washington state informed consent requirements washington state informed consent requirements

Changes to the consent form do not necessarily require researchers to inform all enrolled subjects. Undue influence is often scrutinized by the IRB when subjects will receive significant payment for participation (see GUIDANCE Subject Payment). GUIDANCE Prisoners The American Psychological Association has provided guidance related to informed consent for telehealth services. GUIDANCE Authority and Responsibilities of HSD and UW IRB E-consent may also be useful and appropriate for in-person consent interactions. Informed consent is a process that's required for most medical procedures. 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. : No. A study benefit might raise concerns about undue influence when it is likely to: 1) inhibit a potential subjects adequate consideration of, and reflection about, important study features such as risks, burdens, and discomforts; or 2) impair a potential subjects understanding of the research and their participation in it. 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. Sufficient time should be allocated for complex genomics concepts such as increased disease risk rather than definitive diagnoses and long-term storage and use of data. WORKSHEET Prisoners. 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). See HSDs tutorial, Electronic Consent: What You Need to Know for an overview. 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. However, information that is fully described in the Key Information section does not need to be repeated later in the form or process. Provides the following declaration, which is effective for up to 6 months, signed and dated under penalty of perjury, that recites facts and circumstances demonstrating that they are familiar with the person and that they: Are willing and able to become involved in the persons healthcare (or research participation), Have maintained such regular contact with the person as to be familiar with the persons activities, health, personal values and morals, and. See Protected and Vulnerable Populations for additional discussion. E-consent processes are invaluable when it is not possible to have an in-person interaction with a subject. Are not aware of a person in a higher priority class willing and able to provide informed consent on behalf of the person. This means I was supervised by a licensed clinician for 3600 hours, passed the National Board of Certified Counselors . 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. Informed consent laws were on the books by 2007. 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. Therefore, both serious infections and diarrhea meet the definition of a reasonably foreseeable risk as they are risks that are more likely to occur. the choice of counseling techniques is being dictated by the research design. The IRB will request that researchers fill out the form. A person of higher priority has refused to give consent, or. Answer Generally speaking, applicants need their NVC case number for an expedite request. 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. Informed consent is a process in which a medical provider gives patients and/or their . Consent Forms v. Informed Consent. The American Journal of Bioethics, 20(5), 7-17 (2020), Gelinas, L. The Many Faces of Coercion and Undue Influence'. 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 . The IRB requires a full reconsent for all enrolled subjects including obtaining documentation. (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. 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. Researchers may consider using a video or audio recording of the consent process as part of documenting consent. A witness signature documents that the requirements for consent have been satisfied and that consent was voluntarily given by the subject. Identifying this information is the responsibility of the researcher. 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 research may begin immediately. Answer FDA considered the UW ITHS REDCap signature tool a hand-written signature so the identity verification requirements do not apply. Subpart B consent requirements for pregnant women and neonates are listed in the WORKSHEET Pregnant Women and WORKSHEET Neonates. Regardless of the subjects location, there may also be optional information (for example, hyperlinks or help text) embedded in the electronically delivered material to aid in comprehension of key study elements. How will their experience as a research subject in this study differ from treatment they might receive as a patient outside of the study? For example, this may be accomplished through telephone calls, electronic messaging (examples: email, text messages), video conferencing, live chat, or other methods. There will be some situations where identification of the potential for unduly influencing a subject group or groups will be clear, as will the steps for minimizing that potential. 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). (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. The informed consent process should be a dynamic interaction between researchers, IRBs and participants. The LAR or parent/guardian name and relationship to the subject should also be recorded in the signature area. 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 . Study status. Consent Examples What is the anticipated time commitment for the subject? 