The American Psychological Association has provided guidance related to informed consent for telehealth services. Reconsent. UW research reviewed by an external (non-UW) IRB. 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. This refers to the process for confirming that the individual who provided the signature is the subject. 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. 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. (ii) A person authorized to consent to care under this subsection (2)(b) and the person's employing school or school district are not subject to administrative sanctions or civil damages resulting from the consent or nonconsent for care, any care, or payment for any care, rendered pursuant to this section. Such declaration shall be effective for up to six months . (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 treatment could be one of many estrogens (including the two they are interested in), or one of many bisphosphonate drugs. The risks associated with the two estrogen treatments are research risks and must be included in the consent process/form. Offices of other separately elected officials, independent agencies, boards, councils and WEBPAGE Single Patient Emergency or Compassionate Use The concept of "implied" or "passive" consent (e.g . 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. There is no specific information that must be included in the Key Information. If the consent process is not captured by audio or video, the researcher should create a written description of how the consent information was communicated to the subject and how the researcher ensured the subjects questions were answered. 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. (4) For the purposes of this section, "health care," "health care provider," and "health care facility" shall be defined as established in RCW, (5) A person who knowingly provides a false declaration under this section shall be subject to criminal penalties under chapter, (2) It is the intent of the legislature to assist kinship caregivers in accessing appropriate medical care to meet the needs of a child in their care by permitting such responsible adults who are providing care to a child to give informed consent to medical care." 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. Other vulnerable groups may also require additional protections against the potential for coercion or undue influence. It is HSD policy to generally apply the guidelines described in the FDA Guidance on Informed Consent when enrolling subjects who are illiterate or who have low literacy. Consent Forms v. Informed Consent. 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). Assent outcomes. 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. Oral consent should be documented in the patient record. 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. 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. 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.) GUIDANCE Exempt Research However, information that is fully described in the Key Information section does not need to be repeated later in the form or process. A physician researcher plans to compare the effects of two different FDA-approved vascular stents on oxygen flow in patients with significantly blocked arteries that are life-threatening and for whom the only appropriate clinical treatment is implantation of a vascular stent. Commission consistent with existing statutes governing the practice of medicine within the state of Washington. 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 state board of education denies approval to any private school engaging in a policy of racial segregation or discrimination. The study is fully or conditionally approved by the IRB on or after January 21, 2019 (the date when this regulatory requirement was enacted). 28 CFR 46.117 Documentation of Informed Consent. EXAMPLE Key Information Licensure indicates that a practitioner has met basic education, competency, and supervision standards. The requirements proving informed consent vary by state and by the type of procedure being performed. A full reconsent is required when a LAR consent or parental permission is being replaced by the subject consenting on their own behalf. Medicaid . 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. 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. All research reviewed by the UW IRB, including non-UW institutions and sites for which the UW IRB is providing review. GUIDANCE Authority and Responsibilities of HSD and UW IRB 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. RCW 43.185C.180 Washington homeless client management information system (HMIS consent law) Alternatively, the IRB may grant a waiver of documentation of consent if the criteria are met (WORKSHEET Consent Requirements and Waivers). Check your state's dental practice act or contact your state dental association for more information. Actions Subject to Consent. appropriate alternative procedures or courses of treatment, if any. Yes, you can get these services without consent of an authorized adult. 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 designing the assent process and, if applicable, assent form, researchers should consider the nature of the research as well as the age, maturity, and psychological state of the children. (I) Meets the requirements of (a)(x)(A) of this subsection; (III) Is willing and able to become involved in the patient's health care; (IV) Has maintained such regular contact with the patient as to be familiar with the patient's activities, health, personal values, and morals; and. However, there are additional regulatory requirements for enrolling this population for research funded or supported by the agencies that signed Subpart B. TEMPLATE Other E-signature Attestation Letter The UW IRB may consider alternative methods. (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. 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 risks associated with the two DEXA scans are not research risks because the physician obtains DEXA scans for all of their patients being treated for osteoporosis, not just those who are in the research study. The American Journal of Bioethics, 17:7, 53-55 (2017), Ravi et al., Financial Payments for Participating in Research while Incarcerated: Attitudes of Prisoners. 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. 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. Examples where more formal verification might be appropriate include: UW eSignature (DocuSign) is not valid for FDA-regulated research; and. INFORMED CONSENT FOR COUNSELING SERVICES THERAPIST CREDENTIALS: I am a master's level Licensed Mental Health Counselor (LMHC) in the State of Washington. My license number is LF00001679. [For FDA-regulated research, parental permission can only be waived under the minimal risk criteria.] To ensure subject comprehension, it might be necessary to provide consent using a combination of both paper-based and electronic methods. 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. A robust informed consent process contributes to patient satisfaction and safety in addition to helping ensure compliance with state, federal, and accreditation requirements. 2005. 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. WORKSHEET Neonates voluntary consent is being sought for research; research purpose, expected duration of participation, and procedures; the most important, reasonably foreseeable risks or discomforts, reasonably expected benefits to the subjects or others; and. Potential subjects may express an active willingness to participate, may simply fail to object, or may dissent (express unwillingness to participate). In these cases, it may be more appropriate to waive assent, rather than ask the subject and then not take their wishes into account. Consent materials must have a distinct Key Information section when they are more than 2,000 words (not counting any signatures sections; approximately 5 pages; single-spaced; 1-inch margins). School Counseling. 2 Failure to obtain or . Particularized Standards of Conduct. 