A new genetic analysis is presented to subjects in the form of an addendum. Also, the capacity to consent is protocol-specific and situation-specific. A psychologist at the counseling center is interested in comparing the effectiveness of two of these approaches: a short series of motivational interviews versus participation in a weekly cognitive-behavioral group session. The Key Information requirement applies to the consent process as a whole not simply to consent documents. A meaningful consent process enables prospective subjects to decline participation in research that they judge to be harmful or inappropriate according to their own interests, values, and obligations. The American Journal of Bioethics, 17:7, 53-55 (2017), Ravi et al., Financial Payments for Participating in Research while Incarcerated: Attitudes of Prisoners. Electronic delivery of consent information must meet the same human subjects regulatory requirements as paper-based delivery of the information. See your state's legislation regarding mature minors and consent laws. Rules or WACs carry the full force of the law. The process culminates in the patient's decision to a specific treatment or procedure. A rule or Washington Administrative Code (WAC) is written to provide interpretive support for the individuals or entities to whom the rule applies. (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. (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. You have received information about your health condition and treatment options. SUPPLEMENT Other REDCap Installation A person of higher priority has refused to give consent, or. Verbal discussion. "When I looked this up, I saw that . WEBPAGE Is the UW IRB the Right IRB? 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. [. Primary factor: the subject population. Each psychologist at the counseling center works with their student clients to decide which approach is best suited to the students circumstances. (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. 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. 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. 116 (b) (2); 21 CFR 50.25(a)(2)). The IRB should assess the criteria for waiving documentation of consent when reconsent is being obtained whether it is an addendum, or full consent, or some alternative method. Part IX. Parental permission can be waived or altered, and documentation of permission can be waived, under the same criteria for waiving or altering consent and consent documentation. There is no specific information that must be included in the Key Information. See the document, EXAMPLE Key Information). (iii) Upon request by a health care facility or a health care provider, a person authorized to consent to care under this subsection (2)(b) must provide to the person rendering care a declaration signed and dated under penalty of perjury pursuant to chapter. 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. Consent materials are read to the subject in the presence of an impartial witness who observes the entire consent process. Should these risks be added to the consent form/process as reasonably foreseeable risks? The consent process for these individuals must meet the same regulatory requirements as for any other consent process. Study status. Prior to implementation of human subjects research regulations, there were many instances of subjects being coerced into research. The concept of implied or passive consent (e.g., parental permission is assumed unless the parent opts out of their childs participation in the research) does not meet the requirements for informed consent for research. GUIDANCE Exempt Research 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. 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. I have been a licensed marriage and family therapist in Washington State since 1999. Assent is obtained from subjects who are unable to provide legally-effective informed consent on their own behalf because they are minors or have diminished decision-making capacity. For detail on the selected state law and cases interpreting it, see Washington: Analysis & Codes, an excerpt from CHLP's recently updated compendium of HIV- and STI-related criminal laws and civil . State laws in the jurisdiction where the research is being conducted may affect the consent process (e.g., mandatory reporting; age of majority). (iii) An adult relative of the minor patient or other adult with knowledge of the minor patient and the minor patient's housing situation. Table adapted from the Council for International Organizations of Medical Sciences and FDA prescription drug labeling guidance. Commission consistent with existing statutes governing the practice of medicine within the state of Washington. In some cases it may be appropriate to use a single form to obtain both parental permission and child assent. 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. Minimum Requirements: Two years of experience in clinical research with knowledge of regulatory requirements, informed consent . A researcher may suspect a new study drug might cause slightly increased blood sugar levels. When appropriate, an application for a proposed research study may seek a waiver from the requirements to obtain informed consent or it may seek permission to alter the informed consent requirements.Such a waiver or alteration may be permitted by the DHSIRB when the requirements of 45 C.F.R. 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). NOTE: The GUIDANCE Consent, and TIPSHEET Consent provide the most up-to-date description of best practices for designing consent forms. (c) General requirements for informed consent. I am Licensed in the State of Washington. INSTRUCTIONS UW E-Signature Tools 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. This refers to the process for confirming that the individual who provided the signature is the subject. 