RESPONSIBLE CONDUCT OF RESEARCH
Responsible Conduct of Research (RCR): RCR is the ongoing process of
reconciling regulations, guidelines, standards, and ethics to promote integrity in
the proposing, planning, conducting, reporting, and reviewing of research.
(from http://rcrec.org/charter.html)
CORE COMPETENCIES
The federal Office of Research Integrity has recommended that each research
organization should determine and implement policies which ensure integrity and
responsible research.
They provide recommendations as to critical core
competencies to guide definition of policies, education programs and measures
of effectiveness. (from http://ori.dhhs.gov/html/programs/finalpolicy.asp#core )
1. Data acquisition, management, sharing and ownership –
Accepted practices for acquiring and maintaining research data. Proper
methods for record keeping and electronic data collection and storage in
scientific research. Includes defining what constitutes data; keeping data
notebooks or electronic files; data privacy and confidentiality; data
selection, retention, sharing, ownership and analysis; data as legal
documents and intellectual property, including copyright laws.
2. Mentor/trainee relationships –
The responsibilities of mentors and trainees in predoctoral and post
doctoral research programs. Included the role of mentor, responsibilities
of a mentor, conflicts between mentor and trainee, collaboration and
competition, selection of a mentor, and abusing the mentor/trainee
relationship.
3. Publication of practices and responsible authorship –
The purpose and important of scientific publication, ant the responsibilities
of the authors. Includes topics such as collaborative work and assigning
appropriate credit, acknowledgments, appropriate citations, repetitive
publications, fragmentary publication, sufficient description of methods,
corrections and retractions, conventions for deciding upon authors, author
responsibilities, and the pressure to publish.
4. Peer review –
The purpose of peer review in determining merit for research funding and
publications. Includes topics such as, the definition of peer review,
impartiality, how peer review works, editorial boards and ad hoc reviewers,
responsibilities of the reviewers, privileged information and confidentiality.
5. Collaborative science –
Research collaborations and issues that may arise from such
collaborations. Includes topics such as setting ground rules in the early
collaboration, avoiding authorship disputes, and the sharing of materials
and information with internal and external collaborating scientists.
6. Human subjects –
Issues important in conducting research involving human subjects.
Includes topics such as the definition of human subjects research, ethical
principles for conducting human subjects research, informed consent,
confidentiality and privacy of data and patient records, risks and benefits,
preparation of a research protocol, institutional review boards, adherence
to study protocol, proper conduct of the study, and special protections for
targeted populations, e.g. children, minorities, and the elderly.
7. Research involving animals –
Issues important to conducting research involving animals. Includes
topics such as definition of research involving animals, ethical principles
for conducting research on animals, Federal regulations governing animal
research, institutional animal care and use committees, and treatment of
animals.
8. Research misconduct –
The meaning of research misconduct and the regulations, policies, and
guidelines that govern research misconduct in PHS-funded institutions.
Includes topics such as fabrication, falsification, and plagiarism; error vs.
intentional misconduct; institutional misconduct; policies; identifying
misconduct; procedures for reporting misconduct; protection of
whistleblowers; and outcomes of investigations, including institutional and
Federal actions.
9. Conflict of interest commitment –
The definition of conflicts of interest and how to handle conflicts of interest.
Types of conflicts encountered by researchers and institutions: Includes
topics such as conflicts associated with collaborators, publication, financial
conflicts, obligations to other constituencies, and other types of conflicts.
ADDITIONAL TOPICS OF COMPETENCY FOR CONSIDERATION:
The current research environment has also brought several issues into the
public eye. Other competencies which have value for consideration in our
current research environment are:
Environmental Health and Safety – The impetus for applied education in
laboratory safety is based upon current federal regulations and guidelines.
Prudent education practices apply to all the laboratory environments now
hosting research activities at university and research centers nationwide.
Intellectual Property Rights and Ownership – The definition of intellectual
property is “intangible property that is the result of creativity (such as patents
or trademarks or copyrights.) (from http://www.thefreedictionary.com)
The evolution of the types of creative results that are presently considered
intellectual property include multiple products, such as: an idea, an invention,
an expression of literary creation, a unique name, a business method, a
process, a scientific or chemical formula, a computer program process, a
presentation. These products are quite unique when compared to the
traditional property associated with copyrights, trademarks, clinical trial results
and patents. The protection of these rights is becoming more complex, and
early and consistent clarification of whose rights they actually are will facilitate
research which is absent of legal and financial conflicts.
Fiscal Accountability – The responsibilities for proper fiscal management of
grants and contracts are deeply embedded in federal government regulations
and guidelines. These practices are made more complex when the interests
of state, local and university government must also be practically blended into
a feasible financial management scenario.
The legal responsibility of the Principal Investigator (PI) researcher for
understanding and oversight of grant fiscal management has elevated this set
of rules and guidelines to be crucial components in a researcher’s tool kit.
The tasks associated with determining the grant award amount, expenditures,
cost transfers, unallowable costs and financial reporting, to name a few, have
greatly increased the need for involvement of researchers in the day to day
budget management. The management of risks and liabilities of proper fiscal
management of the grant are the responsibility of the Principal Investigator,
with the university or research center acting as the PI’s facilitator. It is
reasonable to elevate fiscal responsibility as another critical competency to be
instructed and practiced by everyone in the research community.
OSP 9/10/04