Research Integrity: CITI Training & Ethics Guide
Master research integrity, CITI training, and ethics in research to write winning grant proposals with confidence.
Research integrity has become critical for winning competitive grants. Understanding CITI training, ethics in research, and responsible conduct of research principles can determine whether your proposal succeeds or fails.
For grant writers targeting the European Commission's Horizon Europe framework or US agencies like the NIH R01 or NSF, superficial engagement with ethics is a liability. Successful funding now demands expert-level command of responsible conduct of research principles, not merely as a compliance checklist, but as a core component of research design.
The Collaborative Institutional Training Initiative (CITI) Program serves as the global standard for research integrity training. However, the application of these principles varies significantly across jurisdictions. The European model, anchored in the ALLEA Code of Conduct, emphasizes "Ethics by Design," whereas the US model prioritizes regulatory compliance and grant compliance frameworks.
This comprehensive guide provides an exhaustive analysis of the research integrity landscape, synthesizing data from global integrity bodies to help you translate abstract ethical principles into winning proposal narratives. Whether you need to complete CITI training or demonstrate ethics in research, this guide equips you with the knowledge to succeed.
Global Research Integrity Frameworks
To understand grant compliance requirements, you must first grasp the regulatory ecosystems that drive them. The divergence between US and European approaches to ethics in research is not merely bureaucratic; it is philosophical. Understanding these frameworks is essential for demonstrating responsible conduct of research in your proposals.
US CITI Training Framework: Regulation and Individual Protection
The US framework for research integrity is heavily prescriptive, born out of historical scandals. CITI training programs teach these foundational principles from the Belmont Report (1979), which established three basic ethical principles governing federally funded human subjects research:
- Respect for Persons: Demands informed consent and protection for those with diminished autonomy.
- Beneficence: The obligation to "do no harm" and maximize benefits, operationalized through IRB Risk/Benefit assessments.
- Justice: Requires equitable distribution of research burdens and benefits, underpinning NIH's focus on inclusion.
These principles form the foundation of grant compliance requirements across all federal agencies. For detailed guidance on implementing these principles, see our ethics section guide.
The European Framework: Fundamental Rights
In contrast, the European model (Horizon Europe) is rooted in the protection of fundamental rights. The reference document is the ALLEA Code of Conduct, structured around four principles:
- Reliability: Ensuring quality through rigorous design.
- Honesty: Transparency in reporting and reviewing.
- Respect: Extending beyond participants to include ecosystems, cultural heritage, and the environment.
- Accountability: Responsibility for management and mentoring.
Test Your RCR Knowledge
Can you answer these core CITI training questions? Flip the cards to find out.
What is the most effective strategy for preventing research misconduct?
(Tap to flip)
While regulations and training are important, research shows that a strong mentorship culture is the primary defense against misconduct.
Research Integrity: Preventing Research Misconduct
At the core of responsible conduct of research is preventing research misconduct. CITI training emphasizes that for grant writers, this is the existential threat. Global bodies generally agree on the definition of misconduct as FFP (Fabrication, Falsification, and Plagiarism):
Fabrication
Making up data or results and recording or reporting them. Creating "fiction" in the guise of science.
Falsification
Manipulating research materials or omitting data such that the research is not accurately represented (e.g., p-hacking).
Plagiarism
Appropriating another's ideas or words without credit. Crucially, this applies to proposing research too.
Insight: Many researchers believe misconduct only applies to published papers. Grant writers must emphasize that FFP definitions apply the moment a grant is submitted. A copied methodology section or a "placeholder" figure constitutes actionable misconduct. This is a critical component of grant compliance that CITI training emphasizes repeatedly.
Understanding research integrity standards helps you avoid common pitfalls. For AI-specific ethical considerations, explore our AI ethics playbook.
Ethics in Research: Data Management & Grant Compliance
In the digital era, data management has become a central pillar of ethics in research. CITI training emphasizes that you must navigate two powerful mandates: the push for Open Science (FAIR principles) and the pull of Data Protection (GDPR/HIPAA). Proper data management demonstrates responsible conduct of research.
