SafetySyBBURE Searle

Responsible Conduct of Research (RCR)

SafetySyBBURE Searle
Responsible Conduct of Research (RCR)

The Basics

What is Responsible Conduct of Research?

We love that you are eager to explore and design solutions that can potentially impact academia and by large our society. But while doing so, it is our responsibility to conduct research responsibly that results in the highest integrity. It requires that each researcher be aware of and practice professional and ethical principles in all activities and aspects relating to scientific research. The nine core areas of RCR as outlined by the National Institute of Health are:

  • Animal Welfare

  • Human Subject Research

  • Collaborative Research

  • Conflict of Interest

  • Data Management

  • Mentorship

  • Publication and Authorship

  • Peer Review

  • Research Misconduct

Both the National Science Foundation (NSF) and the National Institute of Health (NIH) require that all undergraduates, graduates, and postdoctoral fellows working in research laboratories complete training in Responsible Conduct of Research (RCR).

Core Principles of RCR

Animal Welfare

Animals are typically used in research to explore and gain knowledge in a specific area and/or test the feasibility and biocompatibility of devices. Research with animals must be strictly regulated by your institution to ensure that all federal regulations are being met. All research protocols involving animals should be carefully designed to minimize or eliminate the frequent use of animal models and show no evidence of animal cruelty.

Before Conducting Animal Studies

A research protocol must be submitted to Vanderbilt’s Institutional Animal Care and Use Committee (IACUC)for approval before a study can begin. This protocol must include a literature/background research to provide a rationale for the study, clear objectives, study procedure-which include number of animals and any foreseeable risks. All personnel must also have completed the required institutional animal care and handling training prior to conducting the proposed research.

During Animal Studies

It is your (and your team’s) responsibility to report any incidents or misuse/mistreatment of animals that you may witness while conducting any animal research. This should be reported immediately to Vanderbilt’s IACUC. Also, any deviation or modification to your research protocol should be submitted for review and approval prior to execution. Do not conduct research under an expired protocol.

Human Subject Research

Similar to animal welfare, it is your responsibility as a researcher to ensure all institutional and federal policies are followed while conducting human subject-based research. All researchers must adhere to these three principles:

  • Respect for Persons–ethical obligation to uphold autonomy.

  • Justice –ethical obligation to distribute benefits and burdens fairly.

  • Beneficence–ethical obligation to uphold and protect the well-being of all individuals.

See the Belmont Report for more information. https://www.ncbi.nlm.nih.gov/pubmed/20543620.

Before Conducting Human Studies

A research protocol must be submitted to Vanderbilt’s Institutional Review Board (IRB). This protocol must include a literature/background research to provide a rationale for the study, clear objectives, study procedure-which include number of subjects, consent forms, any foreseeable risks, planned benefits to participants(if any), and protocol to secure participants’ personal information. All personnel must also have completed the required institutional human subjects training prior to conducting the proposed research.

During Human Subject Studies

No research should be conducted without proper written consent from participants that is well documented. It is your (and your team’s) responsibility to report any incidents or misuse/mistreatment of participants that you may witness while conducting the approved research. This should be reported immediately to Vanderbilt’s IRB. Also, any deviation or modification to your research protocol should be submitted for review and approval prior to execution. Do not conduct research under an expired protocol.

Collaborative Research

These days, the most effective research is collaborative. Collaborative research allows experts from different fields or within fields to contribute knowledge and skills to tackle the complexity of a research topic.

The Challenge!

There are certain responsibilities that may arise when conducting collaborative research. These challenges may include, but are not limited to:

  • Meeting multi-institutional policies

  • Managing cultural and people differences

  • Managing complex roles and relationships

  • Finding cohesiveness among different interests

  • Sharing data and results

Challenge Accepted!

To help navigate these challenges, it is best to practice effective communication and have clear research goals and objectives. We must:

  • Communicate effectively-Presume nothing and discuss everything at the start of collaboration or as soon as issues emerge.

  • Discuss goals and roles-Prior to starting any project, you should have clear defined goals.

  • Discuss authorship in advance.

  • Discuss data sharing and have a plan that is agreed on by all and follow institutional policies.

  • Discuss any foreseeable intellectual property issues.

  • Have an accountability system.

Conflict of Interest

Vanderbilt’s definition of a conflict of interest is “o a situation in which an individual’s financial, professional, or other personal considerations may directly or indirectly affect, or have the appearance of affecting, an individual’s professional judgment in exercising any University duty or responsibility, including the conduct or reporting of research.”

Types of Conflict of Interests (https://oprs.usc.edu/files/2018/08/Conflict-of-Interest-Handbook-8.6.18.pdf)

Intangible - those involving academic activities and scholarship. For example,

  • Bias in the choice of experiments

  • Bias towards how data is collected, interpreted and published

  • Bias in reviewing others work for personal gain

Tangible - those involving financial relationships. For example,

  • When students of a researcher perform services for a company in which the PI, or someone closely related to the PI, has an ownership or management role and has the ability to influence the academic progress of the student.

