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HIV/AIDS. LEGAL AND ETHICAL IMPLICATIONS /GUIDELINES. N.SRIKANTH ASST. DIRECTOR CCRAS . Ethics - The discipline of dealing with what is good and bad, with moral duty and obligation -A set of moral principles or values - The principle of conduct governing an individual or group
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HIV/AIDS LEGAL AND ETHICAL IMPLICATIONS /GUIDELINES N.SRIKANTH ASST. DIRECTOR CCRAS
Ethics • -The discipline of dealing with what is good and bad, with moral duty and obligation • -A set of moral principles or values • -The principle of conduct governing an individual or group • -Webster’s Ninth New Collegiate Dictionary
LEGAL AND ETHICAL CHALLENGES IN HIV/AIDS EPIDEMIC • These challenges include - • - limits and significance of confidentiality; • obligatory informed consent before testing and • initiating treatment; • counseling of women to make reproductive • decisions; • burden of infected individuals to protect their • sexual partners; • - issues related to research and care; • obligation of the state to prevent spread of • disease;
LEGAL AND ETHICAL CHALLENGES IN HIV/AIDS EPIDEMIC • -obligation of physicians to care for HIV infected; • issues related to insurance • obligation of developed countries to assist the developing countries • rights of HIV infected men, women and children • AIDS has provided a platform to rethink the traditions of public health in the light of human rights concerns.
Ethical Issues • Ethics of prevention and control • Ethics of care • Ethics of screening and testing • Ethics of research.
Ethics of prevention and control • Mode of spread of HIV infection • Vulnerable groups • Empowerment of women • Cultural and social implications of • Sexual behavior • Drug abuse • Sexual abuse and prostitution • Sex education
Ethics of prevention and control • The basic principle of ethics dictates that individuals - should be treated with respect • their dignity should not be violated • This opposition from conservatives on the basis of morality limits the state’s first ethical responsibility i.e. to protect the vulnerable.
Ethics of prevention and control The traditional public health policies center on - mandatory case finding - reporting, - contact tracing - treating - isolation However, for control of AIDS the consensus is to use public health strategic which are • Voluntaristic • Stressing mass education • Counseling • Respect for privacy
Ethics of care • Discrimination • Confidentiality • Death and preparation of death
Ethics of care • AIDS ,a disease of the socially marginal and frequently despised individuals led to discrimination of HIV-infected by • employers • landlords • school personnel • some health care professionals
Ethics of care • The Centers of Disease Control has estimated of the risk of transmission from an HIV infected surgeon during an operation between 1 in 42,000 to 1 in 420,000. • Despite these estimates there is no documented transmission from an infected health care worker to a patient. • Thus for health care workers, disclosure is tantamount to unemployment. • Because the benefit of patient treatment far outweighs the miniscule chance of HIV-transmission, no ethical reasons should exist why a physician, seropositive, but otherwise unaffected by HIV should restrict his or her practice.
Ethics of screening and testing • Informed consent for testing and treatment • HIV testing: • Voluntary/Mandatory • Confidentiality • Pre/post test counseling • Testing for right to work, going to school, marriage, bearing children, obtaining insurance etc.
Ethics of screening and testing The CDC (2002) recommends an approach to the interview that involves open-ended questions to foster client-centered interactions (vs. close-ended questions that might thwart efforts to make the client comfortable with the interviewer), as illustrated by the following examples: CLOSE-ENDED (DISCOURAGED) • Have you ever injected drugs? • Have you (for a male client) ever had sex with a man? • Do you always use condoms when you have sex? OPEN-ENDED (ENCOURAGED) • What are you doing that you think may put youat risk for HIV infection? • When was the last time you put yourself at risk for HIV? What were the circumstances? • How often do you use condoms when you have sex?
Legal Implications Please Note: This presentation is not legal advice and does not necessarily simplify complex legal issues. It is important to consult a lawyer for information or advice on specific issues. The intent of this presentation is to provide an overview of pertinent legal issues to consider in your practice.
