Consent & Confidentiality Guidelines PDF

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FortunateWilliamsite2551

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Yorkville University

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informed consent confidentiality health care professional ethics

Summary

This document provides guidelines for informed consent and confidentiality in healthcare settings. It covers legal considerations, practical applications, and explains how to determine patient capacity. The document touches on various legal and professional aspects of consent and related topics.

Full Transcript

+ Developmental considerations in informed consent and confidentiality + CPO 7.1 Obtaining Consent n Registrants must ensure they have obtained informed and capable consent from all individuals receiving services, prior to the commencement of services...

+ Developmental considerations in informed consent and confidentiality + CPO 7.1 Obtaining Consent n Registrants must ensure they have obtained informed and capable consent from all individuals receiving services, prior to the commencement of services and whenever changes are made to the nature of services offered or provided. The following principles apply to obtaining appropriate consent: 1. Registrants should ensure they are familiar with and are following the legal requirements for obtaining consent, or proceeding without consent, particular to the service they are providing; 2. Consent obtained in writing, physical or via secure technology, is preferred. However, oral consent is acceptable and must be documented in the client’s file; and + CPO 7.1 Obtaining Consent 3. In the event of lack of clarity or uncertainty concerning consent between substitute decision makers of equal ranking within the hierarchy of substitute decision makers listed in statute, or between a substitute decision maker and an incapable service recipient, registrants should not provide services until they receive clarification of who is authorized to give consent via relevant legislation, court order, or formal and documented agreement. n Practical Application: If authority as a substitute decision maker is either unclear or in dispute, registrants may wish to seek independent legal advice. n Practical Application: In some situations, registrants may believe that third parties have exerted pressure on clients to consent to services or risk a loss of benefits or other rights. When in doubt about whether a client’s consent is freely given, registrants should ensure that they do not exert any pressure on the client to agree and clarify that the client may refuse the service if they choose to do so. In this context, the registrant should encourage the client to seek clarification about their options should services not proceed. Registrants should proceed only if the client expresses a clear wish to proceed (See also Section 3: Equity, Diversity and Inclusion). + Confusion because of different Acts n Education Act requires parental consent for intellectual or personality assessment of a child under 18 n Child and Family Services Act allows for a child aged 12 or over and under the auspices of a Ministry of Community and Social Services agency to con- sent for to counselling services n Health Care Consent Act provides that anyone “capable with respect to treatment” may give consent to treatment on their own behalf. n No discussion of minimum age n Health practitioner should assume that a person is capable of consenting on their own behalf unless there are reasonable grounds to believe otherwise n The Substitute Decisions Act, 1992 provides that a person who is aged 16 years or more is presumed to be capable of giving or refusing consent in connection with their personal care. This does not preclude a practitioner from determining that a younger person is capable of consenting to treatment, but does imply that greater care should be taken in making that determination. The determination of capacity to consent to the particular treatment relies on the judgement of the health practitioner. https://cpbao.ca/wp-content/uploads/V23-n2-October-1996.pdf + Judging capacity n Quality of the decision making process n Context dependent… capacity can change over time or different situations n 4 criteria: If you question capacity… n 1) Do they understand the info provided? n The ability to comprehend the info being disclosed in regard their condition and the nature and potential risks and benefits of the proposed treatment and alternatives (including no treatment). n Ensure that you are assessing the person's actual comprehension, e.g., as evidenced by an ability to describe the information in their own words, rather than the mere ability to parrot-back the words n Can they explain the condition or treatment back in their own words? + Judging capacity n 2) Do they appreciate the info? n The ability to apply the relevant information to one's self and own situation. n For example, an individual experiencing an acute manic episode may demonstrate intellectual understanding of what bipolar disorder and mania are, and the risks and benefits of mood stabilizing medications as treatment of acute mania, as well as the risks of forgoing treatment. n However, if the very presence of a manic episode (which can include a lack of illness insight) causes an individual with intellectual understanding of bipolar disorder and its treatment to fail to appreciate the personal risks of refusing treatment, he/she might be deemed as incapable on that basis n The same may occur in the context of some forms of acquired brain injury or any other disorders associated with impaired insight (Ham et al., 2014). n Explain their views on their condition, treatment and decision and the outcomes of their decisions + Judging capacity n 3) Do they have sound reasoning? n Evidence that the person's decisions reflect the presence of a reasoning process, e.g., ability to engage