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

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

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.”

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

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

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

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

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"

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

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

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

Research Misconduct - Whistleblower Protections Applicable UAMS policies: UAMS Reporting Policy, Admin Guide 15.1.02 Federal False Claims, Admin Guide 15.1.03 Responsible Conduct of Research, Admin Guide 16.1.04 Code of Conduct, Admin Guide 4.4.01

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.

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.

To Report Research Misconduct or Research Integrity Concerns: Please contact one of the following: Dr. Larry Cornett, UAMS Research Integrity Officer 501-686-5441 or CornettLawrenceE@uams.edu Darri Scalzo, UAMS Research Compliance Officer 501-686-8062 or DLScalzo@uams.edu Nancy Rhea, UAMS Research Compliance Analyst 501-686-5186 or RheaNancyL@uams.edu

To Report Research Misconduct or Research Integrity Concerns: To report a concern anonymously, you may call the UAMS Compliance Hotline at 1-888-511-3969

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

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

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

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)

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

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

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

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

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.

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

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

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)

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)

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

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?

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.

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

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!

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

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

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

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?

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?

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

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

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

Irresponsible Research is Costly Time Money Knowledge Public Health Public Trust

Fostering Integrity in Research-NASEM

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

ORI Case Studies Related to Human Subjects Research

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

Questions? For questions or more information, please contact: Darri Scalzo Nancy Rhea Research Compliance Officer Research Compliance Analyst DLScalzo@uams.edu RheaNancyL@uams.edu 501-686-8062 501-686-5186

To Report Research Misconduct or Research Integrity Concerns: Please contact one of the following: Dr. Larry Cornett, UAMS Research Integrity Officer 501-686-5441 or CornettLawrenceE@uams.edu Darri Scalzo, UAMS Research Compliance Officer 501-686-8062 or DLScalzo@uams.edu Nancy Rhea, UAMS Research Compliance Analyst 501-686-5186 or RheaNancyL@uams.edu

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 Instructions iPhone users: Use your camera to scan the QR code then click on the link and continue. Android Users: Use a QR code reader then click on the link and continue. (Download any QR code reader from the Play Store, if you don’t have one). OR Use this link: http://j.mp/2HNvG92