T H E   N I H    C A T A L Y S T      J U L Y  –  A U G U S T   2004

E T H I C S   F O R U M



by Joan P. Schwartz

Joan P. Schwartz, chair, NIH Committee on Scientific Conduct and Ethics

IIn keeping with a new policy issued by the PHS Office of Research Integrity that requires training in the responsible conduct of research (RCR) for all researchers supported by PHS funds, we have launched a computer-based course on Research Ethics. You will find it here.

In keeping with the NIH tradition of crafting useful and stimulating online ethics exercises, this RCR course makes for very interesting reading, is crisp and quite informative, and offers provocative problems to solve and questions to answer.

Who Must Take the Course, and When

Under this policy, all research staff in the NIH IRP who have "direct and substantive involvement in proposing, performing, reviewing, or reporting research, or who receive research training," will participate in RCR instruction.

We define those staff as senior investigators, tenure-track investigators, senior scientists, and clinicians, staff scientists and clinicians, research and clinical fellows, pre- and postdoctoral trainees, technicians, research nurses, and special volunteers or guest researchers involved in these activities.

All current staff must complete the course by October 31 of this year, and all new staff will take it as part of the web-based orientation package they are required to complete.

Baseline Nuts and Bolts

The NIH Committee on Scientific Conduct and Ethics (CSCE) spent the better part of a year developing this web-based Research Ethics course.

The course puts forth standards of research integrity for the performance, presentation, and review of scientific results that are well known to NIH researchers.

These standards cover a variety of issues, from determining authorship to data management, handling collaborations, management of conflicts of interest, peer review, and the ethical issues related to the use of humans and animals in research. Mentoring is also a key component.

The course is designed to ensure that all intramural scientific staff have a baseline understanding of these standards. And it sets the stage for the research ethics case discussions that have been integrated into the conduct of research at NIH (see below).

PHS Objectives

The long-term goals of RCR training, as defined by the PHS, are:

To increase researchers’ knowledge of, and sensitivity to, issues surrounding the responsible conduct of research

To improve the ability of our scientific staff to make ethical and legal choices in the face of conflicts involving scientific research

To develop an appreciation for the range of accepted scientific practices for conducting research

To provide information about the regulations, policies, statutes, and guidelines that govern the conduct of PHS-funded research

To develop positive attitudes toward lifelong learning in matters involving the responsible conduct of research

The PHS policy requires a combination of one-time training in a set of core areas (including data acquisition, management, sharing, and ownership; mentor and trainee responsibilities; publication practices and responsible authorship; peer review; collaborative science; research misconduct; and conflict of interest and commitment; and research involving human subjects and animals)—and yearly follow-ups.

Ethics Case Discussions

The yearly follow-ups have been ongoing here at NIH for several years through the use of research ethics case discussions, led by trained facilitators and given to groups of 20–30 people at a time.

Each year the CSCE chooses a theme for the next year, generally based on the issues that have risen to the top of our attention, or been recommended by intramural scientists, during the previous year. We review a collection of possible cases and select those we feel will be most stimulating and informative for discussion.

A website within the Intramural Research Sourcebook contains the set of cases to be used for each topic, along with supplementary information.

Staff have been trained in each IC to serve as facilitators, whose primary tasks are to ensure that everyone takes part in the discussion, that the key points are covered, and, most importantly, that the discussion is lively.

This year (2004)—given the interest stimulated by Dr. Zerhouni’s Roadmap initiatives—the theme is collaborative science.

The ICs have some flexibility in how they choose to carry out the yearly training, but are expected to adopt the theme chosen for a given year. That allows us to update staff on new policies in a relatively rapid and all-inclusive way. Any scientist interested in serving as a facilitator should contact his or her scientific director or CSCE member. For a list of IC representatives, see this website.

Most of you have participated in these research ethics case discussions, so you already know that they are not only intellectually stimulating but also fun.

The case discussions have been supplemented over the years with Ethics Forum columns such as this one, published in The NIH Catalyst, that address new or difficult issues that come to our attention.

But no part of the training has ensured that everyone has the same baseline understanding of RCR that is outlined in the NIH Guidelines for the Conduct of Research—hence the computer course.

In Your Court

As you go through the course, you will find at the end of each module a quiz or mini-case to test your understanding of what you have just learned, and we hope that you will find these interesting and fun also.

Equally important, we designed the course to serve as a research ethics resource, with a Resources section and a Glossary, and we recommend that you bookmark the course for future reference.

Also built in is the ability to print out "Key Points to Remember from the NIH Ethics Course on the Responsible Conduct of Research," along with a certificate demonstrating that you have completed the course.

We invite you to share your ideas on topics for case discussions and on how to improve the training experience. Comments can be sent to this address.

—Joan P. Schwartz
Assistant Director, OIR


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