CASRAI Dictionary

Tag: FDA research misconduct reporting

  • Scottish Funding Council Research Integrity Policy: What Changes From September 2026

    The Scottish Funding Council Research Integrity Policy takes effect on 1 September 2026 and applies to every Scottish higher education institution that receives SFC research and innovation funding. Its central change is a new, mandatory duty for institutions to report the outcomes of formal research misconduct investigations to SFC within one month of conclusion — a reporting relationship that did not exist under the Concordat to Support Research Integrity alone.

    Research integrity, as SFC adopts the definition from the Concordat, exists “when research is carried out according to the principles of the Concordat, and in a way that is trustworthy, ethical, and responsible.” The policy, published on 26 May 2026 by SFC’s Investment and Research Directorate, sets out what Scottish universities and SFC-funded individuals must do differently, and what SFC itself commits to doing when misconduct is proven.

    What does the policy require of Scottish universities?

    The policy applies to Scottish higher education institutions receiving research and innovation funding from SFC, and to research activities directly funded by SFC. It sets out general responsibilities drawn from the Concordat to Support Research Integrity, of which SFC is a signatory, and adds SFC-specific misconduct-reporting requirements that institutions must meet from 1 September 2026.

    Institutions must maintain transparent, robust and fair research-integrity policies, publish a governing-body-approved annual statement, and make named senior research-integrity contacts publicly available. Universities receiving SFC’s core research grants already link to that annual statement via their Research Assurance and Accountability (RAA) return; the new policy layers a live, case-by-case reporting duty on top.

    SFC is explicit about the limits of its role: it is not an appeals body for individual cases, cannot support parties during investigations, and does not grant ethical clearance or advise on research ethics. Assessment of institutional research-integrity infrastructure under the Research Excellence Framework sits outside the policy’s scope.

    What counts as research misconduct versus a questionable research practice?

    SFC uses the Concordat’s five key principles — honesty, rigour, transparency and open communication, care and respect, and accountability — as its benchmark, then draws a deliberate line between two categories of shortfall that many institutional policies still conflate.

    Questionable research practices are minor infractions or avoidable errors falling short of the five principles without evident intent to deceive, often arising from negligence or attention-to-detail failures. Research misconduct covers deliberate actions falling short of the principles at any point in the research lifecycle: fabrication, falsification, plagiarism, breach of legal or ethical obligations, misrepresentation, and improper handling of allegations — including inappropriate use of non-disclosure agreements to silence concerns. Honest errors and legitimate methodological disagreement are explicitly excluded. Institutions comparing these categories against their own glossaries can cross-check definitions in the CASRAI dictionary of research-integrity terms.

    How must institutions report misconduct investigations to SFC?

    This is the operative change from September 2026. Institutions in scope must inform SFC of the outcome of any formal research misconduct investigation, with reporting due immediately after conclusion and no later than one month afterward. Preliminary or initial assessments that do not proceed to a formal investigation do not need to be reported.

    Each confidential report to SFC must include:

    • A factual statement of the allegation’s nature, disciplinary area and time period, and which misconduct category it falls under (fabrication, falsification, plagiarism, legal/ethical/professional breach, misrepresentation, improper handling, or another category)
    • The investigation’s findings — upheld (fully or partially) or not upheld
    • A timeline of the investigation’s key stages, benchmarked against the institution’s own policy timescales
    • Actions taken where allegations are upheld, such as disciplinary referral, publisher retraction requests, or mitigation for affected research
    • Any resulting changes to institutional policy or practice, and how their effectiveness will be assured
    • What, if anything, will be communicated publicly about the case

    Institutions must also disclose if an investigation touches one of five named SFC strategic investments — Alliances for Research Challenges, the Hydro Nation Scholars Programme, the Scottish Graduate Schools for Arts and Humanities or Social Science, or Royal Society of Edinburgh–supported research — or a member of SFC’s Research & Knowledge Exchange Committee or Board.

    Personal-data protections run in parallel: respondent names, special-category data, criminal-offence information and third-party (e.g. complainant) details must never be routinely sent to SFC, though redacted disclosure can be requested in high-risk or strategic-investment cases. Looking ahead, from academic year 2027-28, SFC will cross-check upheld allegations in institutions’ annual Concordat statements against what has actually been reported to it — a compliance backstop that did not previously exist.

    How does the SFC policy compare with the UK Concordat and UKRI’s good-practice policy?

    SFC’s policy does not replace the UK-wide Concordat to Support Research Integrity, first published in 2012 and refreshed in 2025; it operationalises SFC’s own responsibilities as a signatory and funder. It draws explicitly on UKRI’s Policy on the Governance of Good Research Practice, reused with permission, and was developed with input from the Scottish Research Integrity Network.

    Framework Scope Misconduct reporting to the body Effective / published
    Concordat to Support Research Integrity All UK research employers (signatory-based) Annual statement only, no case-level reporting 2012; refreshed 2025
    UKRI Policy on the Governance of Good Research Practice UKRI-funded research and grant holders UKRI-specific notification duties for funded projects Ongoing, periodically updated
    SFC Research Integrity Policy Scottish HEIs receiving SFC funding; SFC-funded research activity Mandatory outcome reporting within one month of a formal investigation’s conclusion Published 26 May 2026; effective 1 September 2026

    The practical distinction for Scottish institutions is that the Concordat’s annual-statement cycle is now supplemented by live, case-triggered reporting — closing the “lag” SFC identifies between when misconduct is resolved and when it would otherwise surface in annual publications.

