Contents

2. Contents 1. Learning Objectives 2. Identifying Grant Opportunities 3. Establishing Collaborations 4. Research Integrity and Ethics 5. Responsible Conduct of Research 6. Research Compliance 7. Resources

3. Learning Objectives Individuals completing this tutorial will be able to: • Identify grant opportunities available for foreign organizations • Explain the advantages and challenges of research collaborations • Name at least 5 of the 16 ethical principles underlying research codes and policy • Name the three basic principles regarding human subjects in the Belmont Report • Understand key principles of research compliance

4. Identifying Grant Opportunities Register to find grant opportunities • Find grants on Grants.gov. • Submit and track NIH grants with eRACommons. • Two systems working together: • Grants.gov: The U.S. federal government’s online portal to find and apply for federal grant funding • eRA Commons: The NIH Electronic Research Administration system, which allows applicants to receive and transmit applications electronically • Each system has its own registration and application requirements. • Start registration process early; it may take several weeks to complete.

5. Identifying Grant Opportunities NIH opportunities • Find Funding Opportunity Announcements (FOAs) on the NIH guide for grants and contracts (OER) and Grants.gov pages. • Make sure you sign up to receive notifications of changes to the FOA. • Review the list of FOAsthat match your eligibility criteria and interest. • Read and follow all instructions. • Review Section III. Eligibility Information to ensure that foreign organizations or foreign components are eligible to apply. • Pay special attention to Section IV. Application and Submission Information.

6. Identifying Grant Opportunities NIH opportunities: Types of FOAs • Request for Applications (RFA): A one-time call with set-aside • Program Announcements (PA, PAR, PAS): Highlights areas of focus • Parent Announcements (unsolicited applications): Investigator-initiated for basic mechanisms

7. Identifying Grant Opportunities NIH opportunities: Types of grants • Types of NIH grant programs include the following: • NIH Research Project Grant Program (R01) • NIH Small Grant Program (R03) • NIH Academic Research Enhancement Award (AREA) Program (R15): Foreign component • NIH Exploratory/Developmental Research Grant Award (R21) • NIH Clinical Trial Planning Grant Program (R34) • Small Business (R41/R42) • Research Project Cooperative Agreements (U01) • Check FOA Section III. Eligibility Information section to determine if your institution is eligible.

8. Identifying Grant Opportunities NIH opportunities: Activity codes for foreign applicants The following activity codes permit foreign applicants/international collaborations: • D43: AIDS International Training and Research Program • F05: International Research Fellowships • G11: Biomedical/Biobehavioral Research Administration Development (BRAD) • T37: Minority International Research Training Grants • U2R/U2G: International Cooperative Agreements (training, capacity building, HIV/AIDS prevention and care, etc.)

9. Identifying Grant Opportunities NIH opportunities: Resources • Current funding opportunities • Parent announcements • Weekly update via email: NIH Guide LISTSERV • NIH RePORTER: An electronic tool that allows users to search a repository of NIH-funded research projects and access publications and patents resulting from NIH funding. • Information for Foreign Applicants and Grantees

10. Identifying Grant Opportunities Other opportunities • Grants.gov: Lists funding opportunities for 26 U.S. federal agencies • South African Research Innovation Management Association: Organization working to strengthen research and innovation management in the African region as well as other locations • SPIN Global Suite: SPIN (Sponsored Programs Information Network) features a global funding opportunity database; requires subscription • Pivot: A global funding opportunity database; requires subscription

11. Identifying Grant Opportunities Self-assessment question Registration on Grants.gov is required in order to: A: _____ Look for funding opportunity announcements B: _____ Download application package C: _____ Download application instructions D: _____ Electronically submit application(s) for federal funding E: _____ Publish scientific results from clinical trials funded by federal funds

12. Identifying Grant Opportunities Self-assessment answer D. Registration to Grants.gov is required in order to electronically submit application(s) for federal funding.

13. Collaborations What is collaborative research? Collaborative research can refer to work done by researchers who work within the same discipline, either within an institution or in different institutions. When a biochemist solves the crystal structure of a protein for a molecular biologist working on the regulation of the protein, for example, that is a collaboration within the biological sciences.

