Ethical Challenges

5. Current and Unresolved Issues


Special protections for vulnerable people: 
When research is considered to be important and sound but to have more than minimal risk, an ethics review committee may recommend special protections. For example, based on the level and probability of risk, the ethics committee may monitor the research procedures, monitor the consent process, appoint a research partner/advocate, approve the research to be done with a few subjects and then reassess the situation, re-review the research more often than annually, and/or ask the investigator to report back to the ethics committee on research progress and problems.  Sometimes, because of risk of harm, a subject population is judged to be inappropriate for inclusion and a different population must be found.  Special protections and selection of subjects reflects the application of respect for persons, beneficence and justice.

Example 6

The National Children’s Study recruits pregnant women and follows them and their offspring through childhood and adolescence and beyond. Pregnant women and children are considered vulnerable subjects that require special protections. Pregnant women and their children are subject to physical, psychosocial, environmental and educational observations according to protocol. During the study, some subjects are observed to be in a dangerous home situation, e.g. exposed to violence and abuse. For other participants, environmental hazards are identified in laboratory analyses, e.g. dangerous lead levels. This is an observational study, not an intervention study. Do the researchers have an ethical responsibility to intervene if an environmental hazard is identified? What protections might you provide? What are the ethical responsibilities of the researchers in this situation?

This study is referred to a specially convened national committee for ethics review and approval. The committee can serve as a resource as well as a central IRB. Each research site, if a harmful situation is identified, e.g. elevated lead level, can make a referral so that an appropriate intervention is implemented. The study planning and oversight groups work to anticipate ethical and other issues and to address those issues. For example, when the children in the study reach majority age, their consent to continue in the study will need to be obtained.

Research in Developing Countries

Since publication of the Belmont Report, research conducted on a global scale has increased. Concern that research participants in resource poor countries not be exploited has resulted in attention to benefits such as infrastructure support, education and training, and health care in health-related research. Also, it has stimulated research on incentives that are not coercive and on how best to obtain informed consent from groups that may be unaccustomed to being asked for or are unfamiliar with the concept of consent. Such efforts to provide benefit for research subjects are guided by concerns about exploitation and other ethical considerations, specifically providing benefits.