Research Design, Methods, and Responsible Conduct

Trainees should become familiar with the methods and problems inherent in performing and interpreting clinical and basic science research.  This would be best accomplished through participation in the design, performance, and interpretation of a research project.  However, it is realized that for many trainees interested in more clinical careers, such a time investment may not be worthwhile.  In this case, the training program should provide a teaching program that focuses on these components of research.  This is best accomplished through a weekly journal club that critically reviews clinical and basic science articles.

I.   Program Content

1. Trainees must acquire knowledge and understanding of the following areas during the course of their training:

1. Hypothesis development.

2. Experimental design of human, animal or other experiments.

3. Elementary statistical analysis.

4. If necessary, as noted under item B, the writing of protocols that would be submitted to the institutional review board regulating research on humans or the institutional animal care and use committee.

5. Preparation of data for publication.

6. Acquisition, recording and storage of data.

7. Scientific integrity and the responsible conduct of research.

a.  Protection of animal and human subjects (IRB, IACUC).

b.  Integrity in the collection and recording of data.

c.  Integrity in the interpretation of data.

d.  Integrity in the authorship and publication.

e.  Nuremberg code, Helsinki declaration, Belmont Report.

     8.   Scientific misconduct and fraud.

a.  Self deception.

b.  Fabrication, falsification, plagiarism.

c.  Conflicts of interest.

i.  Scientist-scientist relationship.

ii.  Scientist-industry relationship.

II.  Research Experience

This can be acquired in various areas including, but not limited to, physiology, biochemistry, pharmacology, pathology, or clinical research.

1. Trainees working in a laboratory must develop familiarity with and a working knowledge of techniques and assays relevant to their project.

2. Trainees working on a clinical research project in a General Clinical Research Center should admit study subjects to center, participate in obtaining informed consent, and play an active role in the study.

3. Trainees participating in clinical outcomes studies must be familiar with the methods used to acquire data and should participate in a meaningful way in the analysis of such information.

4. Trainees should participate in the preparation of abstracts, manuscripts or reports that originate as a result of the studies.