Collaborative Research

3/5/2020

CITI - Collaborative Institutional Training Initiative

Vanessa Zuleta Quintero ID 9011046

Collaborative Research (RCR-Basic) Universidad de Antioquia - Researchers RCR Switch View

Collaborative Research (RCR-Basic) Content Authors Elizabeth Heitman, PhD University of Texas Southwestern Medical Center Sergio Litewka, MD, MPH University of Miami

Introduction

Please review at least one of the videos below before you begin reading the module. Each video is approximately three minutes long. Life Sciences - Collaboration Research Social/Behavioral/Education Sciences - Collaboration Research This module will describe strategies that may help prevent some of the challenges illustrated within the videos. https://www.citiprogram.org/members/index.cfm?pageID=125#view

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Research was historically a solitary activity. Developments over the past several decades have made collaborative research the norm in academia, government, and industry. A primary cause of this change has been the increased complexity of research questions and the need for diverse knowledge and skills to answer them. Research is now a global phenomenon in which diverse disciplinary standards, societal values, organizational models, and governmental regulations may a ect collaborative projects. Remarkably, there are relatively few regulations on collaborative research itself. Successful collaboration thus often requires attention to a range of discipline-based best practices and regulatory standards in research ethics. Learning Objectives By the end of this module, you should be able to: Explain the importance of collaborative research and why it is increasingly common. Discuss challenges associated with interdisciplinary research collaboration and ways to address them. Describe ethical considerations in international collaborative research and in academic-industry partnerships. Identify regulations, policies, and ethical guidelines that a ect collaborative research. Describe practices for establishing and maintaining e ective research collaborations.

Definitions and Key Concepts

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Collaboration typically refers to working together with others, especially in an intellectual activity (Merriam-Webster 2019). Collaborative research generally means joint work on a research project or program that bene ts from the knowledge, perspectives, and resources of many individuals, disciplines, or organizations. Research collaborations may involve activities such as consultation, educational exchanges, shared access to resources or data, development of joint publications, cooperative hosting of conferences, and participation in research networks. The term partner is a synonym for collaborator that is used frequently in community-based collaborations. Partnership often implies a contractual or other legal relationship as well as common work. The term community partnership is often applied to collaborations between researchers and community groups, civic associations, non-governmental organizations, and local service agencies that address problems in the community. Collaborators may refer to themselves as a team, particularly in laboratory-based research. Team science typically re ects the work of an organized group of researchers with di erent skills and set roles. Team science is not necessarily largescale research; teams may be composed of only a few individuals with complementary knowledge and skills.

The Growth of Collaborative Research

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Many factors are responsible for the shift from individual to collaborative research over the past few decades: Increasingly complex questions need the combined insights and skills of experts in multiple, complementary disciplines. Collaboration allows researchers to have both broader and more nuanced perspectives in de ning key questions. Partnerships among researchers in the social sciences, humanities, physical and life sciences, and engineering can produce signi cant advances. New opportunities for translating research ndings into commercial products, and the economic importance of research and development worldwide, have led to growth in collaborations between academic researchers and industry partners. Tighter governmental budgets for research and increased emphasis on coste ectiveness have led to new collaborative structures, particularly among researchers whose work requires high-cost equipment, specialized sta , or other limited resources. Universities have established centralized research service cores (for example, for imaging, high-speed computation, animal models, and biostatistics) to maximize use of expertise and improve cost-e ectiveness. Similarly, federal agencies and supranational organizations have established collaborative data sharing repositories and groups (for example, the DataNet Federation Consortium, eMERGE Network, European Data Infrastructure, or WormBase). Centralized ethics review bodies, such as the National Cancer Institute's Central IRB, have also been created to reduce the administrative burden of collaboration. Large numbers of international graduate and postdoctoral trainees have created new pathways for collaboration. Over a third of science trainees in the U.S. have https://www.citiprogram.org/members/index.cfm?pageID=125#view