The FAIR Principles for Research Integrity
Major funders require data to be Findable, Accessible, Interoperable, and Reusable. This is a core grant compliance requirement.
Grant Writing Strategy: In your data management plan, do not simply promise to "share data." Be specific. "We will make data FAIR by depositing it in Zenodo (Findable), adhering to SNOMED-CT ontology (Interoperable), and licensing it under CC-BY 4.0 (Reusable)."
The GDPR Challenge
The General Data Protection Regulation (GDPR) creates the "Research Data Paradox": the tension between sharing data and protecting privacy. Remember, even pseudonymized (coded) data is considered personal data under GDPR if a key exists. True anonymization is mathematically difficult.
CITI Training: Vulnerability and Power Dynamics
A nuanced understanding of vulnerability demonstrates research integrity and often separates funded proposals from rejected ones. Reviewers look for evidence that you understand the power dynamics inherent in your research design—a key aspect of responsible conduct of research.
Types of Vulnerability in Ethics Research
Vulnerability is not a static trait; it is situational. CITI training highlights several specific forms that demonstrate grant compliance awareness:
- Cognitive Vulnerability: When a subject lacks the capacity to deliberate (e.g., young children, acute illness).
- Juridic Vulnerability: When a subject is under the authority of others (e.g., prisoners, students).
- Economic Vulnerability: When financial need makes the "voluntary" nature of consent questionable.
Grant Writing Tip: Economic Coercion
If you are paying participants, you must justify the amount. It should be "reimbursement for time and effort," not an "inducement." If a drug study offers free treatment to uninsured patients, this creates economic vulnerability. Your ethics section must explicitly state how you will ensure consent remains voluntary despite this pressure. This demonstrates research integrity and grant compliance.
Managing potential conflicts of interest is another critical aspect of ethics in research. Learn more about conflict of interest disclosure requirements.
Responsible Conduct of Research: Privacy & HIPAA Compliance
Distinguishing between privacy (people) and confidentiality (data) is a hallmark of research integrity and sophisticated grant writing. CITI training dedicates significant attention to these distinctions.
The Certificate of Confidentiality for Grant Compliance
For studies collecting sensitive data (e.g., illegal drug use, sexual behavior), standard confidentiality measures are insufficient for grant compliance. Data can be subpoenaed. A Certificate of Confidentiality (CoC) protects researchers from being compelled to disclose identifying information in legal proceedings—a key component of responsible conduct of research.
Strategy: If your study involves sensitive topics, explicitly state: "We will obtain a Certificate of Confidentiality to protect participant data from legal subpoena." This demonstrates research integrity and foresight.
HIPAA in Research: Ethics and Compliance
For US-based clinical research, HIPAA adds a layer of complexity to ethics in research. It protects Protected Health Information (PHI). Crucially, HIPAA protections supplement the Common Rule; they do not replace it. Understanding this is essential for grant compliance.
Recruitment is a common stumbling block in CITI training scenarios. Contacting patients for research is considered a "use" of PHI. However, it can qualify as "preparatory to research" if the data does not leave the covered entity—demonstrating responsible conduct of research practices.
Horizon Europe: Research Integrity by Design
Horizon Europe represents a departure from the traditional "compliance check" model. It employs an "Ethics by Design" philosophy that emphasizes proactive research integrity. Failing the ethics appraisal can block a grant as effectively as a poor scientific score—making grant compliance critical from the start.
The "Do No Significant Harm" (DNSH) Principle
A critical innovation in Horizon Europe is the integration of DNSH, which expands ethics in research to include environmental sustainability. This represents a broader interpretation of research integrity. A project developing a new chemical process must not only be safe for humans but also ensure it does not create toxic waste. Address this explicitly in your Impact section to demonstrate responsible conduct of research.
Serious and Complex Ethics Issues for Grant Compliance
Certain topics trigger a full Ethics Assessment rather than a simple screening, requiring enhanced demonstration of research integrity:
- Human Embryonic Stem Cells (hESC)
- Artificial Intelligence: Specifically AI that could stigmatize or act autonomously.
- Dual Use / Misuse: Potential military applications.
- Non-EU Countries: Research in countries with lower ethical standards.
