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Chapter 12: Voluntarism & Informed Consent

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Chapter Goals

To ensure site-level staff are able to:

  • Provide accurate and comprehensible information to male clients, spouses of male clients, and guardians of minors seeking VMMC (voluntary medical male circumcision) services to help them make informed decisions.
  • Obtain and document the informed consent of males (and guardians of minors) seeking VMMC services.
  • Ensure clients are aware of and comprehend the risks and benefits of VMMC and that they choose the services voluntarily and without coercion.

What Users Need to Know

Summary

This chapter presents the requirements of the voluntarism and informed consent (IC) process. Specifically covered are the following topics: training site staff on elements and principles of the IC process, administering and documenting IC while ensuring that clients understand the risks and benefits as well as all other information on VMMC procedures, and proper wound care practices. The chapter also discusses issues relating to parental consent and assent for minors, the national age of consent, the role of parents/guardians, obtaining consent from illiterate participants, national policies, international guidelines, and PEPFAR (U.S. President’s Emergency Plan for AIDS Relief ) considerations [See UNAIDS Safe, Voluntary, Informed Male Circumcision and Comprehensive HIV Prevention Programming Guidance for Decision-Makers on Human Rights, Ethical and Legal Considerations and PEPFAR Technical Considerations for COP/ROP 2016]. Finally, two case studies are featured: one from Zambia evaluating clients’ comprehension of key concepts, social norms, and practices regarding IC and the other from Uganda on successful use of the IC process to improve the quality of VMMC services [See Evaluation of the Informed Consent Process for Male Circumcision Scale-Up in Zambia]. The chapter cites and refers the reader to many resources for additional reading.

Informed consent is the voluntary agreement of an individual—or his authorized representative who has the legal capacity to give consent—to undergo a specific medical procedure. All VMMC site staff must be trained in the principles of informed consent and the appropriate ways to obtain it. Adult males opting for VMMC have the right to receive full information on the benefits and risks of the procedure. Only adult male clients who have the appropriate decision-making capacity and legal status (have reached the legal age of consent) are able to give their own informed consent.

A child (as defined by national law) generally lacks the legal status required to provide independent informed consent. However, children and adolescents have the right to participate in decisions affecting their health, and therefore they should provide assent for the VMMC procedure. Those too young to understand the male circumcision procedure and provide assent, or who refuse assent, should have the procedure deferred. Assent is the expression of willingness to undergo a procedure by a person who is by definition (according to his evolving capacity and national laws) too young to give informed consent but who is old enough to understand the procedure. If assent is given, informed consent must also still be obtained from the subject’s parents or a guardian, including providing them (parents/guardians) with sufficient information regarding the benefits and risks of the procedure to determine what is in the best interest of the minor. In countries with laws that allow minors to give independent informed consent, providers must ensure that the client’s personal health history information is not disclosed to the parents without the minor’s consent.

PEPFAR policies follow local laws about consenting clients for VMMC such as age of consent, in cases where some minors under 18 years may consent for VMMC or where school representatives such as head teachers may consent on a minor’s behalf. Minors need to be accompanied when they seek VMMC services, and parents or guardians are advised to participate in all information sessions to ensure they understand the procedure very well and are able to apply the acquired information during wound care. The informed consent process should be conducted in a language that is understood by the VMMC client and his parent or guardian, as necessary.

Illiterate Clients

Clients who are illiterate and therefore cannot sign the informed consent document should be provided the same information as other clients, including having the informed consent read to them. Their name and date should be well printed on the form and close to their thumbprint.

PEPFAR’s annual VMMC Technical Considerations also recommend obtaining and documenting an adult informed consent and assent/parental consent for all minors before the VMMC procedure [See PEPFAR Technical Considerations for COP/ROP 2016]. Although obtaining the written informed consent form is performed once, informed consent is actually a process that must continue throughout the duration of the procedure. Staff, therefore, must ensure that not only does the client offer his signature/thumbprint (or her signature/thumbprint in case of female parents of minors) on the informed consent document, but also that his continued participation to receive the procedure is still acceptable at every step of the process. All information shared with clients and across sites needs to be consistent. This information should be incorporated into a standard operating procedure, and all site staff should be well versed in appropriate information about risks and benefits of VMMC, the VMMC procedure, pre- and post-op care, HIV, sexually transmitted infections (STIs), and so on.

Elements of Informed Consent for VMMC

Obtaining informed consent is a process, not just a signed document. Informed consent should include the following elements [Modified from Code of Federal Regulations - 45 CFR 46.116(a) and 21 CFR Part 50.25(a)]:

  • Purpose and average duration of the procedure and a description of the procedure to be followed such as the type of VMMC (surgical or device and which specific one will be used on the client).
  • Explanation that male circumcision is permanent.
  • Explanation that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the client is entitled, and that the client may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
  • A description of benefits to the client or benefits beyond the client such as indirect protection for women, reduced overall HIV transmission if more men get circumcised, and so forth.
  • A description of any foreseeable risks and discomfort to the client.
  • A description of recommended post-care procedures and schedules for follow-up visits.
  • A statement describing to what extent the client’s confidentiality and privacy of both their records and the procedure itself is maintained.
  • An explanation that VMMC can be obtained at any time and a list of alternative places where it is provided under similar or different conditions.
  • Whom to contact (including phone contact and physical location) for answers to pertinent questions about the VMMC, or the VMMC minimum package of services, or in case of complications.
  • Confirmation that the client understands the key information.
  • Time for questions and answers.

VMMC programs and sites should not deny rights or benefits to those who do not accept VMMC, as this could pressure them into accepting VMMC services. For example, a program should not deny a person access to HIV testing services, antiretroviral therapy, or condoms if they refuse VMMC services [See UNAIDS Safe, Voluntary, Informed Male Circumcision and Comprehensive HIV Prevention Programming: Guidance for Decision- Makers on Human Rights, Ethical and Legal Considerations].

Tools, Instruments, and Guidance Documents

  1. UNAIDS Safe, Voluntary, Informed Male Circumcision and Comprehensive HIV Prevention Programming: Guidance for Decision-Makers on Human Rights, Ethical and Legal Considerations
  2. Evaluation of the Informed Consent Process for Male Circumcision Scale-Up in Zambia
  3. PEPFAR Technical Considerations for COP/ROP 2016
  4. Sample Informed Consent Form

To read more about the frequently referenced information, additional information, and to read related case studies download the chapter PDF.

Download Chapter 12 (PDF, 2 MB)