They should also ensure that the interpreter will accurately convey the information (e.g., Are they capable of interpreting complicated biomedical information?). The IRB, in their review, would have the opportunity to check these assumptions. What are the main reasons a subject will want to join, or not join, this study? in these cases, the subject may sign the form by marking an X on the signature line. For example, depending on the study and population-specifics, information about risks and benefits, time commitments, and certain procedures may be appropriate under the headings, Why I may want to participate and, Why I may not want to participate. The American Journal of Bioethics, 17:7, 53-55 (2017), Ravi et al., Financial Payments for Participating in Research while Incarcerated: Attitudes of Prisoners. If this is not possible, the LAR should consider the persons best interests. 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. 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 IRB has the authority to require revisions or additions to the consent process to ensure that all subjects are adequately informed and are providing truly voluntary consent. Not research risks Answer 45 CFR 46.116 [pre-2018 requirements and 2018 requirements], 45 CFR 46.117 [pre-2018 requirements and 2018 requirements]. The Washington Health Law Manual is now in its Fourth Edition and maintained in an online format. 46.116 (e) & (f) are met. 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. See GUIDANCE Involvement of Children in Research for a discussion of who qualifies as a child. 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. There are other situations when concerns about undue influence may arise. Informed consent is a legal and ethical requirement in which physicians and patients exchange information concerning a patient's condition and proposed treatment options. The process and information presented must include the required characteristics and elements of consent as described in the WORKSHEET Consent Requirements and Waivers. *Pregnant women are not designated as a vulnerable population in the Common Rule or FDA regulations. (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. The research may begin immediately. 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. I have been a licensed marriage and family therapist in Washington State since 1999. 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. Citizenship and Immigration Services Office of the Director MS 2000 Washington DC 20529-2000 May 9 2011 PM-602-0038 Policy Memorandum SUBJECT Requests to Expedite Adjudication of Form I-601. By judicial decision, Washington state provides that mature minors who are capable of meeting the informed consent standard have consent authority. (3) The document must be signed and dated by the eligible patient's treating physician and witnessed in writing by at least one adult. FDA considered the UW ITHS REDCap signature tool a hand-written signature so the identity verification requirements do not apply. 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. 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. (iii) An adult relative of the minor patient or other adult with knowledge of the minor patient and the minor patient's housing situation. When a legally authorized representative (LAR) or parent/guardian provides consent, the subjects name should be printed on the subjects signature line. Recruitment. Informing subjects that there is a new principal investigator, Informing subjects that they can use a commercial lab for blood draws, A modification to add a new battery of measures is submitted; the new measures include sensitive mental health topics that subjects did not previously consent to, The researchers want to add a new genetic analysis to the samples already being collected for the study, New research-related risks are identified or there is an increase in the frequency or magnitude of previously described risks, A decrease in anticipated benefits to subjects is identified, New or alternative therapies are identified (e.g., FDA approval of a new drug or device for the condition under study) or there is a change on the impact of participation on alternative therapies [e.g., the investigational drug or device reduces the effectiveness of alternative treatment(s)], When a study includes online or in-app check-ins, a consent refresher or informing subjects about changes to the research can occur electronically with a checkbox or other method for the subject to confirm they wish to continue participation, Subjects are moving into a new phase of the study with very different procedures, A subject enrolled with parental permission as a minor reaches the age of majority and must provide adult consent, Changes in the cognitive functioning, mental health, or physical health of the subject have occurred over the course of the research and the subject can replace LAR consent with consent on their own behalf, There is a significant delay between providing consent and beginning the study, Subjects are enrolled in a longitudinal study and a consent refresher may be appropriate even if procedures have not changed, There are concerns about the way in which consent has been obtained (e.g., the wrong version of the consent form was used; study staff have not been appropriately trained in obtaining consent). There is no specific information that must be included in the Key Information. In other words, the presence of a cognitive impairment or cognitive-state-altering circumstances does not necessarily mean that the person is incapable of an informed consent decision. Admitted insurer: An insurance company that has met the legal and financial requirements for operation within a given state. However, the IRB may allow the parent(s)/LAR wishes to prevail over the potential participants dissent when the potential participant may directly benefit from the research. 