HSD and/or IRB approval. 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. Similar protections may be appropriate for them. This method may be appropriate for complicated or important information that requires consent because it (1) may impact a subjects willingness to continue participation; but (2) does not require a full reconsent and review of the entire study. The purpose of this study is to investigate the safety and effectiveness of long-term treatment using either a combination of drugs or a single drug to prevent subjects acquiring HIV in subjects who are HIV negative.The investigator brochure lists three rare but serious risks for the drug combination that are not currently in the consent form (viral resistant mutations, interstitial nephritis, and immune reconstitution syndrome) that exclusively affect HIV positive individuals. Unless otherwise indicated, in this guidance the term subject refers to: the subject, the parent(s) or guardian of a minor subject, and the LAR for a decisionally-impaired adult subject. The IRB requires a full reconsent for all enrolled subjects including obtaining documentation. In making this determination, the IRB should consider: Methods for providing new information to subjects. The risks associated with the two estrogen treatments are research risks and must be included in the consent process/form. Waiver of documentation of 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). In those instances, the expert judgement of the researcher, or relevant published literature, would need to be applied when determining frequency. Decision-making impairments may be permanent, temporary, progressive, or fluctuating. GUIDANCE Consent Elements for Externally Reviewed Studies Potential subjects may express an active willingness to participate, may simply fail to object, or may dissent (express unwillingness to participate). 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. Potential or uncertain benefits should be described clearly as to what is known about the uncertainty or likelihood of the potential benefits. A subject may be unable to physically sign a consent form due to some impairment (e.g., injury to hands). The presentation and discussion of consent information, as well as the consent form itself, are single elements of the overall consent process. Undue influence may occur through an excessive offer of something valuable or desirable that influences decision-making in inappropriate ways. So long as the additional protections afforded by LAR consent are in place to offset the subjects diminished autonomy, it is possible that individuals with reduced consent capacity can still participate in research. Analysis The IRB will request that researchers fill out the form. Key information is intended to be the information that is most likely to assist the specific subject population (e.g., end-stage cancer patients; first-year college students; parents of toddlers with autism; prisoners). See the section on Information for subjects in the GUIDANCE Exempt Research for full details. Informed Choice WA is pro Informed Consent. 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. There is also no requirement to document assent with an assent form, although researchers should have some way of recording that they obtained assent. IV. What aspects of research participation in this study are likely to be unfamiliar to a prospective subject, diverge from a subjects expectations, or require special attention? In 2006, CDC published its Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings . This means that practice laws and requirements in the patient's location regulate healthcare professionals' practice. Identifying this information is the responsibility of the researcher. Reconsent. This would likely be a short description of what the experience would be like, how long it would take, and whether there would be any pain or discomfort as a result of participating. (3) The document must be signed and dated by the eligible patient's treating physician and witnessed in writing by at least one adult. GLOSSARY Legally Effective Research Consent Assent requirements. 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. In rare instances, HSD may permit the required information to be communicated to study participants via an alternative method. The method by which consent is obtained depends on the specifics of the study and the regulations that govern the research. When consent information is provided in writing, understanding may be facilitated by breaking up dense text with sectioning, pictures, icons, schematic diagrams of study design, or putting information in side-by-side comparison tables. FDA-regulated research. The Key Information may be in a separate document or in the beginning of the consent form, but it must be presented to subjects at the beginning of the consent process. (ii) "Homeless" means without a fixed, regular, and adequate nighttime residence as set forth in the federal McKinney-Vento homeless education assistance improvements act of 2001, P.L. There are two or more individuals in the same class and the decision is not unanimous among all available members of that class. UW research reviewed by an external (non-UW) IRB. Consent information must be presented in a way that facilitates comprehension. 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. to convey consent information and/or to document informed consent. (f) That the eligible patient is liable for all expenses consequent to the use of the investigational product, except as otherwise provided in the eligible patient's health benefit plan or a contract between the eligible patient and the manufacturer of the investigational product. However, the guidance does generally expect that Key Information include a concise explanation of the following elements: *Risks and discomforts in Key Information should be described with the study context and subject perspective in mind. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979, The PHASES Working Group, Pregnancy and HIV/AIDS: Seeking Equitable Study, Ending the evidence gap for pregnant women around HIV and co-infections: A call to action (2020), WCG IRB Insights, Providing Research Participants with New Information: Is Re-Consent Always Necessary?, Wilfond and Kraft, Attending to the Interrelatedness of the Functions of Consent. (c) General requirements for informed consent. The requirements proving informed consent vary by state and by the type of procedure being performed. The decision may apply to all subjects in the study or may differ by individual subject or group of subjects. On rare occasions, the IRB may approve a process that involves reading the consent form to the subject and noting the consent in some official record that is not part of the research records (e.g., the subjects medical record). Recognizing that technology changes are developed and become applied to practice with . (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. To ensure subject comprehension, it might be necessary to provide consent using a combination of both paper-based and electronic methods. E6 Good Clinical Practice: Consolidated Guidance, April 1996, section 4.8.9. For example, the state of Colorado requires psychologists to present certain written information to their clients, including therapist credentials, client rights, and the State Grievance Board address (Handelsman, 1990 . 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. Numerous guidelines exist for informed consent including: 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. GUIDANCE HIPAA There is no specific information that must be included in the Key Information. In addition to the value of consent to the individual, there is a social value to establishing effective and ethical consent processes and norms to ensure accountability of the research enterprise. (C) A health care provider may, but is not required to, rely on a declaration provided under (a)(x)(B) of this subsection. 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. This would be an example where we would expect the researcher to include risks of increased blood sugar levels in the consent form. FDA considered the UW ITHS REDCap signature tool a hand-written signature so the identity verification requirements do not apply.