New classes of people may provide informed consent for patients who lack capacity but retains the current hierarchy and requirements. For information about who can be LAR for a minor, see the section on Parent/Guardian Permission in Protected and Vulnerable Populations and RCW 7.70.65(2) which describes the somewhat different requirements for an LAR for minors in Washington State, when the parents are not available. It is HSD policy to voluntarily apply the Common Rule (45 CFR 46) consent regulations to all research reviewed by the UW IRB except as described in the HSD Flexibility Policy (GUIDANCE Authority and Responsibilities of HSD and UW IRB), in addition to other applicable requirements. Recognizing that technology changes are developed and become applied to practice with . Consent Templates PROCEDURES AND GUIDELINES. 2 Failure to obtain or . E-consent processes are invaluable when it is not possible to have an in-person interaction with a subject. Electronic informed consent (e-consent) refers to the use of electronic systems and processes that employ some type of electronic media (including text, graphics, audio, video, podcasts, passive and interactive websites, biological recognition devices, card readers, etc.) adult must give his/her own consent for health care. (c) A health care provider may, but is not required to, rely on the representations or declaration of a person claiming to be a relative responsible for the care of the minor patient, under (a)(v) of this subsection, or a person claiming to be authorized to consent to the health care of the minor patient under (b) of this subsection, if the health care provider does not have actual notice of the falsity of any of the statements made by the person claiming to be a relative responsible for the health care of the minor patient, or person claiming to be authorized to consent to the health care of the minor patient. informed consent. See short form consent. This means providing consent information in a logical sequence and in a way that allows for real-time review during discussion between study staff and the prospective subject. In some cases it may be appropriate to use a single form to obtain both parental permission and child assent. GUIDANCE Prisoners Study Summary Federal regulations identify pregnant women*, prisoners, and children as Protected Populations and specify additional protections and consent requirements for them. (ii) A person authorized to consent to care under this subsection (2)(b) and the person's employing school or school district are not subject to administrative sanctions or civil damages resulting from the consent or nonconsent for care, any care, or payment for any care, rendered pursuant to this section. American Journal of Bioethics, 17:12, 3-11 (2017), Dickert et al., Partnering with Patients to Bridge Gaps in Consent for Acute Care Research. When the patient/surrogate has provided specific written consent, the consent form should be included in the record. I have been a licensed marriage and family therapist in Washington State since 1999. Researchers are still responsible for protecting the rights and the welfare of subjects in their research and for providing subjects with information about the research prior to their agreement to participate. These are risks associated with taking the drug if HIV positive, however, the study is excluding HIV positive subjects and regularly testing subjects for HIV transmission. The Common Rule requires that informed consent must begin with a concise and focused presentation of Key Information that is most likely to assist prospective subjects or their representatives in understanding the reasons why they might or might not want to participate in the research. Our current use policy permits free printing and use by health care . The witness and the researcher should also sign and date the form. For example, a consent form may be emailed in advance to a potential subject, followed by an in-person meeting in which the study is discussed, after which an electronic signature is obtained. Alternatively, assent, LAR consent, and/or parental permission may be waived by the IRB. Except in emergencies, healthcare practitioners must generally obtain the patient's informed consent before providing treatment. It is important to remember that the IRB is tasked with minimizing, not eliminating the possibility of undue influence or coercion. Throughout the course of a study, subjects may need to be informed about new information or consent may need to be revisited due to fluctuating decision-making capacity [see Diminished or Fluctuating Consent Capacity and use of a Legally Authorized Representative (LAR)] or because a child subject has reached the age of majority (see Children under Protected and Vulnerable Populations). 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. In making this determination, the IRB should consider: Methods for providing new information to subjects. When consent information is provided in writing, understanding may be facilitated by breaking up dense text with sectioning, pictures, icons, schematic diagrams of study design, or putting information in side-by-side comparison tables. For many other situations, rather than trying to anticipate what might be unduly influential for every individual subject, the IRB should make use of existing minimization tools including some of the other regulatory consent requirements and protections that have been described in this guidance. It is HSD policy that researchers must obtain assent from subjects who are minors or decisionally-impaired adults, when the individuals are capable of providing assent and when it is appropriate to do so. The risks associated with the educational session are not research risks because all students who come into the counseling center participate in those sessions whether or not they are in the research study. 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. Any non-watermarked version used must match exactly the content and format of the IRB-approved watermarked version. RCW 7.70.050 speaks only of "treatment" in connection with the doctrine of informed consent. As with more likely to occur the IRB has discretion to leave out serious risks that are not relevant to a particular population, may be theoretical or unsupported by the data, or would detract from a participants understanding of the more significant risks associated with the primary aim(s) of the research. The IRB will request that researchers fill out the form. Prenatal care services: Yes No No Minors may seek prenatal care at any age without the consent of a parent or guardian. Subjects can be provided with tables or supplemental information sheets with additional study details after the enrollment decision has been made. 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. See the section on Assent for more information. (i) Staff at a governmental or nonprofit human services agency or homeless services agency; (ii) An attorney representing the minor patient; or. California- Written or oral consent required for all patients. What are the types of activities (procedures) that subjects will do in the research? Additional information can be found in the OHRP draft Guidance, Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care. There are certain situations when a person receiving services is required to provide written, informed consent. [For FDA-regulated research, parental permission can only be waived under the minimal risk criteria.] 