OHRP takes its show on the road
An international site visit program begins
U.S. human research funding has a global reach. Each year, millions of dollars, both public and private, go to institutions conducting human subjects research outside this country.
In recent years, that fact has raised numerous concerns about whether research standards in other countries met U.S. guidelines and whether American researchers were exploiting vulnerable populations abroad.
Now the Office of Human Research Protections (OHRP) at the Department of Health and Human Services is taking steps to ensure that international institutions that receive U.S. research dollars are equipped to adequately protect human subjects.
"The United States sponsors a great deal of research internationally, both through government grants and private industry," says Melody H. Lin, PhD, deputy director of the OHRP and director of its Office of International Activities. "We have the opportunity, through this program, to go in and conduct a visit, make a report and recommendations."
Institutions, both in the U.S. and abroad, that receive government funding for human subjects research must obtain a federalwide assurance of the protection of human subjects in research from the OHRP. But such a requirement cannot be placed on privately funded studies.
Last year OHRP opened up its voluntary quality improvement (QI) program to international institutions. The program involves site visits to the institution, a meeting between institutional administrators and OHRP evaluators and a follow-up report and recommendations.
In 2002, the office conducted its first international assessments by performing site visits at six academic medical centers across South Africa, Lin says.
"The key factors in deciding whether to do an international visit is: 1) that they request a visit; and 2) that it be cost-effective," she tells IRB Advisor.
Initially, they received a request from only one institution in South Africa and decided it would not be feasible to send three staff members halfway around the world for that amount of time, she said.
"It took 17 hours just to get there — that is flight time alone not counting layovers," she notes.
However, five more institutions signed on, also requesting site visits, and Lin and two other OHRP officials made the trip — visiting and evaluating six facilities in two weeks.
Institutions conducting human subjects research face challenges not only in complying with federal regulations, but also conducting research in accordance with evolving ethical standards related to advances in technology, science and changing cultural and societal values, says Greg Koski, MD, PhD, formerly the director of the OHRP. He left the position in November to return to the faculty of Harvard University.
"A key element of the remodeling process in human research protections is the move from a system focused on regulatory compliance to a system focused on prevention of harm," Koski said in an open letter to the research community describing the program.
Institutions volunteer to participate in the program and invite representatives from the office to visit the research center or institution or conduct an OHRP-designed self-assessment.
There are three overall components to the new program: quality assurance (QA); QI, and continuous quality improvement. The QA component is designed to help institutions provide a solid foundation for a human subjects protection program.
Following either a site visit or report of the self-assessment, representatives of the office’s division of assurance and quality improvement will interact with the institution either by written correspondence and teleconference, videoconferencing, and/or an on-site consultation and visit.
The self-assessment tool, available on the OHRP web site, http://ohrp.osophs.dhhs.gov/ index.html, asks facilities to consider issues related to the composition of the institutional review boards (IRBs), how potential conflicts of interest among IRB members are disclosed and handled, how complaints about research conduct are resolved, etc.
After the assessment, the Division of Assurances and Quality Improvement (DAQI) staff then will provide tailored recommendations about how the institution can improve its human subjects research protections.
During the South Africa visit, DAQI staff visited all six institutions initially, to conduct the assessment. Then, from a site at one of the facilities, they conducted a videoconference with officials from the other five, says Lin.
Information about the QI program, including the self-assessment tool, and process for applying, is available on the OHRP web site http://ohrp.osophs.dhhs.gov/index.html.
U.S. human research funding has a global reach. Each year, millions of dollars, both public and private, go to institutions conducting human subjects research outside this country.
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