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Informed Consent

Guiding Principles of Consent. Research subjects must understand what is involved in their participation.Subjects must be legally able to give consent (i.e., they are adults, not under guardianship, and not in custody).Consent must be given free from coercion or duress.. Who participates in the process?.

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Informed Consent

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    1. Informed Consent Margaret D. LeCompte, PhD University of Colorado-Boulder [Adapted from a presentation by Karen Hegtvedt, PhD Emory University

    2. Guiding Principles of Consent Research subjects must understand what is involved in their participation. Subjects must be legally able to give consent (i.e., they are adults, not under guardianship, and not in custody). Consent must be given free from coercion or duress.

    3. Who participates in the process? Researcher or his/her assistant Participant Participant’s legally authorized representative when participant is mentally incapacitated

    4. Who participates….[more] when participant is a child Parents or guardians provide consent child provides assent ( e.g., Emory policy: orally ages 6-10, written ages 11-16, co-sign consent 17-18)

    5. What is informed consent? A dynamic process of information exchange between researcher and participant

    6. What does informed consent involve? Respecting the autonomy of persons to make their own decisions Conveying information in a way participants can understand about Study procedures and risks Participants’ rights and researcher responsibilities

    7. Concerns in Obtaining Consent Is what the participant will encounter during the research stated in clear, lay, language at an appropriate level of understanding? Is that understanding documented in writing or other verifiable manner?

    8. How is information conveyed? Written document Orally, with script Orally, without script

    9. Consent as a process Initial consent provision of information (oral or written) opportunity to consider participation, to ask questions absence of pressures

    10. ….more Continued assessment of understanding Withdrawal anytime after full disclosure in cases of deception Without duress

    11. What’s in a letter of consent? (CFR 46.116) Description of the study: what will happen to participant? introduction/purpose of the study study procedures, sample questions or protocol items duration and location of participation in the study -

    12. In a letter of consent…[more] Disclosure of risks/benefits How confidentiality will be assured Assurances regarding voluntary participation and withdrawal Who to contact for questions or complaints

    13. What other qualifiers might be mentioned? (CFR 46.116) Unforeseen risks Compensation Number of participants New findings

    14. …more qualifiers Compensation for injury (if greater than minimal risks) Reasons for involuntary termination Additional costs Consequences for withdrawal

    15. What are the means to document consent? (CFR46.117) Written consent Short form written consent following oral presentation of information witness signs short/long forms Waiver of written consent

    16. Waivers of written consent When consent document is the only record identifying participant & principal risk is breach of confidentiality When the study involves no more than minimal risk

    17. Waiver requires that: (CFR46.116) IRB find that research could not otherwise be carried out research involves no more than minimal risk the alteration/waiver does not aversely affect participants’ rights or welfare

    18. ….waiver requirement …[more] Having a signed waiver would be the only way to identify research participants in ways that could put them at risk

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