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. However, bioethicists now tend to view pregnant subjects as a complex or special rather than vulnerable population, because pregnancy itself does not impair a subjects ability to comprehend an informed consent process. When to Describe Risks for Studies Evaluating Medically Recognized Standards of Care 28 CFR 46.117 Documentation of Informed Consent. 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. There is no specific information that must be included in the Key Information. The risks associated with motivational interview and the cognitive-behavioral group are research risks and must be described in the consent process/form. Diarrhea is a frequent risk according to the investigators brochure. A study of a novel diabetes drug involves routine blood draws with use of topical lidocaine to numb the area of the needlestick but the very rare risk of anaphylaxis from the lidocaine is excluded (i.e., inclusion is not relevant to a reasonable persons meaningful decision to participate in the research). This method requires the most time and effort and should be used when (1) there is no time sensitivity; and (2) the new information is complicated and/or affects many aspects of the study. Actions Subject to Consent. You have received information about your health condition and treatment options. Informed consent. TEMPLATE Other E-signature Attestation Letter The psychologist researcher also obtains the results of their standard clinic questionnaires. See the section on Information for subjects in the GUIDANCE Exempt Research for full details. The treatment could be one of many estrogens (including the two they are interested in), or one of many bisphosphonate drugs. This includes the requirement for consent information to be presented in a language that is understandable to the subject. Revised consent form. (b) Serious are risks that fall under the FDAs definition of a Serious Adverse Event (i.e., anything that would result in death, be life-threatening, would require hospitalization to treat, could cause disability/permanent damage, cause birth defects, require an intervention to prevent permanent impairment or damage or other important medical events). 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. Minimizing the potential for undue influence or coercion. 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. the standard care procedure or treatment is required, subjects have adequate time to consider and discuss participation prior to giving consent; and. This creates challenges for obtaining informed consent because the process typically relies heavily on written materials. A confidentiality breach is described in a Report of New Information (RNI). 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. Providing a clear and accurate description of confidentiality measures should also be discussed in detail, given the confidentiality limits that may exist in prisons because of institutional policies. 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). 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. OHRP Guidance Documents on Informed Consent, from the OHRP website. The research may begin as soon as the researcher receives the photo of the signature. 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). Verbal discussion. 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) My license number is LF00001679. The physician wants to compare the effects of two different FDA-approved estrogens on the osteoporosis. Commission consistent with existing statutes governing the practice of medicine within the state of Washington. It is HSD policy to consider shorter documents (less than 2000 words) to have met the requirement to present Key Information in a concise and focused manner because of their short length. Analysis 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. Witness signatures are required by federal regulations in limited circumstances (e.g., when using short form consent) or may be required by the IRB to ensure an adequate informed consent process. In rare instances, HSD may permit the required information to be communicated to study participants via an alternative method. The IRB, in their review, would have the opportunity to check these assumptions. (V) Is not aware of a person in a higher priority class willing and able to provide informed consent to health care on behalf of the patient. 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. (a) Persons authorized to provide informed consent to health care on behalf of an adult patient who does not have the capacity to make a health care decision shall be a member of one of the following classes of persons in the following order of priority: (i) The appointed guardian of the patient, if any; (ii) The individual, if any, to whom the patient has given a durable power of attorney that encompasses the authority to make health care decisions; (iii) The patient's spouse or state registered domestic partner; (iv) Children of the patient who are at least eighteen years of age; (vi) Adult brothers and sisters of the patient; (vii) Adult grandchildren of the patient who are familiar with the patient; (viii) Adult nieces and nephews of the patient who are familiar with the patient; (ix) Adult aunts and uncles of the patient who are familiar with the patient; and. WEBPAGE Is the UW IRB the Right IRB? RCW 28A.195.040. Washington has an HIV-specific criminal statute. This is particularly important when the study may offer significant benefit to the individual subjects or subject population. Informed Consent is only half of an individual's option when faced with a medical decision the Informed Consent Read More It This would be an example where we would expect the researcher to include risks of increased blood sugar levels in the consent form. Consent