The IRB review focuses on whether the translation method is appropriate rather than approving the translated text. GUIDANCE Exempt Research (3) An unaccompanied homeless youth who is under the age of majority, who is not otherwise authorized to provide informed consent, and is unable to obtain informed consent under subsection (2)(b)(i) of this section is authorized to provide informed consent for nonemergency, outpatient, primary care services, including physical examinations, vision examinations and eyeglasses, dental examinations, hearing examinations and hearing aids, immunizations, treatments for illnesses and conditions, and routine follow-up care customarily provided by a health care provider in an outpatient setting, excluding elective surgeries. TEMPLATE Translation Attestation Additional information can be found in the OHRP draft Guidance, Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care. GUIDANCE Human Subjects Regulations Washington State records retention periods are much longer (see UW Records Management website). 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. Study Summary A potential participants assent cannot override a no from a parent or LAR unless the IRB has waived the requirement for parental permission or completely waived consent. Diarrhea is a frequent risk according to the investigators brochure. 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). 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. This information may be equally or more influential in final decision-making as the consent form. Consent Form Template, Standard. These determinations will depend on several factors including the age, maturity of a minor, psychological state, and/or cognitive capabilities of the prospective subjects. 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). Answer See short form consent. 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. In many cases, multiple approaches will be required depending on where subjects are in the course of the study. The Key Information requirement applies to the consent process as a whole not simply to consent documents. In 2006, CDC published its Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings . The witness and the researcher should also sign and date the form. 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. 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. There are many stents that a physician could use, but the research protocol is restricting the physicians (and subjects) choice to the two that are the focus of the study. This means the person understands, writes, and signs a statement declaring they agree to a treatment, for example. This subsection (1)(c) does not apply to informed consent provided on behalf of a patient who has not reached the age of consent required to make a particular health care decision. The focus of the counseling program is to help students better understand the world they live in and make better . The person must sign by choice. 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. Consent information must be presented in a way that facilitates comprehension. It is best practice (but not required) for researchers to use the Zipline watermarked version of the consent form. Researchers should discuss the consent process, including the. If an adults capacity to consent is reduced, then they can participate in the research only if a legally-authorized representative (LAR) provides consent on their behalf. Written informed consent is obtained from the client that store and forward technology will be used and who the consulting provider is. By judicial decision, Washington state provides that mature minors who are capable of meeting the informed consent standard have consent authority. This is particularly important when the study may offer significant benefit to the individual subjects or subject population. As part of clinical care, the physician normally does a DEXA scan to measure bone density before beginning any osteoporosis treatment, and then repeats the DEXA scan after one year to see whether the treatment is having any beneficial effects. 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). 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. Each student who agrees to participate in the research will have the two educational sessions and will then be randomly assigned to either the motivational interviews or the cognitive-behavioral group. In these cases, unless the IRB has waived the requirement, the researcher must obtain legally effective research consent from the now-adult subject for any ongoing interactions or interventions or continued analysis of identifiable specimens or data. Researcher. For example, complicated clinical trials involving high risk procedures typically involve consent forms of more than 20 pages. For example, when there are power dynamics involved (e.g., professor/student; supervisor/employee), it may be appropriate to ensure the consent process is conducted by someone outside the power dynamic. It is almost never appropriate to use children as interpreters. The counseling always includes two educational sessions, followed by sessions based on one of several widely accepted approaches to reducing binge drinking. LMHC #6901. . Each psychologist at the counseling center works with their student clients to decide which approach is best suited to the students circumstances. 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. Phone: (360) 878-0664. (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. This includes ensuring the information is accessible by subjects for the duration of the research and is easily retrievable for auditors and monitors. Washington State Supreme Court Committee on Jury Instructions. FLORIDA AGENT'S HEALTH INSURANCE (85 scoreable questions plus 15 pretest questions - Time limit: 2 hours) ACCIDENT & HEALTH - GENERAL KNOWLEDGE CONTENT (50 scoreable questions plus 10 pretest questions) I. Potential subjects may express an active willingness to participate, may simply fail to object, or may dissent (express unwillingness to participate). EXAMPLE Key Information There was a therapeutic exceptions in the state's legislative ban on abortions by 1900. The IRB requires a full reconsent for all enrolled subjects including obtaining documentation. American Journal of Bioethics, 17:12, 3-11 (2017), Dickert et al., Partnering with Patients to Bridge Gaps in Consent for Acute Care Research. See Protected and Vulnerable Populations for additional discussion. 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. 