New NIH Policy Protects Human Subjects in Research

New government policies requiring ethics education for research scientists could create administrative headaches for the University.

A new National Institutes of Health (NIH) policy that requires all scientists who use human subjects to undergo special education before receiving NIH grant dollars went into effect Sunday.

The policy does not have the force of law, but the NIH will deny researchers grant money if they have not fulfilled the educational requirements. Harvard researchers received almost $200 million in NIH funding in 1999.

Harvard has responded to the NIH policy already, creating a web-based training program for its personnel. But Harvard administrators will be responsible for filing paperwork to prove that every researcher on every project has viewed the web-based program--and ensuring no grant application is sent to Washington without this paperwork.

At a Faculty Council meeting two weeks ago, Faculty members expressed concern about the time and effort these measures will require.

Faculty worry other proposed guidelines that could come into being as early as November would affect all types of scientific research would only add to the burden.

The Plan

The NIH's policy is part of a program meant to ensure responsible conduct in research, according to Dr. Belinda Seto, deputy director of the Office of Extramural Research at the NIH, which is an agency of DHHS.

Public attention has been focused on research involving human subjects since 18-year-old Jesse Gelsinger died at the University of Pennsylvania during a gene therapy trial.

"In our recent initiative to strengthen the entire system for the protection of human subjects, one of our initiatives is to require researchers

involved with the design or conduct of research to be educated on regulation and on ethical issues in this area," Seto says.

The definition of a course of instruction is purposely flexible, according to Seto, which allows online versions like Harvard's to fulfill the requirement.

"We at the NIH did not prescribe what courses they should take but we gave them sufficient flexibility to make that decision," Seto says.

According to Seto, the type of education appropriate would vary by the type of research conducted.

"Beyond the fundamentals, investigators should adapt what is suitable and commensurate with their

areas of interest," she says.

Harvard's Web

At Harvard the web-based training course is tailored towards the general needs of the kinds of research conducted in an academic setting.

"We wanted to include things in our training that are particular to Harvard and relevant to University investigators," says Dean R. Gallant '72, the executive officer of the use of human subjects research committee. He was also the Faculty of Arts and Science's representative on the team that developed of the web-based training program.

Harvard's program is also flexible in that, after an introductory segment, researchers follow different paths through the training depending on whether they are affiliated with the Faculty of Arts and Science (FAS), the medical school (HMS) or the School of Public Health.

For those professors or lab assistants who work at the bench, the time commitment is small. A quick scan of the website could be completed in as little as an hour.

Once a researcher finishes the training, verification is sent by e-mail to the researcher, as well various administrators who work to process grant applications before sending them to the government.

Additionally, each NIH grant application must include a letter with a delineation of all "key personnel" that received the training and a description of the education program. A sample letter is posted on the FAS website,

The administration will be responsible for compiling all the paperwork and ensuring that no researcher who works with human subjects fails to view the website.

If applications are filled out incorrectly, research projects stand to lose their federal grant funding.

The Way to the Web

According to Gallant, administrators have been working since the early summer to determine their response to the proposal. At decentralized Harvard, the University first had to decide whether FAS and the different graduate schools would respond individually or whether they the University would coordinate a joint response.

The decision was complicated here because other human subject research protection is handled by three separate

Institutional Review Boards (IRBs) in the University--one for the Medical School, one for the School of Public Health and one for FAS, according to Mary H. Mitchell, the associate director for awards management for the University.

But to ease acceptance of the new educational guidelines, administrators decided they had to collaborate across the University.

Individuals from all the three IRBs and from the central administration took part in the development of the website.

Mitchell coordinated the effort.

"It seemed that a lot of places were developing web-based training. It has advantage of not being scheduled out so that people can complete the training on their own times," Gallant says.

Once work actually began on the program, it was developed in six weeks. More features will be added in the coming months, including case studies, according to Mitchell.

In addition to the web-based training, the Medical School last week brought in experts in human subject research to lead a seminar on ethics. With the NIH announcement looming, the seminar was packed.

"The program is widely known

in the IRB community, widely known and provides the kind of training that NIH wants to see," Gallant says. "But as soon the announcement came out, the program was booked because everyone wanted them to come and do their road show."

The NIH currently has its own internal human subject protection training on-line that can be used as resource for researchers at other agencies.

Harvard decided not to adopt that program directly because it was specific to the NIH in too many ways, according to Gallant.

Integrity in Research

But required training for human subject research is only the first of new guidelines for scientific research that the government is expected to hand down in the coming months.

On July 17, the Office of Research Integrity of the Public Health Service (PHS) proposed a new policy requiring universities receiving federal grant dollars to set up educational programs for scientists doing all kinds of research.

The proposal specifies 10 content areas that must be covered by new training programs. Only one of them relates to research with human subjects.

The other content areas include a myriad of other ethical issues facing researchers, including the use of animals, collaborative science and conflict of interest.

The proposed policy would affect grantees of any PHS agency, including the Centers for Disease Control.

If the proposal passes, the government would require Harvard to prove that it had established a comprehensive educational program for its scientists.

That would greatly increase the number of people required to undergo ethics training.

"The content of instruction is up to each institution. We have asked the institutions to have a written plan for instruction. We will look at those to

see if they are consistent with the policy. But we are not going to approve content," says Chris Pascal, director of the office of research integrity at the PHS.

Like the NIH policy, the PHS proposal in its current form would allow web-based programming to fulfill educational requirements.

Burdened By Paper

Faculty members have expressed worry that the new NIH and PHS policies would create new paperwork and cost Faculty and administrators valuable time.

"Clearly there is a lot of administrative work involved in developing a system that requires that you can certify that all the people involved with research in federally funded areas have completed training," Gallant says. "Just the paperwork itself is incredibly complex."

Because University administrators process all grant applications, they would be responsible for keeping track of every researcher who has completed the training and for ensuring that those who had not done the training did so, according to Mitchell.

The NIH maintains that it is aware of the demands on non-funded federal mandate.

"We recognize that this will create additional cost and burden to institutions," Seto says. "The whole topic of regulatory burden is being addressed by NIH."

The PHS proposal has the potential to create an even greater burden on universities, which would be required to certify they administer broad-based training to hundreds of employees.

Pascal says PHS is investigating the possibility of providing grant funding for the development of educational curricula for research institutions. It is also planning on posting material on the Internet that will help institutions to develop their curricula.

The proposal is currently being revised by PHS, which plans to complete the guidelines in November, Pascal says.

According to Mitchell, the PHS policy would give universities two years to develop new educational programs, whereas the University had to comply with the NIH's new guidelines within four months of their announcement in June.

"Initially, we are waiting to see what comes out of Washington so we can design the scope of our program appropriately," Mitchell says.