  • When a researcher holds stock or any other financial benefits and/or power in the decision-making process with a company or sponsor who has interest in the research being conducted.

Your Responsibility:Vanderbilt requires that all conflict of interests be identified and disclosed.Talk to your PI or Team Sybbure if you believe that your research or your participation in research may result in a conflict of interest.

Data Management and Sharing

Any data collected should be properly documented, protected and disclosed appropriately.

Data Collection, Documentation and Sharing

It is the responsibility of all researchers to conduct accurate and honest research. By executing the best data collection practices, we can avoid distorting data, misleading other researchers trying to repeat and use our findings to further advance the field, and waste resources. One good practice is to document all experimental procedures and findings clearly and detailed in a laboratory notebook whether it is on paper or electronically. All documentation should be dated and authorship specified. Sharing of data among collaborators to verify, refine, or refute results is very common and beneficial in research. Any data associated with human subjects should be shared only over secure entities that makes it almost impossible for patient/participant information to be leaked or identifiable without permission.

Storage and Disposal

You should discuss with your PI or research mentor the best place for your data (including notebooks, USB/external drives) to be stored where it is secure and free from all identifiable participant information (if working with human subjects). Similarly, no data should be disposed of without consultation with your PI and institutional policies.

Mentorship

As an undergraduate researcher, having a good mentor is essential in your learning process. Mentorship in research also serves as a means to ensure that you are conducting research properly and following all regulatory guidelines.

Who are your mentors?

A mentor can be a faculty advisor, lab manager, research professor, postdoc, graduate student, or any other person with research experience and/or expertise that would be valuable to your learning experience.

Mentor role/responsibilities:

  • Availability and Willingness to communicate expertise

  • A good listener

  • Open to cultural differences and personality/styles

  • Allow student to share opinions and creativity

  • Lead and teach with clarity and by example

Mentee role/responsibilities:

  • Be available and check-in with mentor regularly

  • A good listener and note-taker

  • Open to cultural differences and personality/styles

  • Be mindful of others time and resources

  • Be open to different forms of learning (i.e. by word and examples)

Publication and Authorship

Publications are great and being the one to get your research published is an amazing achievement. However, it is the responsibility of all authors especially the lead author to ensure that all information within is accurate and free of plagiarism (including self-plagiarism).

One major issue that may present itself during your undergraduate tenure is authorship vs acknowledgment. Who gets named on a publication? Who is the lead? In what order does the other co-authors appear? Authorship versus acknowledgment? In most disciplines the “last”author is reserved for the PI and all other spots should be discussed at the START of the project.

How to tackle this problem? BEFORE starting a new project, all members should have a discussion with the PI as to authorship and acknowledgment. At this meeting the lead author a.k.a the “first” author should be identified. This author is responsible for writing the manuscript, submitting manuscript (based on PI’s preference), and editing/addressing reviewers’ comments.

Questions to ask?

  • What amount and kind of contributions merit authorship?

  • What merits an acknowledgment?

Understand that as the research progress and changes take place, the flow of authorship may also change.

Peer Review

The peer review process is necessary so that research ideas, data, analysis methods, and conclusions are evaluated for accuracy and reliability, by experts in the field (i.e. peers), before the information is distributed to a wider audience. Generally, all manuscripts submitted for publication and grant submissions are peer reviewed. It is the responsibility of the reviewer to provide constructive criticism with impartiality and confidentiality.

Research Misconduct

Research misconduct is defined as plagiarism, fabrication or falsification in research proposals, performance and reporting of research findings.

  • Plagiarism: the use of another person's ideas, texts, methods, or data without giving credit. You can also self-plagiarize by reusing previously published data in the same or different format to inflate work.

  • Fabrication: reporting made-up data or results.

  • Falsification: manipulating research materials/procedures, or changing/deleting data to skew results and conclusions.

What can you do to avoid research misconduct?

  • Conduct research with integrity and in an environment that promotes integrity.

  • Have realistic goals and protocols to accomplish those goals.

  • Keep good and detailed record of all data collected. Do not delete data even if the experiment is being redone because of discrepancies or procedure errors.

  • Speak-up if you feel pressured or overworked.

Reporting Research Misconduct

If you witness, suspect or are being pressured to misconduct research, it is your responsibility to report issues to the Dean. It is Vanderbilt’s responsibility to create an environment where issues can be reported without fear of retaliation. This should be done in the form of a written form to the attention of the Dean of the relevant school, who in turn will notify the Provost of the existence of the allegations (https://www.vanderbilt.edu/faculty-manual/part-iv-disciplinary-actions-and-grievances/ch1-disciplinary-actions/). Let Team Sybbure know immediately if you are uncertain how to proceed or if you are being pressured to engage in research misconduct.

References

https://oprs.usc.edu/training/rcr/

Resources

https://research.vanderbilt.edu/https://about.citiprogram.org/en/series/responsible-conduct-of-research-rcr