46.116 (e) & (f) are met. Or if they agree to release their records. (a) More likely to occur are risks that are frequent/common or very frequent/very common as described in the table below. 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. 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. (c) A health care provider may, but is not required to, rely on the representations or declaration stating that the patient is an unaccompanied homeless youth, 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 authorized to consent to the health care of the minor patient. The choice of how the osteoporosis will be treated has been restricted by the research design (to the two estrogens). Informed consent - adults. With adequate knowledge and understanding of the benefits and . Interpretation. If such a determination cannot be made, the decision to consent to the proposed health care may be made only after determining that the proposed health care is in the patient's best interests. Client Rights: Informed Consent. See GUIDANCE Human Subjects Regulations, GUIDANCE Mandatory State Reporting, and the section on legally authorized representative consent for details. Minimum Requirements: Two years of experience in clinical research with knowledge of regulatory requirements, informed consent . Are they required to notify an adult? TIPSHEET Consent HSD is currently working on updating our consent templates to match the GUIDANCE. For older versions: HSD staff see the SharePoint Document Library; Others contact hsdinfo@uw.edu. A witness signature is not required on the consent form, unless: Your informed consent is obtained through the use of a short form consent process; You have decision-making capacity, but are unable to read, write, talk, or see (due to blindness); or. State v. Koome, 84 Wn.2d 901 (1975).. Outpatient mental health treatment: 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. the choice of counseling techniques is being dictated by the research design. For example, participants need not be told that needle sticks can cause minor pain or that surveys can be boring. Subjects who have the cognitive capability may provide their assent to participate and a parent/guardian or legally-authorized representative (LAR) may provide consent on behalf of the subject. Alternatively, assent, LAR consent, and/or parental permission may be waived the the IRB. This directive went into effect on Nov. 1, 2022. Who does the directive apply to? (b) A health care facility or a health care provider may, in its discretion, require documentation that the minor patient under this subsection (3) is an unaccompanied homeless youth. 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. (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. 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. 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). FDA-regulated research. I am Licensed in the State of Washington. TEMPLATE Other E-signature Attestation Letter 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. 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 . If the subject cannot use their hands at all, the IRB will consider alternative methods of documenting consent. Throughout the course of a study, subjects may need to be informed about new information or consent may need to be revisited due to fluctuating decision-making capacity [see Diminished or Fluctuating Consent Capacity and use of a Legally Authorized Representative (LAR)] or because a child subject has reached the age of majority (see Children under Protected and Vulnerable Populations). HSD and/or IRB approval. If this is not possible, the LAR should consider the persons best interests. 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). The process and information presented must include the required characteristics and elements of consent as described in the WORKSHEET Consent Requirements and Waivers. There are many electronic alternatives to a handwritten signature, including: electronic signatures using tools such as DocuSign or REDCap; digital signatures; computer-readable ID cards; biometrics; or username and password combinations. However, the IRB has the authority to limit, or explicitly not allow the use of LARs to obtain consent when such limits or prohibition is appropriate for a specific study. Failure to object should not be equated with an active willingness to participate. Similar protections may be appropriate for them. participated and which did not. State laws in the jurisdiction where the research is being conducted may affect the consent process (e.g., mandatory reporting; age of majority). The manual was previously published in 1996, 1998, and 2006, and we acknowledge the countless hours of all the volunteers who made the Fourth Edition and prior versions possible. Such information can be described elsewhere in the consent form or process. Telehealth care takes place where the patient is located at the time of the appointment. In these cases, it may be more appropriate to waive assent, rather than ask the subject and then not take their wishes into account. (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. 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. 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. GUIDANCE Authority and Responsibilities of HSD and UW IRB GLOSSARY Legally Authorized Representative 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. Failure to obtain informed consent versus failure to diagnose claims. 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). HCA, in partnership with stakeholders around the state, has developed guidance for providers to help support this work. Medicaid . 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. State and federally-funded homeless and housing service providers use HMIS to collect and manage data gathered while providing housing assistance to people already experiencing homelessness and households at risk of losing their housing. However, there's often confusion about what informed consent is, what it means, and when it's needed. Regulatory requirements. (C) A health care provider may, but is not required to, rely on a declaration provided under (a)(x)(B) of this subsection. See WORKSHEET Children for a full description of waiver criteria. Not research risks 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. 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). OHRP, Guidance on Institutional Review Board Review of Clinical Trial Websites; September 20, 2005. 