Everyone should have the right to make fully informed and voluntary decisions about reproductive health care. For medical providers and research scientists, ensuring this basic human right involves two related concepts: informed choice and informed consent.
Informed choice refers to ensuring that each client has the information about methods and services — including their risks and benefits — that enables clients to make a fully informed decision about whether to obtain or decline treatment or services; which contraceptive method, treatment, or service to select; and whether to seek and follow up on a referral. The process of ensuring informed choice for contraceptive use involves considering a wide range of factors that could affect the person's method choice.
Informed consent is a more formal, legal process in which the individual is first fully informed and then gives consent, usually in writing, to receive a method or service or to participate in a research study. Informed consent is typically required for volunteers who participate in human research and patients who undergo an invasive medical procedure, such as sterilization.
For either informed choice or in-formed consent, great care must be taken to be sure each individual understands the information provided and voluntarily agrees to receive the service or participate in the research study.
Understanding information
Each research participant must be informed about the nature of the research; foreseeable risks and expected benefits; potentially advantageous alternatives to participation; confidentiality; compensation for transportation, lost time, or injuries; and whom to contact with any questions. Each participant should also understand that participation is voluntary. Any research funded by the U.S. government must meet these criteria.1
Simply providing information does not necessarily ensure participants will understand. Common barriers to understanding include illiteracy; language differences; class or power inequalities among scientists, research staff, and participants; and the nature of the consent form itself.
For many years, FHI has advocated the use of readibility tests and other measures to ensure that consent forms are comprehensible; that is, they do not use unnecessarily long sentences and complicated words, and are otherwise appropriate. The consent form for research involving volunteers who have little formal education should be understandable to an illiterate or semiliterate person.2 The sentence: "If there is a history of hypertension, alternative methods of contraception are indicated" could become "If you have high blood pressure, use some other kind of method." Also, the form would need to be read aloud to people who cannot read.
Consent forms are legal documents, often long and complex. Some forms "appear to be more concerned about legal implications for sponsor agencies than … with the welfare of the volunteers," Dr. Jean Pape, who works with research studies in Haiti, said in recent testimony before the U.S. National Bioethics Advisory Committee. "We cannot read them to volunteers because the only time a volunteer had a document like this read to him was when he was in a court of law and had to sign some kind of papers. So this is changing the trust relationship that we have with our participants and, therefore, we have to explain it step-by-step."3
Even when participants understand an informed consent document, they typically have selective recall of its contents, according to an analysis involving 70 women who participated in a contraceptive clinical trial in Latin America, Africa, and North America. Most women correctly recalled such details as the number of visits, tests, and examinations that would be involved.
But the women did not correctly recall aspects of the study that affected their choice of contraception. Only 23 percent recalled the correct risk of pregnancy associated with the method. "The most immediate concern is how better to inform study participants and users of contraceptive methods about the absolute and relative effectiveness of different methods," says Dr. Judith Fortney of FHI, author of the study. Participants also need to understand clearly that participation is voluntary and that other contraceptive methods are available to them if they choose not to participate, she says.4
Studies in both developing and developed countries indicate a potential lack of understanding of informed consent forms. In Bangladesh, a study of informed consent among 105 pregnant women participating in a community-based study of iron supplementation found that while most women understood the objectives of the study, many did not understand they could decline to participate. Eighty-seven percent said they participated "because they believed that doing so might carry such great advantages, primarily in terms of medical treatment for themselves or improved health care for their babies, that is was difficult to say no."5 A study in Italy tested understanding of informed consent by interviewing 250 patients at four national health service clinics to see if they would participate in a clinical trial. Fewer than six of 10 people interviewed understood the meaning and value of informed consent.6
Is it voluntary?
Ensuring that a person agrees voluntarily to participate in a study can be difficult. Many variables of culture and specific study circumstances affect whether consent is voluntary. Potential volunteers can get confused about the difference between experimental research and regular treatment. They may feel unable to withdraw from a study.
A perinatal HIV transmission study at a clinic in South Africa obtained the women's permission to participate in the study prior to testing them for HIV. An analysis found that women clearly understood the nature of the research, so consent was informed. However, more than one fourth of the 112 women in the analysis agreed to the HIV test because they thought a refusal could limit their hospital care. "Many patients perceive that the hospital staff expect them to participate in the studies; this perception seems to have added a subtle element of coercion to ostensibly voluntary consent," concluded Dr. Quarraisha Abdool Karim and colleagues.7
The AIDS epidemic has prompted difficult ethical issues regarding informed consent for research, including participation in HIV vaccine-related trials, and voluntary counseling and testing services. A research team in South Africa, where HIV rates are among the highest in the world, has developed proposed guidelines for culturally sensitive approaches to informed consent in such areas. One of the most important aspects in the process of obtaining consent, the researchers say, is to involve the community. "All decisions regarding participation should be shared decisions of the research team and volunteers, and their representatives," the researchers proposed. "Full consultation should take place with the community, in order to foster a sense of partnership with respect to the research project."8
Involving the community can be a delicate matter, however. A study designed to improve reproductive health services among Aymara women in an isolated area of Bolivia attempted to involve the women in developing research priorities. A culturally sensitive research team that included an Aymaran anthropologist and Latino social scientists examined the lessons they learned in an initial, unsuccessful effort. In a community meeting, the researchers explained the research project, hoping to have the women draw up a mutually agreed upon document.
