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Research Compliance Training

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Research Compliance Training Guide

Training Modules and Resources for Understanding Research Compliance and Institutional Requirements

This training guide organizes the compliance knowledge you need to conduct responsible research at a United States university. It is structured as a set of training modules — each with clear learning objectives, core content, and completion expectations — followed by a resources section of regulations, guides, and institutional offices you will use throughout your research career. Complete the core modules first, then add the role-specific modules that apply to your work. Your goal is not to memorize every regulation, but to recognize when a compliance question arises and to know where to find the answer.

"Compliance training is not a box to check — it is a map. Learn where the roads are, and you will never get lost in the wilderness of a new project."

How to Use This Training Guide

  1. Identify Your Role Determine which modules apply to you based on your position (student, postdoc, faculty) and your research activities (human subjects, animals, data, international collaboration).
  2. Complete Core Modules First Modules 1-3 (Research Integrity, Human Subjects, Data Privacy) are required for all researchers. Build your foundation before moving to specialized topics.
  3. Add Role-Specific Modules Complete the modules relevant to your work: animal research, biosafety, export controls, or sponsored research, as applicable.
  4. Keep Learning Compliance is not a one-time event. Refresh your knowledge annually, and complete new training whenever you take on a new type of research or a new role.
Tip: Most modules in this guide can be completed online in 1-3 hours. Schedule them into your calendar during your first semester, and set a reminder to refresh every 2-3 years.

Training Pathways by Role

Use this table to identify which modules apply to you. Check all that apply — you may need more than one pathway.

Role Core Modules (All) Role-Specific Modules
Undergraduate Researcher 1, 2, 3 Safety (if lab-based), FERPA (if working with student data)
Graduate Student / GA 1, 2, 3 4 (animals), 5 (biosafety), 7 (sponsored research), 8 (FCOI)
Postdoctoral Researcher 1, 2, 3 4, 5, 6 (export controls), 7, 8, 9 (publications)
Faculty / Principal Investigator 1, 2, 3 All of 4-9, plus supervisory responsibilities for team training
Administrator / Staff 1, 3 7 (sponsored research), 8 (FCOI), data security

Core Training Modules

Module 1: Responsible Conduct of Research (RCR)

Required — All Researchers
Duration: 2-3 hoursFrequency: Initial + every 2-3 yearsFormat: Online / In-person workshop

Learning Objectives

  • Define and recognize the three cardinal sins: fabrication, falsification, and plagiarism
  • Identify common ethical dilemmas in research (authorship, duplicate publication, data management)
  • Understand the institutional and federal processes for reporting and investigating research misconduct
  • Apply ethical decision-making frameworks to real-world scenarios
  • Know your institution's policies on research integrity and non-retaliation

Core Content

  • History of research ethics (Nuremberg Code, Belmont Report, NIH policy)
  • Peer review integrity and publication ethics
  • Data management and recordkeeping standards
  • Authorship and contribution norms (ICMJE guidelines)
  • Research misconduct: definitions, examples, and case studies
  • Reporting mechanisms and whistleblower protections

Completion Requirements

  • Pass the module knowledge check (minimum score: 80%)
  • Complete a case-study exercise with written reflection
  • Receive a certificate of completion from the training platform
Resource: The NIH Office of Extramural Research offers a free, self-paced Responsible Conduct of Research Training module used by many institutions.

