The Science of Titration Analysis. (c) General requirements for informed consent. GUIDANCE Authority and Responsibilities of HSD and UW IRB If the subjects family members or friends will be asked to serve as interpreter, the researcher should think carefully about privacy and confidentiality issues, particularly for research that involves health or other sensitive topics. See the section on Information for subjects in the GUIDANCE Exempt Research for full details. For younger children, researchers should focus the assent process and information on the aspects of the research that the children would be mostly likely to understand and be interested in. Consent materials are read to the subject in the presence of an impartial witness who observes the entire consent process. It should include an active process of sharing information between the researcher and potential subject and an affirmative agreement by the subject that they want to participate. There are two electronic signature tools that have been vetted by the UW and its legal counsel as meeting the federal and Washington State definitions of a legally valid electronic signature. The psychologist will use the results of the clinics pre/post questionnaires to assess the two approaches. (b)(i) Informed consent for health care on behalf of a patient who is under the age of majority and who is not otherwise authorized to provide informed consent may be obtained from a school nurse, school counselor, or homeless student liaison when: (A) Consent is necessary for nonemergency, outpatient, primary care services, including physical examinations, vision examinations and eyeglasses, dental examinations, hearing examinations and hearing aids, immunizations, treatments for illnesses and conditions, and routine follow-up care customarily provided by a health care provider in an outpatient setting, excluding elective surgeries; (B) The minor patient meets the definition of a "homeless child or youth" under the federal McKinney-Vento homeless education assistance improvements act of 2001, P.L. When children participate in research, parent/guardian permission and child assent are sought rather than consent. Each student who agrees to participate in the research will have the two educational sessions and will then be randomly assigned to either the motivational interviews or the cognitive-behavioral group. If the subject cannot use their hands at all, the IRB will consider alternative methods of documenting consent. Excerpt: "Ethics codes emphasize informed-consent requirements. The Part 11 regulations are separate from the FDAs human subject regulations and have nothing to do with IRB review and approval. If an adults capacity to consent is reduced, then they can participate in the research only if a legally-authorized representative (LAR) provides consent on their behalf. The drug is an FDA-approved drug for the treatment of this condition and is frequently used in clinical care. It is often funded by public sources and is increasingly integrated into health care delivery systems. Whether a subject may be vulnerable to being unduly influenced or coerced to participate in research is contextual and dependent upon the individual subjects situation, yet the IRB approves research on a population-level. Most research generates knowledge to promote a common good. No, these risks do not need to be added to the consent form. FLORIDA AGENT'S HEALTH INSURANCE (85 scoreable questions plus 15 pretest questions - Time limit: 2 hours) ACCIDENT & HEALTH - GENERAL KNOWLEDGE CONTENT (50 scoreable questions plus 10 pretest questions) I. Changes to the consent form do not necessarily require researchers to inform all enrolled subjects. Documentation of Consent. WORKSHEET Prisoners. Unless otherwise indicated, in this guidance the term subject refers to: the subject, the parent(s) or guardian of a minor subject, and the LAR for a decisionally-impaired adult subject. consent processes and materials are understandable and include Key Information in sufficient detail for the specific subject population to be able to make an informed decision about participation. The research may begin as soon as the researcher receives the photo of the signature. Disagreement among possible LARs. voluntary consent is being sought for research; research purpose, expected duration of participation, and procedures; the most important, reasonably foreseeable risks or discomforts, reasonably expected benefits to the subjects or others; and. (iii) An adult relative of the minor patient or other adult with knowledge of the minor patient and the minor patient's housing situation. Oral consent should be documented in the patient record. LMHC #6901. . GUIDANCE Subject Payment It is HSD policy that that IRB approval must be obtained in advance for the use of any e-signature or electronic signature capture system (e.g., DocuSign, UW ITHS REDCap). Alternatively, the IRB may grant a waiver of documentation of consent if the criteria are met (WORKSHEET Consent Requirements and