Research Integrity & Compliance

• Start/Manage IRB in Cayuse Human Ethics
• Office of Institutional Compliance and Risk Management(Research Security)
• Email ORSP
• Email Institutional Compliance and Risk Management 

What it is

The IRB safeguards the rights and welfare of human participants in research at ACU. All human-subjects studies must be submitted and managed in Cayuse Human Ethics.

When you need IRB

Projects involving interaction/intervention with individuals or the use of identifiable private information or biospecimens typically require IRB review before recruitment or data collection. Most studies fit Exempt, Expedited, or Full review categories.

What you need to do

1. Determine whether your activity meets the federal definition of human-subjects research.
2. Complete required training.
3. Submit your protocol in Cayuse Human Ethics with consent/assent materials and instruments.
4. Conduct research only after IRB approval; follow continuing review/closure/reporting requirements.

Actions

• Start/Manage IRB in Cayuse 
• IRB support → IRB@acu.edu

What it is

The IBC reviews research and teaching activities involving recombinant or synthetic nucleic acids, infectious agents, human/animal tissues and fluids, and certain biological toxins to ensure safe practices and compliance.

When you need IBC

Before starting work with r/sNA constructs, pathogens, human or non-fixed animal materials, or select toxins; when establishing/using biological safety levels (e.g., BSL-1/2); or when incident reporting and waste management guidance is needed.

What you need to do

1. Contact Risk Management (Environmental Health & Safety) for risk assessment, containment, and training.
2. Submit IBC materials as instructed; maintain lab-specific SOPs and training records.
3. Report incidents/exposures promptly and follow corrective actions.

Actions

• Risk Management (EHS) resources
• Email Risk Management

What it is

IACUC oversees the humane care and ethical use of vertebrate animals in research and teaching, including semiannual facility inspections and program reviews.

When you need IACUC

Any activity involving live vertebrate animals for research, teaching, or testing requires an approved IACUC protocol prior to animal use.

What you need to do

1. Email ORSP to initiate IACUC submission and training requirements.
2. Ensure all personnel complete required training and enroll in occupational health & safety.
3. Maintain approved protocols; report unanticipated events; participate in inspections.

Actions

• IACUC inquiries & submissions → orsp@acu.edu
• Call ORSP

What it is

Research Security helps protect controlled data, technology, and collaborations. It includes export control reviews, restricted-party screening, international shipments, and travel approvals, and technology control plans.

When you need Research Security

Before international travel or shipping, engaging with foreign collaborators or restricted entities, or working with controlled/sensitive information, equipment, or software.

What you need to do

1. Contact the office of Institutional Compliance and Risk Management for screening, export determinations, and approvals.
2. Complete any required training and follow technology control plans.
3. Coordinate with ORSP on award terms that include security or publication restrictions.

Actions

• Research Security via Risk Management
• Email Risk Management

• IRB: CITI training → Cayuse submission → approval → conduct & report.
• IBC: Contact IBC/Institutional Compliance and Risk Management → IBC submission/clearance → train & maintain SOPs → report incidents.
• IACUC: Contact ORSP → protocol approval → personnel training & OHS enrollment → facility inspections.

Research Security: Contact Institutional Compliance and Risk Management → export review → follow control plans.

1. Financial COI
2. Department of Energy Interim Conflict of Interest Policy

The Department of Energy implemented an interim conflict of interest (COI) policy on December 20, 2021. This policy harmonizes with the existing ACU COI policy, mandating investigators to disclose financial interests at the proposal stage, annually, and within 30 days of obtaining a new significant financial interest. The DOE interim policy further mandates investigators to undergo COI training before participating in projects tied to any DOE financial assistance award and at least once every four years.

By law (49 USC §40118), travel using federal funds, or travel that will be reimbursed by federal funds, must be purchased on an American flag carrier if one is available, regardless of cost or convenience.

What it is

ACU encourages innovation, research, scholarship, and creative activities that advance knowledge and benefit society. Intellectual property (IP) includes inventions, discoveries, processes, software, data sets, designs, creative works, trademarks, and other forms of expression that may be protected under patent, copyright, trademark, or trade secret law. The Invention Disclosure/IDD process is the University’s mechanism for reporting potentially patentable or commercially valuable IP for review.

What you need to know

• This policy applies to ACU employees, including faculty, staff, visiting scholars, and contractors who create IP within the scope of employment or with university resources. It also applies to students when IP is created through sponsored projects, university employment, or substantial use of university resources.
• ACU generally owns IP created within the scope of employment or developed with university resources or equipment. Students normally own IP created solely for degree requirements unless employment, sponsored-project, or substantial-use conditions apply.
• Intellectual property resulting from sponsored research is governed by the applicable grant or contract. Federal awards may also be subject to the Bayh-Dole Act, which allows universities to retain ownership of certain federally funded inventions while granting the government specific rights.
• Creators/Inventors must disclose potentially patentable or commercially valuable intellectual property to the Division of Research, Scholarship, and Creative Activities (RSCA) before any public disclosure. Public disclosure can include journal publications, conference presentations, theses or dissertations, and public demonstrations.
• After an invention disclosure is submitted, the University Committee on Intellectual Property (UCIP) reviews the disclosure to evaluate ownership, patentability or protectability, commercial potential, and sponsor obligations.