116 (b) (2); 21 CFR 50.25(a)(2)). However, if a blood draw is only one of many procedures and the other study procedures are associated with more significant risks to subjects, then information about the blood draw may be left out of Key Information and instead described in a more detailed Risks section later in the consent process or form. (ii) If there are two or more individuals in the same class and the decision is not unanimous among all available members of that class. GUIDANCE Exempt Research WORKSHEET Neonates (1) If a patient who has capacity to make health a care [a health care] decision, or his or her representative if he or she does not have the capacity to make a health care decision, signs a consent form which sets forth the following, the signed consent form shall constitute prima facie evidence that the patient gave his or her informed consent to the treatment administered and the patient . 4 Paws 4 Life Rescue is a 501(c)3 non-profit animal rescue located in Sedalia, CO. 4P4L . Human subjects regulations require that the consent process minimizes the possibility of undue influence or coercion and notes that some populations of subjects are considered especially vulnerable. This method may be appropriate for communicating information that: (1) is simple; (2) does not change the individual subjects anticipated risks or benefits; (3) is not likely to affect a subjects willingness to continue participation; and (4) does not require documentation that subjects are willing to remain in the study. The subject population will require infrastructure (e.g., reliable internet connection), hardware (e.g., smartphone, computer), and technological experience in order to benefit from the potential advantages of e-consent. (ii) Potential referral to additional services, the department of children, youth, and families, or law enforcement. GLOSSARY Legally Effective Research Consent The Issaquah School District, in compliance with the Washington State rules for Highly Capable Programs (WAC 392-170-047), has a procedure to allow students to exit the Highly Capable Program. One or two parent permission. The researcher may need to take additional steps to ensure the subject comprehends the consent process, has adequate opportunity to ask questions, and voluntarily agrees to participate. The AGO will receive free, prior and informed consent prior to taking certain actions specified in this section that directly and tangibly affect Tribes, rights or tribal lands. Informed consent is a person's decision, given voluntarily, to agree to a healthcare treatment, procedure or other intervention that is made: Following the provision of accurate and relevant information about the healthcare intervention and alternative options available; and. Although rare, the contrast agent does have a risk of severe allergic reaction. In May 2004, CMS issued Interpretive Guidelines for the Medicare Conditions of Participation, including detailed requirements for the content of informed consent forms. That worksheet also lists the consent requirements for federally-designated protected populations (i.e., pregnant women and neonates, prisoners, children). The physician wants to compare the effects of two different FDA-approved estrogens on the osteoporosis. (f) That the eligible patient is liable for all expenses consequent to the use of the investigational product, except as otherwise provided in the eligible patient's health benefit plan or a contract between the eligible patient and the manufacturer of the investigational product. Waiver of documentation of consent. INFORMED CONSENT FOR COUNSELING SERVICES THERAPIST CREDENTIALS: I am a master's level Licensed Mental Health Counselor (LMHC) in the State of Washington. Information provided during consent should emphasize the Key Information that is most likely to assist the particular subject population with making a decision about whether to participate in research. SUPPLEMENT Other REDCap Installation GLOSSARY Legally Authorized Representative This may mean that the researcher needs to consult with publications about research subjects preferences, disease-focused nonprofit groups, patient interest groups, or other researchers/study staff with experience with the specific population. 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. Washington State's current informed consent law (RCW 7.70.065) allows a very limited range of people to make medical decisions on behalf of a patient who is incapacitated. The continued education and engagement of subjects throughout the research process is vital. A rule or Washington Administrative Code (WAC) is written to provide interpretive support for the individuals or entities to whom the rule applies. Table adapted from the Council for International Organizations of Medical Sciences and FDA prescription drug labeling guidance. The Part 11 regulations are separate from the FDAs human subject regulations and have nothing to do with IRB review and approval. 28 CFR 46.117 Documentation of Informed Consent. E-consent allows for using images, animations, embedded comprehension checks, and other technological tools that can improve consent comprehension. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979, The PHASES Working Group, Pregnancy and HIV/AIDS: Seeking Equitable Study, Ending the evidence gap for pregnant women around HIV and co-infections: A call to action (2020), WCG IRB Insights, Providing Research Participants with New Information: Is Re-Consent Always Necessary?, Wilfond and Kraft, Attending to the Interrelatedness of the Functions of Consent. A full reconsent is required when a LAR consent or parental permission is being replaced by the subject consenting on their own behalf. 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. Revised consent form. IV. The LAR or parent/guardian name and relationship to the subject should also be recorded in the signature area. HSD and the UW will not vet other e-signature methods. (C) The minor patient is not under the supervision or control of a parent, custodian, or legal guardian, and is not in the care and custody of the department of social and health services. Many patients undergo a trial-and-error period until they find a treatment plan that is effective for them. By judicial decision, Washington state provides that mature minors who are capable of meeting the informed consent standard have consent authority. There are many stents that a physician could use, but the research protocol is restricting the physicians (and subjects) choice to the two that are the focus of the study. The risks associated with the research questionnaires (depression, social anxiety, stress coping strategies) and with research use of the standard clinic questionnaires are research risks and must be described in the consent process/form. E-consent can take many different forms including, consent information or documents that are delivered electronically (e.g., email, text message); passive or interactive websites; social media platforms; audio; video; podcasts; or any combination of these. WEBPAGE Single Patient Emergency or Compassionate Use 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.