However, the women did not want to make suggestions. They wanted to give unlimited and unconditional consent. As one woman said, "We'll just sign a blank piece of paper." The researchers determined that their initial approach had not worked because, in Bolivia, international research projects often lead to grants for development activities. "The anticipation of material benefits can motivate participation, despite explicit and repeated denial that such prospects exist," the researchers concluded.9
Informed consent documents developed in one country might not work well in another country or cultural setting. In-depth interviews with more than 100 researchers and oversight committee members in eight countries found that informed consent forms developed in another country can be inappropriate in some settings. The study by Duke University in Durham, NC, USA, and FHI recommended that informed consent documents be developed in collaboration with local colleagues, giving special attention to cultural situations and potential problems of translation of particular concepts.
For example, national guidelines for conducting human research in one African country reject a requirement for written informed consent, based on the country's recent experiences of political torture and persecution that were linked to a person's affiliation to various organizations. Just the name of a person could be used to link them with an organization. Consequently, instead of signing research consent forms, individuals are allowed to put an "X," thus concealing the person's identity while following the requirement for written consent within a culturally sensitive context.10
Consent forms approved in English have to be translated accurately into local languages. Incorporating local concepts into translations and explanations can convey even complex scientific issues in creative ways. For example, the idea of an immune response is challenging to many participants who do not understand the concept that something in their blood can attack bacteria or viruses. To overcome this problem, researchers in one country likened the body's immune response to a village with guards. They talked about "a particular kind of watchman" in the person's blood.11
Another example of using local ideas to explain complicated research concepts can be found in a randomized vaccine trial in Senegal. During community meetings, the concept of "randomization" was explained successfully by using agricultural terms involving different seed varieties, ideas that were familiar to farmers in the area. "Communicating information about a choice and its implications can be difficult and time-consuming, but it allows valid, informed decisions," the authors concluded. "We found that widespread illiteracy is not a barrier to comprehension, especially since informed consent is more an interactive process than one that depends on reading."12
Informed choice
The process of informed choice provides a larger context for thinking about informed consent as well as decisions that do not involve legal documents, such as consent forms.
"When a person freely makes a thought-out decision based on accurate, useful information, this is an informed choice," explain Dr. Robert Hatcher and colleagues in The Essentials of Contraceptive Technology, a handbook designed for clinic staff. "Informed" means that "clients have clear, accurate, and specific information that they need to make their own reproductive choices," as well as an understanding of their reproductive needs through person-to-person counseling, mass media messages, and other sources of information. The term "choice" means that clients have a range of family planning methods from which to choose and that clients can make their own decisions.13
Studies have found that family planning clients often do not get the information they need to make an informed choice. In a study in 12 African countries involving some 7,000 client exit interviews and about 7,000 client-provider observations, researchers concluded that "counseling on family planning is broadly lacking across all study sites, in terms of both information taken from the client and information given to the client about her method. These activities are particularly important because they are directly related to client satisfaction, appropriateness of method selected, continuity of use, and sexually transmitted disease/HIV risk."14
If a client receives the contraceptive method she needs and prefers, she is more likely to be satisfied with the method. A study in Indonesia among nearly 2,000 women found that receiving the method they desire resulted in much higher continuation rates. Among the nearly 1,700 women granted their method choice, 91 percent continued using the method a year later. Among the 266 women who did not get their first choice, only 28 percent were using the method a year later.15
To strengthen informed choice, family planning programs have encouraged pro-viders to discuss a full range of contraceptive method choices. Without focusing counseling to the needs of the client, however, discussing all methods can waste time and does not improve method choice or continuation.
A study in Peru found that information for method choice improved when counseling sessions increased from between two and eight minutes to between nine and 14 minutes, but had no impact beyond 14 minutes. "Offering a wide range of contraceptive options took up most of the consultation time and was highly correlated with the session length," the study concluded. "Discussion of the chosen method's side effects and screening for contraindications did not vary by session length. … It is important that providers use the available time more efficiently; that they be more practical in assessing clients' needs; and that they avoid providing too much information about irrelevant methods."16
Another factor in informed choice is the counseling style of the provider. A study among 7,800 reproductive-aged rural women in Bangladesh found higher first use of contraceptives and continuation rates when quality of care was better. Women who were not using a method and who perceived quality of care to be very good were 27 percent more likely to adopt a method, compared with women who perceived quality of care to be poor. And those who perceived a high quality of care were more likely to continue using their method than contraceptive users who perceived quality of care to be low. "The results strongly imply that what may be most critical is not the absolute number of methods offered to the client, but rather the degree of trust, rapport, and confidence established between the field-worker and the client," the authors concluded.17
– William R. Finger
References
Public welfare and the protection of human research subjects. Code of Federal Regulations 45CFR46.116; 46.117(c).