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come from other countries (Yamaner 2018), and numbers are similarly high in Europe and the Commonwealth countries. Students in the U.S. increasingly seek international research opportunities, often with governmental funding (Mitchell et al. 2019). Researchers' increased familiarity with institutions in other countries, together with the spread of English as the language of science and engineering, make international collaboration more possible. The internet, improvements in long-distance communication, and transfer of digital data and resources have enabled collaboration across vast distances, even among researchers in remote locations. Supercomputers have been essential to the creation and analysis of large collaborative datasets that encourage participation from interdisciplinary and international teams. Collaboration accelerates discovery. Collaborative research explores questions from multiple vantage points. Diverse collaborative teams can reach and validate conclusions more quickly as well as discover new dimensions of complex problems (Hong and Page 2004; Nature 2018). However, the increased speed of collaborative research, combined with the increased complexity of communication among collaborators, can also raise the risk of misinterpretation and error.

Types of Collaborations Collaboration Across Disciplines Scholars often distinguish among multidisciplinary, interdisciplinary, and transdisciplinary research:

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Collaboration with Industry Governments fund research to improve citizens' quality of life through the discovery and application of new knowledge. Since the passage of the Bayh-Dole Act (Government Patent 1980) and the Federal Technology Transfer Act (1986), U.S. academic researchers and universities have been able to patent the results of federally-funded research and license the patented technology to others for commercial development. When academic researchers patent promising research ndings, ownership of the patent and the income that it produces are usually divided between the researcher or research team and the university. In many countries outside the U.S., similar regulatory schemes and programs, such as the European Commission's Joint Research Centre's Technology Transfer service, support the development and commercialization of the results of government-funded research.

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'Tech transfer' facilitates research collaborations that can make nancial pro t for institutions and researchers by bringing new ndings to market."

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Many universities have Technology Transfer Offices that identify research projects with potential for commercialization. "Tech transfer" facilitates research collaborations that can make nancial pro t for institutions and researchers by bringing new ndings to market. Collaboration between academic researchers and industry may take other forms as well. Companies often hire academic researchers as consultants and as promotional speakers. Companies may establish agreements with academic researchers to do certain experiments or analyze speci c data. In some cases, they may fund a larger project or an entire line of research. Common challenges when collaborating with industry relate to con icts between the academic goal of pursuing generalizable knowledge and the industry goal of applying speci c knowledge to generate pro t. Researchers who collaborate with industry may be drawn away from basic research toward narrow questions related to their sponsors' product lines. In this context, trainees may also have fewer opportunities to learn basic research methods. When a company funds research, it typically owns the results. Whereas academic success is normally tied to prompt publication of ndings, a company's nancial success often depends on keeping certain information con dential during research and development. Researchers collaborating with industry may be asked to sign a non-disclosure agreement, promising not to publish results or methods without the sponsor's authorization and agreeing to a period of time in which the sponsor can assess the value of new ndings. In an academic collaboration with industry, individual researchers and institutions are subject to con icts of interest and commitment. Such con icts are not necessarily unethical, but they can lead to unconscious bias that can compromise the integrity of research. Studies over the last decade have shown, for example, that industrysponsored research is much more likely to report positive outcomes than are federally-funded studies (Ridker and Torres 2006). Editors' concerns about

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publication bias have led many journals to require authors to disclose the funding sources of their work (ICMJE 2018).

Collaboration with Community Partners Many researchers collaborate with the communities they hope to bene t. True collaboration with community groups goes beyond simply recruiting members as research subjects. In community-engaged research, members of the targeted community may be instrumental in setting research priorities, de ning study questions, designing protocols, collecting and analyzing data, and even writing manuscripts and giving presentations. Community-engaged approaches are particularly common in social, behavioral, and public health research, but e orts to collaborate with the end users of research are evident in engineering and the life sciences as well. Over the past decade, community partners have increasingly assumed the sort of authoritative roles in research that were once reserved for academic researchers. As in interdisciplinary research, working with community partners with di erent experiences and perspectives brings both bene ts and challenges to academic research (Heitman and McKieran 2003). For example:

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Collaboration Across National Borders

