Research Compliance
Sponsor Regulations and Requirements
Federal sponsors must impose federal laws and regulations on funding recipients. Some of these regulations govern the conduct of research activities that involve people, animals, select materials, and national security needs. A robust research compliance program promotes effective adherence to federal regulations plus additional sponsor guidelines, institutional oversight, appropriate reporting, and internal controls in support of ethical research.
Growth Pathway
Level 0: Untrained
Description: Unfamiliar with the compliance landscape and must learn the basics of compliance rules and regulations governing the research enterprise, as well as institutional policies and practices.
Level 1: Beginner
Description: Has basic understanding of one or more major compliance areas, is aware of institutional policy, and can assist with sponsor forms and recording of required data under close supervision.
Level 2: Intermediate
Description: Able to review sponsor guidelines and research proposals to identify compliance areas that require institutional approvals and training documentation. Can assist researchers with completion of forms needed for sponsors and for institutional review and approval.
Level 3: Advanced
Description: Can provide high-level guidance to researchers and committees to ensure compliance with rules, regulations, and sponsor practices. Assists with development of training materials and other documentation standards for staff and researchers; is responsive to changes in sponsor requirements.
Level 4: Expert
Description: Leads compliance activities to ensure an environment of ethical research and compliant research practices. Monitors the compliance environment to establish best practices and responds to change. Develops and delivers training to researchers and staff on sponsor requirements. Resolves questions and concerns from researchers, sponsors, auditors, and other stakeholders.
Research Integrity
Research integrity requires knowledge and awareness of ethical principles, best practices, and standards that govern research. This encompasses the core values of honesty, transparency, objectivity, and accountability in research and promotes high ethical standards in authorship, mentorship, data management, peer review, conflicts of interest and commitment, collaborations and foreign engagements, and use of humans, animals, and select materials in research programs.
Growth Pathway
Level 0: Untrained
Description: Unaware of research integrity principles and practices and requires overall training in the Responsible Conduct of Research (RCR).
Level 1: Beginner
Description: : Basic understanding of one or more major topics related to research integrity. Under close supervision, can assist with program logistics, recordkeeping, and scheduling of training activities. Gathers information as determined by a supervisor.
Level 2: Intermediate
Description: Able to competently guide researchers to sources of information and training and advise researchers on requirements for specific sponsors. Can assist with delivery of training and education programs, and able to assist in the review of research misconduct allegations in an unbiased fashion.
Level 3: Advanced
Description: Independently delivers education and training programs and leads discussions of ethical issues in research. Assesses allegations of research misconduct and works with the Research Integrity Officer (RIO) in the investigation process. Assures accurate and up-to-date documentation of policy, procedure, and training.
Level 4: Expert
Description: Sets the tone for and leads the institution’s program of Responsible Conduct of Research and research integrity. Develops and implements policies, institutional procedures, and training programs that align with laws and regulations. Able to objectively work through ethical challenges with researchers, staff, and students, and leads research misconduct investigation procedures and reporting. May serve as the institution's Research Integrity Officer (RIO).
Human Research Protection Program (HRPP)
Research that requires the use of people (i.e., human subjects) or their identifiable data or biospecimens, from clinical trials to social science studies, is governed by laws, regulations, sponsor policies, and institutional policy and procedures. A major component of an HRPP is the Institutional Review Board (IRB) or Research Ethics Board (REB), which reviews research falling under human subject guidelines to ensure that the studies are ethical and compliant. Separate from the IRB, which is largely composed of faculty performing protocol reviews, is an IRB Administrative Office. Many HRPPs also have a Post-approval (PAM) and Quality Assurance (QA) program that serves an audit, risk assessment, outreach and education, and monitoring role.
Growth Pathway
Level 0: Untrained
Description: Unfamiliar with regulations and policies governing human subject research, and unfamiliar with the operation of an IRB.
Level 1: Beginner
Description: Able to assist with scheduling and recordkeeping for an IRB, under supervision and using defined procedures. Able to help with standard communication using existing templates and procedures.
Level 2: Intermediate
Description: Independently able to assist with IRB forms and electronic protocol systems, able to help set up logistics for IRB meetings, record and securely store meeting minutes, and can monitor internal and external deadlines. Competently provides general guidance to researchers in the submission of their IRB protocols and about training requirements.
Level 3: Advanced
Description: Competently provides training on HRPP policies and procedures, including the importance of an ethical and compliant research program and role of the IRB. Independently works with researchers to resolve problems and concerns and provides high-level guidance on their IRB protocol submissions. Assists with review and reporting of any adverse events.
Level 4: Expert
Description: Leads the institution’s HRPP program in an environment of ethical behavior and integrity and has comprehensive knowledge of rules and regulations governing human subject research. Trains staff, researchers, and IRB members in external and internal policies and procedures. Works with the Research Integrity Officer, the Institutional Official (IO) for Human Research Protections, and other leadership, auditors, and other stakeholders to respond to allegations of breach of policy or ethics involving human subjects. Ensures protocol deviations and adverse events are thoroughly investigated, resolved, and reported.