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). GUIDANCE Subject Payment If a subject enrolls in research at a young age and remains enrolled for many years, it may be necessary to re-assent as the childs capacity to understand increases. The study is non-exempt human subjects research reviewed by the UW IRB (per, The IRB has not fully waived the requirement to obtain consent; and. (3) An unaccompanied homeless youth who is under the age of majority, who is not otherwise authorized to provide informed consent, and is unable to obtain informed consent under subsection (2)(b)(i) of this section is authorized to provide informed consent 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. 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. (1) Prior to treatment of the eligible patient with an investigational product, the treating physician shall obtain written informed consent, consistent with the requirements of RCW. 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. appropriate alternative procedures or courses of treatment, if any. Recognizing that technology changes are developed and become applied to practice with . consent of a parent, guardian or the father of the child. Subject. This method is intended to be used only for the infrequent and unanticipated enrollment of an individual with limited English proficiency in a study for which no consent form in the subjects language has been prepared and there is insufficient time and opportunity to obtain an appropriate written translation of the IRB-approved English consent forms. the standard care procedure or treatment is required, subjects have adequate time to consider and discuss participation prior to giving consent; and. Informed Consent is only half of an individual's option when faced with a medical decision the Informed Consent Read More 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. What impact will participating in this research have on the subject outside of the research? Decision-making by prospective subjects typically begins with the information presented in recruitment materials and in initial discussions with study staff, well before the consent form is presented. It is best practice (but not required) for researchers to use the Zipline watermarked version of the consent form. To ensure subject comprehension, it might be necessary to provide consent using a combination of both paper-based and electronic methods. In general, dissent should be respected. This means the person understands, writes, and signs a statement declaring they agree to a treatment, for example. The Key Information must be organized and presented in a way that facilitates comprehension. 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. Should this risk be added to the consent form/process as a reasonably foreseeable risk? (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. Consent addendum. However, in Gates v. Jensen, 92 Wn.2d 246, 595 P.2d 919 (1979 . GUIDANCE Humanitarian Use Devices (HUDs) In keeping with the Belmont Principle of Justice that selection of subjects should be equitable in terms of fairly distributing the risks and benefits of research, researchers should carefully consider the purpose of the research and the scientific question when considering the inclusion and exclusion of these subject populations. This means that practice laws and requirements in the patient's location regulate healthcare professionals' practice. [For FDA-regulated research, parental permission can only be waived under the minimal risk criteria.] Alternatively, the IRB may grant a waiver of documentation of consent if the criteria are met (WORKSHEET Consent Requirements and Waivers). In these cases, it may be more appropriate to waive assent, rather than ask the subject and then not take their wishes into account. TEMPLATE Translation Attestation Diarrhea is a frequent risk according to the investigators brochure. Alternatively, assent, LAR consent, and/or parental permission may be waived the the IRB. Serious infections are very frequent according to the investigators brochure. Answer However, the IRB has the authority to require a separate Key Information section if appropriate. Although rare, the contrast agent does have a risk of severe allergic reaction. 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. HSD tip. State guidance varies on informed consent and documentation expectations for telehealth/telemedicine. Answer Permission is the agreement of parent(s) or guardian(s) to a childs participation in research. HSD and/or IRB approval. Any non-watermarked version used must match exactly the content and format of the IRB-approved watermarked version. Waiver of documentation of consent. to convey consent information and/or to document informed consent. The informed consent process should be a dynamic interaction between researchers, IRBs and participants. A new addition to Renton Prep for the 2020/2021 school year is school counseling. 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. If the subject cannot use their hands at all, the IRB will consider alternative methods of documenting consent. 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 . The IRB must approve the consent plan, including the process that will be used to ensure that oral and written information will be in a language understandable to subjects throughout the study and at an appropriate reading and comprehension level. The UW IRB is defining the regulatory term reasonably foreseeable as those risks or discomforts that must be included in the informed consent process because they are both reasonably foreseeable and meet any of several additional criteria. It Revised Code of Washington (RCW) 28A.195.010 and 28A.225.010 (1) (a). There is no prior evidence of this, and they think its very unlikely (so it doesnt trigger inclusion based on frequency), and it doesnt meet the serious criteria for inclusion in the consent. WORKSHEET Neonates It is almost never appropriate to use children as interpreters. A drug can be life threatening to children under 5 years of age, but all children are excluded from participating in the study, A researcher proposes including Stevens-Johnson syndrome (SJS) as a possible risk of the study but there has been no incident of SJS to date. 