Waivers). Sufficient time is allowed for questions to ensure subject comprehension. In addition, researchers must obtain some type of assent from the subject, when the individuals are capable of providing assent (see assent). It is noteworthy that, in the 2018 revision to the Common Rule, pregnant women were removed as an example of a population that is potentially vulnerable to coercion or undue influence. However, the IRB may allow the parent(s)/LAR wishes to prevail over the potential participants dissent when the potential participant may directly benefit from the research. See, Guidance for NIH Institutional Training Grants, Office of Research Information Services (ORIS), Washington National Primate Research Center (WaNPRC), Human Embryonic Stem Cell Research Oversight (ESCRO), All Research Administration Learning Resources, Collaborative for Research Education (CORE), Environmental Health & Safety (EH&S) Training, Financial Conflict of Interest (FCOI) Training, Grants Management for Investigators (GMI), Human Subject Division Training and Education, INFORMATION SHEET Certificate of Confidentiality, Single Patient Emergency or Compassionate Use, Identifying and Describing Reasonably Foreseeable Risks in Research, Diminished or Fluctuating Consent Capacity and Use of a Legally Authorized Representative (LAR), Subjects with Comprehension Barriers (e.g., language, literacy, visual impairment) or Who Cannot Write or Speak, Anticipated involvement of subjects with limited English proficiency, Unexpected involvement of subjects with limited English proficiency, Subjects who cannot write a signature on a consent form, Approvable methods for obtaining handwritten signatures, Approvable methods for obtaining electronic signatures, Reconsent and Ongoing Subject Communication, legally authorized representative consent, WORKSHEET Consent Requirements and Waivers, Council for International Organizations of Medical Sciences, Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care, GUIDANCE Involvement of Children in Research, Committee on Ethical Considerations for Revisions to DHHS Regulations for Protecting Prisoners in Research, 2006, Electronic Consent: What You Need to Know, FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures Scope and Application (September 2003), Subjects With Comprehension Barriers or Who Cannot Write or Speak, Requirements specific to electronic consent documentation, TEMPLATE Other E-signature Attestation Letter, Diminished or Fluctuating Consent Capacity and use of a Legally Authorized Representative (LAR), GUIDANCE Consent Elements for Externally Reviewed Studies, TUTORIAL Electronic Consent: What You Need to Know, CHECKLIST Exception from Informed Consent, GLOSSARY Legally Authorized Representative, GLOSSARY Legally Effective Research Consent, GUIDANCE Authority and Responsibilities of HSD and UW IRB, WEBPAGE Single Patient Emergency or Compassionate Use, OHRP Draft Guidance on Disclosing Reasonably Foreseeble Risks in Research Evaluating Standards of Care, 2014, https://www.hhs.gov/ohrp/regulations-and-policy/guidance/informed-consent/index.html, https://www.hhs.gov/ohrp/education-and-outreach/online-education/videos/simplifying-informed-consent-ohrp, FDA Guidance, Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products Content and Format January 2006, FDA Reporting Serious Problems to FDA, What is a Serious Adverse Event?, 2016, SACHRP Recommendations, Attachment A Guidance on Applying the Regulatory Requirements for Research Consent Forms: What Should and Should Not be Included?, July 2011, SACHRP Recommendations, Attachment A Recommended Guidance on Minimal Risk Research and Informed Consent, 2015, SACHRP Recommendations, Attachment A SACHRP Commentary on the FDA Draft Guidance Entitled, Informed Consent Information Sheet; Guidance for IRBs, Clinical Investigators and Sponsors, February 11, 2015, CIOMS III Core Clinical Safety Information, Guidelines for Preparing Core Clinical-Safety Information on Drugs, 1995, https://www.advarra.com/blog/the-many-faces-of-coercion-and-undue-influence/, https://www.wcgirb.com/insights/providing-research-participants-with-new-information-is-re-consent-always-necessary/, University of Washington Office of Research, WA National Primate Research Center (WaNPRC), Institute of Translational Health Sciences (ITHS), Collaborative Proposal Development Resources, Add new section: Identifying and Describing Reasonably Foreseeable Risks in Research, Revise reference from GUIDANCE Electronic Consent Signatures to INSTRUCTIONS UW E-Signature Tools, Add example of undue influence considerations when power dynamics are involved, Add section describing requirements for exempt studies. As of May 2020, the Washington Healthplanfinder application asks for your "sex assigned at birth". Accommodations to the consent form or process will be specific to the needs of the particular subject(s). Undue influence is often scrutinized by the IRB when subjects will receive significant payment for participation (see GUIDANCE Subject