Pro-Tip: Don't wait to be asked. If your proposal involves these issues, voluntarily include an Ethics Advisor in the governance structure. This proactive approach demonstrates responsible conduct of research and strengthens your grant compliance position.
Research Integrity: Mentorship & Authorship
Grant evaluators assess the research environment as much as the project itself. A brilliant project in a toxic environment is a bad investment. Demonstrating strong research integrity through mentorship structures is essential for grant compliance.
Mentorship as the Immune System: CITI training emphasizes that poor mentorship is a leading predictor of misconduct. In training grants (like Marie Curie fellowships), detail a structured mentorship plan using Individual Development Plans (IDPs) to demonstrate responsible conduct of research.
Navigating Authorship: Disputes are common and can undermine research integrity. Avoid "Ghost" authors (omitting contributors) and "Guest" authors (including senior names for prestige). Use the CRediT taxonomy in your Consortium Agreement to define roles early and maintain ethics in research.
Full CITI Training Question Bank
Below is a comprehensive reference table of common CITI training questions and their correct interpretations. Use this to audit your own knowledge and ensure your proposal narrative aligns with federal standards.
| Question / Topic | Correct Answer / Principle | Context & Explanation |
|---|---|---|
| Which of the following is true regarding research misconduct? | Federal funding agencies typically rely on an institution to make the initial response to an allegation of research misconduct. | |
| According to the U.S. Federal Research Misconduct Policy, fabrication involves: | Fabrication involves making up data or results, recording the data in a permanent record, sharing fake data informally or in a written report. | |
| According to the U.S. Federal Research Misconduct Policy, falsification involves: | Falsification involves purposefully manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. | |
| Which of the following is the most effective strategy for preventing research misconduct? | Among the options mentioned, good mentoring is the most effective strategy for preventing research misconduct. | |
| Which of the following is true regarding the U.S. Federal Research Misconduct Policy? | To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly. | |
| Which type of research misconduct most likely occurred if someone intentionally removes data points from the data set in order to generate a deceptive conclusion? | Falsification | |
| Which of the following most accurately describes the practice of ghost authorship? | It is a situation where the individual who wrote the manuscript is not listed as an author. | |
| The two main criteria that the National Science Foundation (NSF) uses to evaluate grant proposals are: | The two main criteria used by NSF to evaluate a grant proposal are the intellectual merit and broader impacts of the proposal. | |
| Which of the following is true about the management of conflicts of interest? | Management plans are often created to reduce the impact of conflicts of interest. | Organizations often create management plans to reduce the impact of conflicts of interest rather than completely eliminating them. However, in some cases, it will be necessary to eliminate a conflict of interest. |
| The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: | Persons with diminished autonomy are entitled to protection. | |
| Which of the following are the three principles discussed in the Belmont Report? | Respect for Persons, Beneficence, Justice | |
| Informed consent is considered an application of which Belmont principle? | Respect for Persons | |
| Issued in 1974, 45 CFR 46 raised to regulatory status: | 45 CFR 46 raised to regulatory status the US Public Health Service policy of 1966 "Clinical research and investigation involving human beings". | |
| Which of the following is included in the Nuremberg Code: | The Nuremberg Code included the requirement of the voluntary consent of subjects. While all of the choices are valid ethical concerns, none of the other choices were included in the Nuremberg Code. | |
| Which of the following brought increased public attention to the problems with the IRB system? | Although all of these are related to the problems with the IRB system, the death of a research subject (Jesse Gelsinger) was what received public attention. | |
| The National Research Act of 1974 | The National Research Act of 1974 established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The identification of guidelines, ethical principles and regulations came as a result of the deliberations of the National Commission. | |
| Census data (the final report as published by the Census Bureau) is an example of: | public information | |
| According to the federal regulations, which of the following studies meets the definition of research with human subjects? | A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period. | |
| According to the federal regulations, which of the following studies meets the definition of research with human subjects? | An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests. | |
| According to the federal regulations, research is eligible for exemption, if: | Research is only eligible for exemption if all the activities associated with the research fall into one of eight categories of activities described in the federal regulations. The regulations do allow some research with children to be exempt (although institutional policy may not). The duration of the study and the experience of the researcher are not criteria for determining eligibility for exemption. | |
| A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence? | Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. | The most appropriate action for the investigator to take is to report the adverse drug experience in a timely manner using the forms provided by the institution. |
