The Government of India has notified guidelines under Section 46 to carry out the different provisions of the HIV and AIDS (Prevention & Control) Act, 2017. As provided under section 46 of the HIV and AIDS (Prevention & Control) Act, 2017, a total of nine guidelines have been notified.

The purpose of guidelines on Informed Consent in the context of HIV is to specify the manner of seeking informed consent pertaining to HIV-related information and while providing HIV-related services. These guidelines are applicable to the Central Government, State Governments and NGOs, establishments, and individuals dealing with the prevention, control, and treatment of HIV or AIDS including all healthcare facilities or Individuals providing HIV-related services.

For testing or diagnostic centre or pathology laboratory or blood bank for HIV tests is to describe the processes to be followed by a testing or diagnostic centre or pathology laboratory or blood bank for HIV test. The guidelines are applicable to all testing or diagnostic centres or pathology laboratories or blood centres performing HIV test.

On confidentiality of data for protected persons is to detail the provisions for storing, accessing, sharing, and disposal of data collected from protected persons at the establishment level. The guidelines are applicable to all establishments and individuals dealing with or keeping the records of HIV-related information of protected persons.

Informed Consent: Section 5. (1) Subject to the provisions of this Act, — (a) no HIV test shall be undertaken or performed upon any person; or (b) no protected person shall be subject to medical treatment, medical interventions, or research, except with the informed consent of such person or his representative and in such manner, as may be specified in the guidelines.

Disclosure of HIV Section 8. (1) Notwithstanding anything contained in any other law for the time being in force, — (i) no person shall be compelled to disclose his HIV status except by an order of the court that the disclosure of such information is necessary in the interest of justice for the determination of issues in the matter before it.

 (ii) no person shall disclose or be compelled to disclose the HIV status or any other private information of other person imparted in confidence or in a relationship of a fiduciary nature, except with the informed consent of that other person or a representative of such another person obtained in the manner as specified in section 5, as the case may be, and the fact of such consent has been recorded in writing by the person making such disclosure: Provided that, in case of a relationship of a fiduciary nature, informed consent shall be recorded in writing. (2) The informed consent for disclosure of HIV-related information under clause (ii) of sub-section (1) is not required where the disclosure is made— (a) by a healthcare provider to another healthcare provider who is involved in the care, treatment or counselling of such person, when such disclosure is necessary to provide care or treatment to that person; (b) by an order of a court that the disclosure of such information is necessary in the interest of justice for the determination of issues and in the matter before it;

Data Protection Section 11:  Every establishment keeping the records of HIV-related information of protected persons shall adopt data protection measures in accordance with the guidelines to ensure that such information is protected from disclosure.

Explanation. — For the purpose of this section, data protection measures shall include procedures for protecting information from disclosure, procedures for accessing information, provision for security systems to protect the information stored in any form and mechanisms to ensure accountability and liability of persons in the establishment.

Section 39.offences and penalty :  Notwithstanding any action that may be taken under any law for the time being in force, whoever discloses information regarding the HIV status of a protected person which is obtained by him in the course of, or in relation to, any proceedings before any court, shall be punishable with fine which may extend to one lakh rupees unless such disclosure is pursuant to any order or direction of a court.

The key compliances:

  • No healthcare provider, except a physician or a counsellor, shall disclose the HIV positive status of a person to his or her partner as per law, time to time.
  • Courts have permitted disclosure in the following situations: 1. Required by law (statutory requirement) 2. Administration of justice 3. In the best interest of the patient (disclosure to a medical team if necessary for the treatment of the patient) 4. To protect another person (partner notification) 5. Necessary for public interest
  • Informed Consent for HIV Testing ICTCs require a patient’s informed consent. This policy on consent is important because HIV is not curable, its implications are life threatening, and the stigma attached to HIV is unprecedented. In addition, counselling (a confidential dialogue between a client and a counsellor, aimed at enabling the client to cope with stress and make a personal decision related to HIV/AIDS testing) is needed. A physician who performs any invasive procedure on a patient can do so only after informed consent, i.e., the patient must have or be given sufficient knowledge about the procedure to make an intelligent decision. The law of informed consent emanates from two sources 1) the fiduciary relationship between a patient and a physician, and 2) protection to the concept of patient autonomy. Informed consent applies to HIV testing and must be real informed consent and not implied consent.
  • Full disclosure of the nature of the HIV disease, of the nature of the proposed test, the implications of a positive and a negative test result, and the consequences of treatment must be made prior to taking consent. Consent must be voluntary, and a patient must be able to understand and be competent enough to refuse.
  • Informed consent for testing and disclosure must be in writing. “If it is not documented, it did not happen,” literally applies to informed consent for HIV testing.
  • HIV testing of a minor or of an incompetent patient can be undertaken with a guardian’s consent. Proxy consent could be given when a client is incapacitated (physically ill / mentally unsound) and is unable to give consent.