Scientific Integrity: Text and Cases in Responsible Conduct of Research, 4th Edition
Francis L. Macrina, 2014, 530 pages, ASM Press, $52.99
Review by Norman M. Goldfarb
Scientific Integrity: Text and Cases in Responsible Conduct of Research, 4th Edition should be required reading for anyone conducting or managing a clinical research.
Clinical research ethics and regulatory compliance primarily deal with the impacts of clinical studies on others, principally the protection of study participants, the generation of high-quality data for study sponsors, and correct billing to government agencies.
Scientific integrity is the foundation of the responsible conduct of scientific research. In addition to impacts mentioned above, it also deals with the scientific research process itself and its impact on researchers. Scientific integrity is based on the following core values, as described in the book:
Honesty. This applies to all aspects of the research process, including proposing, performing, reviewing and reporting research. It requires that conduct across these areas be free from fraud and deception. Honesty requires being responsible for one's actions, being truthful, and being obligated to meet any and all commitments to the research process and to others.
Trust. This value reflects confidence in the research across a spectrum that covers investigator conduct, methods used, data analysis, interpretation and reporting. Trust is earned at the level of both the individual scientist and the institution by the conduct of research that is lawful and compliant with applicable policies, regulations and guidelines.
Fairness. This value reflects behavior characterized by sound and impartial judgment. Being fair as a scientist includes providing appropriate credit to the work of others, citing the literature accurately and responsibly, providing appropriate recommendations, conducting objective peer review, and sharing data.
Openness. Openness is characterized by forthright discussion with and accessibility to the scientific community and to the public. It applies to individual scientist's conduct, conflict disclosure and management, communication with the scientific and public communities, reporting of research results, and acknowledgment of research contributions.
Accountability. Scientists are required to be accountable for and are answerable for their actions in proposing, performing, reviewing and reporting research.
Stewardship. This is expressed in a variety of ways to include efficient and nonwasteful use of resources, responsible use of research funds, duty of care in conducting research that involves human or animal subjects, and responsibility for the training and preparation of future generations of scientists.
Objectivity. Objectivity requires that interpretations be based on facts and evidence that have been properly collected and rigorously analyzed, and that conclusions are free of improper bias.
Accuracy and reliability. These values involve exercising care to avoid errors in the performance of research and precise reporting and communicating of the research process, the results, and the conclusions.
Impartiality and independence. Scientists establish their impartiality by being proactive in the identification of conflicts of interest, and then by disclosing and reporting them as appropriate to their institutions, sponsors and the scientific publication and review enterprise. Where necessary, scientists work with the appropriate bodies to create and implement management plans to reduce or eliminate perceived or real conflicts. This process affirms the scientist's independence in his or her proposing, conducting, reporting or reviewing research by insulating their work from the inappropriate connection to outside interested parties, from ideological or political pressure groups, and from economic interests that might lead to bias in judgment.
The book includes dozens of cases for discussion, such as the following two:
Dr. Colleen May is a participating neurologist in a clinical trial to assess the efficacy and toxicity of a new anticonvulsant medication. For the duration of the 2-year study, each neurologist is to meet with each of his or her patients for an average of 30 minutes each month. In Dr. May's case, this amounts to an average of 20 hours per month. During each visit, the physicians administer a variety of specialized tests, requiring judgments dependent on their experience and training in neurology. At the completion of the study, the results are to be unblinded and analyzed by the project leaders. It is anticipated that at least two publications will be prepared for the New England Joumal of Medicine. Dr. May has just learned that she will be listed in the acknowledgments but not as a coauthor of the manuscript. Dr. May argues that she has provided nearly 500 hours of her expert time, far more than needed to complete a publishable study in her experimental laboratory. Does Dr. May have a case for authorship?
Why or why not?
A proposal currently under consideration by your IRB involves the administration of fluorescently labeled, mouse-derived monoclonal antibodies to patients. These immunologic reagents would be used to test their ability to localize and diagnose tumors. The committee discusses the informed consent form proposed for use in these experiments. Specifcally, one member of the committee argues that the consent form fails reveal that participation in this study could preclude the future use of anti-tumor, mouse-derived monoclonal antibody therapy in these patients. This argument is based on the possibility that such patients could mount an anti-mouse antibody response. Considerable disagreement among committee members erupts as a result of this issue. Where do you stand? Why?
The book includes 11 chapters by seven contributors:
* Methods, Manners, and the Responsible Conduct of Research
* Ethics and the Scientist
* Mentoring
* Authorship and Peer Review
* Use of Humans in Biomedical Experimentation
* Use of Animals in Biomedical Experimentation
* Competing Interests in Research
* Collaborative Research
* Research Data and Intellectual Property
* Scientific Record Keeping
* Science, Technology and Society
-Norman M. Goldfarb is chairman of MAGI and chief collaboration officer of WCG Clinical. Contact him at 1.650.465.0119 or [email protected].
