Additional Information Scenarios and Suggested Options, May 4, 2020, 15 U.W. The focus of the counseling program is to help students better understand the world they live in and make better . 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 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). The original signed consent form, regardless of format (e.g., paper, electronic) is considered a research record and federal regulations require researchers to retain consent forms for a minimum of three years after completion of the research. However, these potential complexities are dependent upon the specific research design and are not necessarily applicable to all studies enrolling pregnant women. Witness. 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 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). 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. The state board of education grants private school approval pursuant to RCW 28A.305.130. Similarly, subjects may be asked questions embedded during the electronic process to gauge their comprehension. 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) 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. Sharing Substance Use Disorder Information: A Guide for Washington State helps clarify the applicable federal regulations and law. (C) A health care provider may, but is not required to, rely on a declaration provided under (a)(x)(B) of this subsection. The Key Information must be organized and presented in a way that facilitates comprehension. Generally speaking, applicants need their NVC case number for an expedite request. For example, if new risks are identified for a study in which enrollment is ongoing, it might be appropriate to provide subjects who have already been enrolled with an addendum while also updating the consent form for subjects who have not yet been enrolled. Informed consent. (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. My license number is LF00001679. TUTORIAL Electronic Consent: What You Need to Know In many cases, multiple approaches will be required depending on where subjects are in the course of the study. A researcher may suspect a new study drug might cause slightly increased blood sugar levels. The state board of education denies approval to any private school engaging in a policy of racial segregation or discrimination. 46.116 (e) & (f) are met. In these cases, HSD defers to the sponsor/funder. Consent requirements may vary depending on the subject population, federal regulations, state laws, international laws, and institutional polices that apply to the research. There are certain situations when a person receiving services is required to provide written, informed consent. Reconsent. 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 . 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. FDA. GUIDANCE Prisoners (2) Information provided in order to obtain the informed consent must, to the extent possible, include the following: (a) That the patient has been diagnosed with a serious or immediately life-threatening disease or condition and explains the currently approved products and treatments for the disease or condition from which the eligible patient suffers; (b) That all currently approved and conventionally recognized treatments are unlikely to prolong the eligible patient's life; (c) Clear identification of the investigational product that the eligible patient seeks to use; (d) The potentially best and worst outcomes of using the investigational product and a realistic description of the most likely outcome. In general, dissent should be respected. Parental permission can be waived or altered, and documentation of permission can be waived, under the same criteria for waiving or altering consent and consent documentation. Our current use policy permits free printing and use by health care . In a . adult must give his/her own consent for health care. SUPPLEMENT Other REDCap Installation Definitions. Email: Asa.Washines@atg.wa.gov. Analysis Researchers must provide the IRB with a written description of what subjects will be told during the consent process, even if consent will not be documented (i.e., no consent form). In those instances, the expert judgement of the researcher, or relevant published literature, would need to be applied when determining frequency. The physician wants to compare the effects of two different FDA-approved estrogens on the osteoporosis. 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. The UW-ITHS-supported non-mobile version of REDCap meets the FDAs Part 11 electronic system requirements. HSD and the UW will not vet other e-signature methods. 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. A rule or Washington Administrative Code (WAC) is written to provide interpretive support for the individuals or entities to whom the rule applies. Regardless of the subjects location, there may also be optional information (for example, hyperlinks or help text) embedded in the electronically delivered material to aid in comprehension of key study elements. Subject. There is no regulatory requirement to provide all the standard elements of consent during the assent process. In addition, it is a way to demonstrate respect and gratitude for their contribution and to maintain trust. Allowing adequate time during the consent process for discussion and opportunities for the subject to ask questions becomes extremely important when enrolling prisoners. The Washington Health Law Manual is now in its Fourth Edition and maintained in an online format. 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. As a general rule, informed consent should be documented by the use of a written consent form approved by the IRB, and signed by the subject or the subject's legally authorized representative. 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. Additional Considerations GLOSSARY Legally Effective Research Consent IRB Ethics & Human Research, 40:6, 1-6 (2018), The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. 28 CFR 46.117 Documentation of Informed Consent. 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. These determinations will depend on several factors including the age, maturity of a minor, psychological state, and/or cognitive capabilities of the prospective subjects. If the subjects family members or friends will be asked to serve as interpreter, the researcher should think carefully about privacy and confidentiality issues, particularly for research that involves health or other sensitive topics. (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. Federal guidance stresses that the Key Information should be meaningful within the context of the study and has therefore avoided strictly defining what information should be included. 