Payment). (f) During a visit with an unaccompanied homeless youth who provides informed consent authorized under this subsection (3), a primary care provider as defined under RCW, (i) Whether the unaccompanied homeless youth may be a victim of human trafficking; and. Prisoners are a federally designated protected population with additional regulatory requirements and protections described in Subpart C of the Common Rule (GUIDANCE Prisoners). A particular condition has several treatment options, but an individuals response to the treatment can be highly variable and unpredictable. Medicaid requires written consent if a recording is made. WEBPAGE Is the UW IRB the Right IRB? Washington State law now allows adults raising a relative's child to consent to medical and mental health care - services even if you don't have legal custody. Researchers are responsible for identifying applicable state or other local laws when the research is conducted outside of Washington State, including internationally (see OHRP webpage for international research). However, Washington State law RCW 7.70.65 defines who may serve as a LAR for providing informed consent for health care. Informed consent serves to: Consent method. Prior to initiating any research activities, including screening procedures or extracting information from records, federal regulations require that the subject sign the IRB-approved consent form and that a copy of the consent form be provided to the subject. For research intended, or likely, to involve subjects who are not fluent in English, researchers are responsible for ensuring all consent information and materials are presented in a language understandable by the subjects and in a way that accurately conveys the information. In these situations, it is important for subjects to be able to reaffirm their willingness to participate in research. Design. State and federally-funded homeless and housing service providers use HMIS to collect and manage data gathered while providing housing assistance to people already experiencing homelessness and households at risk of losing their housing. By placing their name on the consent form, the researcher is confirming that they provided the subject with information about the study, that the subject was given sufficient time to consider participation, that the researcher answered all the subjects questions, and that the subject indicated they understood the nature of the study, including the risks and benefits of participating. Alternatively, assent, LAR consent, and/or parental permission may be waived the the IRB. For example, when there are power dynamics involved (e.g., professor/student; supervisor/employee), it may be appropriate to ensure the consent process is conducted by someone outside the power dynamic. The UW-ITHS-supported non-mobile version of REDCap meets the FDAs Part 11 electronic system requirements. An individual, if any, to whom the person has given a durable power of attorney that encompasses the authority to make health care decisions, Spouse or state-registered domestic partner, Children, if they are at least 18 years old, Adult grandchildren, who are familiar with the person, Adult nieces and nephews, who are familiar with the person. Reconsent. Researchers are asked to describe their plans (if any) for obtaining and documenting assent in the IRB application. So long as the additional protections afforded by LAR consent are in place to offset the subjects diminished autonomy, it is possible that individuals with reduced consent capacity can still participate in research. An impartial witness should witness the mark and sign the form. All research reviewed by the UW IRB, including non-UW institutions and sites for which the UW IRB is providing review. Adolescents and mature minors are legally and ethically authorized to provide informed consent if they are emancipated, and in many states, including Washington, they may provide consent for matters regarding sexual and reproductive health, mental health, and substance abuse. The risks associated with motivational interview and the cognitive-behavioral group are research risks and must be described in the consent process/form. As is noted in Consent Consideration # 5, with the appropriate protections in place, prisoners may still be able to take advantage of opportunities to share in the risks and benefits of research. Examples where more formal verification might be appropriate include: UW eSignature (DocuSign) is not valid for FDA-regulated research; and. Reasonably Foreseeable Risks E-consent allows for using images, animations, embedded comprehension checks, and other technological tools that can improve consent comprehension. The informed consent requirements in this policy are not intended to preempt any applicable Federal, state, or local laws (including tribal laws passed by the official governing body of an American Indian or Alaska Native tribe) that require additional information to be disclosed in order for informed consent to be legally effective.