Policy Differences in an International University-Industry Collaboration

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As more countries invest in scholarly research, research is becoming a global enterprise (IAP 2012; IAP 2016). International research collaboration typically refers to researchers or sponsors from one country conducting or funding work in another. The additional terms transnational and global research re ect the growing importance of supranational governmental organizations, such as the European Union, in funding research and setting research policy, and of research on problems that cross national boundaries, such as climate change or infectious diseases. International collaborators may nd their work a ected by signi cantly di erent standards of practice from one country to the next because many research policies and regulatory frameworks have been developed within speci c national contexts and structures of governance. The U.S. and European nations have di erent approaches to regulation of research ethics that re ect their respective scienti c and political cultures. In developing countries, moreover, the lack of systems of governance for science may hamper international collaboration due to vague research integrity policies and the inconsistent application of rules. Research collaborations between organizations in industrialized and developing countries increasingly include e orts to create policy infrastructure as part of building research capacity. Cultural values and national academic traditions also shape institutional policies and their interpretation, which, in turn, a ects expectations and administrative oversight of international collaborations. Factors that can impact international collaborations include: The use of animals in research is subject to little oversight in some countries but is highly regulated in others. This variability is due in part to cultural views on the legitimate use of animals. Although the Declaration of Helsinki provides widely recognized international ethical guidelines for biomedical research (WMA 2013), national regulations on

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research with human subjects vary worldwide as do cultural interpretations of vulnerability and protection (OHRP 2019; Loue and Lo 2013). Expectations for original work, concern about the unattributed use of others' text or data, and attitudes about plagiarism can vary markedly among researchers from di erent countries (Vasconcelos et al. 2009). Similarly, there is signi cant diversity among national policies on research misconduct more generally (Resnick et al. 2015). International collaborations may be a ected by national export controls that limit or prohibit sharing research data, materials, or training with citizens of countries seen to pose risks to national security. National security concerns may be especially prominent in collaborative research with potential for "dual use," in other words, for use as weapons or harm as well as human bene t (IAP 2012). The U.S. government has become increasingly concerned about foreign in uence in research activities and related issues (such as the protection of intellectual property). In response, academic institutions are seeking to develop guidelines and policies for addressing the matter (AAU and APLU 2019). Language barriers may persist even among collaborators who use English in their professional work. In addition to disciplinary jargon, there may be concepts in one culture for which other languages have no word or multiple words with important nuances.

Potential Challenges in Collaboration The di erences between disciplines is one potential challenge to collaboration. Many disciplines have developed their own internal guidelines, norms, and rules. Thus working across disciplinary lines can generate many challenges due to di erences in research practice. Failure to identify and reconcile such di erences can a ect the integrity of the research process and its ndings, and even end a collaboration.

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Examples of Collaboration Challenges Researchers' experience with discipline-based grants or national funding systems may lead to di erent expectations about whether and how much external funding they need for a collaborative project, appropriate sponsors, the nature of grant writing and peer review, and the policies that may a ect their work. Practical dimensions of data collection, management, and analysis in di erent elds or languages may require new approaches to joint work to ensure that results are not lost, corrupted, or misinterpreted. "Normal misbehaviors" (De Vries et al. 2006) that are tolerated or ignored in one eld or country may be seen as overt misconduct by collaborators in another. Di ering standards of productivity, including the number of experiments conducted, amount of data generated, number of manuscripts published, and amount of grant funding acquired, may cause collaborators to question the quality of their partners' work and commitment to integrity. Variable standards for authorship across disciplines and countries, and the valuation of speci c kinds of contributions, may lead to tension among team members who all need to publish work that is credible to their own peers. The expected roles of trainees and technical sta in a collaborative research project may vary across disciplines, organizations, and nations. Signi cant di erences in trainees' and technicians' perceived authority or opportunity, or the credit their work receives, may a ect morale and the willingness to work together.

Regulation, Policy, and Guidelines Federal Regulation and Related Policy https://www.citiprogram.org/members/index.cfm?pageID=125#view

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Although research collaboration itself is not regulated, general research regulations and policies address various aspects of collaboration. These include:

The ownership and sharing of data generated in federally-sponsored research is regulated by the granting agency. For example, as part of every grant application, the National Institutes of Health and National Science Foundation require a data sharing or data management plan that de nes the kind of data the research is expected to generate, how the data will be stored, how the data and information will be released to others, and how the data will be archived for future access. Such plans may cover data, samples, physical collections, tools, software, models, and publications. Collaborators' organizations may require a materials transfer agreement to de ne the speci c terms of such sharing. In collaborations involving research with human subjects, animals, or recombinant DNA, the principal investigator's institution typically takes the lead in reviewing and approving joint work. However, collaborators from di erent institutions are also

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responsible to their respective Institutional Review Board, Institutional Animal Care and Use Committee, and Institutional Biosafety Committee. International collaborations may be subject to a wide range of local and national laws and regulations. Moreover, U.S. regulations typically govern collaborative research funded by U.S. federal agencies wherever the research takes place.