Actions

1. Complete and submit the invention disclosure to ORSP before publicly disclosing the invention, software, process, or other potentially protectable work.
2. Work with RSCA and UCIP during evaluation and, if applicable, protection or commercialization activities such as patent, copyright, trademark, licensing, or startup review.
3. Follow applicable sponsor requirements and university conflict of interest policies throughout disclosure, evaluation, and commercialization

What it is

Research Misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, reviewing, or reporting research.

• Fabrication: Making up data or results and recording or reporting them.
• Falsification: Manipulating materials, equipment, processes, or data such that the research record is misrepresented.
• Plagiarism: Appropriation of another’s ideas, processes, results, or words without giving appropriate credit.

Exclusions: Honest error or differences of opinion are not considered research misconduct.

To be formally considered Research Misconduct, three conditions must be met:

1. Significant departure from accepted practices of the relevant research community;
2. The misconduct is committed intentionally, knowingly, or recklessly; and
3. The allegation is proven by a preponderance of the evidence.

What you need to know

• Applies to all ACU-affiliated individuals: faculty, staff, students, trainees, fellows, technicians, guest researchers, and collaborators.
• Covers all research under ACU, whether federally funded, non-federally funded, or unfunded.
• Key terms:
  • Allegation: A written or oral statement indicating possible research misconduct.
  • Complainant: An individual who makes an allegation of misconduct.
  • Respondent: The person against whom an allegation is directed.
  • Inquiry: Preliminary information gathering and fact-finding to determine if an investigation is warranted.
  • Investigation: The formal process of developing a factual record and determining whether research misconduct occurred.
  • Retaliation: Any adverse action taken against an individual for making a good faith allegation or for cooperating in an inquiry or investigation.

Institutional Responsibilities

In accordance with 42 CFR Part 93, ACU will:

1. Maintain written procedures consistent with federal regulations.
2. Promptly assess allegations to determine if an inquiry is warranted.
3. Secure all research records immediately upon receiving an allegation.
4. Complete inquiries within 60 days and investigations within 120 days, unless extended by the U.S. Office of Research Integrity (ORI).
5. Ensure committees are free of conflicts of interest and have appropriate expertise.
6. Provide confidentiality to the extent possible and protect participants from retaliation.
7. Report to ORI at required stages: initiation of inquiry, initiation of investigation, final institutional findings, and outcomes.
8. Retain all records related to allegations and proceedings for at least 7 years after the case is closed.

Actions

1. Initial Allegations
   • Allegations, whether oral, written, or anonymous, must be reported to the Assistant Provost for Curriculum and Assessment (“Assistant Provost”).
   • If federally funded research is involved, the Assistant Provost must notify the Executive Director of Research, who will advise on sponsor-specific requirements.
   • The Assistant Provost will conduct an informal review to determine if the allegation warrants an inquiry.
2. Inquiry
   • If warranted, the Assistant Provost will appoint a qualified Fact Finder free of conflict of interest.
   • The Fact Finder will review evidence and testimony to determine whether a full investigation is warranted.
   • A written inquiry report will summarize the process, evidence, and findings.
   • The respondent has 10 days to review and respond in writing.
   • If sufficient evidence exists, an investigation is initiated.
3. Investigation
   • The Assistant Provost will appoint an Investigation Committee of no fewer than three qualified individuals without conflicts of interest.
   • The Committee will review all records, interview relevant individuals, and prepare a full written report.
   • The respondent has 10 days to review and respond in writing.
   • The investigation must be completed within 120 days unless ORI approves an extension.
4. Adjudication
   • The Provost reviews the investigation report and issues ACU’s final decision.
   • Actions may include:
     1. Withdrawal or correction of publications.
     2. Notification to sponsors, journals, and collaborators.
     3. Restitution of funds if appropriate.
     4. Disciplinary actions, which may range from a letter of warning to dismissal.
   • If no misconduct is found, efforts will be made to restore the respondent’s reputation.
5. Appeals
   • The respondent may appeal findings and actions through ACU’s established complaint and grievance procedures.

Confidentiality & Protections

• The identities of complainants, respondents, and witnesses will be protected to the extent possible and disclosed only to those with a legitimate need to know.
• ACU prohibits retaliation against individuals who, in good faith, make allegations of research misconduct or cooperate in an inquiry or investigation.
• If allegations are not substantiated, ACU will take steps to restore reputations that may have been harmed.