Module 2: Human Subjects Research and IRB

Required — Human Subjects Researchers
Duration: 2-4 hoursFrequency: Initial + annual refresherFormat: Online + IRB office workshop

Learning Objectives

  • Distinguish between research and quality improvement activities
  • Identify when IRB review is required and which pathway applies (exempt, expedited, full board)
  • Prepare a complete IRB application including informed consent documents
  • Apply the three Belmont Report principles: respect for persons, beneficence, and justice
  • Understand protections for vulnerable populations (minors, prisoners, cognitively impaired)
  • Manage continuing review, protocol amendments, and unanticipated problem reporting

Core Content

  • Common Rule (45 CFR 46) and institutional IRB procedures
  • Informed consent: elements, waivers, and assent for minors
  • Risk assessment and minimization strategies
  • Recruitment ethics and compensation for participants
  • Data confidentiality in human subjects research
  • IRB submission process, timelines, and communication
  • Case studies: common consent form errors and how to avoid them

Completion Requirements

  • Pass the module knowledge check (minimum score: 80%)
  • Draft a sample informed consent form for review (or complete a guided exercise)
  • Attend the IRB office's orientation session (if offered)
  • Receive a certificate of completion
Resource: The HHS Office for Human Research Protections (OHRP) provides the Belmont Report, Common Rule text, and guidance documents.

Module 3: Data Privacy and Security

Required — All Researchers Handling Data
Duration: 2-3 hoursFrequency: Initial + every 2 yearsFormat: Online + hands-on lab

Learning Objectives

  • Identify personally identifiable information (PII) and protected health information (PHI)
  • Apply FERPA, HIPAA, and state privacy laws to research data scenarios
  • De-identify data using the HIPAA Safe Harbor or Expert Determination methods
  • Implement secure data storage, transfer, and disposal practices
  • Recognize and report data breaches and security incidents
  • Develop a basic Data Management Plan (DMP)

Core Content

  • Federal privacy frameworks: FERPA, HIPAA, Common Rule, GLBA, COPPA
  • State privacy and biometric information laws (CCPA/CPRA, BIPA, etc.)
  • Data minimization, de-identification, and re-identification risk
  • Secure storage, encryption, access control, and audit logging
  • Data sharing agreements and third-party data use
  • Incident response: what to do in the first 24 hours of a breach
  • Hands-on: de-identify a sample dataset using institutional tools

Completion Requirements

  • Pass the module knowledge check (minimum score: 80%)
  • Complete the hands-on de-identification exercise
  • Receive a certificate of completion
Resource: The HHS HIPAA website and the U.S. Department of Education's FERPA page are the authoritative sources for the federal frameworks covered in this module.

Role-Specific Training Modules

Module 4: Animal Research and the IACUC

Required — Animal Researchers
Duration: 3-4 hoursFrequency: Initial + annualFormat: Online + animal facility tour

Learning Objectives

  • Apply the 3Rs principle (Replacement, Reduction, Refinement) to study design
  • Prepare an IACUC protocol including species, procedures, and anesthesia/analgesia plans
  • Identify when IACUC review is required (live vertebrates, invertebrates per institutional policy)
  • Follow the Guide for the Care and Use of Laboratory Animals (NRC)
  • Report unanticipated problems and protocol deviations promptly

Core Content

  • Animal Welfare Act (9 CFR Part 1) and NIH Policy on Humane Care
  • Species-specific care requirements and housing standards
  • Procedural detail: anesthesia, analgesia, euthanasia methods
  • Personnel training and authorization levels
  • IACUC inspection process and compliance expectations
Resource: The NIH Office of Laboratory Animal Welfare (OLAW) and the NRC Guide for the Care and Use of Laboratory Animals.

Module 5: Biosafety and the IBC

Required — Biosafety Researchers
Duration: 2-3 hoursFrequency: Initial + annualFormat: Online + lab safety practical

Learning Objectives

  • Classify biological agents by risk group (RG1-RG4) per the BMBL
  • Apply appropriate containment levels (BSL-1 through BSL-4) to your work
  • Identify when IBC approval is required for research activities
  • Follow select agent and toxin regulations (CDC/USDA) where applicable
  • Respond to biosafety incidents: exposure, spills, and equipment failure

Core Content

  • BMBL 4th Edition: risk group classification and containment
  • Personal protective equipment (PPE) and biosafety cabinet use
  • Select agent list and federal registration requirements
  • Waste disposal and decontamination procedures
  • IBC submission process and continuing review
Resource: The CDC BMBL and the CDC Select Agent Program.

