GUIDANCE Authority and Responsibilities of HSD and UW IRB Coercion occurs when an overt or implicit threat of harm is intentionally presented by one person to another to obtain compliance. GUIDANCE Consent Elements for Externally Reviewed Studies This description must include the possibility that new, unanticipated, different, or worse symptoms may result and that death could be hastened by the proposed treatment. A workable definition of reasonably foreseeable is required to ensure that a description of any reasonably foreseeable risks or discomforts to the subject are presented to a potential research participant as part of the informed consent process (45 CFR 46. When a legally authorized representative (LAR) or parent/guardian provides consent, the subjects name should be printed on the subjects signature line. It may be useful to involve genetic counselors in the informed consent . Revised consent form. WORKSHEET Consent Requirements and Waivers, SOP Consent [HSD staff and IRB member access only] Informed consent serves to: Consent method. (d) The health care provider or health care facility where services are rendered is immune from suit in any action, civil or criminal, and from professional or other disciplinary action when such reliance is based on a declaration signed under penalty of perjury pursuant to chapter. The original signed consent form, regardless of format (e.g., paper, electronic) is considered a research record and federal regulations require researchers to retain consent forms for a minimum of three years after completion of the research. 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. Such information can be described elsewhere in the consent form or process. WASHINGTON, Dec 28 (Reuters) - In September, U.S. State Department officials invited a foreign delegation to the Guantanamo Bay detention center to persuade the group to take detainee Tariq Ba Odah to their country. HSD recommends, and the IRB may require, that researchers provide subjects with a written description of the consent information (e.g., information statement) even when a waiver of consent documentation has been granted (i.e., no consent form). However, there are also potential limitations to using e-consent. During the 2021 legislative session, the Legislature passed Substitute Senate Bill (SSB) 5030, which was the result of a multi-year effort by the Washington School Counselor Association (WSCA) and other statewide advocates to clarify the role of the school counselor in alignment with . All research reviewed by the UW IRB, including non-UW institutions and sites for which the UW IRB is providing review. NOTE: The GUIDANCE Consent, and TIPSHEET Consent provide the most up-to-date description of best practices for designing consent forms. Particularized Standards of Conduct. 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. See the section on Assent for more information. Translation. [. The decision may apply to all subjects in the study or may differ by individual subject or group of subjects. INSTRUCTIONS UW E-Signature Tools However, no person under this section may provide informed consent to health care: (i) If a person of higher priority under this section has refused to give such authorization; or. (SACHRP recommendations), For minimal risk procedures, risks or burdens that are immaterial or obvious to potential participants need not be explicitly addressed in the consent form or dialogue. Parents/guardians or school staff may refer students for counseling, or students may request counseling. State laws in the jurisdiction where the research is being conducted may affect the consent process (e.g., mandatory reporting; age of majority). For studies that span several age groups, it may be necessary to design multiple assent procedures and/or forms based on the comprehension capability of the different groups. Analysis 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. Design. If such a determination cannot be made, the decision to consent to the proposed health care may be made only after determining that the proposed health care is in the patient's best interests. TEMPLATE Consent Form, Short (English) 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. 107-110, January 8, 2002, 115 Stat. GLOSSARY Capacity to Consent 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. However, information that is fully described in the Key Information section does not need to be repeated later in the form or process. Witness. WEBPAGE Single Patient Emergency or Compassionate Use Recruitment. 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). Alternatively, the IRB may grant a waiver of documentation of consent if the criteria are met (WORKSHEET Consent Requirements and Waivers). 