Assessing recall and understanding of informed consent in a contraceptive clinical trial

Recall and understanding of information provided to contraceptive study participants in four sites were assessed. Analysis was completed of data for 70 women who were asked about their recollection of information and understanding of participation. Most women understood the purpose of the study. Their reasons for agreeing to participate varied by site and included wanting to try a new method, wanting to help others, and wishing to avoid pregnancy. Most women recalled correctly the burden of participation—number and frequency of visits, tests, and examinations. Most understood that they could withdraw from the study without jeopardizing their care. The women were also asked to recall the risks and benefits of the contraceptive they were testing. Only 23 percent recalled the pregnancy risk correctly; 40 percent underestimated and 19 percent overestimated it. Few women interpreted rates of risk correctly; some perceived high rates as low ones and the rates of the spermicide being studied as better than those of other contraceptives. This study confirms that risk is better recalled than understood. The participants surveyed remembered the information they were questioned about better than did participants in some other studies, a finding that supports earlier research results showing that younger, healthier patients (such as contraceptive users) recall better than older, less healthy ones.     

Readability of informed consent

A comparative study has been made of the readability of informed consent form of the Navarra Health Service, using the Flesh and SMOG formulas. Signed editorial articles from the local newspapers Diario de Navarra and Diario de Noticias were used as a term of comparison. The results show that the readability of informed consent form is -4 (with a second paragraph of -9), while the editorial articles showed a comprehensibility of 22. The text of the second paragraph of the informed consent form is barely comprehensible, and alternative texts that are more easily comprehensible must be studied.     

Personal autonomy and informed consent

Two ways of understanding the notion of autonomy are outlined and discussed in this article, in order to clarify how and if informed consent requirements in biotechnological research are to be justified by the promotion of personal autonomy: A proceduralist conception linking autonomy with authenticity, and a substantivist conception linking autonomy with control. The importance of distinguishing autonomy from liberty is emphasised, which opens for a possible conflict between respecting the freedom and the autonomy of research participants. It is argued that this has implications for how consent requirements based on different criteria of specificity and understanding should be viewed and justified.     

Ethical considerations of informed consent: a case study

Presentation is made of a case study concerning a patient with chronic obstructive pulmonary disease who was also discovered to have small cell carcinoma. The patient had indicated many years prior to his hospitalization that if he ever had cancer he would not want to receive chemotherapy. He also indicated to his physician he did not want to hear any 'bad news'. The dilemmas posed by the ethical relationship between consultant and primary care physician and between consultant and patient in such a case are explored. The role of a hospital ethics committee in advising the parties involved is also reviewed.     

The effect of contraceptive knowledge source upon knowledge accuracy and contraceptive behavior

The study purpose was to determine the relationship(s) of the source of contraceptive knowledge to contraceptive knowledge accuracy and contraceptive behavior of college freshmen. Sources of contraceptive knowledge were divided into 2 categories for the purposes of this study: structures/organized sources -- schools, church, college, planned parenthood, and health services; and unstructured/unorganized sources -- home, peers, sexual partner, and mass media. The sample consisted of 340 1st or 2nd semester college freshmen (58.5% males and 41.5% females) entering a required health education course at a midwestern college. Participants were volunteers. Subjects were given a 67-item contraceptive-knowledge test previously utilized by Reichelt and Wereley (1976). The survey instrument was modified to include a section pertaining to sources of contraceptive knowledge. The sources of contraceptive knowledge the students identified revealed that peers and the mass media were the major contributors. The unorganized/unstructured sources of information contributed more to the knowledge level than did the organized/structured sources. School was the largest source of information in the organized/structured category; 34 subjects stated 50% or more of their knowledge came from school, and a total of 164 subjects identified school as a source. All other organized/structured sources were identified as having contributed little to contraceptive knowledge. To determine if the source of contraceptive knowledge affected the accuracy of this knowledge, subjects were divided into organized/structured sources and unorganized/unstructured sources of knowledge acquisition. Overall, the contraceptive knowledge accuracy of the subjects was poor. Contraceptive knowledge accuracy exceeded 70% for only the "other" (less effective) category; knowledge accuracy from all other categories was less than 70% for both organized and unorganized sources. For each of the 6 categories of contraceptive method (oral contraceptive, IUD, condom, diaphragm, spermicides, and the less effective methods), the subjects from organized/structured sources scored higher than the unorganized/unstructured sources. Knowledge accuracy concerning the IUD was exceedingly poor for both organized (39%) and unorganized (29%) sources. The largest difference between knowledge sources and accuracy was in the "other" category. Subjects from the organized/structured source had a 72% accuracy; those from the unstructured/unorganized source had only a 58% accuracy. Of the 89 subjects from the organized/structured source and the 55 from the unorganized/unstructured source who were sexually active at the time of the study, the organized/structured knowledge source subjects used oral contraceptives more and used "other" methods less than did the unorganized/unstructured group (46% and 34% and 19% versus 25% respectively.     

The informed consent procedure in epidemiological research

After a brief introduction on the beginning and subsequent developments of informed consent (IC), this paper analyses its ethical, legal, medical and scientific implications and its specific applications to epidemiological research. The aim is to highlight how IC principles should be fulfilled through different procedures responding to the ethical and scientific requirements of epidemiological research. At least two improper applications, in fact, can deprive IC of its meaning: referring to ethical principles without discernment, or following IC guidelines without critical evaluation. Attempts to improve IC procedures adapting them to specific needs and scientific developments should be evaluated carefully and without preconceptions.     

Obtaining informed consent for genetic studies: The multiethnic study of atherosclerosis

Studies of DNA may yield important information about atherosclerosis. To determine how often study participants' consent to examine DNA is denied and the factors associated with that denial, information was collected on participants in the US Multiethnic Study of Atherosclerosis (MESA) during 2000-2004. Permission was sought for preparation of DNA, transformation of cells into cell lines, evaluation of genes related to heart and other health conditions, and access to DNA by private companies. Of the 5,494 participants at entry, 897 (16.3%) refused consent for some items and 247 (4.5%) completely denied consent. At a second examination 18 months later, 819 (15.0%) partially refused and 229 (4.2%) completely denied consent. Age among men (odds ratio per 10 years = 0.68, 95% confidence interval: 0.54, 0.85; p = 0.004), ethnicity (odds ratio for African American = 2.34, 95% confidence interval: 1.66, 3.32; p < 0.001), and field center (p < 0.001) were associated with complete denial. For those giving partial consent, the most common item refused was access to DNA by private companies (baseline: 99%; second examination: 90%); younger age, male gender, and African-American ethnicity were associated with refusal. The authors concluded that a small percentage of participants in epidemiologic studies refuse consent for DNA studies, and the majority are concerned about sharing their DNA data with industry.