14. Collaborations Types of collaborations • Multidisciplinary research is a form of collaborative research that involves researchers working across disciplines, either within an institution or in different institutions. • A physician working with an engineer to manufacture a new imaging device, or an epidemiologist working with a political scientist on a tobacco-control initiative, are examples of multidisciplinary research projects. • International collaborations cross geopolitical borders. Such partnerships can take many different forms. • Researchers could travel to another country to carry out a research project, or data or samples could be shared with scientists who are physically located in another country (in accordance with laws governing data/sample sharing).

15. Collaborations Why engage in collaborations? The collaborating organizations often share a common research agenda. • By collaborating, the partners can make the best use of scarce research funding. • Many funding organizations prefer strong collaborations and encourage them in their grant application processes. • The collaborators can work together to write a strong application for funding.

16. Collaborations Need for complementary skills and expertise Collaborations take advantage of individual strengths. A collaborator might have expertise with certain tools or particular areas of research of interest to another institution, as in the following examples: • Familiarity with local language, culture, policies, resources, and laws • Capability to carry out genetic testing or other specialized types of tests • Data management skills • Biostatistics expertise • Expertise in the conduct of clinical trials • Access to clinical care facilities and staff

17. Collaborations Challenges in international collaborations When it comes to allocating and distributing resources among research partners, keep the following points in mind: • The different needs of the partners in terms of technical and financial support • Whether capital investments or just study-related expenditures (or some combination of the two) are needed • Whether resources should be spent for capacity building (and, if so, what capacities and for what purposes)

18. Collaborations Twelve principles of research partnerships For successful and sustainable collaborations, the partners must follow the following principles: • Decide on the objectives together. • Build up mutual trust. • Establish lines of communication. • Share information and develop networks. • Share responsibility. • Create transparency. • Monitor and evaluate the collaboration. • Disseminate the results. • Apply the results. • Share profits equitably. • Increase research capacity. • Build on achievements.

19. Collaborations Key questions The collaborating organizations need to be able to answer these questions: • Why are we doing this research, and how will collaborating help? • Is the study aim aligned with the institutions’ mission and research goals? • Who is in charge (the principal investigator)? • How will decisions be made? • How will the collaborators communicate (e.g., in person, by telephone, or by electronic means)? • How will progress be monitored?

20. Collaborations To minimize the potential for conflict, plan, communicate, and agree. • Come to an agreement about publication and dissemination of findings—even if they are negative. • Discuss how authorship will be assigned. • Decide who owns the data—and who will be responsible for preserving, maintaining, and sharing the data. • Clarify your mutual understanding about ownership of intellectual property.

21. Collaborations Aspects of collaboration Increasingly, collaborations must involve the institutions (which are considered the legal entities behind the research partnership) to deal with a number of aspects, including the following: • Contracts • Material transfer agreements • Intellectual property • Research compliance • Grants management

22. Collaborations What makes collaborations work? Finally, how does an organization exit a collaboration? • It is best if the collaborators have defined an endpoint in a prospective way. • The collaborators should have an agreement on premature termination of collaborative agreements if necessary.

23. Collaborations Self-assessment question Which one of the following choices is NOT an advantage of research collaboration? A. Many funding organizations encourage collaborative research. B. By collaborating, research organizations can access different types of expertise. C. Collaborations will ensure that a project is approved for funding by the sponsor. D. Collaboration is a way to maximize use of limited research resources.

24. Collaborations Self-assessment answer C. Collaborations will ensure that a project is approved for funding by the sponsor.

25. Integrity and Ethics What is research integrity? • Research integrity is active adherence to the ethical principles and professional standards essential for the responsible conduct of research.

26. Integrity and Ethics Historical background • Nuremburg Code. Developed for the Nuremberg Military Tribunal as a standard by which to judge the human experimentation conducted by the Nazis. It captures the basic principles governing the ethical conduct of research involving human subjects. • Declaration of Helsinki. Includes similar ethical principles for research on human subjects. Revised several times, most recently in 2001. • Belmont Report. Released by the National Commission in 1979, the report is a key document in human research ethics regulations in the United States. • Singapore Statement on Research Integrity. The principles and responsibilities set out in the Singapore Statement on Research Integrity represented the first international effort to encourage the development of unified policies, guidelines and codes of conduct, with the long-range goal of fostering greater integrity in research worldwide.

