Responsible Conduct of Research RCR David R Clark

Responsible Conduct of Research (RCR) David R. Clark (drclark@wsu. edu) Research Compliance Officer (335 -1585) www. research-compliance. wsu. edu Research Compliance Office 05/04/06

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Responsible Conduct of Research (RCR) I. Introduction II. Core Instructional Topics 1. 2. 3. 4. 5. 6. 7. 8. 9. III. Data Acquisition, Management, Sharing, and Ownership Conflict of Interest and Commitment Human Subjects Animal Subjects Research Misconduct Publication Practices and Responsible Authorship Mentor/Trainee Responsibilities Peer Review Collaborative Science Conclusion

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav I. Introduction The material presented here (sometimes verbatim) is primarily summarized from “Introduction to the Responsible Conduct of Research”. This book can be downloaded at http: //ori. hhs. gov/documents/rcr intro. pdf Additional information can be found at the U. S. Dept of Health and Human Services (DHHS) Office of Research Integrity (ORI) website http: //ori. hhs. gov/

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Why discuss responsible conduct of research? • Research responsibilities are complex and must be discussed in order to be understood • Research responsibilities are found in many different sources § Professional codes § Government regulations § Institutional policies and procedures § Personal convictions

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Why discuss responsible conduct of research? • Establish an environment that fosters open • • • communication Develop a common foundation Promote best practices Share ideas Increase understanding Establish a culture of concern • Seek to overcome the lack of a perceived need for guidance on the responsible conduct of research

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav II. RCR Core Instructional Areas ORI supports programs designed to promote education and training in the responsible conduct of research (RCR) that covers the following nine instructional areas: 1. 2. 3. 4. 5. 6. Data Acquisition, Management, Sharing and Ownership Conflict of Interest and Commitment Human Subjects Animal Welfare Research Misconduct Publication Practices and Responsible Authorship 7. Mentor / Trainee Responsibilities 8. Peer Review 9. Collaborative Science

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav 1. Data Acquisition, Management, Sharing, and Ownership • Data are integral to the research process. • Data management practices are complex (including collection, management, sharing, and ownership) and should be discussed before data are collected. • The integrity of data is of paramount importance and requires careful planning.

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Data Acquisition (Collection) Considerations regarding data acquisition include: • • • Appropriate methods Attention to detail Authorizations § Human subjects (IRB http: //www. irb. wsu. edu/) § Animal subjects (IACUC http: //www. iacuc. wsu. edu/) § Biological agents (IBC http: //www. bio-safety. wsu. edu/) § Radioactive materials (RSC http: //www. rso. wsu. edu/) § Hazardous Materials (EH&S http: //www. ehs. wsu. edu/) § Copyrighted or patented processes or materials

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Data Management (Protection) Data must be protected for later use (confirmation, establish priority, or be reanalyzed by others): • Data Storage: Lab notebooks in a safe place; computer files backed up; samples saved so as not to degrade • Confidentiality: Some data may be subject to privacy restrictions (human subjects or confidential business information) • Retention: In general data must be retained for 3 years after the completion of the research.

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Data Sharing Although there is general agreement that research data must be shared there are often difficult questions that must be addressed: • Preliminary data: generally should not be released • Confirmed or validated data: keeping data confidential until publication is widely accepted • Published data: Once published there is an expectation that all the information about that experiment (including final data) should be freely available

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Data Ownership • In general for government funding (state or federal): • Grants: researchers perform research and submit reports, but control of the data remains with the institution that received the funds • Contracts: require the researcher to deliver a product or service which is then owned or controlled by the government • Support for research institutions is awarded to the research institution, not to individual researchers • In general WSU owns the data Who owns research data?

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav 2. Conflict of Interest and Commitment a. Financial conflicts b. Conflicts of commitment Conflicts of interest are to be expected in the complex world of research with many competing demands and interests. Conflicts of interest or commitment are not necessarily good or bad – what is important is how they are acted on. Whose interest comes first?