in consequential and comparative reasoning and to manipulate information rationally. n Do they seem to have logic to their decision making process? n 4) Is there an Expression of a Choice? n Refers to the ability to communicate a decision that is clear and consistent n Can they make up their mind over several consecutive days? + Definitions n What is appropriate consent? n The consent must be related to the treatment, it must be informed, it must be given voluntarily and it must not be obtained through misrepresentation or fraud. n What does ‘informed’ mean n Before giving it, the person received information about the nature of the treatment, the expected benefits of the treatment, the material risks of the treatment, the material side effects of the treatment, alternative courses of action and the likely consequences of not having the treatment. n The information should be of the sort that a reasonable person in the same circumstances would require in order to make a decision about the treatment. The person must also have received responses to their requests for additional information about those matters. n Members should make reasonable efforts to ensure that the information provided to the person is in a form appropriate to the understanding, language and needs of the person while communicating accurately the nature and expected outcomes of the proposed treatment. n Consent may be express or implied and may be withdrawn at any time by the person, or by the person’s substitute decision maker if the person is incapable with respect to the particular treatment. + Things that should be covered in consent goals n Informed consent concerns giving people the right to withdraw from their participation at any point n Implies the need for researchers / clinicians to ensure that they have people's ongoing consent to participate in a study n sensitive to recognizing participants' expressions of desire to opt out + Definitions n What is treatment? n The Health Care Consent Act defines "treatment" as anything that is done for a therapeutic, preventative, palliative, diagnostic, cosmetic or other health-related purpose, and includes a course of treatment or a plan of treatment. It does not include the taking of a person’s health history, the assessment or examination of a person to determine the general nature of a person’s condition, a treatment that in the circumstances poses little or no risk of harm to the person, or the assessment for the purpose of the Health Care Consent Act of a person’s capacity with respect to treatment. n A member can conduct an intake interview to determine whether a more formal assessment is required, to propose a preliminary treatment plan and to evaluate the person’s capacity to understand and give consent to the proposed treatment. n If the member is conducting a formal capacity assessment under the Substitute Decisions Act, this is not considered “treatment” within the meaning of the Health Care Consent Act and may be carried out without meeting the full requirements for consent under the Health Care Consent Act. n SO WHAT ABOUT A PSYCHOED ASSESSMENT? + How old must a child be in order to consent to his or her own treatment? n The child’s consent to treatment is sufficient so long as the child is capable with respect to treatment, that is, so long as the child n understands the proposed treatment n the possible risks and benefits of having or not having the treatment. n Members are advised to use their professional judgement and to exercise appropriate care in determining whether a child is capable of conenting to treatment. n Where the member determines that a child is incapable with respect to treatment, treatment may not be carried out unless consent has been obtained from the parent of the child (this does not apply to a parent who has only a right of access except in certain circumstances discussed below) or a children’s aid society having custody of the child or other person who is lawfully entitled to give consent or refuse consent in the place of the parent. n The person described above may give or refuse consent only if he or she: n is capable with respect to the treatment, n is at least 16 years old (unless he or she is the incapable person’s parent), n is not prohibited by court order or separation agreement from having access to the incapable person or giving or refusing consent on his or her behalf, n is available, and is willing to assume the responsibility of giving or refusing consent. + What is the effect of the Education Act? n Other than requiring prior written permission from the pupil, or from the parent of the pupil if the pupil is a minor, before administering a proposed test of intelligence or personality n Neither the Education Act nor the regulations made under it appear to affect the law of consent to psychological treatment set out in the Health Care Consent Act. n If a member is planning to give a pupil an intelligence test or a personality test, the member must first obtain the written consent of the pupil if the pupil is 18 years of age or older; if the person is under the age of 18, the consent of the parent or guardian is required. n For any other treatment, the pupil's consent is adequate provided that the pupil is capable with respect to the proposed treatment. + How do I determine whether the child (or parent) is capable with respect to the treatment? n A person is considered capable with respect to treatment if the person is able to understand the information that is relevant to making a decision about the treatment and able to appreciate the reasonably foreseeable consequences of a decision or lack of a decision n A practitioner may presume that a person is capable with respect to treatment unless the practitioner has reasonable grounds to believe otherwise. n A practitioner should take greater care, however, in relying on a presumption of capacity for a person under the age of 16. + Rhetoric than reality (Homan; 