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. Informed consent means: You are informed. Waivers and alterations. Review the INSTRUCTIONS UW E-Signature Tools for more information on how to use these tools. Electronic delivery of consent information must meet the same human subjects regulatory requirements as paper-based delivery of the information. appropriate alternative procedures or courses of treatment, if any. Severe allergic reaction is a rare risk and is therefore not more likely to occur. Letter or email. However, they are planning to actively monitor subject blood glucose levels throughout the study and intervene when appropriate. Similar protections may be appropriate for them. You have the right to help decide what medical care you want to receive. If they succeeded, the transfer would mark a small step toward realizing President Barack Obama's goal of closing the prison before he leaves office.The foreign officials told the . Prenatal care services: Yes No No Minors may seek prenatal care at any age without the consent of a parent or guardian. Researcher. For most biomedical studies, information about compensation for injury, specific protections for privacy and confidentiality, and how data and specimens will be shared and stored does not need to be in the Key Information. . 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. WORKSHEET Neonates The purpose of this study is to investigate the safety and effectiveness of long-term treatment using either a combination of drugs or a single drug to prevent subjects acquiring HIV in subjects who are HIV negative.The investigator brochure lists three rare but serious risks for the drug combination that are not currently in the consent form (viral resistant mutations, interstitial nephritis, and immune reconstitution syndrome) that exclusively affect HIV positive individuals. A researcher may suspect a new study drug might cause slightly increased blood sugar levels. Consent information must be presented in a way that facilitates comprehension. Federal regulations identify pregnant women*, prisoners, and children as Protected Populations and specify additional protections and consent requirements for them. 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. Many patients undergo a trial-and-error period until they find a treatment plan that is effective for them. The IRB may approve other methods so long as they meet regulatory requirements and are consistent with any applicable local law. Informed consent for research must be legally effective and obtained before the subject can participate in any study-related activities. On rare occasions, the IRB may approve a process that involves reading the consent form to the subject and noting the consent in some official record that is not part of the research records (e.g., the subjects medical record). 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. (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. Study Summary The UW-ITHS-supported non-mobile version of REDCap meets the FDAs Part 11 electronic system requirements. Federal regulatory guidance concedes that there is no bright line between mere influence and undue influence and so it is up to the IRB to make that distinction. It also includes additional provider and patient resources, such as a sample consent form. 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. Washington State Addendum to Box 2 of Part B - Plan Administrator Response : English (Word) English (Adobe PDF) Russian (Adobe PDF) Spanish (Adobe PDF) 09-741 : Child Support Order Review Request : English (Word) English (Adobe PDF) Amharic (Adobe PDF) Arabic (Adobe PDF) Armenian (Adobe PDF) Cambodian (Khmer) (Adobe PDF) The subject receives the consent form by mail or email, the consent discussion occurs by phone or video, the subject signs the form and texts or emails a photo of the signature to the researcher, and the subject mails the signed consent form to the researcher. The qualifications of the translator must also be described. Additional Information Scenarios and Suggested Options, May 4, 2020, 15 U.W. Providing context that is meaningful and language that is familiar and at an appropriate reading level for the particular subject population will make the content easier for subjects to understand. Study status. There are certain situations when a person receiving services is required to provide written, informed consent. 2005; and. IV. This means I was supervised by a licensed clinician for 3600 hours, passed the National Board of Certified Counselors . RCW 43.185C.180 Washington homeless client management information system (HMIS consent law) WORKSHEET Consent Review for IRB Members [HSD staff and IRB member access only], CHECKLIST Exception from Informed Consent Using an e-signature method not vetted by the UW is permitted on a case-by-case basis. 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. It can be difficult to determine which risks to include in the consent form when the research involves medically recognized standards of care procedures or treatments in addition to, or instead of, any investigational procedures or treatments. (c) Before any person authorized to provide informed consent on behalf of a patient who does not have the capacity to make a health care decision exercises that authority, the person must first determine in good faith that that patient, if he or she had the capacity to make the health care decision, would consent to the proposed health care. Students who join the cognitive-behavioral group or who undergo the motivational interview approach are referred to the psychologist researcher before they begin counseling. If a waiver is granted, none of the requirements listed below in this section apply to the study. Additional information can be found in the OHRP draft Guidance, Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care. 