Module 6: Export Controls and International Collaboration

Required — International Collaborators
Duration: 1-2 hoursFrequency: Initial + as regulations changeFormat: Online

Learning Objectives

  • Distinguish between ITAR (defense) and EAR (dual-use) controlled technology
  • Identify when a technology control plan (TCP) is required
  • Understand "deemed export" rules for foreign national access to controlled data
  • Recognize red flags in international collaboration and data transfer
  • Know when to consult the Export Control Officer before sharing technical information

Core Content

  • ITAR (22 CFR 120-130) and EAR (15 CFR 730-774) basics
  • Country groups and embargoed destinations
  • License exceptions and exemption pathways
  • Technology control plans: content, scope, and enforcement
  • Case studies: common export control violations in academia
Resource: The Bureau of Industry and Security (BIS) and the State Department Directorate of Defense Trade Controls (DDTC).

Module 7: Sponsored Research Compliance

Required — PIs and Grant Administrators
Duration: 2-3 hoursFrequency: Initial + annualFormat: Online + sponsored programs office workshop

Learning Objectives

  • Apply the Uniform Guidance (2 CFR 200) to allowable cost determination
  • Distinguish between direct and indirect (F&A) costs
  • Follow sponsor-specific terms for budget, reporting, and publication
  • Manage subawards and interagency agreements
  • Maintain accurate records and prepare for audits

Core Content

  • Uniform Guidance: cost principles, audit requirements, and reporting
  • Bayh-Dole Act: IP ownership and publication rights
  • Sponsor-specific requirements: NIH, NSF, DOE, DOD, and private foundations
  • Subrecipient monitoring and compliance
  • Audit preparation: documentation, record retention, and finding responses
Resource: The Grants.gov Uniform Guidance and the NSF Policy on Responsible Conduct.

Module 8: Conflicts of Interest and Commitment

Required — Faculty and PIs
Duration: 1-2 hoursFrequency: AnnualFormat: Online

Learning Objectives

  • Distinguish between a conflict of interest and a conflict of commitment
  • Identify significant financial interests that require disclosure
  • Complete annual FCOI and COC disclosure forms accurately
  • Understand the institution's management plan requirements
  • Recognize how COI disclosure affects publication, peer review, and grant review

Core Content

  • NIH FCOI policy (42 CFR Part 50, Subpart F) and institutional equivalents
  • Types of financial interests: equity, consulting, royalties, patents
  • Management plans: mitigation, elimination, and disclosure to participants
  • COI in publication and peer review (ICMJE disclosure requirements)
  • Conflicts of commitment: outside employment and time allocation

Module 9: Publications, Authorship, and Data Sharing

Recommended — All Researchers
Duration: 1-2 hoursFrequency: As neededFormat: Online / Workshop

Learning Objectives

  • Apply ICMJE authorship criteria to real team scenarios
  • Draft a Data Management Plan (DMP) for a grant application
  • Understand open access, preprint, and data repository requirements
  • Navigate publication review periods under sponsored agreements
  • Respond to retraction, correction, and erratum situations ethically

Core Content

  • ICMJE Recommendations: authorship, contributorship, and disclosure
  • Data sharing policies: NIH, NSF, and journal-specific requirements
  • Open access models and article processing charges (APCs)
  • Preprints and their role in research communication
  • Ethical retraction: when and how to correct the record
Resource: The ICMJE, DOAJ (Directory of Open Access Journals), and your institution's Data Repository.

