washington state informed consent requirements

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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. 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. These may be used in place of, or in combination with, paper-based consent methods. (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. WORKSHEET Neonates Minimizing the potential for undue influence or coercion. The informed consent process should be a dynamic interaction between researchers, IRBs and participants. The Issaquah School District, in compliance with the Washington State rules for Highly Capable Programs (WAC 392-170-047), has a procedure to allow students to exit the Highly Capable Program. Study procedures include a contrast-enhanced ultrasound using a contrast agent (FDA approved). 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. Sending the new information in a letter or by email may be appropriate when:(1) the information iseasy to understand; (2) the information is not likely to affect a subjects willingness to participate; and (3) it is important for subjects to have the information in writing for future reference. Translated documents must be: 1) linguistically accurate; 2) at an appropriate reading level for the participant population; and 3) culturally sensitive for the locale in which they will be used. 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. 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. Assent determinations. 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. 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. There are other situations when concerns about undue influence may arise. Exception: If the consent form is being used as the summary document when using the short form consent process, the researcher must provide a signature on the consent form. 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. The research may begin as soon as the researcher receives the photo of the signature. (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. Study Summary See your state's legislation regarding mature minors and consent laws. Each psychologist at the counseling center works with their student clients to decide which approach is best suited to the students circumstances. In these cases, it may be more appropriate to waive assent, rather than ask the subject and then not take their wishes into account. Potential or uncertain benefits should be described clearly as to what is known about the uncertainty or likelihood of the potential benefits. The purpose of this template is to provide general sample language for consent forms. It is often funded by public sources and is increasingly integrated into health care delivery systems. Documentation of Consent. 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. This can be accomplished in a number of ways such as: the research team visually witnesses the signature; subjects share some form of official identification with the research team (e.g., scanned copy or digital photo); the subject answers security questions (similar to questions sometimes used by banks). 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. Researchers who do not plan to obtain assent from these subjects must provide the IRB with justification about why obtaining assent is not appropriate. LMHC #6901. . GLOSSARY Exempt Research 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. 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). That worksheet also lists the consent requirements for federally-designated protected populations (i.e., pregnant women and neonates, prisoners, children). We are also pro Informed Dissent. The concept of "implied" or "passive" consent (e.g . (ii) Potential referral to additional services, the department of children, youth, and families, or law enforcement. 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. I have been a licensed marriage and family therapist in Washington State since 1999. : No. Prisoners are a federally designated protected population with additional regulatory requirements and protections described in Subpart C of the Common Rule (GUIDANCE Prisoners). It is almost never appropriate to use children as interpreters. 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. (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. However, if a blood draw is only one of many procedures and the other study procedures are associated with more significant risks to subjects, then information about the blood draw may be left out of Key Information and instead described in a more detailed Risks section later in the consent process or form. These recommendations support routine testing and differ from previous recommendations in ways that impacted state laws addressing HIV testing procedures in regards to informed consent and pre-test counseling. GUIDANCE Authority and Responsibilities of HSD and UW IRB 46.116 (e) & (f) are met. 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. Study Summary Sufficient time is allowed for questions to ensure subject comprehension. 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 most important thing to keep in mind is this: Informed consent is a process, not a piece of paper. 1 If the patient lacks capacity due to age or incompetence, consent must be obtained from a personal representative authorized by law to provide consent. It Researchers must describe in the IRB application how translations will be obtained for consent and all study materials that will be presented to subjects (e.g., surveys). See HSDs tutorial, Electronic Consent: What You Need to Know for an overview. The confidentiality risks associated with the questionnaire for research purposes are research risks and must be described in the consent form. What is the anticipated time commitment for the subject? When writing Key Information, consider the following questions: Relationship to the rest of the consent form/materials. The IRB, in their review, would have the opportunity to check these assumptions. [. An effective consent process provides the information that a reasonable person would want to have, in a transparent way, so that the prospective subjects are in control of their decision to provide authorization (or not) to participate, based on whether their own values and opinions align with those of the research, and considering the risks and benefits from their individual perspectives. Recognizing that technology changes are developed and become applied to practice with . 