PI Action alerts & updates ... 2000

Draft Centers for Disease Control Guidelines
Weaken Right to Informed Consent for Pregnant Women

Your Public Comment Is Needed by November 30
On October 30, 2000, the Centers for Disease Control and Prevention (CDC) issued two draft documents for public comment.

They are “Revised Guidelines for HIV Counseling, Testing, and Referral” and “U.S. Public Health Service Recommendations for HIV Screening of Pregnant Women.” They can be found at the CDC’s website at www.cdc.gov/hiv or you can get a copy by calling 1-800-458-5231.

Guidelines are often issued through administrative agencies, such as the CDC, National Institutes of Health, and Health and Human Services. They are not legislation, but recommendations. However, they are very influential since they are written by experts. They also often set the stage for state legislative battles, as many states try to adopt the guidelines into law. Additionally, HIV care providers, especially those who may be less experienced, often use federal guidelines as the primary standards for clinical practice.

When an agency releases draft guidelines, there is always a public comment period (usually about a month) so that those most affected can respond and provide input. The agency takes this input into consideration before submitting final guidelines.

Project Inform is particularly concerned about the guidelines on HIV screening of pregnant women. The guidelines do contain some good provisions, and they do attempt to increase the availability of HIV testing for pregnant women. However, we object to the general trend of the guidelines of weakening a pregnant woman’s right to informed consent for HIV testing. This right means getting the complete information needed in order to make an informed choice on whether or not to test for HIV.

The guidelines do maintain a voluntary approach to testing and acknowledge a woman’s right to refuse testing. They also contain a strong warning against coercing women into testing under any circumstances. The guidelines also recognize that there are both benefits and risks to many pregnant women who test for HIV and advise discussion and trust building around these issues.

Despite these statements, the guidelines emphasize universal HIV testing as the primary goal and offer the possibility of making the informed consent process more “flexible”. They also call for “simplifying” the process so that pre-test counseling is not a barrier to testing. In short, the provisions give the doctor or the provider the ability to lower the standards of informed consent, including pre-test counseling, if they are determined to be a barrier to testing a woman for HIV. Although this might seem like a small change, it is a clear decision to make the goal of testing pregnant women for HIV more important than the goal of providing each pregnant woman with the same standard of informed consent that most other people receive.

Additionally, the guidelines encourage the use of “rapid HIV testing” in the context of labor and delivery when a woman does not know her HIV status. Informed consent is very important in the context of labor because it is a time when women are particularly vulnerable. Moreover, without adequate precautions or guidelines, rapid HIV testing in the labor setting could easily lead to HIV treatment that is not fully understood or agreed to. While the difficulties of obtaining a truly informed consent for HIV testing and treatment during labor are mentioned in the revised guidelines, there is no discussion or guidance on best practice. Project Inform feels that the CDC has to consider this area further and seek the opinion of clinical experts and women living with HIV/AIDS before the guidelines are finalized.

Action needed:
The public comment period is a great opportunity to express your opinion about these suggested changes. You are encouraged to write or email the CDC and encourage them to reconsider their decision to lower the standards of informed consent for pregnant women. Public comments can be mailed, faxed, or emailed, but they must be received by November 30, 2000, in order to be considered.

You can use the sample letter below to help craft your message. Remember to be personal in your message. The CDC will receive a lot of comments from advocacy organizations, but it is important that they know how these changed guidelines could affect you or someone you know and care about.

Sample letter:

Mail to:
Technical Information and Communications Branch
Mailstop E-49
Division of HIV/AIDS Prevention
National Center for HIV, STD, and TB Prevention
Centers for Disease Control and Prevention (CDC)
1600 Clifton Road, N.E.
Atlanta, GA 30333
Email: hivmail@cdc.gov
Fax: 404-639-2007

To Whom It May Concern:

I am writing in response to the draft document, “USPHS Recommendations for HIV Screening of Pregnant Women”. I appreciate the CDC’s attempt to increase the availability of HIV testing for pregnant women. I also support the guidelines’ recognition of the importance of a voluntary, non-coercive approach to HIV testing, and your acknowledgement of a woman’s right to refuse testing.

However, I am concerned about provisions in the guidelines that weaken the right of pregnant women to informed consent for HIV testing. The importance of written informed consent should be stressed as the ideal situation in this document. In addition, the guidelines should ensure that appropriate, face-to-face counseling remain part of the informed consent process.

Insert personal statement. If you or someone you know would be affected by these changes in the guidelines, write about that here.

Finally, I also encourage you to review your language encouraging rapid HIV testing in the context of labor when a woman is not aware of her HIV status. Although the difficulty of obtaining informed consent during labor is discussed, there is no clear guidance on best practices of getting this consent. Labor and delivery is a time when informed consent should be a priority. I encourage the CDC to consider this issue further and seek the input of clinical experts and women living with and at risk for HIV regarding best clinical practices before finalizing these guidelines.