Recommended Training Schedule

First Semester (Weeks 1-12)

Week Module Format Estimated Time
1-2 Module 1: RCR Online 3 hours
3-4 Module 2: Human Subjects / IRB Online + IRB workshop 4 hours
5-6 Module 3: Data Privacy and Security Online + hands-on lab 3 hours
7-8 Role-specific module (4, 5, 6, or 7) Per module 2-4 hours
9-10 Module 8 or 9 (as applicable) Online 1-2 hours
11-12 Buffer / make-up / additional modules — —

Annual Refreshers

  • RCR refresher — every 2-3 years
  • Human Subjects / IRB — annually
  • Data Privacy and Security — every 2 years
  • Animal Research (IACUC) — annually
  • Biosafety (IBC) — annually
  • FCOI disclosure — annually
  • Export Control — as regulations change or when starting new international work
Tip: Set calendar reminders 30 days before each refresher deadline. Most training platforms will send automated reminders, but don't rely on them alone — a missed deadline can delay your IRB submission or grant renewal.

Key Resources for Research Compliance

Federal Regulations and Guidance

Resource Topic URL
Common Rule (45 CFR 46) Human subjects protection ecfr.gov
Belmont Report Ethical principles for human research asa.org
HHS OHRP Office for Human Research Protections hhs.gov/ohrp
HIPAA (42 CFR Part 164) Health information privacy hhs.gov/hipaa
FERPA (20 U.S.C. § 1232g) Student education records studentprivacy.ed.gov
Uniform Guidance (2 CFR 200) Federal grant cost principles grants.gov
Animal Welfare Act (9 CFR Part 1) Animal research standards ecfr.gov
BMBL 4th Edition Biosafety in microbiology labs cdc.gov
ITAR (22 CFR 120-130) International traffic in arms ecfr.gov
EAR (15 CFR 730-774) Export administration regulations ecfr.gov
Bayh-Dole Act (35 U.S.C. § 200) University IP and federal inventions uspto.gov
ICMJE Recommendations Authorship and publication ethics icmje.org

Institutional Resources (typical)

IRB Office

Protocol submissions, consent templates, training

IACUC Office

Animal protocols, facility access, training

IBC Office

Biosafety reviews, select agent registration

Privacy Office

FERPA, HIPAA, data protection, breach response

Sponsored Programs

Grants, export controls, IP, subawards

Research Integrity

RCR, misconduct, COI, ethics hotline

Professional Organizations and Certifications

Completion, Certification, and Tracking

Certificates and Records

  • Each completed module generates a certificate of completion with the date, score, and content summary
  • Certificates are stored in your institutional learning management system (LMS) and can be exported as PDF
  • Keep a personal record of your certificates — they are useful for job applications, visa applications, and grant proposals

Tracking Compliance

  • Your department or the graduate school will track your compliance status through the LMS
  • Some roles (GTA, GRA) require proof of specific trainings before you can begin duties
  • Check your compliance dashboard regularly to see what is current and what is due for renewal

⚠️ Consequences of Non-Completion

Failing to complete required training can delay your IRB submission, block access to animal facilities, suspend your assistantship, or put your grant at risk. If you are behind on training, contact the relevant compliance office immediately — most will work with you to create a catch-up plan.

Final Note

Compliance training is an investment in your research career. Researchers who understand the rules can move faster, avoid costly delays, and focus their energy on the science itself. Treat this guide as a living document — revisit it when you start a new project, take on a new role, or encounter a question you are not sure how to answer. When in doubt, ask. The compliance offices exist to help you, not to police you.

My Training Checklist

Track your progress through the modules. Check each item as you complete it.

  • Module 1: Responsible Conduct of Research (RCR)
  • Module 2: Human Subjects Research and IRB
  • Module 3: Data Privacy and Security
  • Module 4: Animal Research and the IACUC (if applicable)
  • Module 5: Biosafety and the IBC (if applicable)
  • Module 6: Export Controls (if applicable)
  • Module 7: Sponsored Research Compliance (if applicable)
  • Module 8: Conflicts of Interest and Commitment (if applicable)
  • Module 9: Publications, Authorship, and Data Sharing (recommended)
  • Annual refresher completed for all required modules
  • FCOI disclosure form submitted (if applicable)
  • Data Management Plan drafted (if required by sponsor)