Rivera R, Reed JS, Menius D. Evaluating the readability of informed consent forms used in contraceptive clinical trials. Int J Gynecol Obstet 1992;38(3):227-30.
Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries, Volume I. (Bethesda, MD: National Bioethics Advisory Commission, 2001)49.
Fortney JA. Assessing recall and understanding of informed consent in a contraceptive clinical trial. Stud Fam Plann 1999;30(4):339-46.
Lynöe N, Hyder Z, Chowdhury M, et al. Obtaining informed consent in Bangladesh. N Eng J Med 2001;344(6):460-61.
Dazzi D, Agnetti B, Bandini L, et al. What do the people think (and know) about informed consent for participation in a medical trial. Arch Int Med 2001;161(5):768-69.
Abdool Karim Q, Abdool Karim SS, Coovadia HM, et al. Informed consent for HIV testing in a South African hospital: is it truly informed and truly voluntary? Am J Public Health 1998;88(4):637-40.
Richter LM, Lindegger GC, Abdool Karim Q, et al. Discussion document: guidelines for the development of culturally sensitive approaches to obtaining informed consent for participation in HIV vaccine-related trials. Unpublished paper. University of Natal, 1999.
Mulder SS, Rance S, Suárez MS, et al. Unethical ethics? Reflections on intercultural research practices. Reprod Health Matters 2000;8(15):104-11.
Sugarman J, Popkin B, Fortney J, et al. International perspectives on protecting human research subjects. In: Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries, Volume II. Bethesda, MD: National Bioethics Advisory Commission, 2001.
Kass N, Hyder AA. Attitudes and experiences of U.S. and developing country investigators regarding U.S. human subjects regulations. In: Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries, Volume II. Bethesda, MD: National Bioethics Advisory Commission, 2001.
Preziosi M, Yam A, Ndiaye M. Prac-tical experiences in obtaining informed consent for a vaccine trial in rural Africa. N Eng J Med 1997;336(5):370-73.
Hatcher RA, Rinehart W, Blackburn R, et al. The Essentials of Contraceptive Technology. (Baltimore, MD: Population Information Program, 1997)3-3.
Miller K, Miller R, Askew I, et al., eds. Clinic-Based Family Planning and Reproductive Health Services in Africa: Findings from Situation Analysis Studies. (New York: Population Council, 1998)29.
Pariani S, Heer DM, Van Arsdol MD. Does choice make a difference to contraceptive use? Evidence from East Java. Stud Fam Plann 1991;22(6):384-90.
León FR, Monge R, Zumarán A, et al. Length of counseling sessions and the amount of relevant information exchanged: a study in Peruvian clinics. Int Fam Plann Perspect 2001;27(1):28-33, 46.
Koenig MA, Hossain MB, Whittaker M. The influence of quality of care upon contraceptive use in rural Bangladesh. Stud Fam Plann 1997;28(4):278-89.
Ensuring that the informed consent process is implemented fully in FHI research studies typically involves many steps. Below are some of the key steps taken in one recent study involving sexually transmitted infections (STIs):
Researchers converted a standard consent format to a booklet with simple illustrations, suitable for the reading level of people in the communities where volunteers would be sought.
Two institutional review boards (IRBs) approved the exact wording of the booklet as well as the study protocol: FHI's Protection of Human Subjects Committee and the national ethics committee for research in the country where the study was conducted.
Study coordinators trained staff who would counsel the women during the consent interview and throughout the study. While the counselors had to follow the exact wording of the consent booklet, they needed to make the information culturally appropriate.
During each interview with a prospective volunteer, both the counselor and the volunteer referred to the booklets. If the woman could not read, a witness attended the session with her to be sure the counselor read the booklet correctly. The counselor read each paragraph, one at a time, stopping to ask the participant to explain complicated information. Discussing the paragraphs helped the counselor determine if the woman understood details such as when she would be tested for STIs, what would happen if she had an infection, what she would be asked in follow-up visits, how her confidentiality would be protected, and that she could leave the study at any time she wished.
Screening involved two steps. First, women interested in the study were examined to see if they currently were infected. Women found to be infected were treated but were not eligible to participate in the study. Those potentially eligible for the study went through another informed consent interview later.
Volunteers who qualified for the study needed to understand randomization. Because lotteries are popular in the country where the study was conducted, the counselors found a way to explain randomization in terms of a lottery.
Monitoring of informed consent continued after the women signed the form and entered the study. At each monitoring visit, investigators interviewed study participants in order to see if the women continued to understand the study and the key elements of their participation.