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. 2005; and. The assent process and any materials should provide information that is relevant for the subject population considering their capacity for comprehension and the research procedures. What are the types of activities (procedures) that subjects will do in the research? A revised package insert includes three new post-market risks. The brief tells the court that, in addition to being inconsistent with state statutes and case law on informed consent, this novel cause of action is inconsistent with the purpose of informed consent in health care. Part 11 compliance is the responsibility of the researcher. Yes, the risk of severe (life-threatening) allergic reaction should be added to the consent form. Email: Asa.Washines@atg.wa.gov. GUIDANCE Subject Payment The regulations do not provide details about how new information should be provided and do not specifically mention reconsent, although the Secretarys Advisory Committee on Human Research Protections (SACHRP) provides recommendations on reconsent. What information about the subject is being collected as part of this research? GUIDANCE Human Subjects Regulations Study Summary . Actions Subject to Consent. 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. 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. The research may begin immediately. There are two or more individuals in the same class and the decision is not unanimous among all available members of that class. Informed Consent is only half of an individual's option when faced with a medical decision the Informed Consent Read More Such declaration shall be effective for up to six months . The risks of serious infection and diarrhea need to be added to the consent form/process. "When I looked this up, I saw that . (d) No rights under Washington's death with dignity act, chapter. Electronic delivery of consent information must meet the same human subjects regulatory requirements as paper-based delivery of the information. The risks associated with each of the two stents are research risks and must be included in the consent process/form. OHRP, Simplifying Informed Consent, webinar, FDA, Guide to Informed Consent Information Sheet, July, 2014, FDA and OHRP Guidance, Use of Electronic Informed Consent: Questions and Answers, December, 2016, FDA Guidance, Part 11, Electronic Records: Electronic Signatures Scope and Application, August 2003, FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency (updated July 2, 2020). 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. A subject may be unable to physically sign a consent form due to some impairment (e.g., injury to hands). If the subject cannot use their hands at all, the IRB will consider alternative methods of documenting consent. These protections, and restrictions about the types of research in which prisoners may participate, were put into place to prevent a return to past research practices that exploited prisoners by exposing them to an unfair burden of risks, coercive and unduly influential enrollment practices, and an absence of informed consent procedures. In addition, it is a way to demonstrate respect and gratitude for their contribution and to maintain trust. To ensure subject comprehension, it might be necessary to provide consent using a combination of both paper-based and electronic methods. 45 CFR 46.116 [pre-2018 requirements and 2018 requirements], 45 CFR 46.117 [pre-2018 requirements and 2018 requirements]. As described in Consideration 2, the consent form does not need to include every procedure the subject would undergo and should instead focus on the procedures and other information that would be most likely to influence the subjects decision about whether to enroll in the study. This is particularly relevant for risks associated with drugs, devices, or complex procedures where the number of risks may be large, and inclusion of all possible risks may detract from an individuals ability to consider those risks that are relevant to their decision to participate in the research. 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. 360-870-8563. This refers to the process for confirming that the individual who provided the signature is the subject. These additional safeguards must be considered throughout the vulnerable subjects participation in the study (i.e., recruitment, obtaining consent, and after enrollment). UW research reviewed by an external (non-UW) IRB. (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. Study Summary California- Written or oral consent required for all patients. REQUEST External IRB Review 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. In the absence of indications to the contrary (e.g., a diagnosis of advanced dementia; impaired decision-making ability due to a stroke in specific brain areas), such capacity can be assumed without further evaluation of documentation unless required by the IRB. A parent is defined as the childs biological or adoptive parent and a guardian is an individual who is authorized under applicable State or local law to consent on behalf of the child to general medical care. 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. Information provided during consent should emphasize the Key Information that is most likely to assist the particular subject population with making a decision about whether to participate in research. If you applied for health coverage through Washington Healthplanfinder, report this change by either calling Health Care Authority at 1-800-562-3022, email AskMAGI@hca.wa.gov, or online at Washington Healthplanfinder . 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. New classes of people may provide informed consent for patients who lack capacity but retains the current hierarchy and requirements. This information may be equally or more influential in final decision-making as the consent form. 