Professional Guidelines Early e orts to develop professional standards for collaboration began in the oftencontentious area of joint authorship. For example, since the late 1990s, guidelines from the American Chemical Society (ACS 2015) and International Committee of Medical Journal Editors (ICMJE 2018) have advised collaborators to use formal criteria for authorship and to agree on authorship roles early in their projects. Many international societies have established guidelines for collaborative research. In 2007, the Organization for Economic Co-Operation and Development's Global Science Forum organized a workshop on responsible practices in international collaborations. In 2011, the European Science Foundation and the All European Academies (ALLEA) produced a joint code of conduct for research integrity, which was updated in 2017. The InterAcademies Partnership report entitled Responsible Conduct in the Global Research Enterprise and Doing Global Science: A Guide to Responsible Conduct in the Global Research Enterprise provide principles and guidelines that intend to serve as a common framework of good practices for global research (IAP 2012; IAP 2016). The World Conferences on Research Integrity have brought together academics and governmental leaders to promote international standards in research integrity. The 3rd World Conference on Research Integrity (2013) produced the Montreal Statement on Research Integrity in Cross-Boundary Research Collaborations to highlight the critical importance of integrity in collaborative research.

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Establishing and Maintaining a Successful Collaboration

Collaboration in a Research Fellowship

Successful collaboration depends on mutually agreed upon goals, as well as the ability and willingness to work together. Collaborators must have regular and honest communication both before the work begins and throughout the project, particularly regarding their respective needs, expectations, and obligations. The ability to work e ectively as a team may evolve as researchers work on a speci c project. Short-term collaborations, in particular, may remain loosely de ned. Nonetheless, most collaborations bene t from written agreements that outline roles and responsibilities. A memorandum of understanding may be written broadly to document an open-ended relationship or may detail expectations and commitments on a time-limited project. A memorandum usually spells out the goals of the collaboration, the contexts and time period in which the research will occur, the people bound by the document, ownership of intellectual property, responsibilities of authorship, trainees' roles and supervision, and who bears certain nancial costs. Collaborations funded by a grant or contract may involve subcontracts among the parties that de ne payment schedules, intellectual property rights and access to data, and the scope of work for each researcher or research team. Such subcontracts are usually developed by institutional o cials with concern for legal commitments and nancial liability. One of the most important steps in establishing a collaboration is to determine who is accountable for the various components of the project and create a leadership plan that describes processes for making important decisions. Equally important,

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however, is a shared commitment to values and practices that support the honesty, reliability, and integrity of the research as a whole.

Summary The future of research is increasingly collaborative. Following the model of the Montreal Statement on Research Integrity in Cross-Boundary Research Collaborations, formal and informal review and open communication over the life of the collaboration can enhance the integrity of the research.

References All European Academies (ALLEA). 2017. "The European Code of Conduct for Research Integrity, Revised Edition." Accessed May 22, 2019. American Chemical Society (ACS). 2015. "Ethical Guidelines to Publication of Chemical Research." Accessed May 22, 2019. Anderson, Emily E., Stephanie Solomon, Elizabeth Heitman, James M. DuBois, Celia B. Fisher, Rhonda G. Kost, Mary Ellen Lawless, Cornelia Ramsey, Bonnie Jones, Alice Ammerman, and Lainie F. Ross. 2012. "Research Ethics Education for Community Engaged Research: A Review and Research Agenda." Journal of Empirical Research in Human Research Ethics 7(2):3-19. De Vries, Raymond, Melissa S. Anderson, and Brian C. Martinson. 2006. "Normal Misbehavior: Scientists Talk About the Ethics of Research." Journal of Empirical Research in Human Research Ethics 1(1):43-50. Federal Technology Transfer Act of 1986, Pub. L. No. 99-502, 100 Stat. 1785-97 (1986). Government Patent Policy (Bayh-Dole) Act of 1980, 94 Stat. 3015 (1980). Heitman, Elizabeth, and Laura C. McKieran. 2003. "Community-based Practice and Research: Collaboration and Sharing Power." In Ethics and Public Health: A New Curriculum, 103-32. Washington, DC: Association of Schools of Public Health.