27. Integrity and Ethics Ethical principles underlying codes and policies • Honesty • Objectivity • Integrity • Carefulness • Openness • Respect for intellectual property • Confidentiality • Responsible publication • Responsible mentoring • Respect for colleagues • Social responsibility • Nondiscrimination • Competence • Legality • Animal care • Human subjects protection

28. Integrity and Ethics Self-assessment question Which ethical document was directly triggered by the prosecution of Nazis for medical experimentation during World War II? A: _____ Belmont Report B: _____ Common Rule C: _____ Nuremberg Code D: _____ Helsinki Report E: _____ Charter for Council for International Organizations of Medical Sciences

29. Integrity and Ethics Self-assessment answer C. The Nuremberg Code was the ethical document that was directly triggered by the prosecution of Nazis for medical experimentation during World War II.

30. Responsible Conduct of Research Sources guiding responsible conduct of research • Government legislation • HHS Regulations: • 45 CFR part 46: HHS Regulations for the Protection of Human Subjects • 45 CFR part 160 and part 164: Health Insurance Portability and Accountability Act (HIPAA) Regulations for Standards for Privacy of Individually Identifiable Health Information • 42 CFR part 50, subpart F: HHS Regulations for Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought • FDA Regulations: • 21 CFR part 50: FDA Regulations for the Protection of Human Subjects • 21 CFR part 56: FDA Regulations for Institutional Review Boards

31. Responsible Conduct of Research Sources guiding responsible conduct of research • Professional codes • American Association for the Advancement of Science • National Academy of Sciences • Association of American Medical Colleges • Institutional policies governing: • Human subjects • Animal subjects • Research misconduct • Conflicts of interest • Personal values and responsibility

32. Responsible Conduct of Research Data management • Begins with experimental design and protocol approval • Involves recordkeeping in a way that ensures accuracy and avoids bias • Guides criteria for including and excluding data from statistical analyses

33. Responsible Conduct of Research Collecting, using, storing, and sharing data • Entails responsibility for collection, use, storage, and sharing of data • Lab notebooks should be stored in a safe place. • Computer files should be backed up and the backup data saved in a secure place that is physically removed from the original data. • Samples should be appropriately saved so that they will not degrade over time. • Care should be taken to reduce the risk of fire, flood, and other catastrophic events.

34. Responsible Conduct of Research Data sharing • Data sharing allows scientists to expedite the translation of research results into knowledge, products, and procedures to improve human health. • Data should be made as widely and freely available as possible while safeguarding the privacy of participants and protecting confidential and proprietary data. • Investigators submitting a research application requesting $500,000 or more of direct costs in any single year to NIH on or after October 1, 2003, are expected to include a plan for sharing final research data for research purposes, or state why data sharing is not possible.

35. Responsible Conduct of Research NIH policies on data sharing • NIH requires that researchers who receive its funds must make available not only data, but also “unique resources,” to other scholars. • Unique data include large surveys that are too expensive to replicate; studies of unique populations, such as centenarians; studies conducted at unique times, such as a natural disaster; and studies of rare phenomena, such as rare metabolic diseases. • NIH Grants Policy Statement • NIH Data Sharing Policy and Implementation Guidance

36. Responsible Conduct of Research Data retention • NIH requires that data be retained for 3 years. • OMB Circular A-110 states that the retention period is 3 years from the date the final financial report is submitted. • NSF states in its General Grant Conditions (2005) that records must be retained for 3 years after the submission of all required reports (research and other special reports). • This could mean that if the final project report were submitted a month after the expiration date of a grant, but a special required report was submitted 2 months after the final project report, then the project records must be retained for 3 years after submission of the special report, rather than the expiration date or submission of the final project report. Therefore, one should check the record retention requirements for each sponsor that funds projects with which one is involved. • Retain research data pertinent to patented inventions for the life of the patent in case the patent is challenged or lawsuits arise.