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. The AGO will receive free, prior and informed consent prior to taking certain actions specified in this section that directly and tangibly affect Tribes, rights or tribal lands. For example, complicated clinical trials involving high risk procedures typically involve consent forms of more than 20 pages. 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) 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. Whether a subject may be vulnerable to being unduly influenced or coerced to participate in research is contextual and dependent upon the individual subjects situation, yet the IRB approves research on a population-level. You have received information about your health condition and treatment options. Should this risk be added to the consent form/process as a reasonably foreseeable risk? Abortion in Delaware is legal up to the point of fetal viability. This subsection (1)(c) does not apply to informed consent provided on behalf of a patient who has not reached the age of consent required to make a particular health care decision. Answer 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. Potential subjects may express an active willingness to participate, may simply fail to object, or may dissent (express unwillingness to participate). 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. However, to fully comply with Part 11, researchers must also implement all other procedural requirements for Part 11 (e.g., limiting system access to only authorized users). Researchers should discuss the consent process, including the. A full reconsent is required when a LAR consent or parental permission is being replaced by the subject consenting on their own behalf. Informed consent for research must be legally effective and obtained before the subject can participate in any study-related activities. (d) A health care facility or a health care provider may, in its discretion, require documentation of a person's claimed status as being a relative responsible for the health care of the minor patient, or a person claiming to be authorized to consent to the health care of the minor patient under (b) of this subsection. Waiver of documentation of consent. Consent from Tribes on Certain AGO Actions. American Journal of Bioethics, 17:12, 3-11 (2017), Dickert et al., Partnering with Patients to Bridge Gaps in Consent for Acute Care Research. Electronic documentation of consent must meet the same requirements as for handwritten signatures in addition to the following requirements that are specific to electronic consent documentation: It is HSDs general expectation that this additional required information is provided in the consent form(s) and HIPAA authorization (if applicable). Alternatively, assent, LAR consent, and/or parental permission may be waived the the IRB. A physician researcher at a local clinic plans to do a research study with patients who have been recently diagnosed with osteoporosis and who require treatment. (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. Coercion occurs when an overt or implicit threat of harm is intentionally presented by one person to another to obtain compliance. Additional Information Scenarios and Suggested Options, May 4, 2020, 15 U.W. There are many electronic alternatives to a handwritten signature, including: electronic signatures using tools such as DocuSign or REDCap; digital signatures; computer-readable ID cards; biometrics; or username and password combinations. Informed consent - adults. promote voluntariness about whether to participate. The consenting process described above for illiterate individuals may be used, but it is preferable to provide the subjects with an electronic copy of the materials which can then be examined by using an electronic device (e.g., computer) with a screen reader. 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. 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.) The physician is interested in the effects of the two FDA-approved estrogens. This information applies to: The following specialized consent-related topics are covered elsewhere: Informed consent for research must be legally effective and obtained before the subject can participate in any study-related activities. Revised Code of Washington (RCW) 28A.195.010 and 28A.225.010 (1) (a). Table adapted from the Council for International Organizations of Medical Sciences and FDA prescription drug labeling guidance. Researcher. In some cases it may be appropriate to use a single form to obtain both parental permission and child assent. 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. HSD is currently working on updating our consent templates to match the GUIDANCE. Study Summary A disagreement between a parent(s)/LAR and the potential participant may arise for many reasons and every effort should be made to reach consensus between the parent(s)/LAR and potential participant. informed consent. The IRB may waive informed consent requirements or the need to obtain informed consent for research involving public benefit and service programs that require approval by state or local officials (45 CFR 46. . 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). Note that some sponsors or funders may require a full reconsent for any change to the consent form. EXAMPLE Key Information (m) Signature and date blocks for the client, and the certified counselor or certified adviser, including an attestation that the client agrees that the required disclosure statement has been provided and that the client has read and understands the information. 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. Advarra Blog, Dec 2, 2020, Kraft et al., Comprehension and Choice Under the Revised Common Rule: Improving Informed Consent by Offering Reasons Why Some Enroll in Research and Others Do Not. The treatment could be one of many estrogens (including the two they are interested in), or one of many bisphosphonate drugs. *Pregnant women are not designated as a vulnerable population in the Common Rule or FDA regulations. The focus of the counseling program is to help students better understand the world they live in and make better . 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.

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