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. A new genetic analysis is presented to subjects in the form of an addendum. WORKSHEET Consent Review for IRB Members [HSD staff and IRB member access only], CHECKLIST Exception from Informed Consent Oral consent should be documented in the patient record. FDA. The permission of one or both parents may be required depending on the childrens risk level category as determined by the IRB (GUIDANCE Involvement of Children in Research; WORKSHEET Children). In general, dissent should be respected. 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.) A revised package insert includes three new post-market risks. HSD recommends, and the IRB may require, that researchers provide subjects with a written description of the consent information (e.g., information statement) even when a waiver of consent documentation has been granted (i.e., no consent form). The physician will randomly assign each subject to one of two FDA-approved estrogen treatments for osteoporosis. RCW 7.70.050 speaks only of "treatment" in connection with the doctrine of informed consent. 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. However, the IRB will expect the researcher to assess the impact of the circumstances on the persons decision-making ability about the specific participation decision. (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. If you rent your home, you must have consent from your landlord. Part 11 compliance is the responsibility of the researcher. See HSDs tutorial, Electronic Consent: What You Need to Know for an overview. However, severe allergic reaction meets the definition of a serious risk as it could be life threatening. HSD policies related to consent can be found in the WORKSHEET Consent Requirements and Waivers and throughout this guidance. All research reviewed by the UW IRB, including non-UW institutions and sites for which the UW IRB is providing review. Researchers who do not plan to obtain assent from these subjects must provide the IRB with justification about why obtaining assent is not appropriate. 28 CFR 46.117 Documentation of Informed Consent. Prisoners are a federally designated protected population with additional regulatory requirements and protections described in Subpart C of the Common Rule (GUIDANCE Prisoners). For a concise overview of changes, see HIV Criminal Law Reform, Before and After: Washington. The UW IRB may consider alternative methods. If the child reaches the legal age of consent while enrolled, the regulations about child participants no longer apply. Yes, the risk of severe (life-threatening) allergic reaction should be added to the consent form. Washington state laws, federal regulations, Joint Commission standards, and standards for patient safety organizations such as Leapfrog, also set forth requirements for informed consent. Washington has an HIV-specific criminal statute. GUIDANCE Humanitarian Use Devices (HUDs) The risks associated with each of the two stents are research risks and must be included in the consent process/form. TEMPLATE Consent Form, Short (English) Most research generates knowledge to promote a common good. Coercion occurs when an overt or implicit threat of harm is intentionally presented by one person to another to obtain compliance. The process culminates in the patient's decision to a specific treatment or procedure. In addition, researchers must obtain some type of assent from the subject, when the individuals are capable of providing assent (see assent). The UW IRB is defining the regulatory term reasonably foreseeable as those risks or discomforts that must be included in the informed consent process because they are both reasonably foreseeable and meet any of several additional criteria. A particular condition has several treatment options, but an individuals response to the treatment can be highly variable and unpredictable. Such declaration shall be effective for up to six months . 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. 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. Headings should be subject-focused rather than regulations-focused. (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. Assent is obtained from subjects who are unable to provide legally-effective informed consent on their own behalf because they are minors or have diminished decision-making capacity. There are no Washington State laws that directly address the use of LARs in research. (i) "Unaccompanied" means a youth experiencing homelessness while not in the physical custody of a parent or guardian. Washington State's current informed consent law (RCW 7.70.065) allows a very limited range of people to make medical decisions on behalf of a patient who is incapacitated. 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. Known benefits should be accurately described and not exaggerated. GUIDANCE HIPAA E-consent processes are invaluable when it is not possible to have an in-person interaction with a subject. The purpose of this study is to identify biomarkers that may help predict a response to a specific drug in individuals diagnosed with the condition. If a waiver is granted, none of the requirements listed below in this section apply to the study. Analysis A psychologist at the counseling center is interested in comparing the effectiveness of two of these approaches: a short series of motivational interviews versus participation in a weekly cognitive-behavioral group session. Electronic delivery of consent information must meet the same human subjects regulatory requirements as paper-based delivery of the information. WEBPAGE Is the UW IRB the Right IRB? Researchers are asked to describe their plans (if any) for obtaining and documenting assent in the IRB application. UW research reviewed by an external (non-UW) IRB. Post-enrollment communication, such as answering subject questions and providing them with relevant new information, is also part of the consent process, because subjects consider throughout a study whether they wish to continue their participation. While all stakeholders are encouraged to read and become familiar with this entire guidance, the following resources provide a summary of the most vital aspects of consent: This guidance provides researchers, the Human Subjects Division (HSD), and the UW Institutional Review Boards (IRBs) with an overview of the requirements and best practices for obtaining regulatorily compliant and meaningful consent, parental permission, and assent for participation in research. The Part 11 requirements are outlined in the. 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.
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