2 Failure to obtain or . Consent must be documented in the client record. 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. 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. Answer Failure to obtain informed consent versus failure to diagnose claims. This refers to the process for confirming that the individual who provided the signature is the subject. Regulatory protections and IRB oversight have reduced the likelihood of coercion in research, but it is still something researchers and the IRB should be cautious about, particularly when researchers are in a position of power over subjects (e.g., physician and patient or professor and student). Documentation of Consent. RCW 9.02.100(1); State v. Koome, 84 Wn.2d 901 (1975). TEMPLATE Consent Form, Short (English) 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. Ultimately, it is up to the IRB to determine whether reconsent is required and to identify the most appropriate method for communicating new or revised information. 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. 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. GUIDANCE Humanitarian Use Devices (HUDs) An impartial witness should witness the mark and sign the 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). It may also involve directly consulting selected members of the study population. (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. Study Summary . Check your state's dental practice act or contact your state dental association for more information. It is HSD policy that for greater than minimal risk research, the consent form must contain the legible name of the person who obtained consent from the subject. Primary factor: the subject population. Study Summary GUIDANCE Subject Payment However, Washington State law RCW 7.70.65 defines who may serve as a LAR for providing informed consent for health care. (C) The minor patient is not under the supervision or control of a parent, custodian, or legal guardian, and is not in the care and custody of the department of social and health services. These may be used in place of, or in combination with, paper-based consent methods. 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. (c) A health care provider may, but is not required to, rely on the representations or declaration of a person claiming to be a relative responsible for the care of the minor patient, under (a)(v) of this subsection, or a person claiming to be authorized to consent to the health care of the minor patient under (b) of this subsection, 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 a relative responsible for the health care of the minor patient, or person claiming to be authorized to consent to the health care of the minor patient. In general, dissent should be respected. During the 2021 legislative session, the Legislature passed Substitute Senate Bill (SSB) 5030, which was the result of a multi-year effort by the Washington School Counselor Association (WSCA) and other statewide advocates to clarify the role of the school counselor in alignment with . The drug is an FDA-approved drug for the treatment of this condition and is frequently used in clinical care. UW research reviewed by an external (non-UW) IRB. This includes the requirement for consent information to be presented in a language that is understandable to the subject. It may be useful to involve genetic counselors in the informed consent . 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. These determinations will depend on several factors including the age, maturity of a minor, psychological state, and/or cognitive capabilities of the prospective subjects. 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. 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. This procedure adds approximately 15 additional minutes to the patients standard of care ultrasound. If the IRB did not waive documentation of consent, the subject documents their willingness to participate by signing, or marking an X, on the consent form. FDA. Revised Code of Washington (RCW) 28A.195.010 and 28A.225.010 (1) (a). 116 (b) (2); 21 CFR 50.25(a)(2)). 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. The Key Information must be organized and presented in a way that facilitates comprehension. In rare instances, HSD may permit the required information to be communicated to study participants via an alternative method. PROCEDURES AND GUIDELINES. The physician wants to compare the effects of two different FDA-approved estrogens on the osteoporosis. In general, one or both parents or guardians must be provided with the same information that is provided during an adult consent process, unless the regulatory criteria are met for waiving permission or waiving or altering elements of permission (WORKSHEET Children). What is the research question the study is trying to answer and why is it relevant to the prospective subject? 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. FDA-regulated research. Washington State records retention periods are much longer (see UW Records Management website). 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. 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. E-consent may also be useful and appropriate for in-person consent interactions. 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. Work situations are varied and require strong organization, prioritization, data analysis, verbal and written communication skills, the use of discretion, good judgement, problem solving, decision-making and leadership. If more information is needed, contact the Department of Health, PO Box 47890, Olympia, Washington 98504-7890, (360) 236-4030.