Thought you were done with formal education? Well, think again! Many U.S. scientists will be required to pick up their pencils and go back to school later this year to fulfil new training mechanisms being established by federal funding agencies.

On 1 October 2000, the National Institutes of Health (NIH) will implement a new policy requiring grant applicants who wish to use men, women, or children in research studies to become "educated" on the protection of human research participants. Posted last month, the NIH's notice reveals that "investigators must provide a description of education completed in the protection of human subjects" before funds can be awarded.

Moreover, according to a draft of an anticipated Public Health Service (PHS) policy from the Office of Research Integrity (ORI) at the Department of Health and Human Services (DHHS), the NIH scheme is only one part of a much larger federal effort aimed at improving the conduct of all research projects--not only those that use humans.

In part, these policy changes are a response to the string of seemingly unethical research practices and experimental oversights that came to light earlier this year. At that time, DHHS Secretary Donna Shalala announced several new initiatives aimed at improving and tightening supervision of federally funded medical research. By demanding better education of students, researchers, and professionals, it is hoped that human studies will be designed and conducted with more focused consideration of ethical details and research conduct.

The idea is not an entirely new one: Awardees of NIH's training grants have had to show that all beneficiaries of the grant receive appropriate training in ethics and research conduct. But now the policy covers all NIH grants that have a human subject component.

What does this mean for you? In the not-too-distant future, all investigators supported by federal funds will likely have to receive training in the "responsible conduct of research," regardless of their scientific pursuits. Certainly, the NIH policy--requiring that scientists be trained in the protection of human research subjects--is a done deal; however, the public has until 21 August to comment on the draft PHS policy.

So, how are you going to obtain the necessary training to show that you understand the ethics of human research? Although courses on the protection of human subjects will not be evaluated by the NIH, universities and research institutions will have to provide their own "educational programs" for their investigators. "The important issue is that scientists and students have access to such courses," remarks Mark S. Frankel, director of Scientific Freedom, Responsibility, and Law Program at the American Association for the Advancement of Science (publisher of Science's Next Wave). The development of Web-based tutorials--such as Virginia Commonwealth University's self-instructional program--will enable students across the country to enroll in training programs, and perhaps lessen the pressure on some institutions to come up with their own courses right away. "Students don't have to be lodged at the particular institution" to participate, Frankel says.

Sample Questions From Protecting Study Volunteers in Research

  • Which of the following constitutes informed consent from a study subject?

    a) reading the consent form
    b) signing the consent form
    c) reading and signing the consent form
    d) reading the consent form, asking questions, understanding the information, and signing the consent form

  • What actions must an investigator take to make changes in a study protocol?

    a) obtain IRB approval of the change before implementing the change
    b) modify the consent form, if needed, and get IRB approval
    c) obtain new consent from subjects already enrolled if directed by the IRB
    d) all of the above
    e) none of the above

  • The University of Rochester, for example, already has in place a training scheme to guide and test investigators who work with human subjects. A training manual-- Protecting Study Volunteers in Research --co-written by Rochester's Cynthia Dunn, director of the Clinical Research Institute, and Gary Chadwick, executive director of the Research Subjects Review Board, was released last September. According to CenterWatch, an online clinical trials listing service that publishes the manual, approximately 20,000 copies have been sold so far: The sales were "beyond what we expected," reveals Chadwick, underscoring the fact that there is huge demand for such materials.

    Other universities, including those that do not have medical schools, are working hard--"scrambling" even--to get similar ethics courses and resources up and running, after being notified this June of the October deadline. To help institutions through the process, the NIH will provide financial support for short-term courses in research ethics, says Ruth Fischbach, NIH's senior bioethics advisor.

    Under the NIH policy, applicants will have to provide program officers with documentation certifying they have completed training. However, the NIH's "Just-in-Time" submission practices will allow applicants to send in those papers after they receive their application's review score and not at the time of submission.

    But the new NIH policy is only the first step. The ORI's PHS Policy on Instruction in the Responsible Conduct of Research is an all-encompassing draft of guidelines that will eventually supercede the NIH policy. It is unclear at this stage just what specific research areas are to be covered by the draft policy, which includes the following statement: "The policy pertains to all research, including animal, human, or basic research, or research training, conducted with grant, contract, or cooperative agreement support from any agency, or office, of the PHS."

    PHS/ORI Core Instructional Areas

    While there are no clear guidelines stipulating the design of courses on the protection of human subjects to fulfil the NIH policy, the draft of the PHS policy specifically requires institutions and universities to "contain the following core areas of instruction" when designing their training programs:

  • Data acquisition, management, sharing, and ownership

  • Mentor/trainee responsibilities

  • Publication practices and responsible authorship

  • Peer review

  • Collaborative science

  • Human subjects

  • Research involving animals

  • Research misconduct

  • Conflict of interest and commitment

  • Compliance with existing PHS and institutional policies

  • Those agencies and offices include the NIH, the Centers for Disease Control and Prevention, and the Food and Drug Administration. Under the PHS policy draft, anyone receiving funds from these sources will have to take a course in responsible research conduct.

    Although the NIH policy on human subjects research training applies to each applicant, the PHS-drafted policy would be institution-wide. That is, the onus will be on universities--not individual applicants--to show that training courses exist and that researchers can, and do, attend.

    PHS officials hope to finalize the draft policy for release in October this year. But, explains ORI's acting director Chris Pascal, there will be a 2-year "phasing-in" period, beginning 1 June 2001, during which institutions can set up courses and begin to implement the policy. Researchers have until 21 August to comment on the PHS policy draft. After its predicted release in October, Pascal envisions the NIH and PHS policies will work "in parallel" over the next couple of years. The PHS rulings, he remarks, will "not supercede the NIH policy" until a separate announcement is made that NIH's human subjects' guidelines have been merged into the larger PHS policy.

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