(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." A LAR for an adult must be a member of one of the following classes of persons in the following order or priority: Availability. That worksheet also lists the consent requirements for federally-designated protected populations (i.e., pregnant women and neonates, prisoners, children). 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. 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. What is the anticipated time commitment for the subject? None of the risks associated with the two estrogen treatments and none of the risks associated with the DEXA scans are research risks because they are not dictated by the research protocol. Interpretation. Failure to object should not be equated with an active willingness to participate. Most research generates knowledge to promote a common good. 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. However, these potential complexities are dependent upon the specific research design and are not necessarily applicable to all studies enrolling pregnant women. These methods are based on the SACHRP recommendations and an article from WCG IRB. 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 regulations allow an alternative method of obtaining and documenting consent called short form consent. 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. Electronic delivery of consent information must meet the same human subjects regulatory requirements as paper-based delivery of the information. Other populations are also vulnerable to undue influence or coercion. The process and information presented must include the required characteristics and elements of consent as described in the WORKSHEET Consent Requirements and Waivers. If a person . (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. SOP Limited IRB Review This directive applies to all executive cabinet and small cabinet agency worksites and employees. Study procedures include a contrast-enhanced ultrasound using a contrast agent (FDA approved). Licensure indicates that a practitioner has met basic education, competency, and supervision standards. The decision may apply to all subjects in the study or may differ by individual subject or group of subjects. the standard care procedure or treatment is required, subjects have adequate time to consider and discuss participation prior to giving consent; and. Risks expected or known to be very frequent/very common or frequent/common should generally be included in the consent form and/or consent process. 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. 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). The state board of education denies approval to any private school engaging in a policy of racial segregation or discrimination. 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. 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) Washington State Supreme Court Committee on Jury Instructions. The most important thing to keep in mind is this: Informed consent is a process, not a piece of paper. State laws in the jurisdiction where the research is being conducted may affect the consent process (e.g., mandatory reporting; age of majority). Accommodations to the consent form or process will be specific to the needs of the particular subject(s). TEMPLATE Other E-signature Attestation Letter IV. INFORMED CONSENT FOR COUNSELING SERVICES THERAPIST CREDENTIALS: I am a master's level Licensed Mental Health Counselor (LMHC) in the State of Washington. For research intended, or likely, to involve subjects who are not fluent in English, researchers are responsible for ensuring all consent information and materials are presented in a language understandable by the subjects and in a way that accurately conveys the information. Decision-making by prospective subjects typically begins with the information presented in recruitment materials and in initial discussions with study staff, well before the consent form is presented. 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. The name may be placed on the consent form in advance of the consenting interaction. None of the risks associated with the two counseling approaches or with administration of the standard clinic questionnaires are research risks. 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. If the child reaches the legal age of consent while enrolled, the regulations about child participants no longer apply. Commission consistent with existing statutes governing the practice of medicine within the state of Washington. A revised package insert includes three new post-market risks. A careful balance of the Belmont Ethical Principles is vital to enrolling subjects with diminished consent capacity. However, no person under this section may provide informed consent to health care: (i) If a person of higher priority under this section has refused to give such authorization; or. It may also be important to ensure that the person in power is not aware of which of their students, supervisees, etc. (C) A health care provider may, but is not required to, rely on a declaration provided under (a)(x)(B) of this subsection. It is HSD policy that that IRB approval must be obtained in advance for the use of any e-signature or electronic signature capture system (e.g., DocuSign, UW ITHS REDCap). Identifying this information is the responsibility of the researcher. UW research reviewed by an external (non-UW) IRB. The Science of Titration Analysis. "When I looked this up, I saw that . For example, participants need not be told that needle sticks can cause minor pain or that surveys can be boring. 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. Answer However, in Gates v. Jensen, 92 Wn.2d 246, 595 P.2d 919 (1979 . For example, it may be appropriate to conduct an oral consent process without providing the subjects with printed consent materials if the study is a low risk, one-time interview with adults. (B) An adult who meets the requirements of (a)(x)(A) of this subsection shall provide a declaration, which is effective for up to six months from the date of the declaration, signed and dated under penalty of perjury pursuant to chapter. (ii) Potential referral to additional services, the department of children, youth, and families, or law enforcement. Should these risks be added to the consent form/process as reasonably foreseeable risks? 