1991, 1992) n True informed consent n participants are given a full explanation n able to reach a clear understanding of what participation involves n Difficulties of explaining research fully in a way a participant can understand n Impossibility of knowing all the consequences of participating before a study has commenced + Rhetoric than reality (Homan; 1991, 1992) n Tension between participant’s right to refuse and the motivation of the researcher to achieve a high response rate n various strategies, including providing less than full information and incentives to participate, to encourage participation + Is there such a thing as too much information? n Harris and Dyson (2001) and Homan (1991) n researchers also need to avoid providing information in such a way that it might put people off participating n not overwhelming study participants with information n presented in a friendly and attractive way (Alderson, 2004) + Tensions in developmental adaptations n Keeping written information to a minimum and incorporating pictures and graphics (e.g., Connors and Stalker, 2003; Alderson, 2004) n Caution about minimising (or maximizing) the amount of information they give + What do consent forms looks like? + + Participant tensions n Participants are often very keen to take part n an interest in the topic n don’t want to appear uncooperative by saying 'no' n unaware of any risks that participation might involve n study participants often disregard researchers' explanations of what the research will involve or are reluctant to take the time to read information sheets (Wiles et al, 2004) + Participant tensions n Participants are often reluctant to take part n Unsure of reasons / process n Unmotivated n Not their decision n Aversive experiences + Proxy consent tensions When are proxy consents used? Research with ‘vulnerable’ groups who are viewed as lacking the capability or ‘competence’ to understand what participating in a study will involve and so are unable to provide informed consent for themselves (see, Cameron et al, 2004) n proxy consent are generally relatives or caregivers of the individual Should proxy consents be used if…. + n Adult with an intellectual disability? n Typically developing adolescent? n 8 year old child? n Adult with autism? n Teen with autism? n Teen with ADHD? n … + Gatekeepers n researchers frequently are not able to approach potential participants directly but have to negotiate access through a range of gatekeepers n gatekeepers have no legal rights in respect of the person’s decision to participate but generally control the places where people are accessed from and they may, in addition, have legal responsibility for an individual’s well being in that setting (Masson, 2004) n Two specific problems with gatekeepers n over-protectiveness of gatekeepers which may result in people being denied the opportunity to participate in research (Heath et al, 2005). n a failure of gatekeepers to provide opportunities for potential participants to exercise choice in participating (Miller and Bell, 2002). + + Rules of thumb n http://www.intellectualdisability.info/how-to../consent-and-people-with- intellectual-disabilities-the-basics n Assume capacity. All adults have capacity unless and until they are shown not to n Capacity refers to the ability to make a particular decision at a particular time n Capacity can vary in the same person for different decisions and can fluctuate over time n A person with capacity has the right to refuse treatment n A health professional has a duty of care to patients n If an adult lacks capacity the health professional has a duty to provide treatment and care in the best interests of that adult, even if the person does not agree + Rules of thumb n The professional giving the treatment is responsible for assessing the patient's capacity, and for asking for any assistance they need to do so n Capacity depends on understanding n Understanding depends on effective communication and accessible information as well as cognitive abilities n Even people who lack capacity may want and have the right to receive information n Consent obtained by force (under duress) is not valid n Consent can be shown behaviourally + + 8. Confidentiality and privacy n 8.1 Limits of Confidentiality n Before or at the onset of service provision, registrants must ensure that service recipients are advised of the limits of confidentiality relevant to the services provided. n 8.2 Applicable Privacy Legislation n Members are responsible for ensuring that access to an individual’s personal or personal health information is provided to the individual and/or their authorized representative unless prohibited by law or the member is otherwise permitted to refuse access. + Confidentiality and privacy https://cpbao.ca/wp-content/uploads/Document-Attachment-to- PHIPPA-Update-What-You-Need-to-Know-About-Privacy-Law.pdf n Practical Application: In most cases, the applicable privacy legislation is the Personal Health Information Protection Act, 2004. n In some circumstances services may be governed by other privacy legislation, as is often the case with services provided within organizations operated or funded under municipal, provincial, or federal legislation n Practical Application: Eligibility to act as a custodian of personal and personal health information may vary between different privacy statutes. The Personal Health Information Protection Act addresses privacy with respect to most services provided by Regulated Health Professionals. It allows for, among other things, a health care practitioner or a person who operates a group practice of health care practitioners to act as an HIC. + Definitions n What info is protected under PHIPA? Personal health info n Any info that can identify an individual (or can be combined with other info to identify the individual, AND related to: n Physical or mental health of individual (incl. family health history) n Provision of health care