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. *Pregnant women are not designated as a vulnerable population in the Common Rule or FDA regulations. There was a therapeutic exceptions in the state's legislative ban on abortions by 1900. 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. Consent Requirements. One or two parent permission. 4 Paws 4 Life Rescue is a 501(c)3 non-profit animal rescue located in Sedalia, CO. 4P4L . This means that practice laws and requirements in the patient's location regulate healthcare professionals' practice. Yes, you can get these services without consent of an authorized adult. Sample informed consent forms for the disclosure of program partic Once you have entered your information, you may save the data so it will appear the next time you open the form. As part of clinical care, the physician normally does a DEXA scan to measure bone density before beginning any osteoporosis treatment, and then repeats the DEXA scan after one year to see whether the treatment is having any beneficial effects. Code Chapter 96 The Electronic Signatures in Global and National Commerce Act (E-Sign Act), National Conference of Commissioners of Uniform State Laws, Uniform Electronic Transactions Act (UETA), (1999), Revised Code of Washington (RCW) Chapter 19.360, Electronic Signatures and Records, Chapter 1.80 Revised Code of Washington (RCW) Uniform Electronic Transactions Act (Washingtons adoption of UETA), Committee On Ethical Considerations for Revisions to DHHS Regulations for Protecting Prisoners in Research, Ethical Considerations for Research Involving Prisoners (2006), Dickert et al., Reframing Consent for Clinical Research: A Function-Based Approach. Consent Templates 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. NOTE: The ITHS REDCap Mobile software application, DocuSign is not valid for FDA-regulated research (see FDA-Regulated research under, Study status (procedures: not yet begun; ongoing; limited to long-term follow-up; complete), Magnitude of the changes and their likelihood to influence a subjects decision to continue participation, Eliminating certain procedures from a study visit, Payment method being changed from cash to a gift card, A verbal discussion may be the first step for time sensitive information that should be shared immediately with subjects while a written notification (e.g., consent addendum; revised consent form) is being prepared, A new questionnaire is being added to the weekly battery of measures that subjects complete that does not change the type of scope of questions that were already being asked and is estimated to increase participation time by about 5-7 minutes each week. (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. The American Journal of Bioethics, 17:12, 12-13 (2017). Any non-watermarked version used must match exactly the content and format of the IRB-approved watermarked version. All consent-related materials must include Key Information if the study meets these criteria: The Common Rule does not require Key Information in assent forms for children and decisionally-impaired adults, however, it is HSD policy to require Key Information when assent forms have more than 2000 words. Definitions. 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. While all stakeholders are encouraged to read and become familiar with this entire guidance, the following resources provide a summary of the most vital aspects of consent: This guidance provides researchers, the Human Subjects Division (HSD), and the UW Institutional Review Boards (IRBs) with an overview of the requirements and best practices for obtaining regulatorily compliant and meaningful consent, parental permission, and assent for participation in research. Informed consent. EXAMPLE Key Information [For FDA-regulated research, parental permission can only be waived under the minimal risk criteria.] 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. A particular condition has several treatment options, but an individuals response to the treatment can be highly variable and unpredictable. Subject. Washington state has passed laws related to telehealth and telemedicine, addressing definitions; regulations; scope of practice; licensing, credentialing, and privileging requirements . Additional Considerations For example, it has been shown that undue influence was significantly higher among prisoners with lower educational attainment and those who had spent a longer time in prison (Ravi et al., 2018). A new genetic analysis is presented to subjects in the form of an addendum. Citizenship and Immigration Services Office of the Director MS 2000 Washington DC 20529-2000 May 9 2011 PM-602-0038 Policy Memorandum SUBJECT Requests to Expedite Adjudication of Form I-601. The Washington state rule, however, does not mean that a child can walk into a drug store and get vaccinated against COVID-19 today without parental consent. Ultimately, it is up to the IRB to determine whether reconsent is required and to identify the most appropriate method for communicating new or revised information.