washington state informed consent requirements washington state informed consent requirements

Our current use policy permits free printing and use by health care . Witness. When designing the assent process and, if applicable, assent form, researchers should consider the nature of the research as well as the age, maturity, and psychological state of the children. In most cases, when there is a separate Key Information section, it will be relatively short compared to the rest of the consent document or process. What information about the subject is being collected as part of this research? The subject signs the consent form in the presence of the researcher. Gerberding Hall G80 Box 351202 Seattle, WA 98195, 2023 University of Washington | Seattle, WA, Specific information about consent for studies being reviewed by a non-UW IRB can be found in the webpages and documents related to, Many other topics that intersect with consent are referenced within this guidance and linked in, *Pregnant women are not designated as a vulnerable population in the Common Rule or FDA regulations. Study Summary Additional information can be found in the OHRP draft Guidance, Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care. This includes consent forms, online or paper information statements, e-consent information, the short form consent process, oral consent with no written component, parental permission, and LAR consent. In general, the reasonably foreseeable risks associated with a standard of care procedure or treatment should be described in the consent form when: The examples below illustrate how to identify: (1) which risks are research risks and should be described in the consent process/form; and (2) which risks are not research risks and should not be described in the consent process/form. Regardless of the method used (e.g., oral, electronic, in-person), consent processes must include all the applicable regulatory requirements (Regulatory Oversight) unless the IRB determines any requirements can be waived. OHRP Guidance Documents on Informed Consent, from the OHRP website. Key information is intended to be the information that is most likely to assist the specific subject population (e.g., end-stage cancer patients; first-year college students; parents of toddlers with autism; prisoners). What are the main reasons a subject will want to join, or not join, this study? If a waiver is granted, none of the requirements listed below in this section apply to the study. Examples of undue influence and coercion adapted from an Advarra IRB blog post: Children are a federally designated protected population with additional regulatory protections and requirements described in Subpart D of the Common Rule. (I) Has exhibited special care and concern for the patient; (II) Is familiar with the patient's personal values; (III) Is reasonably available to make health care decisions; (IV) Is not any of the following: A physician to the patient or an employee of the physician; the owner, administrator, or employee of a health care facility, nursing home, or long-term care facility where the patient resides or receives care; or a person who receives compensation to provide care to the patient; and. STATE OF WASHINGTON DEPARTMENT OF CORRECTIONS REVISION DATE 5/17/22 POLICY APPLICABILITY PRISON FACILITY/SPANISH MANUALS PAGE NUMBER 4 of 7 NUMBER DOC 610.010 TITLE PATIENT CONSENT FOR HEALTH CARE C. For patients who are unable to provide informed consent for an extended period of time or do not have an authorized person, the Chief Medical . Severe allergic reaction is a rare risk and is therefore not more likely to occur. (e) A person who provides a statement for documentation that the minor patient is an unaccompanied homeless youth is not subject to administrative sanctions or civil liability for providing documentation in good faith based upon the person's knowledge of the minor patient and the minor patient's housing situation. Failure to object should not be equated with an active willingness to participate. Consent Requirements. Medicaid . A physician researcher at a local clinic plans to do a research study with patients who have been recently diagnosed with osteoporosis and who require treatment. Researcher. (b) A health care facility or a health care provider may, in its discretion, require documentation that the minor patient under this subsection (3) is an unaccompanied homeless youth. Other vulnerable groups may also require additional protections against the potential for coercion or undue influence. 2 Failure to obtain or . It may also be important to ensure that the person in power is not aware of which of their students, supervisees, etc. In determining whether the patient is a mature minor, providers will evaluate the minor's "age, intelligence, maturity, training, experience, economic independence or lack thereof, general . Telehealth care takes place where the patient is located at the time of the appointment. For example, depending on the study and population-specifics, information about risks and benefits, time commitments, and certain procedures may be appropriate under the headings, Why I may want to participate and, Why I may not want to participate. 