to the individual (including identifying the individual’s health care provider) n Home and community care n Payments or eligibility for health coverage n Donation or testing of an individual’s body part or substance n Health number n Identification of a substitute decision maker + Confidentiality and privacy n 8.3 Collection, Use and Disclosure of Personal and Personal Health Information n Registrants must ensure that the collection, use, and disclosure of information occurs only with the consent of the person about whom the information applies, or as permitted by legislation. When the service provider is not considered the HIC, Registrants must demonstrate efforts to ensure that the HIC acts in accordance with these requirements. n Practical Application: When unsolicited information is received without appropriate consent or does not appear to meet any of the statutory exceptions to the requirement for consent to collect information, the HIC must return the information to the sender, If possible. In so doing, Registrants should not even acknowledge that they are providing services to the relevant individual without consent. n 8.4 Information about Third Parties n Information about a party other than a recipient of service that is contained in a record, may only be disclosed if permitted or required by law, or with consent of the parties to whom the information relates. n 8.5 Access by Client or Client’s Authorized Representative n Registrants are responsible for ensuring that access to an individual’s personal or personal health information is provided to the individual and/or their authorized representative, unless prohibited by law, or the registrant is otherwise permitted to refuse access, even when contrary to the wishes of a third-party funder. + Confidentiality and privacy n 8.6 Protection of Test Security n Registrants must respect test security and copyright restrictions. As such, they must prevent the distribution of materials and information that could adversely affect the integrity and validity of tests. n Test questions, items, and other proprietary materials should not be released without permission of the publisher of the documents. n When prevented from providing proprietary information by copyright protections, registrants are expected to seek the permission of the publisher of the document or, if necessary, provide transcribed responses to test items without revealing test questions or other proprietary information. + PHIPA obligations n Obtain consent to collect, use, or disclose PHI n Maintain security of PHI by taking reasonable steps to protect against theft, loss, unauthorized use or disclosure n Ensure accuracy of PHI n Collect, use, or disclose only as much PHI as is necessary in the circumstances n Provide individuals with access to PHI upon request (except if info was created primary for legal proceeding or when providing access could result in a risk of serious harm) n Correct PHI if record is incomplete or inaccurate + PHIPA obligations n Do I need to obtain express consent from the individual in every situation? n No. PHIPA provides that consent may be expressed or implied n Express consent is required where PHI is disclosed to a person who is NOT a HIC (such as an insurance company) or it is NOT disclosed for the purpose of providing health care n Implied consent is sufficient when a client answers questions about their health history in a context where it is obvious that the info will be used to assess and treat n Can assume implied consent IF n Info was received by the person or substitute; n Info was received for the purpose of providing health care to the individual n Info is collected, used or disclosed for the purpose of providing care n If info is being disclosed, it must only be disclosed to another HIC; AND n The individual has not withheld or withdrawn consent n THIS IS WHAT IS DESCRIBED AS CIRCLE OF CARE + Limited exceptions to PHI disclosures Consent is not required if: n To collect PHI from an individual if it is reasonable necessary to provide health care and consent cannot be obtained in a timely manner; n To disclose PHI about an individual if HIC believes on reasonable grounds that disclosure is necessary for the purpose of eliminating or reducing a significant risk of serious bodily harm; n To disclose PHI in the context of a legal proceeding if HIC is apart or witness; or n To disclose PHI to a regulatory college + Mandatory Reporting n Cases of mandatory reporting: n RHPA: to “file a report if the member has reasonable grounds, obtained in the course of practising the profession, to believe that another member of the same or different College has sexually abused a patient.” Members are required to report only information obtained in the course of practising the profession. Members must submit a report only if the name of the practitioner who was involved in the alleged abuse is known. Members must not include the client’s name without their written consent. Submit a written report within 30 days to the Registrar of the College representing the profession of the person who is the subject of the report. n or Submit the report immediately if there is reason to believe the abuse will continue or abuse of other clients will occur. The RHPA provides protection to a member, who files a report in good faith, from actions or other proceedings being taken against that person. + Mandatory reporting n Child, Youth and Family Services Act, 2017 (CYFSA) n This duty overrides any other provincial statutes, including the Personal Health Information Protection Act, 2004, and specifically overrides any provisions that would otherwise prohibit someone from making a disclosure. Only lawyers may not divulge “privileged” information about their clients. n The public, including professionals who work with children, must promptly report any suspicions that a child is, or may be, in need of protection to a children’s aid society (society). n The