1. Responsible Conduct of Research (RCR)
What is it?
Why does it matter?
June 7, 2019

2. OBJECTIVES
Discuss what Responsible Conduct of Research is and why it is important
Become familiar with RCR core domains
Identify strategies for avoiding common ethical issues related to research
Identify how RCR concepts intersect with daily work duties
Explore case studies related to human subjects research

3. What is Responsible Conduct of Research (RCR)?
NIH - “Responsible conduct of research is defined as the practice of scientific investigation with integrity. It involves the awareness and application of established professional norms and ethical principles in the performance of all activities related to scientific research.”

4. Why is RCR Important?
Irresponsible conduct of research = bad science = bad data
Public safety
Public trust in science
Today’s research is a building block for tomorrow’s research
Federal regulations
Institutional policies
Professional code

5. Everyone has a role in ensuring the Responsible Conduct of Research!

7. Nine Core Domains of RCR
Conflict of interest
Research misconduct
Mentor/trainee responsibilities
Collaborative research
Peer review
Data acquisition, management, sharing, and ownership
Responsible authorship and publication
Research involving animals
Research involving human subjects

8. RCR Training
Portions of this training were taken from “Introduction to the Responsible Conduct of Research” - an ORI publication written by Nicholas H. Steneck.

9. Conflict of Interest
A conflict of interest is any circumstance where personal, professional, financial, or other private interests of a person or institution compromise or have the potential to compromise the exercise of professional judgment or obligations, or may be perceived as doing so.
(2014) CITI "Conflicts of Interest Guide"

10. Conflict of Interest Financial conflicts Conflicts of commitment
Personal and intellectual conflicts

11. Research Misconduct
Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
Fabrication is making up data or results and recording or reporting them.
Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record.
Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.
Research misconduct does not include honest error or differences of opinion
42 cfr 93

12. Research Misconduct
A finding of research misconduct requires the following:
There be a significant departure from accepted practices of the relevant research community, and
The misconduct be committed intentionally, knowingly, or recklessly, and
The allegation must be proven by a preponderance of the evidence.
42 CFR 93

14. Research Misconduct - Whistleblower Protections
Applicable UAMS policies:
UAMS Reporting Policy, Admin Guide
Federal False Claims, Admin Guide
Responsible Conduct of Research, Admin Guide
Code of Conduct, Admin Guide

15. Research Misconduct - Whistleblower Protections
Protections are provided for employees who report suspected misconduct, fraud, or other inappropriate behavior in good faith….
Good Faith means having a belief in the truth of one’s allegation or testimony based on the information known at the time. An allegation or testimony is not in good faith if made with knowledge or reckless disregard of information that would negate the allegation or testimony.

16. Research Misconduct - Whistleblower Protections
UAMS shall take reasonable and practical efforts to protect or restore the position and reputation of any Complainant, witness, or Inquiry or Investigation committee member and shall take appropriate disciplinary action against any individual who retaliates against someone for making an allegation of Research Misconduct or participating in a Research Misconduct proceeding.

17. To Report Research Misconduct or Research Integrity Concerns:
Please contact one of the following:
Dr. Larry Cornett, UAMS Research Integrity Officer or
Darri Scalzo, UAMS Research Compliance Officer or
Nancy Rhea, UAMS Research Compliance Analyst or

18. To Report Research Misconduct or Research Integrity Concerns:
To report a concern anonymously, you may call the UAMS Compliance Hotline at

19. Mentor/Trainee Relationship
Keys to a good mentor/trainee relationship:
Clear understanding of mutual responsibilities
Commitment to a productive and supportive research environment
Proper supervision
Focus on preparing trainees to become successful researchers

20. Mentor/Trainee Relationship
Points for the Trainee to consider early in the relationship:
Expectations of time commitment
Criteria used for judging performance (letters of recommendation…)
Division or sharing of research responsibilities
Procedures for recording and interpreting data
Authorship and ownership of data

21. Mentor/Trainee Relationship
Mentor expects that the trainee will:
Complete assigned work in a conscientious manner
Use resources responsibly
Respect authority of others
Follow research regulations and research protocols
Abide by established agreements for authorship and data ownership

23. Collaborative Research
Things to consider…
Working relationships range from simple to extremely complex
Goals may be similar, but not identical
Federal and sponsor regulations
Institutional policies
Cultural differences (individuals and universities)

24. Collaborative Research
Early in the project:
Spell out goals
Define role of each partner
Determine how data will be collected, stored, and shared
Agree how and who will make changes in research design
Establish who will draft publications and who will be the lead/corresponding author

25. Collaborative Research
Also consider these early in the project:
Criteria for determining authorship
Who holds responsibility for report submissions
Who can speak publicly about the project
How are intellectual property rights & ownership issues resolved
How can the collaboration be changed
When does the collaboration end

26. Collaborative Research
Compliance considerations:
Follow compliance policies for work at UAMS
Learn about compliance expectations for other sites
In order for a project to be successful, all sites must be in compliance with applicable policies and regulations

27. Collaborative Research
When collaborating with another discipline:
Be aware of and fulfill ALL responsibilities (do not ignore any)
When evaluating the most appropriate course of action, select the most demanding

28. Peer Review
Peer review is the evaluation by colleagues with similar knowledge and experience.
Don’t agree to serve as a peer reviewer if you don’t meet the qualifications above.

