35 Documentation of Informed Consent Documentation of parental permission shall be in accord with §46.117 §46.408(d) The IRB shall determine whether and how assent must be documented §46.408(e)

    36. 36 Other Considerations Timing Child reaching legal age of consent Passive consent - not recognized by the regulations at 45 CFR part 46

    37. 37 Summary- Vulnerable Populations HHS regulations provide additional protections for research with Pregnant women, human fetuses and neonates Prisoners Children Special “informed consent” provisions for protecting vulnerable subjects IRB will ensure that protections are adequate

    38. 38 Resources

    39. 39 Frequently Asked Questions Informed Consent http://www.hhs.gov/ohrp/informconsfaq.html Prisoners http://www.hhs.gov/ohrp/prisonerfaq.html Research with Children http://www.hhs.gov/ohrp/researchfaq.html Others http://www.hhs.gov/ohrp/faq.html

    40. 40 Other Guidance Informed consent http://www.hhs.gov/ohrp/policy/index.html#informed Research with Prisoners http://www.hhs.gov/ohrp/humansubjects/guidance/prisoner.htm Other Guidance by Topic http://www.hhs.gov/ohrp/policy/index.html#topics NIH guidance re: research with questionable capacity to consent http://www.grants.nih.gov/grants/policy/questionablecapacity.htm?Display=Text

    41. 41 How to Contact OHRP OHRP Web page: http://www.hhs.gov/ohrp Join Listserv: http://www.hhs.gov/ohrp/news/index.html Contact OHRP: Phone: (240)453-6900, (866) 447-4777 E-mail: ohrp@hhs.gov

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