Animal Care and Use
Research that requires the use of live vertebrate animals, both in and outside of a laboratory environment, is governed by laws, regulations, sponsor policies, and institutional policy and procedures. A major component of an animal welfare program is the Institutional Animal Care and Use Committee (IACUC), which reviews research subject to animal care guidelines to ensure that animals are used appropriately, receive humane care, and experience minimal pain and distress. Separate from the IACUC which is largely composed of faculty performing protocol reviews, is an IACUC Administrative Office. Many animal welfare programs also have a Post-approval (PAM) and Quality Assurance (QA) program that serves an audit, risk assessment, outreach and education, and monitoring role.
Growth Pathway
Level 0: Untrained
Description: Unfamiliar with regulations and policies governing activities requiring use of vertebrate animals, and unfamiliar with the operation of an IACUC.
Level 1: Beginner
Description: Able to assist with scheduling and recordkeeping for an IACUC and related lab inspections, under supervision and using defined procedures. Able to help with standard communication using existing templates and procedures.
Level 2: Intermediate
Description: Independently able to assist with IACUC forms and electronic protocol systems, able to help set up logistics for IACUC meetings, record and securely store meeting minutes, and can monitor internal and external deadlines. Able to provide general guidance to researchers on policies, procedures, and training requirements. Under supervision, can assist with scheduling facility inspections.
Level 3: Advanced
Description: Competently provides training on animal care and use policies and procedures as part of an ethical and compliant research program. Independently works with researchers and the IACUC to resolve problems and concerns, and provides guidance on IACUC protocol submissions, revisions, renewals, and reports. Assists with review and reporting of adverse events. Assists with preparation of reports to monitoring agencies and helps with correction of identified deficiencies.
Level 4: Expert
Description: Leads the institution’s animal welfare program in an environment of ethical behavior and integrity, and has comprehensive knowledge of rules and regulations governing research using vertebrate animals. Trains staff, researchers, and IACUC members on external and internal policies and procedures. Works with the Research Integrity Officer, the Institutional Official (IO) for animal welfare, the Lead Veterinarian, and other leadership, auditors, inspectors, and other stakeholders to respond to allegations of breach of policy or ethics involving animal research. Ensures protocol noncompliance and adverse events are properly investigated, resolved, and reported.
Institutional Biosafety Committee
Research that requires the use of recombinant DNA (rDNA), recombinant synthetic nucleic acids (rsNA), or other biohazards is governed by laws, regulations, sponsor policies, and institutional policy and procedure. A major component of a biosafety program is the Institutional Biosafety Committee (IBC), which reviews research that uses biohazardous material that can impact human health or the environment. Separate from the IBC, which is largely composed of faculty performing protocol reviews, is an IBC Administrative Office.
Growth Pathway
Level 0: Untrained
Description: Unfamiliar with regulations and policies governing activities requiring use of biohazardous materials, and unfamiliar with the operation of the IBC.
Level 1: Beginner
Description: Able to assist with scheduling and recordkeeping for an IBC and related lab inspections, under supervision and using defined procedures. Able to help with standard communication using existing templates and procedures.
Level 2: Intermediate
Description: Independently able to assist with electronic protocol systems, completion and revision of IBC forms, able to record and securely store meeting minutes, and able to provide general guidance to researchers on policies, procedures, and training requirements. Under supervision, assists with facility and lab inspections.
Level 3: Advanced
Description: Competently provides training on policies and procedures for use of biohazard materials as part of an ethical and compliant research program. Independently works with researchers and the IBC to resolve problems and concerns, and provides high-level guidance on IBC protocol submissions, revisions, renewals, and reports. Assists with training on good laboratory practices (GLPs) and safe handling of biohazards. Assists with preparation of reports to monitoring agencies and helps with correction of identified deficiencies.
Level 4: Expert
Description: Leads the institution’s biosafety program in support of ethical behavior and integrity and has comprehensive knowledge of rules and regulations governing research using biohazards. Trains staff, researchers, and IBC members on external and internal policies and procedures. Works with the Research Integrity Officer, the Environmental Health and Safety office (including the Biosafety Officer), the Radiation Safety Committee (RSC), other leadership, auditors, inspectors, and other stakeholders to respond to allegations of breach of policy or ethics involving biohazards. Ensures incidents and injuries are thoroughly investigated, resolved, and reported to appropriate authorities.
Export Controls
Export control laws, embargoes and sanctions are designed to protect national security, foreign policy, and economic interests without imposing undue regulatory burdens on legitimate international trade. Depending on the size of the institution, the export control office may be one full FTE, or several.
Growth Pathway
Level 0: Untrained
Description: Unfamiliar with laws or regulations related to the export/import of goods, materials, and technology.
