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October 6, 2010

JHSPH Researchers Create Training Guide to Protect Study Participants

In a Health in Action article published in the October 5 edition of PLoS Medicine, Maria Merritt and colleagues at the Johns Hopkins Bloomberg School of Public Health report on a Field Training Guide for Human Subjects Research Ethics that they have developed to help train field workers in research ethics. In research involving human subjects, investigators are responsible for scientific integrity and the protection of research participants’ rights, safety and welfare. Research in low resource settings often involves hundreds to tens of thousands of participants, requiring investigators to rely heavily on study team members or field workers, with varied educational backgrounds, to interact directly with human participants. Although training materials exist, many are too complex for broad application, prompting researchers from the Bloomberg School to develop the Field Training Guide. The Guide was designed to help train field workers to understand basic ethical principles and act accordingly in their conduct of research activities.

“We found that field workers lacked appropriate training materials, tailored to varying levels of human subject responsibility, that focus on basic principles of community research,” said Maria Merritt, PhD, lead author of the PLoS Medicine article and an assistant professor with the JHU Berman Bioethics Institute and the Bloomberg School’s Department of International Health. “Although tools exist, many are too complex and some require institutional affiliations or annual institutional fees. In addition, few are written in languages other than English and are not written at an appropriate educational level for field workers. The Field Training Guide for Human Subjects Research Ethics is the first step toward developing locally adaptable research ethics training tools for study teams working in a variety of settings around the world.” 

The Guide, produced with input from experienced investigators, identifies the role of the Data Collector as a study team member who may obtain informed consent from research participants and/or collect data from human subjects though direct contact.  The Guide emphasizes ethical principles and conveys the importance of accurate data recording and systematic transmittal of data records. It also addresses the cultural challenge of encouraging data collectors to admit to mistakes or procedural lapses, or to ask questions about things they do not understand. The current version of the Guide was posted in August 2009 on the training page of the Bloomberg School’s Institutional Review Board (IRB) website www.jhsph.edu/irb/Training.html, which is accessible to the public. Researchers working in various countries and situations are encouraged to adapt the delivery of content to their specific projects.

“To train every cadre of field worker in research ethics requires simplified training guidelines that can be easily translated and adapted for use in a wide variety of settings and cultural frameworks, especially where field workers have limited formal education,” said Joan Pettit, JD, MA, a co-author of the PLoS Medicine article and director of the Bloomberg School’s IRB. “In addition to establishing the role of the data collector, the Guide is innovative as it presents the main responsibilities of the data collector’s role in concrete terms that trainers can readily convey to workers in the field. This includes detailed instruction on specific behaviors that promote basic ethical principles: for example, paying attention to body language when seeking informed consent or recording interview responses, and safeguarding data-collection sheets to protect the confidentiality of personal information.”

“We hope to open a wider conversation about how to address field training needs so as to meet high standards of research ethics at every level of human subject interaction,” added Merritt.  “We encourage readers to examine the Guide, try it out, translate it and identify potential improvements.”

Public Affairs media contact: Natalie Wood-Wright at 410-614-6029 or nwoodwri@jhsph.edu.