37. Responsible Conduct of Research Biosecurity • Minimizes the likelihood that research will be misused for malicious purposes such as bioweapons • Dual-use research is any type of legitimate life sciences research which has the potential to be misused for malicious purposes • National Science Advisory Board for Biosecurity Proposed Framework for the Oversight of Dual Use Life Sciences Research: Strategies for Minimizing the Potential Misuse of Research Information

38. Responsible Conduct of Research Conflict of interest • Conflict of interest must be reported to the funding agency. • NIH policy and guidance on Financial Conflict of Interest “A conflict of interest in research exists when the individual has interests in the outcome of the research that may lead to a personal advantage and that might therefore, in actuality or appearance, compromise the integrity of the research.” —National Academy of Sciences, Integrity in Scientific Research

39. Responsible Conduct of Research Mentoring • Mentoring may include one-to-one training in research ethics to ensure that early-career investigators understand the rules of research at the institution. • Helps maintain the institution’s culture of ethical research by emphasizing its importance • Reduces the risk of research misconduct

40. Responsible Conduct of Research Peer review • Peer review is the evaluation of scientific, academic, or professional work by others working in the same field. • The integrity of science depends on effective peer review. • Effective peer review depends on competent and responsible reviewers. • Project proposals and published papers are subject to peer review.

41. Responsible Conduct of Research Self-assessment question Which of the following are among the ethical principles underlying codes and policies? (You can select more than one) A: _____ Data should be shared as widely as possible even if it permits linkages to individual research participants. B: _____ Computer files should be saved in a secure place that is physically removed from the original data C: _____ NIH data must be retained for only 1 year D: _____ Mentoring only includes one-on-one training on a long-term basis.

42. Responsible Conduct of Research Self-assessment answer B. Computer files should be saved in a secure place that is physically removed from the original data

43. Research Compliance Protection of human subjects • Guiding principles in The Belmont Report • Autonomy: Ensuring the right to self-determination • Beneficence: Maximizing the possible benefits to persons • Justice: Ensuring fair and equitable distribution of harms and benefits

44. Research Compliance Protection of human subjects • Critically evaluate decision to conduct research involving human beings • Key personnel involved in human subjects research must receive training in Protecting Human Research Participants • Protect individual rights to self-determination • Promote responsible use of human subjects • Obtain appropriate approval before conducting research involving human subjects

45. Research Compliance Informed consent • Research subjects should be fully informed about experiments in which they may participate and give their consent before they enroll. • Some subjects, such as children, some adults with impaired decision-making capacity, and some critically ill patients, cannot give informed consent, either because they are not old enough to understand the information or because they cannot understand. • Elements of informed consent include: • Autonomy to make decisions • Full information about benefits, risks, alternatives • Comprehension of the information • Voluntary • Right to withdraw

46. Research Compliance Institutional Review Boards (IRBs) and Federalwide Assurance • An IRB must review and approve research use of human subjects. • Provides an opportunity for persons with different backgrounds to judge acceptability of the project • Must have at least five members, including one scientist, one nonscientist, and a community representative not affiliated with the institution • Federalwide Assurance for the Protection of Human Subjects • Demonstrates an institution’s commitment to comply with federal requirements • Must be renewed every three years with the Office for Human Research Protections (OHRP)

47. Research Compliance Self-assessment question Which are the three basic principles regarding human subjects in the Belmont Report? A: _____ Confidentiality, privacy, justice B: _____Informed consent, privacy, researcher responsibility C: _____ Beneficence, justice, autonomy D: _____ Do not harm, maximize benefits, privacy E: _____ Fairness, IRB review, privacy

48. Research Compliance Self-assessment answer C. Beneficence, justice, autonomy are the three basic principles regarding human subjects in the Belmont Report?

49. Research Compliance Animal welfare • Humane Animal Care and Use • Protect animal subjects • Promote humane treatment without compromising scientific and medical aims • Obtain an Animal Welfare Assurance • For foreign grants, renew at the end of the project period (usually 5 years) with the Office of Laboratory Animal Welfare

50. Research Compliance Institutional Animal Care and Use Committee (IACUC) • IACUCs are local institutional committees with federally mandated oversight responsibilities. • IACUCs must be established by institutions that use laboratory animals for research or instructional purposes to oversee and evaluate all aspects of the institution’s animal care and use program. See IACUC.org for more information.