It may also involve directly consulting selected members of the study population. The assent process and any materials should provide information that is relevant for the subject population considering their capacity for comprehension and the research procedures. (m) Signature and date blocks for the client, and the certified counselor or certified adviser, including an attestation that the client agrees that the required disclosure statement has been provided and that the client has read and understands the information. IRB Ethics & Human Research, 40:6, 1-6 (2018), The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. HSD tip. In other words, there is flexibility in how the presentation of Key Information is structured if it is organized and presented in a way that facilitates comprehension for prospective subjects. Consent must be documented in the client record. Examples where more formal verification might be appropriate include: UW eSignature (DocuSign) is not valid for FDA-regulated research; and. See HSDs tutorial, Electronic Consent: What You Need to Know for an overview. Comprehensive School Counseling Programs | OSPI - K12.wa.us Federal regulations identify pregnant women*, prisoners, and children as Protected Populations and specify additional protections and consent requirements for them. No LAR may provide consent on behalf of the person if: Decision-making standard. Emergency or Compassionate Use of investigational drugs or devices for clinical care (not research) (. Waivers and alterations. 46.116 (e) & (f) are met. Regulatory protections and IRB oversight have reduced the likelihood of coercion in research, but it is still something researchers and the IRB should be cautious about, particularly when researchers are in a position of power over subjects (e.g., physician and patient or professor and student). (4) For the purposes of this section, "health care," "health care provider," and "health care facility" shall be defined as established in RCW, (5) A person who knowingly provides a false declaration under this section shall be subject to criminal penalties under chapter, (2) It is the intent of the legislature to assist kinship caregivers in accessing appropriate medical care to meet the needs of a child in their care by permitting such responsible adults who are providing care to a child to give informed consent to medical care."

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