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

Individuals completing this tutorial will be able to:

1. Identify grant opportunities available for foreign organizations

2. Explain the advantages and challenges of research collaborations

3. Name at least 5 of the 16 ethical principles underlying research codes and policy

4. Name the three basic principles regarding human subjects in the Belmont Report

5. Understand key principles of research compliance

Learning Objectives

• Find grants on Grants.gov.

• Submit and track NIH grants with eRA Commons.

• 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.

Register to find grant opportunities

Identifying Grant 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 FOAs that 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.

NIH opportunities

Identifying Grant Opportunities

• 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

NIH opportunities: Types of FOAs

Identifying Grant Opportunities

• 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.

NIH opportunities: Types of grants

Identifying Grant Opportunities

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.)

NIH opportunities: Activity codes for foreign applicants

Identifying Grant Opportunities

• 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

NIH opportunities: Resources

Identifying Grant 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

Other opportunities

Identifying Grant Opportunities

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

Self-assessment question

Identifying Grant Opportunities

D. Registration to Grants.gov is required in order to electronically submit application(s) for federal funding.

Self-assessment answer

Identifying Grant Opportunities

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.

What is collaborative research?

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).

Types of collaborations

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.

Why engage in collaborations?

Collaborations

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

Need for complementary skills and expertise

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)

Challenges in international collaborations

Collaborations

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.

Twelve principles of research partnerships

Collaborations

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?

Key questions

Collaborations

• 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.

To minimize the potential for conflict, plan, communicate, and agree.

Collaborations

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

Aspects of collaboration

Collaborations

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.

What makes collaborations work?

Collaborations

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.

Self-assessment question

Collaborations

C. Collaborations will ensure that a project is approved for funding by the sponsor.

Self-assessment answer

Collaborations

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

What is research integrity?

Integrity and Ethics

• 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.

Historical background

Integrity and Ethics

1. Honesty

2. Objectivity

3. Integrity

4. Carefulness

5. Openness

6. Respect for intellectual property

7. Confidentiality

8. Responsible publication

9. Responsible mentoring

10. Respect for colleagues

11. Social responsibility

12. Nondiscrimination

13. Competence

14. Legality

15. Animal care

16. Human subjects protection

Ethical principles underlying codes and policies

Integrity and Ethics

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

Self-assessment question

Integrity and Ethics

C. The Nuremberg Code was the ethical document that was directly triggered by the prosecution of Nazis for medical experimentation during World War II.

Self-assessment answer

Integrity and Ethics

• Government legislation

• HHS Regulations:

o 45 CFR part 46: HHS Regulations for the Protection of Human Subjects

o 45 CFR part 160 and part 164: Health Insurance Portability and Accountability Act (HIPAA) Regulations for Standards for Privacy of Individually Identifiable Health Information

o 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:

o 21 CFR part 50: FDA Regulations for the Protection of Human Subjects

o 21 CFR part 56: FDA Regulations for Institutional Review Boards

Sources guiding responsible conduct of research

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

Sources guiding responsible conduct of research

Responsible Conduct of Research

• 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

Data management

Responsible Conduct of Research

• 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.

Collecting, using, storing, and sharing data

Responsible Conduct of Research

• 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.

Data sharing

Responsible Conduct of Research

• 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

NIH policies on data sharing

Responsible Conduct of Research

• 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).

o 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.

Data retention

Responsible Conduct of Research

• 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

Biosecurity

Responsible Conduct of Research

• Conflict of interest must be reported to the funding agency.

• NIH policy and guidance on Financial Conflict of Interest

Conflict of interest

Responsible Conduct of Research

“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

• 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

Mentoring

Responsible Conduct of Research

• 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.

Peer review

Responsible Conduct of Research

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.

Self-assessment question

Responsible Conduct of Research

B. Computer files should be saved in a secure place that is physically removed from the original data

Self-assessment answer

Responsible Conduct of Research

• 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

Protection of human subjects

Research Compliance

• 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

Protection of human subjects

Research Compliance

• 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

Informed consent

Research Compliance

• 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)

Institutional Review Boards (IRBs) and Federalwide Assurance

Research Compliance

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

Self-assessment question

Research Compliance

C. Beneficence, justice, autonomy are the three basic principles regarding human subjects in the Belmont Report?

Self-assessment answer

Research Compliance

• Humane Animal Care and Use

• Protect animal subjects

• Promote humane treatment without compromising scientific and medical aims

• Obtain an Animal Welfare Assurance

o For foreign grants, renew at the end of the project period (usually 5 years) with the Office of Laboratory Animal Welfare

Animal welfare

Research Compliance

• 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.