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Financial Conflict of Interest • Financial Conflicts • Potential financial conflicts are not inherently wrong. Researchers should: § report significant ($10, 000 per year, or equity interest >5%) financial conflicts before any research is undertaken § Manage, reduce, or eliminate significant fianncial conflicts. This is generally accomplished by disclosure to the WSU Conflict of Interest Committee. • WSU Policy http: //www. ogrd. wsu. edu/policies_guidelines. asp (Document #3, Conflict of interest policy)

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Conflicts of Commitment Conflicts of commitment occur from the competing demands on a researcher’s time and loyalties: • • Working on more than one funded project Preparing proposals for new projects Teaching and advising students Attending professional meetings Serving as a peer reviewer Serving on advisory boards Working as a paid consultant, officer, or employee in a private company Concerns include allocation of time; relationships with students; use of resources; disclosure of affiliations; and representing outside entities

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav 3. Human Subjects IRB (Institutional Review Board)

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Human Subjects Research involving humans has many benefits for society and is often a necessary component of research. Research involving human subjects has many specific requirements • IRB review and approval § Risks to subjects are minimized § Informed consent § Belmont principles (respect for persons, beneficence, justice) § Education/Training http: //www. irb. wsu. edu/

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav 4. Animal Welfare IACUC (Institutional Animal Care and Use Committee)

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav 4. Animal Welfare The use of animals in research requires careful planning and Institutional approval. • IACUC review and approval § Reviewing animal use protocols § Review WSU’s animal care program § Inspect animal facilities § Submit reports § Education/training http: //www. iacuc. wsu. edu/ http: //campusvet. wsu. edu/

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Animal Welfare • The IACUC (and the OCV) are concerned with many principles § The humane use of animals in research § Justifying the use of animals § The 3 Rs (replacement, reduction, refinement) § Minimizing any pain or suffering § Minimizing the number of animals • The WSU has accreditation form the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC)

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav 5. Research Misconduct • Research misconduct is serious and has received considerable public attention. • Researchers who act dishonestly § § § When research misconduct becomes public Waste public funds Harm the research record Distort the research process Undermine public trust May adversely impact public health and safety

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Research Misconduct Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting 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 the research is not accurately represented in the research record § Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving them appropriate credit From: io. uwinnipeg. ca (Chronicle of Higher Ed)

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Research Misconduct Research misconduct does not include honest errors, differences of opinion, or honest differences in interpretations or judgments of data.

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Research Misconduct • Possible research misconduct should be reported to the Vice Provost for Research. The WSU policy can be found at http: //officeofresearch. wsu. edu/faculty_resources/policies. h tml • Laws and policies are meant to protect both the individuals that make complaints and the individual who is accused of misconduct. • Inquiries and investigations are handled with extreme confidentiality.

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav 6. Publication Practices and Responsible Authorship • Researchers typically share the • results of their activities with colleagues and the public through publication. Results of publication in research should meet some minimum standards: § A full and fair description of the work, § An accurate report of the results, § An honest and open assessment of the findings.

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Responsible Publications • Elements of a responsible publication § Abstracts § Methods § Results § Discussion § Notes, bibliography, and acknowledgements

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Responsible Publications • Practices that should be avoided § Honorary authorship § Practices that put quantity above quality • Salami (sometimes called bologna or trivial publications). The practice of dividing one significant piece of research into a number of small experiments (least publishable units or LPUs). • Duplicate publications § Premature public statements

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Responsible Authorship • The names on a paper let others know who conducted the research and should get credit for the work • The authors listed on papers should fairly and accurately represent the person(s) responsible for the work

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Responsible Authorship • Contribution: Authorship is generally limited to individuals who make significant contributions to the work. A high standard (International Committee of Medical Journal Editors) recommends limiting authorship to persons who contribute to the conception and design or data collection and interpretation, and assist in drafting and finalizing the manuscript. • Importance: Authors are usually listed in order of importance. The designation first or last author usually carries special weight (most significant contribution). • Corresponding or primary author: This is an important responsibility as these authors will act on behalf of their colleagues.

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav 7. Mentor / Trainee Responsibilities • Successful, experienced, • established, and/or senior researchers often assume the added role of mentor while conducting investigations. The mentor/trainee relationship is complex and may harbor potential conflicts (who gets credit? Who owns the results? When does the trainee become independent? ).

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Mentor / Trainee • Basic Responsibilities: The mentor/trainee relationship begins when an experienced an inexperienced research agree to work together. Each brings something to the arrangement and each expects to get something out of the arrangement. § Trainees need to know: How much time mentor expects them to work on mentors research; criteria to judge performance; how responsibilities are divided or shared, SOPs, authorship. § Mentors need to know that a trainee will: do assigned work conscientiously, respect the authority of others in the research; follow SOPs, protocols, procedures; live by authorship and ownership agreements.