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. The LAR must decide in good faith whether the person would consent to the research. 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.) Study Summary The IRB can always exclude frequent/very frequent risks that dont apply to the target population (for example the study includes an adverse drug reaction with acetaminophen but subjects taking acetaminophen are excluded from participating). What is the research question the study is trying to answer and why is it relevant to the prospective subject? HSD does not apply consent regulations to research that is determined to be exempt from IRB review. Detailed descriptions of all potential risks are counterproductive if they do not provide potential subjects with useful information and may inadvertently distract subjects from relevant data. The witness and the researcher should also sign and date the form. E-consent processes are invaluable when it is not possible to have an in-person interaction with a subject. For purposes of this section, a person who is of the age of consent to make a particular health care decision is presumed to have capacity, unless a health care provider reasonably determines the person lacks capacity to make the health care decision due to the person's demonstrated inability to understand and appreciate the nature and consequences of a health condition, the proposed treatment, including the anticipated results, benefits, risks, and alternatives to the proposed treatment, including nontreatment, and reach an informed decision as a result of cognitive impairment; and the health care provider documents the basis for the determination in the medical record. 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. If the IRB determines that assent is possible, the IRB may nonetheless waive the assent requirement under the same criteria for waiving consent (WORKSHEET Consent Requirements and Waivers). A careful balance of the Belmont Ethical Principles is vital to enrolling subjects with diminished consent capacity. 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. RCW 43.185C.180 Washington homeless client management information system (HMIS consent law) Remembering that consent is a process, researchers must have a plan for ongoing communication between the research team and the subjects throughout their participation in the research. However, these potential complexities are dependent upon the specific research design and are not necessarily applicable to all studies enrolling pregnant women. The risks associated with motivational interview and the cognitive-behavioral group are research risks and must be described in the consent process/form. (d) No rights under Washington's death with dignity act, chapter. Open the accordion below for version changes to this guidance. (1) Informed consent for health care for a patient who does not have the capacity to make a health care decision may be obtained from a person authorized to consent on behalf of such patient. By law, your health care providers must explain your health condition and treatment choices to you. See GUIDANCE Human Subjects Regulations, GUIDANCE Mandatory State Reporting, and the section on legally authorized representative consent for details. (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. Part 11 compliance is the responsibility of the researcher. There is no regulatory requirement to provide all the standard elements of consent during the assent process. Client Rights: Informed Consent. The permission of one or both parents may be required depending on the childrens risk level category as determined by the IRB (GUIDANCE Involvement of Children in Research; WORKSHEET Children). UW research reviewed by an external (non-UW) IRB. adult must give his/her own consent for health care. RCW 7.70.050 speaks only of "treatment" in connection with the doctrine of informed consent. Consent materials must have a distinct Key Information section when they are more than 2,000 words (not counting any signatures sections; approximately 5 pages; single-spaced; 1-inch margins). IRB Ethics & Human Research, 40:6, 1-6 (2018), The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The qualifications of the translator must also be described. The following is a FAQ related to vaccine requirements for state employees, pursuant to Directive 22-13.1. 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). Some research with pregnant women may have additional complexities such as weighing the risks and benefits of both the pregnant woman and the fetus or mitigating risk of exploitation in some specific contexts. This includes ensuring the information is accessible by subjects for the duration of the research and is easily retrievable for auditors and monitors. 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. Written consent materials should be presented from the perspective of the subject and what it would mean to them to participate (e.g., the pros and cons, and whys and why nots of the many aspects of the study). Many patients undergo a trial-and-error period until they find a treatment plan that is effective for them. Yes, the risk of severe (life-threatening) allergic reaction should be added to the consent form. A brochure Consent to Health Care for the Child in Your Care (PDF) is also TUTORIAL Electronic Consent: What You Need to Know 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. 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. 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). This directive applies to all executive cabinet and small cabinet agency worksites and employees. Particularized Standards of Conduct. 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.