How Ethical Is International Perinatal Research? Challenges and Misconceptions

Contrary to common belief, international health research does not necessarily imply health promotion. Such research may also be unethical. The ideological value of “contributing to the improvement of global health” does not always justify exploiting the resources of developing countries without their receiving any benefit. Although such projects advance international health research, they do not promote the health of those who live in the participating countries. Theoretically, local researchers gain from participating in multinational or international research trials through obtaining knowledge of hitherto unknown research methodologies, employment income, and (possibly) some academic credit. However, they seldom gain sufficient understanding of the research methods followed to enable them to independently emulate the methods, report or publish the research findings locally, or offer any direct benefit to the study participants. The study findings themselves often lack any relevance to the countries under investigation and fail to be implemented locally where they will benefit the population. International perinatal research groups too often fail to address health problems that are a priority for developing countries. Multicenter studies that include developing countries should address both their needs and those of the developed world. For example, the Term Breech Trial 1, one of the largest multinational randomized controlled trials to be undertaken in recent years in perinatal care, addressed the issue of the optimal method of delivery of babies presenting at term in a breech position, a problem that affects perhaps 4 percent of newborns and is likely to contribute to deaths in about half that number if cesarean section is not performed. In some of the participating countries in this trial, where maternal and neonatal mortality rates are at extremely high levels, largely for reasons other than breech position at term, one can only wonder at the value and priority of this research question for them. The conclusions of this trial, which have contributed to a growing cesarean section rate worldwide, raise concerns about the applicability of the trial’s findings and the concurrent promotion of cesarean sections in developing countries. In rural African communities, for example, a woman having a cesarean section may find the experience so undesirable that she will avoid seeking (Western) medical care during her next pregnancy, thereby enhancing her chances of a disastrous birth outcome. Even if she were willing to seek medical care or have a repeat cesarean section, her lack of access to care or facilities will add to her risk. Increasing the rate of cesarean section for all but the most essential indications can have life-threatening consequences in such settings. Those researchers who promote more cesarean sections should be responsible for following up to determine the consequences of their recommendations. Instead, the serious ethical implications of implementing such a policy (particularly cesarean deliveries for nonessential or non life-threatening reasons) are left to local interests to pursue. Methods of funding research contribute to the conflict between health research and health promotion. Grants are awarded to researchers to evaluate the benefits of a health intervention, but no funding is provided for implementing the research findings. If the intervention results prove positive, its benefits are not applied to the control arm of the study population, and similarly, if they prove detrimental, neither is the intervention withdrawn from the experimental group. The study participants are simply the guinea pigs of research and are expected—like so many research participants—to be willing to contribute to lofty ideological goals, such as “the betterment of care in future.” It is rare, but not impossible, to conduct major international, health research studies differently. For example, the PROBIT study 2, which examined over 17,000 Belarussian mother-baby pairs, did consider the ethical implications of manipulating populations for the purposes of gaining research findings. This study, arguably the largest and most significant to determine the impact on infant health of the WHO/UNICEF Baby-Friendly Hospital Initiative 3, revealed clear infant health benefits to being born in a Baby-Friendly hospital. Nevertheless, the granting agencies that supported this trial were not asked for funds to provide the intervention to the control group in the event it had a positive impact (or, conversely, its withdrawal from the experimental group in the event it proved to be harmful), since such requests are viewed as outside the scope of research grant applications. Team members felt obliged to obtain further funding for such follow-up interventions, however, and after the trial’s conclusion, training was conducted for hospitals that had agreed not to implement the Baby-Friendly Hospital Initiative during the trial. Curiously, we accept that a trial should be stopped if an interim analysis reveals clear negative consequences if it were to be continued. Yet, on the other hand, a positive impact finding does not result in a decision to apply the findings to all in an endeavor to improve the status quo. Who benefits from the expenditure of international research and health promotion activity? The recipient country or the donor? International funds have to cross country borders and are subject to excessive international banking fees. This practice is akin to that of universities or research institutes requiring a significant proportion of research grants to be funneled back to the institution and not spent on direct research activities. Similarly, many grants require their major expenditure to be reserved for donor country services, such as the purchase of air tickets, equipment, resources, or services for the donor country rather than for use in the recipient country. In reality, and shamefully, a disproportionate amount of funds are channeled away from those international partners where they are needed most—an ideological contradiction about which international research and health promotion partners are well aware and resent. Most researchers who have worked in a multinational capacity rapidly recognize the existence of different standards of research ethics across the globe. Selection of willing participants in studies, or those whose characteristics best meet criteria for the experimental (or control) group arm; a lack of respect for anonymity of response; requiring participants to collaborate rather then requesting that they do so; disregard for (or ignorance of) the need for informed consent; and avoidance of coercion of participants—these concepts are frequently and literally foreign to many local researchers. To conduct international health research that meets international standards, it must become both an educational process in research methodology and ethics and a fact-finding mission. International researchers must collaborate respectfully and ask some hard questions: To whom do the data belong? The local researchers? The international team? How will local ownership of data be recognized? Ideally, data collected in a country will remain theirs even if the coordinating research team “owns” the collated data that are derived from several countries. Authorship and publication should be shared based on commonly discussed and agreed-upon procedures before participation in the study, or at least, before data collection. Publication in local journals and the international literature should receive equal priority. At the very least, translation of international publications into local languages for local publication should be encouraged. Preferably, researchers will also examine local interests with a view to implementing practical programs and needed services. On the other hand, local “theft” of data sometimes occurs. Local collaborators may use data obtained from studies to publish in their local journal without giving credit to international collaborators, frequently through a lack of awareness of international publication protocols. As local journals adopt international standards requiring sign-off from all contributors, acknowledgment of funding sources, standards of eligibility for authorship, co-authorship, and contributory authorship, such problems will diminish. The phenomenally rapid growth of web-based journals as well as free access to international journals, which occur today, will help to speed the process of equalizing international standards. Conflicts between the goals and methods of research and health promotion remain, despite attempts to improve international research standards 4-7. International health professionals obviously need to try harder to meet the challenges of promoting health while conducting research, and to do so ethically.

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