| How long is an investigator required to keep consent documents, IRB correspondence, and research records? | For a minimum of three years after completion of the study | |
| According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB? | The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations | |
| IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must: | Occur at least annually. | |
| Identify the example of when situation and time are key to assessing risk of harm in a research study: | Asking women if they have had an abortion | |
| What statement about risks in social and behavioral sciences research is most accurate: | Risks are specific to time, situation, and culture. | |
| The primary purpose of a Certificate of Confidentiality is to: | Protect identifiable research information from compelled disclosure. | |
| Risk of harm in social and behavioral sciences generally fall in three categories, which are: | Invasion of privacy, breach of confidentiality, and study procedures | |
| If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful: | If the only identifier collected in the course of a study would be the signature on the consent document and the principal source of harm would be a breach of confidentiality disclosing one's participation in the study, a waiver of documentation of informed consent should be sought. With such a waiver, the informed consent process could be conducted verbally with no written evidence of the subject's participation in the research. | |
| A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language? | Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries | |
| As part of the consent process, the federal regulations require researchers to: | Provide potential subjects with information at the appropriate reading comprehension level. | |
| A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred? | There was neither a violation of privacy nor a breach of confidentiality | |
| Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)? | A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified. | |
| In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information? | Although data encryption, using pseudonyms, and waiving documentation of consent, provide data protection, the researcher can link individuals to their responses. Therefore, the data are vulnerable to subpoena in civil, criminal, and administrative court proceedings. Unless the researcher has a Certificate of Confidentiality, he or she may be compelled to release individually identifiable information about research subjects. The Certificate provides the highest level of protection. | |
| When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider: | Is there a power differential between researchers and subjects? | |
| A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of: | Economic vulnerability | |
| In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for: | Situational cognitive vulnerability | |
| According to the authors, there are four common abuses that historically are described as giving rise to vulnerability. Which response below contains the correct four? | Physical control, coercion, undue influence, and manipulation | There are four common abuses that historically are described as giving rise to vulnerability 1) physical control, 2) coercion, 3) undue influence, and 4) manipulation. These exist along a continuum of severity with physical control being the most severe and undue influence and manipulation being the least (Nelson and Merz 2002, V69-80). The other abuses- prejudice, neglect, and disrespect - should still be avoided in research. |
| When required, the information provided to the data subject in a HIPAA disclosure accounting ... | must be more detailed for disclosures that involve fewer than 50 subject records. | |
| HIPAA protects a category of information known as protected health information (PHI). PHI covered under HIPAA include | Identifiable health information that is created or held by covered entities and their business associates. | |
| Recruiting into research ... | Can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity. | It is still permissible under HIPAA to discuss recruitment into research with patients for whom such involvement might be appropriate. This common practice is considered to fall within the definition of treatment, at least when the conversation is undertaken by one of the patient's healthcare providers. If the contact will be made by someone other than the patient's healthcare provider, permission will be required. |
| A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT: | Data that does not cross state lines when disclosed by the covered entity. | |
| The HIPAA "minimum necessary" standard applies... | To all human subjects research that uses PHI without an authorization from the data subject. | |
| If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with: | An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue. | |
| HIPAA's protections for health information used for research purposes... | Supplement those of the Common Rule and FDA. | |
| Under HIPAA, a "disclosure accounting" is required: | For all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets. | |
| Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally ... | Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization. |
The Future of Research Integrity and Grant Compliance
Research integrity is evolving rapidly. The emergence of Generative AI presents new challenges that CITI training programs and ALLEA are racing to address. For grant writers, the lesson is clear: ethics in research is not a static set of rules, but a dynamic component of research strategy that requires ongoing attention to responsible conduct of research principles.
By embedding "Ethics by Design," adhering to FAIR principles, and fostering a culture of mentorship, you do more than just achieve grant compliance—you demonstrate the excellence and reliability that funders are seeking to support. Master these research integrity principles to write proposals that win.
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