1. LEGAL AND ETHICAL IMPLICATIONS /GUIDELINES
HIV/AIDS
N.SRIKANTH
ASST. DIRECTOR
CCRAS

2. -Webster’s Ninth New Collegiate Dictionary
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

3. 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;

4. 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.

5. Ethical Issues Ethics of prevention and control Ethics of care
Ethics of screening and testing
Ethics of research.

6. 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

7. 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.

8. 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

9. Ethics of care Discrimination Confidentiality
Death and preparation of death

10. 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

11. 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.

12. 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.

13. 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 you at 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?

14. 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. 1

15. PATIENT’S RIGHT To confidentiality
Consent of patient is must to reveal information
THE PATIENT HAS A RIGHT TO CONFIDENTIALITY. THE PHYSICIAN SHOULD NOT REVEAL COMMUNICATIONS OR INFORAMTION, WITHOUT THE CONSENT OF THE PATIENT, UNLESS PROVIDED FOR BY LAW OR THE NEED TO PROTECT THE WELFARE OF THE INDIVIDUAL OR PUBLIC INTEREST.

16. 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
Courts have recognized that privacy concerns are of paramount importance for people with HIV.
Privacy protections are evolving. Healthcare workers must be careful to ensure that medical information and records are adequately protected and not revealed to other providers, friends, or family of the patients, and even to employees who are not directly involved in patient care, without the patient’s written informed consent.

17. Legal Sources of Privacy Protection
Most countries have laws which protect a patient’s right to privacy in review and release of medical information
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.

18. …….literally applies to informed consent for HIV testing
“if it is not documented, it did not happen”
…….literally applies to informed consent for HIV testing

19. 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
Consent for an HIV test or the release of the results of an HIV test must be written, not oral, and must be HIV-specific, not general.
This implies to the release of any information or records indicating a patient’s HIV status, not just the actual HIV test result.
A release for HIV-related information must state the purpose for which the information is being requested.
There must be an opportunity to withdraw the consent at any time without penalty. This should be written into the consent.

20. 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.

21. 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:

22. 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.

23. 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.

24. 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.
Consult an attorney, consult your patient, get permission to talk to your patient’s attorney. Be cautious on the side of requesting an HIV-specific release.

25. 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.

26. Legal Sources of Privacy Protection

27. 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.

28. 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)

29. DISCRIMINATION
A doctor 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.

30. 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

31. 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

32. People who face discrimination due to HIV/AIDS
Persons belonging to groups suspected of infection
Minorities
Women
Ethnic groups
Immigrants
CSW
Homosexuals
Drug abusers

33. 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

34. Forms of discrimination
Discriminatory Legislation
Discriminatory practice by
public authorities
private organizations
Medical personnel
Stigma by communities, families, individuals

35. 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

36. 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

37. Discriminatory practices in prisons
Mandatory testing
Lack of confidentiality
Isolation
Denial to health care
Harassment
Physical violence

38. 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

39. Be mindful that the following practices
Can be illegal:
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. A doctor cannot require that a patient take an HIV test prior to providing medical treatment, except where diagnosis of the condition is required

40. 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.

41. 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.

42. 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.
Patients with HIV may be safely treated in private clinics when appropriate infection control procedures are employed. Such infection control procedures provide protection both for patients and medical personnel.
Based on current scientific and epidemiological data, universal precautions continue to be an effective means of reducing blood contacts that can result in disease transmission, minimizing even further the already low risk of blood-borne disease transmission in medical practice
Given the data, patients with blood-borne diseases may be treated in the private clinics with no significant risk of disease transmission, provided appropriate infection control procedures are employed.

43. 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

44. PRINCIPLES AND FOUNDATIONS OF
SUMMARY :
PRINCIPLES AND FOUNDATIONS OF
RESEARCH ETHICS

45. RESEARCH IS A PRIVILEGE, NOT A RIGHT THE WELL-BEING OF THE PARTICIPANT
IS PARAMOUNT
Justice
Respect
For
persons
Beneficence

46. 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