CYFSA defines the phrase “child in need of protection” and explains what must be reported to a society. It includes physical, sexual and emotional abuse, neglect, and risk of harm. + Mandatory reporting n It is not necessary for you to be certain a child is, or may be, in need of protection to make a report to a society. “Reasonable grounds” refers to the information that an average person, using normal and honest judgment, would need in order to decide to report. n Even if you know a report has already been made about a child who is under 16, you must make a further report to the society if there are additional reasonable grounds to suspect that the child is, or may be, in need of protection. n You must report directly to a society. You must not rely on anyone else to report on your behalf. + Mandatory reporting n The duty to report applies to any child who is, or appears to be, under the age of 16 years. n On January 1, 2018, Ontario raised the age of protection from 16 to 18. n A professional, or member of the public, who is concerned that a 16- or 17- year-old is, or may be, in need of protection may, but is not required to, make a report to a society and the society is required to assess the reported information + Who to contact? n the disclosure must be made to someone who is in a position to ‘eliminate or reduce a significant risk of serious bodily harm’. n When faced with serious concern about a client’s/patient’s risk of harm to self or others, members have to make the difficult judgment about who to contact in this time of crisis n When initially reviewing the limits of confidentiality regarding risk of harm with a client/patient, members may wish to discuss this with the client/patient. n Engage the client in a discussion of who they believe should be called in the event of a crisis. The client/patient may identify a family member, other health care provider, close friend, member of the clergy, a community worker, an organization with which they have been involved or some other individual. + Who to contact? n While the ultimate decision rests with each member based on their best clinical judgement, taking into account their understanding of the client/patient and the particular situation, this previous discussion may prove helpful in deciding upon the most appropriate action. n It is important to make a distinction between situations of client/patient risk of harm to themselves or others, often referred to as “duty to warn” and other mandatory reporting obligations. n Section 40 of PHIPA does not apply to situations where one has reasonable grounds to suspect that a child is in need of protection or one suspects abuse or neglect in a retirement or long-term care facility. In these situations, mandatory reporting to the appropriate authority is required. + Duty to warn? n In Ontario, there is no duty to warn (for harm), if one interprets “duty” to mean a mandatory requirement. n That is, there is no obligation to report concerns that a client/patient may pose a danger to themselves or others. n It is important to understand however, that this does not mean that one cannot, or should not, take some action in the face of such serious concerns. n The Personal Health Information Protection Act, 2004 (PHIPA) sets out a member’s obligations with respect to maintaining the confidentiality and privacy of personal health information. n The legislation does provide an exception to the duty of confidentiality where a member finds it necessary to notify someone of a serious risk to a person’s safety n A key concept in PHIPA is contained in the words “may disclose”. PHIPA does not oblige a member to make such disclosures, but it permits one to do so “for the purpose of eliminating or reducing a significant risk of serious bodily harm”. n With this purpose in mind, PHIPA reinforces a member’s need to use their knowledge of the client/patient and their professional judgement to determine the best, most appropriate, action to take. + To sum up n Where the registrant believes on reasonable grounds that disclosure is necessary to eliminate or reduce a significant risk of serious harm to the client or anyone else, e.g., suicide, homicide. n Note: If the registrant believes a significant, imminent risk of serious bodily harm exists, there may be a professional and legal duty to warn the intended victim, to contact relevant authorities such as the police or crisis intervention services, or to inform a physician who is involved in the care of the client.* n *The law in Canada concerning the “duty to warn” is complex and evolving. Registrants are advised to consult their legal advisor when faced with a situation where this exception to the duty of confidentiality may apply. n Where a mandatory report is required (sexual abuse or child abuse/neglect) n Where necessary for particular legal proceedings (e.g., when the registrant is subpoenaed); n To facilitate an investigation or inspection authorized by warrant or by any provincial or federal law (e.g., a criminal investigation against the registrant, their staff, or a client). Registrants should seek legal advice when they are unsure whether a warrant or law permits them to disclose personal health information. n For the purpose of contacting a relative, friend or potential substitute decision-maker of the individual, if the individual is injured, incapacitated, or ill and unable to give consent personally; and + To sum up n disclosing information to a college for the purpose of administration or enforcement of the Regulated Health Professions Act, 1991 (e.g., when a complaint has been made about a registrant, assessment of the registrant’s practice as part of the Quality Assurance Program). n When compelled to disclose client information for a legal proceeding, registrants should exercise prudence, and are advised to consult their legal advisor to determine the best way to respond.

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