Thank you for drafting these important guidelines. I appreciate your consideration of my input.

Sincerely,
Your name

Background:
In spite of dramatic decreases in vertical transmission due to more effective treatment and care for HIV positive pregnant women in the United States and other countries where treatment is available, the CDC has estimated that 300 to 400 babies were born with HIV in 1999. Most HIV positive children are born to mothers who don’t know their status. The reasons for women not testing are varied. Studies have shown that many women are not tested for HIV because they lack prenatal care. Many others are not offered testing because their providers don’t consider them to be at risk for HIV. A very small percentage of women may refuse testing because they perceive themselves to be at low risk of infection.

It is important to ensure that all pregnant women are offered an HIV test with a complete informed consent process as early as possible in their pregnancy. Studies show that the number of women infected through sharing of needles and other drug use is declining while the proportion of women infected through heterosexual sex has increased. Therefore a woman may be unaware of her risk factors for HIV. In addition, there are many provider biases about who is at risk and who is not that lead to low-income women of color being offered HIV testing at much higher rates than other women.

However, the commendable public health goal of offering an HIV test to all pregnant women doesn’t have to conflict with appropriate informed consent. Complete informed consent should be available to all people at risk for HIV. For more information on HIV testing for pregnant women and the importance of written informed consent, see “Striking a Balance: HIV Testing for Pregnant Women and Newborns” in the PI Perspective #30. The article can be also be obtained by calling our toll-free hotline at 1-800-822-7422

The revised CDC guidelines on testing for pregnant women differ from current guidelines in five areas:

• They emphasize HIV testing as a routine part of prenatal care and strengthen the recommendation that all pregnant women be tested for HIV.
• They recommend a simplification of the testing process so that previously required pretest counseling is not a barrier to the provision of testing.
• They make the consent process more flexible to allow for various types of informed consent.
• They recommend that providers explore and address reasons for refusal of testing.
• They place more emphasis on HIV testing and treatment at the time of delivery for women who have not received prenatal testing and chemoprophylaxis.

Specifically, the three areas of most concern are the “simplification” of the testing process, making the informed consent more flexible, and placing more emphasis on HIV testing and treatment at the time of delivery. The simplification of the testing process allows providers to give a minimum level of information to pregnant women before an HIV test. It can be provided in the form of a brochure, pamphlet, or video rather than a face to face encounter, although the guidelines assume that the information must be culturally and linguistically appropriate.

This information has to cover 6 points including:

• a small amount of information about HIV and transmission including vertical transmission risks,
• the fact that a woman may be at risk for HIV even if she has had only one sex partner
• the fact that effective HIV disease and transmission risk interventions exist for mothers and infants
• a recommendation that all pregnant women test for HIV
• the fact that HIV prevention and care services are available to women and their infants
• the fact that women who decline testing will not be denied care for themselves or their infants

This simplification provision appears to be based on an Institute of Medicine report that found that some health care providers did not offer testing to all pregnant women in part because they felt that standard HIV testing protocols, especially pre-test counseling, were too cumbersome. Making the provision of information more standard may prove to be a positive step. However, allowing providers to choose the information conveyed based on limited interaction with their patients and to skip a face-to-face counseling process tailored to the needs of pregnant women runs a significant risk of leaving women with little recourse for unanswered questions and fears that may influence her decision to test or to return for test results.

The guidelines also state that while written informed consent is ideal and is required by law in some states, it could be a barrier. They do not explain why, but allow providers the flexibility, where there is no law, to obtain verbal consent with medical record documentation if written consent is determined to be a barrier. Again, the revised guidelines leave the degree of protection for the pregnant woman up to the discretion of a provider who may have limited knowledge about their patient. If written informed consent is the ideal, it should be upheld in federal guidelines.

Finally, the emphasis on rapid testing for women who are in labor and do not know their HIV status raises many concerns. Without ensuring a laboring woman’s informed consent, rapid testing and subsequent treatment upon diagnosis may undermine a critical decision about a woman’s HIV care, treatment and perinatal transmission prevention options. Generally, people living with HIV are afforded an opportunity to consider the benefits and risks of antiretroviral treatment before making a decision about their use. Pregnant women, whether in the first weeks of their pregnancy or in the first hour of labor, should be afforded that same opportunity. The guidelines, however, do not define how this will or should optimally be handled in the labor setting.

In conclusion, the revised guidelines must account for these concerns before they run the risk of becoming law or clinical practice that undermines women’s ability to make informed medical decisions for herself and her baby.