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. Undue influence is often scrutinized by the IRB when subjects will receive significant payment for participation (see GUIDANCE Subject Payment). Examples where more formal verification might be appropriate include: UW eSignature (DocuSign) is not valid for FDA-regulated research; and. (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. The IRB must determine whether the prospective subjects are capable of providing assent and, if they are, whether the proposed assent process is adequate for helping subjects decide whether they want to participate in the research (WORKSHEET Consent Requirements and Waivers). Although a Key Information section may serve as an abstract or executive summary for a longer consent form, that is not its primary function. Consent Forms v. Informed Consent. 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. Assent requirements. GLOSSARY Exempt Research Note that some sponsors or funders may require a full reconsent for any change to the consent form. Providing context that is meaningful and language that is familiar and at an appropriate reading level for the particular subject population will make the content easier for subjects to understand. 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. Review the INSTRUCTIONS UW E-Signature Tools for more information on how to use these tools. The drug is an FDA-approved drug for the treatment of this condition and is frequently used in clinical care. Oral consent should be documented in the patient record. The American Journal of Bioethics, 17:12, 12-13 (2017). "When I looked this up, I saw that . See short form consent. Gerberding Hall G80 Box 351202 Seattle, WA 98195, 2023 University of Washington | Seattle, WA, Specific information about consent for studies being reviewed by a non-UW IRB can be found in the webpages and documents related to, Many other topics that intersect with consent are referenced within this guidance and linked in, *Pregnant women are not designated as a vulnerable population in the Common Rule or FDA regulations. Severe allergic reaction is a rare risk and is therefore not more likely to occur. 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. 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. In these cases, the federal agencies expect that the Key Information section would be no more than a few pages. These risks should generally be included regardless of the potential frequency of occurrence. 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. Consent addendum. The IRB review focuses on whether the translation method is appropriate rather than approving the translated text. If they succeeded, the transfer would mark a small step toward realizing President Barack Obama's goal of closing the prison before he leaves office.The foreign officials told the . The assent process should be viewed as ongoing throughout the duration of the research. Recognizing that technology changes are developed and become applied to practice with . Licensure indicates that a practitioner has met basic education, competency, and supervision standards. 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. Minimum Requirements: Two years of experience in clinical research with knowledge of regulatory requirements, informed consent . Failure to object should not be equated with an active willingness to participate. The subject is required to sign and date the consent form to document that all their questions have been answered and they agree to participate in the research. A new genetic analysis is presented to subjects in the form of an addendum. Researchers may encounter individuals who are interested in participating in research and have the cognitive ability to consent on their own behalf, but who have limited ability to understand or read consent information presented in English, or to sign a consent form. Study Summary (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. (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 5.50 RCW stating that the adult person is a relative responsible for the health care of the minor patient. The IRB may approve other methods so long as they meet regulatory requirements and are consistent with any applicable local law. This means that practice laws and requirements in the patient's location regulate healthcare professionals' practice. Other vulnerable groups may also require additional protections against the potential for coercion or undue influence. (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. 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. In making this determination, the IRB should consider: Methods for providing new information to subjects. 55% of adults said in a poll by the Pew Research Center that abortion should be legal in all or most cases. Conversely, the IRB can require the inclusion of infrequent, rare, or very rare risks that dont otherwise meet the overall definition above if they determine the target population would find them meaningful to their decision to participate in the research (e.g., rare permanent teeth discoloration). A robust informed consent process contributes to patient satisfaction and safety in addition to helping ensure compliance with state, federal, and accreditation requirements. For more in-depth information about this law, read A Kinship Caregiver's Guide to Consenting to Health Care from Washington Law Help website. 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. What information about the subject is being collected as part of this research? Have any dogs/cats in your home spayed or neutered, if they are 6 months or older, unless there are medical reasons for not doing so. See WORKSHEET Children for a full description of waiver criteria. (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. Waiver of documentation of consent. To ensure subject comprehension, it might be necessary to provide consent using a combination of both paper-based and electronic methods. PROCEDURES AND GUIDELINES. The LAR or parent/guardian name and relationship to the subject should also be recorded in the signature area. This is especially helpful if your practice frequently provides complex . 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. Rules or WACs carry the full force of the law. 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. This creates challenges for obtaining informed consent because the process typically relies heavily on written materials. WORKSHEET Consent Review for IRB Members [HSD staff and IRB member access only], CHECKLIST Exception from Informed Consent E6 Good Clinical Practice: Consolidated Guidance, April 1996, section 4.8.9. It is best practice to date the form at the time when consent is obtained. 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. to convey consent information and/or to document informed consent. 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).