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Mentor / Trainee • Research Environment: Mentors tend to establish the research environment. Some may emphasize competition and others may emphasize cooperation. No matter what their style mentors should: § Provide equal treatment § Maintain a professional atmosphere § Train and educate in the responsible conduct of research

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Mentor / Trainee • Supervision and review: Mentors assume responsibility to properly and appropriately train. § Assure proper instruction in research methods § Foster intellectual development § Impart an understanding of responsible research practices § Routinely check and “coach” to make sure the trainee develops into a responsible researcher

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Mentor / Trainee § Transition to independent researcher: The ultimate goal of research training is to produce successful, independent researchers. The mentors final responsibility of the mentor is to help the trainee become firmly established as independent researchers. History has repeatedly shown that experienced researchers often do not give over control to the next generation easily.

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav 8. Peer Review Benefit of peer review? Peer review (the evaluation by colleagues with similar knowledge and experience) is an essential component of research and the self-regulation of professionals. • Grant reviews • Manuscript reviews • Personnel reviews • Literature reviews and expert testimony

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Peer Review Regardless of the type of peer review it must: • Meet the deadline: Be timely. • Assess quality: Be thorough with respect to methods, calculations, conclusions, literature cited. • Judge importance: Is the research important? Does it contribute in a significant way?

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav 8. Peer Review • Preserve confidentiality: Peer review occurs with the understanding that the information will not be used or shared with anyone else. It is not permissible to do any of the following (without permission) § Ask a student or anyone else to do the review assigned to you § Use an idea or information contained in a grant or unpublished manuscript § Discuss a grant proposal or manuscript with colleagues § Retain a copy of the reviewed materials § Discuss hiring decisions with colleagues not on the committee or providing a reference.

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav 9. Collaborative Science • Researchers collaborate with colleagues who have expertise and/or resources to contribute to a project. • Federal agencies and universities seek to foster interdisciplinary science. • Any project with more than one person working on it requires collaboration – working together. Collaboration or competition?

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Collaborative Science Collaboration can offer many benefits and advantages, however, there added responsibilities: § Increasingly complex roles and relationships § More complex management requirements § Common, but not necessarily identical interests § Cultural differences

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Collaborative Science Roles and relationships: Effective collaboration begins with a clear understanding of roles and relationships, which should begin the day the collaboration is established. • Goals and anticipated outcomes • Roles of each partner • Data collection, storage, sharing • Agreeing to changes in research design • • • Who will draft publications Criteria to rank authors Authority to speak publicly Intellectual property rights and ownership How the collaboration can be changed When the collaboration will end

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Collaborative Science Effective management must include: • Financial management: Responsibility for ensuring that federal funds (project funds) are expended in accordance with federal rules (A-21 and A-110). • Training and supervision: All research staff and project personnel should be properly trained and supervised. • Formal agreements: Some aspects of collaboration must be worked out with formal agreements in advance (who owns materials; uses/restrictions on the materials, acknowledgements of the source). • Compliance: When a research institution is involved in a collaboration responsibility for compliance can extend to other institutions (as well as compliance responsibilities at their own institution).

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Collaborative Science • Research interests: Collaborative projects encourage researchers to pursue interdisciplinary research, however, most researchers have devoted their career to one field of research and spend their time talking to colleagues with similar interests. This may cause tension or competing goals in a collaborative project. • Cultural difference: Not only geographic differences, but differences resulting from the research field. Researchers from different fields may bring different practices or expectations to a project. Such differences may include potential conflict of interest, ownership and intellectual property, collecting data, publishing results, etc. When in doubt, it is advisable to follow the more stringent course of action (the highest standard of conduct).

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav III. Conclusion NIH WSU RSO IACUC Responsible conduct of research IBC WSU EHS DOT/FAA DHHS/OHRP Researcher DHHS/ORI WSU IRB Policy/Procedure WSU BSO Collaborative obligations FDA USDA/APHIS

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Assistance and Resources • • Research Compliance Officer David Clark, Phone 335 -1585, drclark@wsu. edu IACUC Coordinator Rebecca Van Wyck, Phone 335 -9661, vanwycrj@wsu. edu IRB & IBC & COI Coordinator Malathi Jandhyala, Phone 335 -9661, mjandhyala@wsu. edu Biological Safety Officer Lorraine Mc. Connell, Phone 335 -9661, lorrmcc@wsu. edu Research Compliance Office website: http: //www. research-compliance. wsu. edu/ forms (IACUC, IBC, IRB): http: //www. ogrd. wsu. edu/forms. asp Vice Provost for Research WSU RCR Education website: https: //myresearch. wsu. edu/

Respo (RCR) h rc a e s e R f o t nsible Conduc liance Office p esearch Com R , rk la C. R id Dav Responsible Conduct of Research