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. The IRB requires a full reconsent for all enrolled subjects including obtaining documentation. Although a Key Information section may serve as an abstract or executive summary for a longer consent form, that is not its primary function. Undue influence is often scrutinized by the IRB when subjects will receive significant payment for participation (see GUIDANCE Subject Payment). GLOSSARY Capacity to Consent adult must give his/her own consent for health care. Although the overall study is greater than minimal risk and requires documentation of consent, the new component is minimal risk, so the IRB waives documentation of consent for the addendum. This means the person understands, writes, and signs a statement declaring they agree to a treatment, for example. This letter must be signed by the Chief Information Officer, Chief Information Security Officer, or other individual at the company/institution with sufficient authority and subject matter expertise to make the above attestation. This is especially helpful if your practice frequently provides complex . (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. The IRB must determine whether the prospective subjects are capable of providing assent and, if they are, whether the proposed assent process is adequate for helping subjects decide whether they want to participate in the research (WORKSHEET Consent Requirements and Waivers). Serious infections are very frequent according to the investigators brochure. This makes it particularly important that the Key Information about a study be tailored to the prisoner population and communicated in language that is understandable to them. FDA-regulated research. Signed consent materials must be easily retrievable for auditors and monitors. GUIDANCE Human Subjects Regulations promote voluntariness about whether to participate. SUPPLEMENT Other REDCap Installation The IRB has the authority to require revisions or additions to the consent process to ensure that all subjects are adequately informed and are providing truly voluntary consent. The purpose of this study is to identify biomarkers that may help predict a response to a specific drug in individuals diagnosed with the condition. The regulations allow an alternative method of obtaining and documenting consent called short form consent. The requirements proving informed consent vary by state and by the type of procedure being performed. Analysis Identifying this information is the responsibility of the researcher. However, there are additional regulatory requirements for enrolling this population for research funded or supported by the agencies that signed Subpart B. Prior IRB approval of using LARs to obtain consent is not required by federal regulations. It 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. 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. Sharing Substance Use Disorder Information: A Guide for Washington State helps clarify the applicable federal regulations and law. WORKSHEET Neonates 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. Finally, the initial consent procedure may need to be repeated or supplemented if relevant new information becomes available or if the study involves a lengthy commitment from subjects. In some cases it may be appropriate to use a single form to obtain both parental permission and child assent. Coercion occurs when an overt or implicit threat of harm is intentionally presented by one person to another to obtain compliance. HSD policies related to consent can be found in the WORKSHEET Consent Requirements and Waivers and throughout this guidance. For more information on these assessments families can review online practice tests, sample items and more at . Established legal opinion has determined that it is appropriate to apply this definition of LAR for research consent as well. Nothing in this section prevents a health care facility or a health care provider from seeking reimbursement from other sources for care provided to a minor patient under this subsection (2)(b). Assent outcomes. 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 American Journal of Bioethics, 20(5), 7-17 (2020), Gelinas, L. The Many Faces of Coercion and Undue Influence'. IRB Ethics & Human Research, 40:6, 1-6 (2018), The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Informed consent is a process that's required for most medical procedures. GLOSSARY Exempt Research In these cases, unless the IRB has waived the requirement, the researcher must obtain legally effective research consent from the now-adult subject for any ongoing interactions or interventions or continued analysis of identifiable specimens or data. Prior to implementation of human subjects research regulations, there were many instances of subjects being coerced into research. A researcher may suspect a new study drug might cause slightly increased blood sugar levels. Part IX. For example, an individual may have the capacity to make the research participation decision for a low-risk study in usual circumstances but not have the capacity in a stressful situation to understand and evaluate a high-risk study. to convey consent information and/or to document informed consent. Research Risks Assent is a subjects affirmative agreement to participate in research. If the consent process is not captured by audio or video, the researcher should create a written description of how the consent information was communicated to the subject and how the researcher ensured the subjects questions were answered. These additional safeguards must be considered throughout the vulnerable subjects participation in the study (i.e., recruitment, obtaining consent, and after enrollment). UW research reviewed by an external (non-UW) IRB. participated and which did not. A particular condition has several treatment options, but an individuals response to the treatment can be highly variable and unpredictable. "When I looked this up, I saw that . For example, the state of Colorado requires psychologists to present certain written information to their clients, including therapist credentials, client rights, and the State Grievance Board address (Handelsman, 1990 . 