The risks of serious infection and diarrhea need to be added to the consent form/process. However, there are also potential limitations to using e-consent. WORKSHEET Prisoners. It is important to remember that the IRB is tasked with minimizing, not eliminating the possibility of undue influence or coercion. The risks associated with the educational session are not research risks because all students who come into the counseling center participate in those sessions whether or not they are in the research study. In other words, there is flexibility in how the presentation of Key Information is structured if it is organized and presented in a way that facilitates comprehension for prospective subjects. If the IRB determines that assent is possible, the IRB may nonetheless waive the assent requirement under the same criteria for waiving consent (WORKSHEET Consent Requirements and Waivers). Informed consent is the process by which the practitioner discloses to and discusses appropriate information with a patient so that the patient may make a voluntary choice about whether to accept the proposed diagnostic or therapeutic procedure or course of treatment. The UW-ITHS-supported non-mobile version of REDCap meets the FDAs Part 11 electronic system requirements. Potential subjects may express an active willingness to participate, may simply fail to object, or may dissent (express unwillingness to participate). OHRP Guidance Documents on Informed Consent, from the OHRP website. For example, participants need not be told that needle sticks can cause minor pain or that surveys can be boring. Witness Requirements. 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. (SACHRP recommendations), For minimal risk procedures, risks or burdens that are immaterial or obvious to potential participants need not be explicitly addressed in the consent form or dialogue. The risks associated with motivational interview and the cognitive-behavioral group are research risks and must be described in the consent process/form. Federal regulations identify pregnant women*, prisoners, and children as Protected Populations and specify additional protections and consent requirements for them. 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. When documentation of consent can be waived, researchers have greater flexibility in the ways in which they can design the consent process. If a person . As with more likely to occur the IRB has discretion to leave out serious risks that are not relevant to a particular population, may be theoretical or unsupported by the data, or would detract from a participants understanding of the more significant risks associated with the primary aim(s) of the research. Check your state's dental practice act or contact your state dental association for more information. What impact will participating in this research have on the subject outside of the research? The Washington Health Law Manual is now in its Fourth Edition and maintained in an online format. 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. provide sufficient details about the study so prospective subjects can make an informed decision about whether to participate; facilitate understanding of what has been disclosed; and. 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. For many other situations, rather than trying to anticipate what might be unduly influential for every individual subject, the IRB should make use of existing minimization tools including some of the other regulatory consent requirements and protections that have been described in this guidance. These protections, and restrictions about the types of research in which prisoners may participate, were put into place to prevent a return to past research practices that exploited prisoners by exposing them to an unfair burden of risks, coercive and unduly influential enrollment practices, and an absence of informed consent procedures. For younger children, researchers should focus the assent process and information on the aspects of the research that the children would be mostly likely to understand and be interested in. The informed consent requirements in this policy are not intended to preempt any applicable Federal, state, or local laws (including tribal laws passed by the official governing body of an American Indian or Alaska Native tribe) that require additional information to be disclosed in order for informed consent to be legally effective. For more in-depth information about this law, read A Kinship Caregiver's Guide to Consenting to Health Care from Washington Law Help website. What is the research question the study is trying to answer and why is it relevant to the prospective subject? 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. Researcher. 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. This directive applies to all executive cabinet and small cabinet agency worksites and employees. The physician wants to compare the effects of two different FDA-approved estrogens on the osteoporosis. In addition, it is a way to demonstrate respect and gratitude for their contribution and to maintain trust. informed consent. (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." HSD tip. The IRB review focuses on whether the translation method is appropriate rather than approving the translated text. 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. Actions Subject to Consent. Advertisements, announcements, social media (e.g., Facebook, Twitter) postings, and other recruitment processes and materials are generally considered to be part of the consent process. 45 CFR 46.116 [pre-2018 requirements and 2018 requirements], 45 CFR 46.117 [pre-2018 requirements and 2018 requirements]. 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. Prior to initiating any research activities, including screening procedures or extracting information from records, federal regulations require that the subject sign the IRB-approved consent form and that a copy of the consent form be provided to the subject. 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 focus of the counseling program is to help students better understand the world they live in and make better . TEMPLATE Consent Form, Short (English) 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. 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. GLOSSARY Exempt Research Yes, the risk of severe (life-threatening) allergic reaction should be added to the consent form. 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. 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. See Protected and Vulnerable Populations for additional discussion. 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. (I) Has exhibited special care and concern for the patient; (II) Is familiar with the patient's personal values; (III) Is reasonably available to make health care decisions; (IV) Is not any of the following: A physician to the patient or an employee of the physician; the owner, administrator, or employee of a health care facility, nursing home, or long-term care facility where the patient resides or receives care; or a person who receives compensation to provide care to the patient; and. This may mean that the researcher needs to consult with publications about research subjects preferences, disease-focused nonprofit groups, patient interest groups, or other researchers/study staff with experience with the specific population. Washington State Supreme Court Committee on Jury Instructions. The risks associated with the research questionnaires (depression, social anxiety, stress coping strategies) and with research use of the standard clinic questionnaires are research risks and must be described in the consent process/form. For example, this may be accomplished through telephone calls, electronic messaging (examples: email, text messages), video conferencing, live chat, or other methods. Code Chapter 96 The Electronic Signatures in Global and National Commerce Act (E-Sign Act), National Conference of Commissioners of Uniform State Laws, Uniform Electronic Transactions Act (UETA), (1999), Revised Code of Washington (RCW) Chapter 19.360, Electronic Signatures and Records, Chapter 1.80 Revised Code of Washington (RCW) Uniform Electronic Transactions Act (Washingtons adoption of UETA), Committee On Ethical Considerations for Revisions to DHHS Regulations for Protecting Prisoners in Research, Ethical Considerations for Research Involving Prisoners (2006), Dickert et al., Reframing Consent for Clinical Research: A Function-Based Approach. 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. What are the main reasons a subject will want to join, or not join, this study? The qualifications of the translator must also be described. Definitions. promote voluntariness about whether to participate. However, they are planning to actively monitor subject blood glucose levels throughout the study and intervene when appropriate. Although the overall study is greater than minimal risk and requires documentation of consent, the new component is minimal risk, so the IRB waives documentation of consent for the addendum. 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). 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. There is no regulatory requirement to provide all the standard elements of consent during the assent process. The risks associated with the two estrogen treatments are research risks and must be included in the consent process/form. Designing consent with prisoners. Severe allergic reaction is a rare risk and is therefore not more likely to occur. Subject. The study aims to optimize the imaging of abdominal organs with a contrast enhanced ultrasound comparing clinical ultrasounds with research ultrasounds. For this reason, HSD recommends the use of a consent addendum, rather than a re-review of the entire consent form, for most situations. 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 . Interpretation. Department of Health rules are written and adopted by a board or commission, or the secretary of the Department of Health. 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. 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 . 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. There are other situations when concerns about undue influence may arise. 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. SUPPLEMENT Other REDCap Installation In these situations, it is important for subjects to be able to reaffirm their willingness to participate in research. (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. The method by which consent is obtained depends on the specifics of the study and the regulations that govern the research. Study Summary (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. Accommodations to the consent form or process will be specific to the needs of the particular subject(s). It is best practice (but not required) for researchers to use the Zipline watermarked version of the consent form. (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.