PATIENT’S RIGHT • To confidentiality • Consent of patient is must to reveal information
Privacy of Patient Information and Medical Records • Adequate protection of medical records and information • Must be kept in safe custody • Not revealed to others including family • Not revealed to other medical personnel not directly involved in patient care
Legal Sources of Privacy Protection A person’s written informed consent is must before: • Test a person for HIV; • Reveal to third-parties that a person took an HIV test; or • Disclose to third-parties the results of a person’s HIV test. Most countries have laws which protect a patient’s right to privacy in review and release of medical information
“if it is not documented, it did not happen” …….literally applies to informed consent for HIV testing
Informed consent • Written, not oral • HIV-specific, not general • Must state the purpose for which information can be released • Must be signed and dated • Must have the provision to withdraw the consent at any time
Information Consent Please note: There are no exceptions to the requirement of specific written informed consent for an HIV test or the release of HIV-related information • including in an emergency or • in the the event of an occupational exposure to a patient’s blood.
Example I _______ [patient name] authorize you________ [doctor] to release information pertaining to my HIV status to my primary care provider _______ [provider name] solely for the purpose of providing ------------- services as agreed upon. This authorization is granted on the condition that due care must be exercised with respect to my rights to privacy and confidentiality. My consent is valid so long as --------- service is received. I understand that I may revoke this authorization in writing at any time without penalty. Date____________ Signature ______________________ Witnessed ______________________ Please send to:
Legal Sources of Privacy Protection Right against unreasonable, substantial or serious interference with his privacy. • Courts have tried to determine if there is any legitimate business reason for a disclosure; and if so, courts will balance the legitimate reason against the nature and substantiality of the intrusion into privacy. • This law applies to employees as well as patients.
Legal Sources of Privacy Protection Miscellaneous Additional Protections for Patients • Disclosure of medical records violates a patient’s right to privacy. • Patients have right to inspect and copy records. • Patients have a right to privacy during medical treatment in any hospital or clinic.
Legal Sources of Privacy Protection Strategies to Reduce the Risk of Liability for Privacy Violations • Train all staff and employees on privacy law. • Segregate sensitive information from general medical information and limit access. • Create own medical records or information release form. Make sure every record which goes out is inspected. • Be wary of subpoenas.
Legal Sources of Privacy Protection Even if a doctor does not have a patient’s actual HIV test result, there is still a legal obligation to protect confidential HIV-related patient information.
ETHICAL ASPECTS IN HIV –At A Glance • The doctor/patient relationship is founded on mutual trust and respect. • The doctors will extend to HIV infected or AIDS patient the same high standard of medical care and support which they would offer to any other patient. • Doctors who think they may have been infected with HIV should seek appropriate diagnostic testing and counseling and, if found to be infected, have regular medical supervision. • They should also seek advise regarding the limits to their clinical practice from competent local consultants so as not to put their patients at risk of HIV infection.
ETHICAL ASPECTS IN HIV • Doctors infected with HIV have the same rights to confidentiality and support as afforded to other patients. • Explicit informed consent is a must for HIV testing. Only in most exceptional circumstances (discussed earlier) can testing without explicit consent be justified. • Confidentiality of result must be maintained. Only under circumstances where the clinicians feels that with holding the test result will put either the colleagues or others at risk the confidentiality can be breached and shared in a limited manner with relevant individuals only (shared confidentiality)
DISCRIMINATION • Adoctor has the general obligation to provide care to those in need. • A decision not to provide treatment because the individual has AIDS or is HIV-seropositive, based solely on that fact, is unethical.