Level 1: Beginner
Description: With close supervision, able to search defined information and databases to determine if an item is considered controlled under one or more export regulations, or if persons or entities are ineligible to receive export-controlled information or items. Also with supervision, able to prepare shipping information for items being exported. Understands the concept of deemed exports. Understands the tenets of the Fundamental Research Exclusion and what types of contract language can nullify that protection.
Level 2: Intermediate
Description: Familiar with regulations governing information and technology export (International Traffic in Arms, Export Administration Regulations, and Office of Foreign Asset Control). Familiar with the application of the Cybersecurity Model of Maturity Certification (CMMC) for institutions receiving specified federal contracts and managing controlled unclassified information (CUI). Able to monitor required export control training and practices. Able to advise on measures that should be taken when a researcher leaves the country or collaborates with a foreign citizen.
Level 3: Advanced
Description: Able to independently review research programs to identify security risks and categorize controlled technologies, then formulate a plan to mitigate those risks in conjunction with offices of technology transfer, legal counsel, and other stakeholders. Able to deliver training on policy and procedure related to export control. Competent in drafting technology control plans and seeking licenses required for export.
Level 4: Expert
Description: Leads export control functions. Ensures and delivers robust training and practices in these areas. Develops policy and procedure in conjunction with technology transfer, human resources, procurement, legal, and other institutional stakeholders. Conducts institutional risk assessments and provides solutions to high-risk areas. Interacts and cooperates with the FBI and other external resources and may serve as the Empowered or Institutional Official.
Conflicts of Interest and Commitment
Eliminating, reducing, or managing financial conflicts of interest and other non-financial conflicts of commitment ensures that research is free of real or perceived bias. Governmental, sponsor, and institutional policies and regulations require that research be designed, conducted, and reported with a high degree of objectivity.
Growth Pathway
Level 0: Untrained
Description: Unfamiliar with regulations and policies surrounding conflicts of interest and conflicts of commitment in a research setting.
Level 1: Beginner
Description: Able to assist with scheduling and secure recordkeeping for a Conflict of Interest and Commitment Committee, under supervision and using defined procedures. Able to help with standard communication using existing templates and procedures.
Level 2: Intermediate
Description: Independently able to assist with completion and revision of appropriate conflict disclosure forms and electronic disclosure systems, able to record and securely store meeting minutes, and able to provide general guidance to researchers on policies, procedures, and training requirements. Able to monitor and follow up on institutional reporting requirements.
Level 3: Advanced
Description: Competently provides training on conflict of interest and conflict of commitment disclosure policies and procedures as part of an ethical and compliant research program. Independently works with researchers and the conflict committee(s) to respond to questions and concerns and provides guidance on preparation of disclosure forms. Advises on and assists with development of conflict management plans and conducts periodic review of and compliance with those plans.
Level 4: Expert
Description: Leads the institution’s conflict of interest and commitment efforts by creating policy and procedure designed to comply with governmental and institutional rules and regulations, ensuring and delivering training, and supporting an environment of ethics and integrity. In conjunction with the researcher and committee(s), creates and enforces an appropriate management plan that eliminates or mitigates the identified conflict. May serve as the Designated Official (IO) for COIs with federally funded projects.
Research Security
Research and innovation rely on the integrity of the scientists performing the work, and benefits from international collaborations. Research security protects intellectual property and national security by supporting research performance in compliance with laws, regulations, and policies. Research security is an emerging area of concern and area of responsibility, whether leading or supporting, for research administration. Research administrators support compliant collaboration among researchers while facilitating global cooperation. Research security is multifaceted and best accomplished thorough holistic programs with shared governance and input from multiple stakeholders.
Growth Pathway
Level 0: Untrained
Description: While untrained, research administrators and support staff working in research administration should be aware of the existence of threats to research security. Beginning research administrators need to understand the basic concepts of ethical conduct of research.
Level 1: Beginner
Description: Should have completed required training in the four elements of research security: research integrity, cybersecurity, foreign travel, and export controls. Understands the importance of completing checklists as mandated by their institution and complete required screening of sub-awardees, collaborators and key persons on research projects. If an entry-level research administrator has a concern, they should know who to contact at their institution and feel assured that they can do so in confidence.
Level 2: Intermediate
Description: Understands the breadth of research security concerns and recognizes the appearance of non-compliance. Assists with creating checklists and reviewing proposals, awards and reporting to parse out potential concerns. Able to advise researchers on risks for national security when collaborating with a foreign citizen.
Level 3: Advanced
Description: Drafts and implements policies, procedures and checklists. Delivers elements of training and helps build website resources. Drafts communications and participates in cross-disciplinary administrative working groups.
Level 4: Expert
Description: May serve as the institutional Research Security Official. May lead but will participate as a member of institutional research security oversight committees. Investigates issues of noncompliance. Participates in external thought groups and professional meetings and may serve as liaison with enforcement agencies. Contributes to the body of knowledge on this emerging area of research administration.