Over the next three years, the GREmap aims to have information about approximately 70 countries and confederations.
The GREmap may be the most detailed resource yet developed for understanding the regulatory systems and processes of specific countries. Several agencies and organizations offer information about human subjects issues. The World Health Organization maintains contact information for national bioethics committees. The U.S. Office for Human Research Protections has an International Compilation of Human Subjects Research Protections. But the GREmap offers information, for example, on likely future changes in regulations.
"A goal of the site is to help researchers and ethical review boards become better informed about human subjects requirements in countries hosting research on human participants," said Sarah Putney, director of the HSPH Human Subjects Administration (HSA), which has spearheaded the site's development. "The content of the GREmap improves investigators' compliance with ethical review and monitoring processes that otherwise might be overlooked or misinterpreted."
She added, "Another anticipated benefit is a reduction in delays in ethical review processes. This may help accelerate research involving human subjects in many health-related fields."
The initial focus of the site is on resource-limited countries. Currently featured are Botswana, Ghana, Kenya, Kuwait, Malawi, Nepal, Pakistan, Philippines, Senegal, South Africa, and Tanzania. Soon to be released will be information for France, Germany, Spain, Indonesia, China, Australia, Bangladesh, the United Kingdom, and the European Union. In total, the HSA aims to expand the web site to include 70 countries and confederations within the next three years.
The GREmap, developed by Kevin Wnek in HSPH Information Technology, addresses questions such as:
- Which government agency or ministry is responsible for human subjects oversight?
- Is there a national ethical review committee?
- Are there national regulations or guidelines?
- How does the process of ethical review work on the national and/or local level?
- What enforcement mechanisms are used to encourage adherence?
- What future changes are possible or likely?
The site offers contact information for people and agencies involved in the regulation of research, links to related web sites, and downloadable documents such as PDFs of laws, regulations, and guidelines.
"One of the main reasons for the site is to help researchers be respectful of a country's governance and protection of its population," said Michelle Mello, co-chair of the HSPH Human Subjects Committee and C. Boyden Gray Associate Professor of Health Policy and Law at HSPH.
The breadth of international human subjects research has expanded over the past few decades. Putney and her team reviewed the field's recent history while preparing a grant application to support the GREmap. Citing statistics from studies involving the FDA, the HSA staff found that clinical trials took place in 28 foreign countries in 1990. That number increased to 79 countries by 1999. Most of the growth occurred in Russia and in developing countries in Latin America and Eastern Europe. The HSA team also cited an increase in the number of organizations contracted to do research in countries, some of which are inexperienced in hosting international human subjects research.
"In the past, researchers sometimes had to do a lot of groundwork to identify the rules and expectations overseeing a country's research projects," said Ichiro Kawachi, who co-chairs the HSPH Human Subject Committee with Michelle Mello. Kawachi is Professor of Social Epidemiology at HSPH. "There could be quite a few rounds of phone calls. The GREmap is an effort to produce a long-term concerted connection to various countries to keep this information accessible and current."
The seed for the web site was sown within the HSPH Human Subjects Administration. Initially, the goal was to add another internal resource to aid the School's researchers. But the tool's usefulness for any researcher conducting work abroad under U.S. government regulations became quickly apparent, explained Kelly Safreed Harmon, MS 04, who provided project management services for the GREmap during its first release. So the decision was made to make the web site available to anyone with an Internet connection.
In 2005, a law student interning at the HSA began collecting information about human subjects requirements in various countries. Elizabeth Bowie conducted literature and Internet searches and began establishing a network of contacts in foreign countries who could point the HSA team to the appropriate resources, often with the help of Harvard faculty experienced in conducting projects in those countries.
In addition, Bowie worked as a junior fellow in 2006 at the Department of Ethics, Trade, Human Rights and Health Law at the World Health Organization. The department and the HSA worked together to bring the first release online, and they anticipate continuing the collaboration as the list of profiles expands.
"The GREmap's primary goal is to provide the research community with a resource that will provide up-to-date, site-specific information regarding local human subjects ethical review in order to facilitate international research," said Bowie. "In addition, it can be used as a capacity-building tool. Institutions, governments, or other groups interested in developing or revising ethical review policies can use the tool to research a range of ethical review models that are being used in various countries."
A second law intern, Elizabeth Grimm, worked with Putney and Bowie this past summer to develop more country profiles for a second release anticipated this fall. Both Bowie and Grimm have been hired as staff at the HSA.
"The HSA team is a skilled group of people who have a deep and passionate commitment to this endeavor," said Mello. "The effort will benefit not only Harvard researchers but the broader research community, which will be particularly helpful to research organizations where resources to investigate these kinds of issues are scarce."
Copyright, 2007, President and Fellows of Harvard College