Principles of non-discrimination • Right to equal protection of law • Right to life • Freedom from inhuman or degrading treatment or punishment • Right to privacy • Right to liberty and security • Right to highest attainable standard of physical and mental health • Right to marry and to found a family • Right to work • Right to education • Right to social security, assistance and welfare • Freedom of movement • Right to seek and enjoy asylum • Right to share in scientific advancement and its benefits • Right to participate in public and cultural life
People who face discrimination due to HIV/AIDS • People Living with HIV/AIDS • Their families • Their orphaned children • Their friends and relatives • Their care givers • Persons who have had HIV test done irrespective of result
People who face discrimination due to HIV/AIDS • Persons belonging to groups suspected of infection • Minorities • Women • Ethnic groups • Immigrants • CSW • Homosexuals • Drug abusers
Causes of discrimination • Fear of infection, disease, death • Ignorance about disease, routes of transmission • Pre-existing disapproval of or discrimination against certain groups • Social and religious mores regarding certain groups, lifestyles and behavior
Forms of discrimination • Discriminatory Legislation • Discriminatory practice by • public authorities • private organizations • Medical personnel • Stigma by communities, families, individuals
Discriminatory practices by Public health authorities • Denial of treatment • Denial of access to • Education • Information • Social benefits • Health services • Isolation • Mandatory screening • Coerced abortions/sterilizations • Lack of confidentiality
Discriminatory practices by other Public authorities • Travel/movement • Discretion of immigration officials to require testing/certificates/declaration from various individuals/groups • Public housing • Denial to access • Eviction • Notification without confidentiality
Discriminatory practices in prisons • Mandatory testing • Lack of confidentiality • Isolation • Denial to health care • Harassment • Physical violence
Following practices can be illegal: • 1. Denial of full and equal medical services or to denial of “opportunity to benefit” from medical services in same manner as other patients. • 2. Establishing any eligibility criteria for receiving medical services, which tend to screen out HIV infected persons. • 3. Provide different or separate services to HIV-positive patients. • Deny equal services to a person who is spouse, partner, child, friend, relative, associate of HIV infected person
1. A physician cannot decline to treat a person with HIV based on a perceived risk of HIV transmission or because the doctor simply does not feel comfortable treating a person with HIV. 2. Adoctor cannot require that a patient take an HIV test prior to providing medical treatment, except where diagnosis of the condition is required Be mindful that the following practices Can be illegal:
3. A doctor cannot increase the cost of services to an HIV-positive patient in order to use additional precautions beyond the recommended infection control procedures. Under certain circumstances, it may well be a violation even to use unnecessary additional precautions which tend to stigmatize a patient simply on the basis of HIV status. 4. A doctor cannot limit the scheduled times for treating HIV-positive patients, such as insisting that an HIV-positive patient come in at the end of the day.
Referrals and/or Refusals to Treat • A doctor cannot refer an HIV-positive patient to another clinic or doctor, unless the required medical treatment is outside the scope of the doctors usual practice or specialty. • The referrals of HIV-positive patients should be made on the same basis as are referrals for other patients. • The treatment being sought is outside the referring provider’s area of specialization. • In the normal course of operations, the referring provider would make a similar referral for any individual who seeks or requires the same treatment or services.
Ethics of treatment 1.HIV-[positive] individuals should be treated with compassion and dignity. 2. There is little risk of transmission of HIV through regular OPD/Clinical treatment if recommended infection control procedures are routinely followed. 3. A denial of treatment to an individual because the individual has AIDS or is HIV-seropositive, based solely on that fact, is unethical.
Ethics for Research • Impossible to reach the important conclusions without studying humans • Human physiology- because animals often are not the same • Epidemiological studies- because they depend on human susceptibilities and human interactions • Agents for treating humans because- animal experiments don’t predict results
SUMMARY : PRINCIPLES AND FOUNDATIONS OF RESEARCH ETHICS
RESEARCH IS A PRIVILEGE, NOT A RIGHT • THE WELL-BEING OF THE PARTICIPANT • IS PARAMOUNT • Justice Respect For persons • Beneficence
Ethics for Research • Principal of essentiality • Principles of voluntaries, informed consent and community agreement • Principles of non-exploitation • Principles of privacy and confidentiality • Principles of precaution and risk minimization • Principles of professional competence • Principles of accountability and transparency • Principles of the maximization of the public interest and of distributive justice • Principles of institutional arrangements • Principles of public domain • Principles of totality of responsibility • Principles of compliance