requirements may vary depending on the subject population, federal regulations, state laws, international laws, and institutional polices that apply to the research. Informed consent forms should be specific to the procedure. State laws in the jurisdiction where the research is being conducted may affect the consent process (e.g., mandatory reporting; age of majority). Parents/guardians or school staff may refer students for counseling, or students may request counseling. When the patient/surrogate has provided specific written consent, the consent form should be included in the record. The Key Information may be in a separate document or in the beginning of the consent form, but it must be presented to subjects at the beginning of the consent process. Risks expected or known to be very frequent/very common or frequent/common should generally be included in the consent form and/or consent process. In these cases, HSD defers to the sponsor/funder. GUIDANCE Consent Elements for Externally Reviewed Studies A potential participants assent cannot override a no from a parent or LAR unless the IRB has waived the requirement for parental permission or completely waived consent. What are the types of activities (procedures) that subjects will do in the research? Assent is a subjects affirmative agreement to participate in research. When choosing whether to employ paper-based consent or e-consent, it is important to understand the needs and capabilities of the subject population(s). Oral consent should be documented in the patient record. There are no Washington State laws that directly address the use of LARs in research. Project MKUltra (or MK-Ultra) was an illegal human experimentation program designed and undertaken by the U.S. Central Intelligence Agency (CIA), intended to develop procedures and identify drugs that could be used in interrogations to weaken individuals and force confessions through brainwashing and psychological torture. Who can be a LAR is determined by the laws of the jurisdiction in which the research is conducted. A witness signature is not required on the consent form, unless: Your informed consent is obtained through the use of a short form consent process; You have decision-making capacity, but are unable to read, write, talk, or see (due to blindness); or. Consent addendum. 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. However, there is no obligation to require such documentation. Washington State Supreme Court Committee on Jury Instructions. TEMPLATE Translation Attestation (ii) "Homeless" means without a fixed, regular, and adequate nighttime residence as set forth in the federal McKinney-Vento homeless education assistance improvements act of 2001, P.L. 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. The Science of Titration Analysis. 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. 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. If Washington's top court allows that to stand, Davies can take the informed-consent claim to a new jury. Washington state has passed laws related to telehealth and telemedicine, addressing definitions; regulations; scope of practice; licensing, credentialing, and privileging requirements . TUTORIAL Electronic Consent: What You Need to Know 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. No LAR may provide consent on behalf of the person if: Decision-making standard. Kim Reykdal. If a waiver is granted, none of the requirements listed below in this section apply to the study. INSTRUCTIONS UW E-Signature Tools Written informed consent is obtained from the client that store and forward technology will be used and who the consulting provider is. A full reconsent is required when a LAR consent or parental permission is being replaced by the subject consenting on their own behalf. Phone: (360) 878-0664. Researchers should use the information in this guidance to assess the new/revised information and determine what, if any, method should be used to inform subjects of new information and/or obtain reconsent. Using a non-UW installation of REDCap may be permitted, so long as it meets all of the requirements outlined in the SUPPLEMENT Other REDCap Installation and a copy is provided with the IRB application. (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 . Reasonably foreseeable risks are those risks that a reasonable person in the target population would find meaningful to their decision to participate in the research. However, the guidance does generally expect that Key Information include a concise explanation of the following elements: *Risks and discomforts in Key Information should be described with the study context and subject perspective in mind. A rule or Washington Administrative Code (WAC) is written to provide interpretive support for the individuals or entities to whom the rule applies. in these cases, the subject may sign the form by marking an X on the signature line. The WORKSHEET Consent Requirements and Waivers provides a summary of the required general characteristics and elements of consent as well as the criteria for waiving required elements and documentation of consent for the Common Rule, FDA, and other federal regulatory agencies (e.g., Department of Justice). Additional information can be found in the OHRP draft Guidance, Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care. A. Abortion in Delaware is legal up to the point of fetal viability. If this is not possible, the LAR should consider the persons best interests. 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. Prenatal care services: Yes No No Minors may seek prenatal care at any age without the consent of a parent or guardian.