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). We recognize that in some cases, there is no written source or data (e.g., drug Investigator Brochure or package insert) to rely on when determining frequency of risks. There is also no need to specifically state the absence of risk where none exists. Consent information must be presented in a way that facilitates comprehension. The assent process should be viewed as ongoing throughout the duration of the research. Federal regulations identify pregnant women*, prisoners, and children as Protected Populations and specify additional protections and consent requirements for them. New Information Provided to Previously Enrolled Subjects, May 4, 2020, SACHRP Recommendations, Attachment A2 Reconsent Appendix 2. (d) The health care provider or health care facility where services are rendered is immune from suit in any action, civil or criminal, and from professional or other disciplinary action when such reliance is based on a declaration signed under penalty of perjury pursuant to chapter. It is important to note that the informed consent requirements in the regulations are not intended to preempt any applicable federal, state, or local laws that require additional information to be disclosed for consent to be legally effective (45 CFR 46.116(e)). Yes, the risk of severe (life-threatening) allergic reaction should be added to the consent form. The purpose of this template is to provide general sample language for consent forms. Open the accordion below for version changes to this guidance. Arkansas- Providers are required to follow applicable state and federal laws, but there is no specific requirement for informed consent. 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). 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. The regulations designate three protected populations (pregnant women, prisoners, children) that each have additional required protections. Additional information can be found in the OHRP draft Guidance, Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care. Headings should be subject-focused rather than regulations-focused. WORKSHEET Pregnant Women Numerous guidelines exist for informed consent including: FDA-regulated research. (a) Persons authorized to provide informed consent to health care, including mental health care, on behalf of a patient who is under the age of majority and who is not otherwise authorized to provide informed consent, shall be a member of one of the following classes of persons in the following order of priority: (i) The appointed guardian, or legal custodian authorized pursuant to Title, (ii) A person authorized by the court to consent to medical care for a child in out-of-home placement pursuant to chapter, (iv) The individual, if any, to whom the minor's parent has given a signed authorization to make health care decisions for the minor patient; and, (v) A competent adult representing himself or herself to be a relative responsible for the health care of such minor patient or a competent adult who has signed and dated a declaration under penalty of perjury pursuant to chapter. . Use of electronic systems, archiving, and retention of consent materials must meet the FDA Part 11 requirements. GUIDANCE Subject Payment Researchers may consider using a video or audio recording of the consent process as part of documenting consent. Kim Reykdal. If the subject cannot use their hands at all, the IRB will consider alternative methods of documenting consent. HSD is currently working on updating our consent templates to match the GUIDANCE. 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. No, these risks do not need to be added to the consent form. The IRB review focuses on whether the translation method is appropriate rather than approving the translated text. Decision-making impairments may be permanent, temporary, progressive, or fluctuating. Subpart B consent requirements for pregnant women and neonates are listed in the WORKSHEET Pregnant Women and WORKSHEET Neonates. Your legal guardian or legally-authorized representative is unable to . In emergencies, when a decision must be made urgently, the patient is not able to participate in . The process culminates in the patient's decision to a specific treatment or procedure. Not research risks 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. Informed consent forms should be specific to the procedure. However, these additional required protections may not be enough to ensure consent comprehension and voluntary participation for these groups. WASHINGTON, Dec 28 (Reuters) - In September, U.S. State Department officials invited a foreign delegation to the Guantanamo Bay detention center to persuade the group to take detainee Tariq Ba Odah to their country. Failure to object should not be equated with an active willingness 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. This procedure adds approximately 15 additional minutes to the patients standard of care ultrasound. In most cases, when there is a separate Key Information section, it will be relatively short compared to the rest of the consent document or process. For this reason, HSD recommends the use of a consent addendum, rather than a re-review of the entire consent form, for most situations. If this is not possible, the LAR should consider the persons best interests. The Key Information must be organized and presented in a way that facilitates comprehension. 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. WORKSHEET Children As is noted in Consent Consideration # 5, with the appropriate protections in place, prisoners may still be able to take advantage of opportunities to share in the risks and benefits of research. GUIDANCE The Belmont Report 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. Washington State law now allows adults raising a relative's child to consent to medical and mental health care - services even if you don't have legal custody. (d) No rights under Washington's death with dignity act, chapter. 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). Washington state has passed laws related to telehealth and telemedicine, addressing definitions; regulations; scope of practice; licensing, credentialing, and privileging requirements . Remembering that consent is a process, researchers must have a plan for ongoing communication between the research team and the subjects throughout their participation in the research. This letter must be signed by the Chief Information Officer, Chief Information Security Officer, or other individual at the company/institution with sufficient authority and subject matter expertise to make the above attestation. Guidance for Industry. 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 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). Risk statements in consent forms should be simplified such that the information included is understandable and relevant to the subject population. In May 2004, CMS issued Interpretive Guidelines for the Medicare Conditions of Participation, including detailed requirements for the content of informed consent forms. The qualifications of the translator must also be described. Analysis Department of Health rules are written and adopted by a board or commission, or the secretary of the Department of Health. I am Licensed in the State of Washington. This is especially helpful if your practice frequently provides complex . It is HSD policy that researchers must obtain assent from subjects who are minors or decisionally-impaired adults, when the individuals are capable of providing assent and when it is appropriate to do so. The research may begin immediately. However, severe allergic reaction meets the definition of a serious risk as it could be life threatening. See GUIDANCE Human Subjects Regulations, GUIDANCE Mandatory State Reporting, and the section on legally authorized representative consent for details. This means the person understands, writes, and signs a statement declaring they agree to a treatment, for example. This includes the requirement for consent information to be presented in a language that is understandable to the subject. They should also ensure that the interpreter will accurately convey the information (e.g., Are they capable of interpreting complicated biomedical information?). If subjects will participate in the study remotely (e.g., low risk computer surveys) then providing the subjects with an electronic information statement would be appropriate. 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. 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.