Institutional Animal Care and Use Committee (IACUC)

Research Compliance

• The committee’s responsibilities include:

• Reviewing animal-use protocols

• Reviewing significant changes to protocols

• Evaluating institutional compliance with Public Health Service (PHS) policy, U.S. Department of Agriculture animal welfare regulations, and institutional policies

• Monitoring institutional animal care and use programs, including inspecting animal facilities

• Reviewing concerns about animal care or use

• Reporting noncompliance and suspensions to the Office of Laboratory Animal Welfare (OLAW)

• For more information, see What Investigators Need to Know About the Use of Animals

IACUC responsibilities

Research Compliance

• Regulations cover human cloning and the extent of permissible stem cell research.

• “All experiments pertinent to human embryonic stem cell research that involve pre-implantation stages of human development, human embryos or embryonic cells, or that entail incorporating human totipotent or pluripotent cells into animal chimeras, shall be subject to review, approval and ongoing monitoring by a special oversight mechanism or body equipped to evaluate the unique aspects of the science.” ―International Society for Stem Cell Research, Guidelines for the Conduct of Human Embryonic Stem Cell Research (2006)

Stem cell research

Research Compliance

• Institutions have an obligation to address allegations of research misconduct.

• Must have procedures to investigate misconduct and, when appropriate, take action.

• Individuals who witness misconduct have an obligation to act.

Whistleblowing

Research Compliance

The primary responsibility of an IACUC is to:

A: _____ Review proposals for scientific and ethical integrity

B: _____ Protect sponsor funds from misuse by the investigating team

C: _____ Ensure that the study team complies with approved protocol and applicable regulations

D: _____ Oversee and evaluate the use of laboratory animals

E: _____ Actively participate in the grant writing process and execution of study-related activities

Self-assessment question

Research Compliance

D. The primary responsibility of an IACUC is to oversee and evaluate of the use of laboratory animals.

Self-assessment answer

Research Compliance

• Violation of the standard codes of scholarly conduct and ethical behavior in professional scientific research

• Plagiarism

• False attribution of authorship to a publication

• Failure to disclose conflict of interest

• Conducting research prior to obtaining ethical approval

• Failure to renew expired ethical approval

• Misappropriation of research funds

Research misconduct

Research Compliance

• Examples of protocol violations:

• Failure to obtain informed consent

• Informed consent performed by unauthorized individual

• Enrollment of a participant who does not fulfill protocol inclusion or exclusion criteria

• Performing study procedures not approved by IRB

• Failure to report a serious adverse event to IRB

• Enrolling study participants after IRB approval date expired

• Missing original signed and dated consent form (only a photocopy available)

• Over-enrollment of research participants

Research protocol violations

Research Compliance

• Fraud, waste, or abuse

• Nonperformance

• Noncompliance

• Mismanagement

Financial misconduct

Research Compliance

• The research administrator’s oversight responsibilities ensure compliance with funding agency regulations and standards.

• Develop a handbook or summary of funding agency policies and procedures for staff, to ensure all parties understand required regulations and standards.

• Ensure committees such as the IRB and IACUC have:

• Administrative support, including preparing the agenda for meetings

• Maintenance of minutes and other documentation

Compliance management

Research Compliance

• Research is incomplete until published

• Authors are responsible for providing accurate, complete, clear, and unbiased representation of the research.

• Examples of violations of the standard codes of scholarly conduct and ethical behavior in professional scientific research include:

• Fabrication

• Falsification

• Plagiarism

• Self-plagiarism

• Ghost writing

• Photo manipulation

• Suppression or nonpublication of data

Publications

Research Compliance

• Investigators receive credit and take responsibility.

• The International Committee of Medical Journal Editors definition of authorship has three elements:

• Made substantial contributions to conception and design, or analysis of the data, or acquisition and interpretation of the data

• Drafted the article or revised it critically for important intellectual content

• Approved the final version to be published

Authorship

Research Compliance

• Getting Started at NIH

• Grant Writing Tips

• Information for Foreign Applicants and Grantees

• NIH Grants and Funding

• Office of Laboratory Animal Welfare

• Research Involving Human Subjects

• Office of Human Research Protections (OHRP)

• Find Grants

• NIH Funding Opportunities and Notices

Helpful websites

Resources