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Hong, Lu, and Scott E. Page. 2004. “Groups of Diverse Problem Solvers Can Outperform Groups of High-Ability Problem Solvers.” Proceedings of the National Academy of Sciences of the United States of America 101(46):16385-9. InterAcademy Partnership (IAP). 2012. "Responsible Conduct in the Global Research Enterprise, A Policy Report." Accessed May 22, 2019. InterAcademy Partnership (IAP). 2016. Doing Global Science: A Guide to Responsible Conduct in the Global Research Enterprise. Princeton, NJ: Princeton University Press. Accessed May 22, 2019. International Committee of Medical Journal Editors (ICMJE). 2018. "Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals." Accessed May 22, 2019. Loue, Sana, and Bebe Lo . 2013. "Is There a Universal Understanding of Vulnerability? Experiences with Russian and Romanian Trainees in Research Ethics." Journal of Empirical Research in Human Research Ethics 8(5):17-27. Merriam-Webster Online Dictionary. 2019. "Collaborate." Accessed May 22, 2019. Mitchell, Brian S., Mary Bester eld-Sacre, Rajika Bhandari, and Brent Jesiek. 2019. “Final Report: Best Practices in International Research Experiences for Graduate Students.” Accessed May 24, 2019. Nature. 2018. “Editorial: Science Benefits from Diversity.” Nature 558(5). Accessed May 22, 2019. Organization for Economic Co-Operation and Development, Global Science Forum. 2007. "Best Practices for Ensuring Scientific Integrity and Preventing Misconduct." Accessed May 22, 2019. Resnick, David B., Lisa M. Rasmussen, and Grace E. Kissling. 2015. “An International Study of Research Misconduct Policies.” Accountability in Research 22(5):249-66. Ridker, Paul M., and José Torres. 2006. "Reported Outcomes in Major Cardiovascular Clinical Trials Funded By For-Pro t and Not-For-Pro t Organizations: 2000-2005." JAMA 295(19):2270-4. The Association of American Universities (AAU) and Association of Public and Land-grant Universities (APLU). 2019. “Actions Taken by Universities to Address Growing Concerns about Security Threats and Undue Foreign Influence on Campus.” Accessed June 21. https://www.citiprogram.org/members/index.cfm?pageID=125#view

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U.S. Department of Health and Human Services, O ce for Human Research Protections (OHRP). 2019. "International Compilation of Human Research Standards, 2019 Edition." Accessed May 22. Vasconcelos, Sonia, Jacqueline Leta, Lídia Costa, André Pinto, and Martha M. Sorenson. 2009. "Discussing Plagiarism in Latin American Science. Brazilian Researchers Begin to Address an Ethical Issue." EMBO Reports 10(7):677-82. World Conference on Research Integrity. 2013. "Montreal Statement on Research Integrity in Cross-Boundary Research Collaborations." Accessed May 22, 2019. World Medical Association (WMA). 2013. "Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects." Accessed May 22, 2019. Yamaner, Michael. 2018. “Full-Time Graduate Enrollment in Science and Engineering Continues to Grow in 2016 Due to Increased Enrollment by Foreign Students on Temporary Visas.” InfoBrief, February. Accessed May 22, 2019.

Additional Resources Government-University-Industry Research Roundtable, National Academy of Sciences. 2011. "Examining Core Elements of International Research Collaboration: Summary of a Workshop." Washington, DC: National Academies Press. Accessed March 22, 2017. National Research Council (NRC). 2015. Enhancing the Effectiveness of Team Science. Washington, DC: The National Academies Press. Accessed May 22, 2019. Original Release: August 2014 Last Updated: June 2019

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