Celia B. Fisher, Ph.D., Marie Ward Doty University Chair and professor of psychology, has received a $1.6 million grant from the National Institute on Drug Abuse.
The grant will fund a five-year training program that will teach HIV investigators to identify and address ethical issues in HIV-prevention research.
Fordham faculty members and other international experts will conduct the program.
In addition to lectures and skills-based activities, trainees will gain experience by engaging research participants and communities in the construction and evaluation of research protections, which are rules that researchers use to preserve the safety and dignity of the people they are studying.
Ultimately, the program will generate empirical data that can be used to inform ethical procedures and policies in HIV-prevention science.
“The award of this highly competitive training grant reflects recognition of Fordham’s Center for Ethics Education as a national leader in drug abuse and HIV research ethics scholarship and training,” said Fisher, the center’s director. “The grant is a natural extension of the center’s decade of ethics-education and research initiatives.”
The program will start in July with an intensive summer institute. It will be offered to early career scientists in social, behavioral, medical and public health who are experts in HIV-prevention research. Applicants must be able to initiate research on the conduct, improvement and evaluation of population-sensitive HIV prevention research ethical procedures.
It will consist of four cohorts of six trainees each. After the first year, the program will feature:
• a two-year individually mentored and financially supported research pilot project on an ethical issue in HIV prevention research;
• an advanced summer seminar for trainees in their second year focused on data analysis, professional and community dissemination of their mentored research project and grant writing incorporating the mentored project as a pilot study for a grant supplement or new grant;
• access to web-based platform for HIV-prevention ethics resources and collegial exchange; and
• participation in a mini-conference on HIV-prevention research ethics in the fifth year.
HIV is a particularly important area for ethics research, Fisher noted. There are ethical challenges in settings where concepts of autonomy differ from traditional Western values, or are imbalanced when it comes to gender.
This is especially prevalent in developing countries, where women are afflicted with the virus more than men.
“Under what cultural conditions is it morally unacceptable to require male permission for a competent adult woman to participate in an HIV-prevention trial?” she asked. “In such situations, what measures are sufficient to ensure respect for a woman’s autonomy? When does an investigator’s pressure for female autonomy violate a woman’s cultural choices and values?”
Studying couples who are serodiscordant, (one is HIV positive, one is negative) also presents challenges, she said. On the one hand, informed consent procedures require that infected individuals disclose their HIV status to their partners.
But testing the partner, which occurs at the screening stage, presents social and physical risks if the partner also tests positive for HIV. This would exclude the couple from the study (since they both have HIV) and expose their status.
“Investigators need to inform the partner of these potential risks and take steps to minimize the risk,” Fisher said. “They need to consider whether a single or multi-stage consent process at the time of screening is most appropriate for the population that is being studied.”
Although HIV/AIDS is not as prevalent in the United States as it once was, Fisher said that more than 2.5 million adults and children became infected with HIV in 2008. By the end of that year an estimated 33.4 million people worldwide were living with HIV/AIDS.
It was responsible for two million deaths—increasing to 25 million the number of people who have died from AIDS since 1981. The burden of the disease now falls hardest on poor, disempowered, stigmatized populations and marginalized racial/ethnic and tribal groups.
“Through years of experience, seasoned HIV investigators have acquired the knowledge and skills to make significant contributions to HIV ethical practice, but early career HIV scientists have few opportunities for formal research ethics training or ethics consultation with senior colleagues,” Fisher said.
“The proposed program will provide early career HIV prevention scientists with knowledge and skills to ensure the responsible conduct of their own work and to contribute to the advancement of research ethics policy in the field.”