washington state informed consent requirements

Adolescents and mature minors are legally and ethically authorized to provide informed consent if they are emancipated, and in many states, including Washington, they may provide consent for matters regarding sexual and reproductive health, mental health, and substance abuse. New classes of people may provide informed consent for patients who lack capacity but retains the current hierarchy and requirements. However, the Conditions of Participation leave the specific content of informed consent forms to be defined by hospitals or applicable law. 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 . Longitudinal research and children who reach the age of majority. 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. Assent is a subjects affirmative agreement to participate in research. The regulations designate three protected populations (pregnant women, prisoners, children) that each have additional required protections. Our current use policy permits free printing and use by health care . 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. GUIDANCE Prisoners The state board of education denies approval to any private school engaging in a policy of racial segregation or discrimination. HSD and the UW will not vet other e-signature methods. The IRB review focuses on whether the translation method is appropriate rather than approving the translated text. It also includes additional provider and patient resources, such as a sample consent form. 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. Once you have entered your information, you may save the data so it will appear the next time you open the form. It may also involve directly consulting selected members of the study population. Except in emergencies, healthcare practitioners must generally obtain the patient's informed consent before providing treatment. OHRP Guidance Documents on Informed Consent, from the OHRP website. 107-110, January 8, 2002, 115 Stat. (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. Oral consent should be documented in the patient record. State laws in the jurisdiction where the research is being conducted may affect the consent process (e.g., mandatory reporting; age of majority). See Protected and Vulnerable Populations for additional discussion. 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). Acceptable documentation that a minor patient is an unaccompanied homeless youth includes a written or electronic statement signed under penalty of perjury pursuant to chapter. (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. Washington state laws, federal regulations, Joint Commission standards, and standards for patient safety organizations such as Leapfrog, also set forth requirements for informed consent. The physician will randomly assign each subject to one of two FDA-approved estrogen treatments for osteoporosis. However, there is no obligation to require such documentation. 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. This means I was supervised by a licensed clinician for 3600 hours, passed the National Board of Certified Counselors . Each psychologist at the counseling center works with their student clients to decide which approach is best suited to the students circumstances. Washington State's current informed consent law (RCW 7.70.065) allows a very limited range of people to make medical decisions on behalf of a patient who is incapacitated. 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. Meeting of the Secretarys Advisory Committee on Human Research Protections, Key Information videotape, July 10-11, 2018, SACHRP Recommendations, Attachment A Addressing Ethical Concerns Regarding Offers of Payment to Research Participants, October 18, 2019, SACHRP Recommendations, Attachment A1 Reconsent Appendix 1. When the research involves adolescents whose capacity to understand resembles that of adults, the assent procedure and form would be similar to one designed for adults. GUIDANCE Humanitarian Use Devices (HUDs) 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. 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. For more in-depth information about this law, read A Kinship Caregiver's Guide to Consenting to Health Care from Washington Law Help website. OHRP, Guidance on Institutional Review Board Review of Clinical Trial Websites; September 20, 2005. Other populations are also vulnerable to undue influence or coercion. 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. Any alternative method of providing this additional required information must still provide the information: 1) in writing; 2) prior to obtaining documentation of informed consent or authorization (e-signature); 3) in a manner that allows the participant to print, access it at a later date, or otherwise retain a copy in some fashion. See your state's legislation regarding mature minors and consent laws. The method by which consent is obtained depends on the specifics of the study and the regulations that govern the research. The person must sign by choice. Disagreement among possible LARs. 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. (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. Using an e-signature method not vetted by the UW is permitted on a case-by-case basis. PROCEDURES AND GUIDELINES. Consent requirements may vary depending on the subject population, federal regulations, state laws, international laws, and institutional polices that apply to the research. The informed parental consent or court order needs to be a general authorization for the administration of psychotropic medications at the direction of a qualified, licensed physician so that a change in the consent or court order is unnecessary when it is necessary for the physician to adjust the medication. Such information can be described elsewhere in the consent form or process. Note that some sponsors or funders may require a full reconsent for any change to the consent form. This risk is already described in the consent form but as part of the corrective action plan, the IRB determines that subjects should be informed of the breach. Client consent should be obtained promptlyordinarily within 10 days of the lawyer's providing disclosure. 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. 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. Undue influence is often scrutinized by the IRB when subjects will receive significant payment for participation (see GUIDANCE Subject Payment). Kim Reykdal. GUIDANCE The Belmont Report Most research generates knowledge to promote a common good. 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. These methods are based on the SACHRP recommendations and an article from WCG IRB. See short form consent. A witness signature documents that the requirements for consent have been satisfied and that consent was voluntarily given by the subject. To ensure subject comprehension, it might be necessary to provide consent using a combination of both paper-based and electronic methods. A person of higher priority has refused to give consent, or. Most minimal risk studies will qualify for a waiver of documentation of consent. This directive applies to all executive cabinet and small cabinet agency worksites and employees. You have the right to help decide what medical care you want to receive. For information about who can be LAR for a minor, see the section on Parent/Guardian Permission in Protected and Vulnerable Populations and RCW 7.70.65(2) which describes the somewhat different requirements for an LAR for minors in Washington State, when the parents are not available. Yes, the risk of severe (life-threatening) allergic reaction should be added to the consent form. A particular condition has several treatment options, but an individuals response to the treatment can be highly variable and unpredictable. However, these same protections can unfortunately restrict prisoners autonomy to independently weigh what risks they are willing to assume and possibly limit their access to potentially beneficial research. Excerpt: "Ethics codes emphasize informed-consent requirements. 