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. WORKSHEET Consent Requirements and Waivers, SOP Consent [HSD staff and IRB member access only] Note that some sponsors or funders may require a full reconsent for any change to the consent form. Oral consent should be documented in the patient record. This is particularly important when the study may offer significant benefit to the individual subjects or subject population. It began in 1953 and was halted in 1973. 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. 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. (CMHS). There was a therapeutic exceptions in the state's legislative ban on abortions by 1900. Have any dogs/cats in your home spayed or neutered, if they are 6 months or older, unless there are medical reasons for not doing so. It may also involve directly consulting selected members of the study population. Individuals who have reached the age of legal consent in the jurisdiction in which the research is being conducted are presumed to have capacity to give informed consent for research. Waivers and alterations. GUIDANCE Mandatory State Reporting Witness Requirements. Regulatory requirements. *Pregnant women are not designated as a vulnerable population in the Common Rule or FDA regulations. 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. 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. Poor reading and communication skills tend to be more common in prison populations (Committee on Ethical Considerations for Revisions to DHHS Regulations for Protecting Prisoners in Research, 2006). However, the IRB has the authority to require a separate Key Information section if appropriate. The psychologist will use the results of the clinics pre/post questionnaires to assess the two approaches. (c) A health care provider may, but is not required to, rely on the representations or declaration stating that the patient is an unaccompanied homeless youth, 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 authorized to consent to the health care of the minor patient. 28 CFR 46.117 Documentation of Informed Consent. The focus of the counseling program is to help students better understand the world they live in and make better . Table adapted from the Council for International Organizations of Medical Sciences and FDA prescription drug labeling guidance. One or two parent permission. The process and information presented must include the required characteristics and elements of consent as described in the WORKSHEET Consent Requirements and Waivers. For example: (c) Risks that the research is evaluating. If researchers design and conduct a study for the purpose of evaluating a particular risk then the research risk being evaluated has been recognized as a sufficiently possible outcome to be considered reasonably foreseeable and should be disclosed to prospective subjects (adapted from OHRP Comparative Effectiveness Guidance). Known benefits should be accurately described and not exaggerated. 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). This includes the requirement for consent information to be presented in a language that is understandable to the subject. See the document, EXAMPLE Key Information). The risks associated with each of the two stents are research risks and must be included in the consent process/form. It is important to remember that the IRB is tasked with minimizing, not eliminating the possibility of undue influence or coercion. Numerous guidelines exist for informed consent including: It is almost never appropriate to use children as interpreters. Certain lawyers are excluded from the disclosure requirements of Rule 1.4(c), including full-time judges, arbitrators and mediators, in-house lawyers for a single entity, and employees of governmental agencies. Similar protections may be appropriate for them. Recruitment. (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. A. The regulations designate three protected populations (pregnant women, prisoners, children) that each have additional required protections. Longitudinal research and children who reach the age of majority. Failure to obtain informed consent versus failure to diagnose claims. Phone: (360) 878-0664. A LAR for an adult must be a member of one of the following classes of persons in the following order or priority: Availability. You have received information about your health condition and treatment options. Electronic delivery of consent information must meet the same human subjects regulatory requirements as paper-based delivery of the information. The researcher must provide (as part of their Zipline application) a signed TEMPLATE Other E-signature Attestation Letter confirming the signature system meets all the applicable e-signature laws in the jurisdiction where the signature will be obtained and follows best practices for technical security.