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. Medicaid . Similarly, if the Key Information section includes any of the elements of consent described in the WORKSHEET Consent Requirements and Waivers, those elements do not need to be repeated later in the form or consent process. RCW 43.185C.180 Washington homeless client management information system (HMIS consent law) HSD policies related to consent can be found in the WORKSHEET Consent Requirements and Waivers and throughout this guidance. An IRB may waive the requirements to obtain a . Notes and sources: You can get an abortion and abortion related services at any age without the consent of an authorized adult or the person responsible for the pregnancy RCW 9.02.100(2); State v. Koome, 84 Wn.2d 901 (1975). Yes, the risk of severe (life-threatening) allergic reaction should be added to the consent form. However, the IRB has the authority to require a separate Key Information section if appropriate. A workable definition of reasonably foreseeable is required to ensure that a description of any reasonably foreseeable risks or discomforts to the subject are presented to a potential research participant as part of the informed consent process (45 CFR 46. Known benefits should be accurately described and not exaggerated. What is the research question the study is trying to answer and why is it relevant to the prospective subject? Study status. 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). Although a Key Information section may serve as an abstract or executive summary for a longer consent form, that is not its primary function. My license number is LF00001679. Letter or email. 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. Assent outcomes. Disagreement among possible LARs. In 2006, CDC published its Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings . Definitions. 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. 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. A full reconsent is required when a LAR consent or parental permission is being replaced by the subject consenting on their own behalf. 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). GUIDANCE Consent Elements for Externally Reviewed Studies 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. Coercion occurs when an overt or implicit threat of harm is intentionally presented by one person to another to obtain compliance. Detailed descriptions of all potential risks are counterproductive if they do not provide potential subjects with useful information and may inadvertently distract subjects from relevant data. Washington state has passed laws related to telehealth and telemedicine, addressing definitions; regulations; scope of practice; licensing, credentialing, and privileging requirements . 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. For older versions: HSD staff see the SharePoint Document Library; Others contact hsdinfo@uw.edu. Research Risks RCW 28A.195.040. The LAR must decide in good faith whether the person would consent to the research. 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. . The counseling always includes two educational sessions, followed by sessions based on one of several widely accepted approaches to reducing binge drinking. 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. (V) Provides a declaration under (a)(x)(B) of this subsection. Consent Examples 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. By judicial decision, Washington state provides that mature minors who are capable of meeting the informed consent standard have consent authority. (a) More likely to occur are risks that are frequent/common or very frequent/very common as described in the table below. 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. The IRB will request that researchers fill out the form. *Pregnant women are not designated as a vulnerable population in the Common Rule or FDA regulations. Washington, DC: American Psychiatric Publishing, 2007. . 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). See short form consent. GUIDANCE Involvement of Children in Research Pregnant women and neonates are a federally designated protected population with additional regulatory requirements and protections described in Subpart B of the Common Rule. However, those agencies have also stressed that the section should be meaningful within the context of the study and have therefore purposely avoided specifying length requirements. Part 11 compliance is the responsibility of the researcher. Signed consent materials must be easily retrievable for auditors and monitors. The risks associated with the surgery, including the surgical procedures, general anesthesia, and any angiography with radio-opaque dyes performed during the surgery to verify the placement and efficacy of the stent are not different than they would be if the patient were not enrolled in the research and should not be included in the consent process/form. For example, a UW researcher participates in a multicenter trial using an external IRB and there may be no UW-site-specific form that can include this information. (e) A person who provides a statement for documentation that the minor patient is an unaccompanied homeless youth is not subject to administrative sanctions or civil liability for providing documentation in good faith based upon the person's knowledge of the minor patient and the minor patient's housing situation. A new genetic analysis is presented to subjects in the form of an addendum. It is HSD policy to voluntarily apply the Common Rule (45 CFR 46) consent regulations to all research reviewed by the UW IRB except as described in the HSD Flexibility Policy (GUIDANCE Authority and Responsibilities of HSD and UW IRB), in addition to other applicable requirements. Generally speaking, applicants need their NVC case number for an expedite request. 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 Common Rule requires that informed consent must begin with a concise and focused presentation of Key Information that is most likely to assist prospective subjects or their representatives in understanding the reasons why they might or might not want to participate in the research. OHRP, Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English, memorandum; November 9, 1995.