29. Peer Review Peer review determines: Which projects get funded
Which research findings are published
Which research is reliable
Who is promoted or hired

30. Peer Review Can make or break a professional career
Can determine the fate of programs, health initiatives, etc.
Can lead to determinations regarding regulations
Can play a role in decisions regarding safety and environment

31. Ethical Standards of Peer Review
If you don’t feel qualified, contact editor or agency promptly
Reviews should be submitted in a timely manner
Be objective in the review
Quality of work
Validity of experimental and theoretical work
Validity of interpretations
Consider through a lens of high scientific and literary standards
Committee on Publication Ethics (COPE)

32. Ethical Standards of Peer Review
REMEMBER: Review documents/manuscripts are confidential
Never disclose unpublished information that was seen during the peer review process
Committee on Publication Ethics (COPE)

33. Data Acquisition, Management, Sharing, and Ownership
Research begins and ends with data
Data related issues should be discussed and figured out before any data is collected

34. Data Acquisition, Management, Sharing, and Ownership
Determine proper methods of data collection and stick with them throughout the project
Determine data ownership before project begins
Are there any obligations related to collecting the data?
Are certain permissions needed to use the data?
Is data stored so that it is protected?
What rules apply to data sharing?

35. Responsible Authorship and Publication
Authorship is limited to individuals who make a significant contribution to the work described in the manuscript.
All who qualify for authorship should be listed in the manuscript.
Authors should take responsibility for the work described in the manuscript.
Corresponding or primary author refers to person who will answer questions and represent all of the colleagues. Note: this is a very important role since a misstep could negatively impact the careers of others.

36. Responsible Authorship and Publication
Avoid the following:
Honorary or gift authorships
Salami publications (dividing work into least publishable units in order to increase the number of publications)
Duplicate publications/self plagiarism
Premature statements

38. Animal Research Animal research is necessary.
The FDA requires prior animal studies before a new drug may be studied in humans. Pharmacology and toxicology information from animal studies must be submitted with an application to study a new investigational drug.
In order to have good human subject research, we must first have good animal research!

39. Animal Research
Highly regulated - extensive federal regulations and institutional policies are in place to ensure humane care and use of animals in research
Protocols must be reviewed and approved by the Institutional Animal Care and Use Committee (IACUC)
Continuing review is required annually and full protocol renewal is required every 3 years
Researchers must be aware of and follow regulations
Training is required
Non-compliance can be reportable to federal agencies

41. Human Subjects Research
Human subjects research benefits society greatly (drug studies, medical procedures, behavioral studies…)
It also poses certain risks to human participants (physical, emotional, loss of confidentiality…)
Regulations are created to protect research participants and society
Risk/benefit analysis is needed for all research

42. Human Subjects Research
Keep in mind the Belmont Report as the basis for research regulations (Respect for persons, Beneficence and Justice)
The Institutional Review Board (IRB) must review and approve the study before it may begin.
The IRB review is to ensure that the risks to subjects are minimized, benefits outweigh the risks, subject selection is equitable, and adequate protections are in place for subjects.
Appropriate and valid informed consent must be obtained from subjects before starting study procedures unless waived by the IRB

43. Human Subjects Research
Things to consider throughout the study:
Is the study design ethical?
Are the principles of Respect for Persons, Beneficence, and Justice employed?
Is there a proper risk/benefit ratio?
Are the appropriate subjects being recruited?
Is informed consent appropriately obtained and confirmed throughout?
Are subjects being protected?
Is the protocol being followed?

44. Human Subjects Research
More things to consider throughout the study:
Is data collection adequate? Is it well-documented?
Is data storage secure?
Are there provisions to protect the privacy of subjects and the confidentiality of data?
Is there an appropriate statistical analysis of the data?
Is there a plan for monitoring data to ensure safety of subjects?
Are the results interpreted and presented accurately?

45. Animal and Human Subjects Research
In order to conduct research responsibly, research staff must:
Know the regulations that apply to their research
Know how to comply with those regulations
Understand that projects must be reviewed and approved by the appropriate institutional oversight committee – IACUC for animal work and IRB for human subjects work
Be appropriately trained
Accept the responsibilities associated with all stages of the research

46. Fostering Integrity in Research National Academies of Sciences and Engineering Medicine (NASEM)
Detrimental research practices
Honorary authorship
Demanding authorship in return for access to data
Denying authorship to those who have earned it
Not retaining data
Not making data available
Neglectful or exploitative supervision

47. Fostering Integrity in Research National Academies of Sciences and Engineering Medicine (NASEM)
Detrimental research practices continued…
Misleading statistical results
Inadequate institutional policies and procedures to foster research integrity and to address research misconduct
Abusive or irresponsible publishing

48. Irresponsible Research is Costly
Time
Money
Knowledge
Public Health
Public Trust

49. Fostering Integrity in Research-NASEM

50. “The scientific research enterprise, like other human activities, is built on a foundation of trust.”
National Academy of Sciences, “On Being a Scientist”. 1995

51. ORI Case Studies Related to Human Subjects Research

52. “Values first. Logic and data second.”
-Bruce A. McPheron, PhD, Executive Vice President and Provost, The Ohio State University

53. Questions? For questions or more information, please contact:
Darri Scalzo Nancy Rhea
Research Compliance Officer Research Compliance Analyst

54. To Report Research Misconduct or Research Integrity Concerns:
Please contact one of the following:
Dr. Larry Cornett, UAMS Research Integrity Officer or
Darri Scalzo, UAMS Research Compliance Officer or
Nancy Rhea, UAMS Research Compliance Analyst or

55. Use the QR code to log your attendance and give us feedback
Date: June 7, 2019
Category: Research Fundamentals
Instructor(s): Darri Scalzo and Nancy Rhea
Session title: Responsible Conduct of Research
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