Biomedical Graduate Studies

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Responsible Conduct of Research (RCR) and Scientific Rigor and Reproducibility (SRR)

The value of individual drive and ingenuity is incalculable, but no one can go it alone for any length of time and still maintain a high degree of competitiveness. For this reason and others, collaboration is a central feature of biomedical research. Some forms of collaboration, such as those between like-minded laboratories in close proximity, can be straightforward. Others are more complex, particularly those involving different ‘cultures’, which exist between academic laboratories and industry, laboratories in different countries, and basic and clinical laboratories attempting to forge a translational effort. All forms of collaboration require considerable skill to manage in a way that all parties are completely satisfied with progress and outcome. 

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Different parties enter into collaborations with assorted values and expectations. Disparities are perhaps most striking in collaborations between academic laboratories and industry, wherein the goals, desire for openness, and obligations have very little in the way of overlap. But differences exist in even the simplest forms of collaboration. The mechanics of a successful collaboration rely, consequently, on asking a number of important questions, as discussed at length in Scientific Integrity.¹

• What are the goals and objectives for the collaboration? How will roles and responsibilities in relation to these goals and objectives be assigned and then clarified as the project progresses? When is the collaboration “over?”
• How will the group communicate? What will be the means and frequency? Who will communicate, and when?
• How will information, results, data, and reagents be shared? What signals a publication? What are the criteria for authorship, authorship order, and otherwise assigning credit? Will institutional reviews be required prior to publication, and what kinds of delay might such reviews occasion? Who can give presentations or comment publicly on the data, and when?
• How will the group manage conflict? What are the rules of engagement? What if a conflict becomes "irreconcilable?"
• Do any conflicts of interest exist? Is there potential for intellectual property? Is the proposed work in any way relevant to existing intellectual property? If intellectual property is anticipated, who will take responsibility for it, and how will attribution be assigned.

And of course, there can be institutional overlays in the form of contracts and agreements. At Penn, the Office of Research Services and the Penn Center for Innovation provide control for investigators at this level. Recommendations for university-industry relationships are discussed at some length in Responsible Conduct of Research.² Among these are three guidelines from the perspective of university obligation that can be relevant to individual investigators in the sense of identifying potential pitfalls.

• Policies should be developed and implemented for managing individual and institutional COIs and other areas of concern, such as misconduct, data management, and intellectual property.
• Contracts should allow companies to review data and results prior to publication but not to prevent publication.
• Extreme caution must be exercised in involving students in secret research conducted for industry. Students must be able to discuss their work with colleagues and teachers.

¹Scientific Integrity, Macrina, ASM Press, 4^th Edition.
²Responsible Conduct of Research, Shamoo and Resnik, Oxford University Press, 3^rd Edition.

 

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Formal procedures and guidelines come into play when research materials are transferred into or out of Penn (or CHOP or Wistar), or when the research is sponsored by outside parties. At Penn, the Office of Research Services (ORS; http://www.upenn.edu/researchservices/) is the primary office providing the relevant information and regulation.

Transfer of research materials into or out of Penn requires a Material Transfer Agreement. Three standard MTA’s exist. These are Penn Academic/Non-Profit MTA, Uniform Biological MTA, and Penn Corporate/For-Profit MTA. Training is provided by a ‘Material Transfer Training Walkthrough’. These MTAs and information relevant to special-circumstance MTAs can be found through the ORS site above.

Guidelines for sponsored research are provided in the Sponsored Projects Handbook (http://www.upenn.edu/researchservices/Manual.html). Of note, any project that meets any of the following criteria is considered a sponsored project.

• The project commits the University to a specific line of scholarly or scientific inquiry, typically documented by a statement of work;
• A specific commitment is made regarding the level of personnel effort, deliverables, or milestones;
• Project activities are budgeted, and the award includes conditions for specific formal fiscal reports, and/or invoicing;
• The project requires that unexpended funds be returned to the sponsor at the end of the project period;
• The award provides for the disposition of either tangible property (e.g., equipment, records, technical reports, theses or dissertations) or intangible property (e.g., inventions, copyrights or rights in data) which may result from the project; and
• The sponsor identifies a period of performance as a term and condition.

Gifts to the University of a restricted or unrestricted nature which do not include any of the above conditions are not viewed as sponsored projects and are processed through the normal gift transmittal procedures. In cases where there is a question whether a particular project should be treated as a sponsored project or gift, the Associate Vice President and Associate Vice Provost of ORS,  will consult with representatives of the School(s) involved, the Corporate and Foundations Relations Office, and the Office of the Treasurer to determine its appropriate classification.

The Office of Research Services sponsors mandatory and optional training programs for all individuals involved in sponsored research activities.  

Please note, as well, that the Penn Center for Innovation (PCI; http://pci.upenn.edu/about/) facilitates technology development between Penn and the private sector. The Center states that it serves as a dedicated one-stop shop for commercial partnering with Penn.

 

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Access to case studies requires a PennKey. They are available here.

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Two textbooks provide excellent discussions of data acquisition and management. Both are electronically accessible through the Biomedical Library. These are:

Scientific Integrity, F.L. Macrina, 4th ed.
Responsible Conduct of Research, A.E. Shamoo and D.B. Resnick, 3rd ed.

Penn-specific resources, including guidelines, can be found at the Office of Research Services (http://www.upenn.edu/researchservices/). The Penn Center for Innovation (http://www.pci.upenn.edu/) provides resources relevant to technology development between Penn and the private sector.

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