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. Are they required to notify an adult? Primary factor: the subject population. By placing their name on the consent form, the researcher is confirming that they provided the subject with information about the study, that the subject was given sufficient time to consider participation, that the researcher answered all the subjects questions, and that the subject indicated they understood the nature of the study, including the risks and benefits of participating. In many cases, multiple approaches will be required depending on where subjects are in the course of the study. For example, a consent form may be emailed in advance to a potential subject, followed by an in-person meeting in which the study is discussed, after which an electronic signature is obtained. 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. GUIDANCE Mandatory State Reporting In addition, it is a way to demonstrate respect and gratitude for their contribution and to maintain trust. Prisoners are a federally designated protected population with additional regulatory requirements and protections described in Subpart C of the Common Rule (GUIDANCE Prisoners). With adequate knowledge and understanding of the benefits and . GUIDANCE Involvement of Children in Research 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. Informed consent forms should be specific to the procedure. Written informed consent is obtained from the client that store and forward technology will be used and who the consulting provider is. Diarrhea is a frequent risk according to the investigators brochure. The subject signs the consent form in the presence of the researcher. For older versions: HSD staff see the SharePoint Document Library; Others contact hsdinfo@uw.edu. FDA-regulated research. Failure to obtain informed consent versus failure to diagnose claims. 116 (b) (2); 21 CFR 50.25(a)(2)). If this is not possible, the LAR should consider the persons best interests. When writing Key Information, consider the following questions: Relationship to the rest of the consent form/materials. promote voluntariness about whether to participate. The following definition, built upon FDA guidance and SACHRP guidance, should be used to help evaluate which risks the UW IRB considers reasonably foreseeable and, therefore, should be included in the consent form or included as part of the informed consent process. Consent Requirements. Therefore, both serious infections and diarrhea meet the definition of a reasonably foreseeable risk as they are risks that are more likely to occur. appropriate alternative procedures or courses of treatment, if any. Interpretation. Should this risk be added to the consent form/process as a reasonably foreseeable risk? Advertisements, announcements, social media (e.g., Facebook, Twitter) postings, and other recruitment processes and materials are generally considered to be part of the consent process. For example, if the most important risks associated with the study are from a blood draw, these risks should be described in Key Information. WORKSHEET Neonates 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. INSTRUCTIONS UW E-Signature Tools Subpart B consent requirements for pregnant women and neonates are listed in the WORKSHEET Pregnant Women and WORKSHEET Neonates. (iii) An adult relative of the minor patient or other adult with knowledge of the minor patient and the minor patient's housing situation. TEMPLATE Translation Attestation 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. Rules or WACs carry the full force of the law. 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. The research may begin immediately. An adult who meets all of the following criteria: Has exhibited special care and concern for the person, Is familiar with the persons personal values, Is reasonably available to make health care (and research) decisions, Is not any of the following: a physician for the person; an employee of the person; the owner, administrator, or employee of a health care facility, nursing home, or long-term care facility where the person resides or receives care; or a person who receives compensation to provide care to the person. In addition to the value of consent to the individual, there is a social value to establishing effective and ethical consent processes and norms to ensure accountability of the research enterprise. NOTE: The GUIDANCE Consent, and TIPSHEET Consent provide the most up-to-date description of best practices for designing consent forms. 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. 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. In those instances, the expert judgement of the researcher, or relevant published literature, would need to be applied when determining frequency. 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. 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. It may also be important to ensure that the person in power is not aware of which of their students, supervisees, etc. Such declaration shall be effective for up to six months . (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. However, there are also potential limitations to using e-consent. Arkansas- Providers are required to follow applicable state and federal laws, but there is no specific requirement for informed consent. Revised consent form. The informed consent process should be a dynamic interaction between researchers, IRBs and participants. None of the risks associated with the two counseling approaches or with administration of the standard clinic questionnaires are research risks. The counseling always includes two educational sessions, followed by sessions based on one of several widely accepted approaches to reducing binge drinking. TEMPLATE Consent Form, Short (English) Identifying this information is the responsibility of the researcher. Particularized Standards of Conduct. This means providing consent information in a logical sequence and in a way that allows for real-time review during discussion between study staff and the prospective subject. LMHC #6901. . Exceptions may rarely be allowed when the children are considered adults in the local setting, the risks are low, there are no alternatives, and there are no potential conflicts of interest. When consent is not an in-person process, the researcher and the IRB must consider how subjects will be provided with an opportunity to ask questions and have the research team answer them (if appropriate) and/or whether alternative ways of facilitating comprehension may be appropriate. If reasonable efforts to locate and secure consent from a competent person in the first of succeeding class are unsuccessful, then consent may be given by any person in the next class in order of descending priority. Consent Examples