    Answer-first Q&A: research integrity principles and misconduct

    What are the 5 principles of research integrity?

    Under the Concordat definition SFC adopts, the five principles are honesty, rigour, transparency and open communication, care and respect, and accountability. Research has integrity when it is carried out according to these principles in a way that is trustworthy, ethical and responsible, at every stage of the research lifecycle.

    What are the violations of research integrity?

    Violations range from serious research misconduct — fabrication, falsification, plagiarism, breach of legal or ethical obligations, misrepresentation, and improper handling of allegations — to lesser questionable research practices such as avoidable errors or negligent attention to detail. Honest errors and genuine methodological disagreement are not violations.

    What should Scottish universities change before 1 September 2026?

    SFC acknowledges that existing institutional policies may not currently permit disclosure of investigation outcomes to an external funder, which would limit reporting on cases already underway. Research administrators and research integrity leads should treat this as a compliance gap to close now, not after September.

    • Review misconduct policies for clauses that would block or delay disclosure of outcomes to SFC, including confidentiality wording that predates this requirement
    • Confirm named contacts and senior oversight roles for research integrity are published and current, as the policy expects
    • Align internal misconduct categorisation with the Concordat’s fabrication/falsification/plagiarism/legal-ethical-breach/misrepresentation/improper-handling taxonomy so outcome reports map cleanly to SFC’s required fields
    • Check that non-disclosure agreements are not used to close out misconduct findings, which the policy treats as improper handling in itself
    • Flag any live or upcoming investigation touching SFC strategic investments (Alliances for Research Challenges, Hydro Nation Scholars, the two Scottish Graduate Schools, or RSE-supported work) for the additional disclosure requirement

    These changes matter beyond Scotland: institutions with cross-UK portfolios should map SFC’s requirements against equivalent obligations to UKRI and other funders, so research administration teams work from one internal reference of reporting triggers and timescales rather than several conflicting ones.

    What happens next?

    From 1 September 2026, SFC expects to act on most reports without further intervention, reserving formal letters and improvement plans — and, for systemic governance failures, restrictions on strategic funding applications or suspension of all SFC research funding — for the most serious or repeated cases. From AY 2027-28, its cross-check between reported outcomes and annual Concordat statements becomes the enforcement backstop, giving universities roughly one full reporting cycle to embed compliant processes first.

    Institutions treating September 2026 as a wording exercise rather than a change to reporting workflows, confidentiality clauses and NDA practice risk falling foul of that 2027-28 check.

  • Examples of Misconduct in Clinical Research: When Sponsors Must Report It

    Examples of misconduct in clinical research include data fabrication, falsification of records, consent violations, and undisclosed protocol deviations — and when a sponsor or CRO suspects any of these mid-trial, reporting is not optional. Under the EU Clinical Trials Regulation, a “serious breach” must reach the competent authority within seven calendar days of discovery; US sponsors face a less prescriptive but equally binding duty to act “promptly” under 21 CFR 312.56. This article maps who a sponsor must notify, on what timeline, and how that notification interacts with a regulator’s decision to inspect.

    Research misconduct in a clinical trial is the fabrication, falsification, or reckless misrepresentation of data or research conduct, distinct from good-faith error or a minor, adequately documented protocol deviation.

    What Counts as Misconduct in a Clinical Trial?

    Clinical research misconduct is behaviour that deliberately or recklessly falls short of accepted standards for proposing, conducting, or reporting research. It is distinguished from an honest mistake or a single, well-documented deviation by intent, recklessness, or a repeated pattern.

    Documented case categories from the US Office of Research Integrity (ORI) and academic reviews of clinical trial fraud include:

    • Data fabrication — inventing patient visits, lab values, or entire case report forms that never occurred.
    • Falsification — altering screening logs, backdating eligibility assessments, or changing test results to fit protocol windows.
    • Consent violations — enrolling participants without valid informed consent, or forging consent documentation.
    • Protocol violations — substituting one subject’s records for another’s, or conducting procedures without certified staff while reporting otherwise.
    • Undisclosed conflicts of interest — financial or personal interests that bias trial design, conduct, or reporting.
    • Failure to report adverse events — concealing or delaying safety data owed to an institutional review board (IRB) or ethics committee.

    ORI’s published case summaries describe real findings including “falsely reporting to a data coordinating center that certain clinical trial staff… had done so, when they had not” and “creating records of interviews of subjects that were never performed.” These are not hypothetical categories — they are the recurring fact patterns behind actual PHS misconduct findings.

    When Must a Sponsor Report Suspected Misconduct, and to Whom?

    A sponsor’s reporting duty is triggered the moment it has credible grounds to suspect misconduct — not once an investigation has confirmed it. The recipient, deadline, and legal basis all depend on which regulatory regime governs the trial, and sponsors running multi-region studies must satisfy all of them in parallel.

    Jurisdiction Trigger Notify Deadline Legal basis
    United States (IND-regulated drug/biologic trials) Investigator non-compliance the sponsor cannot correct, or safety/data-integrity concerns forcing suspension FDA and the reviewing IRB Promptly — no fixed calendar-day rule, but expected without delay once the decision is made 21 CFR 312.56(b)–(d)
    United States (PHS/NIH-funded, non-IND research) Suspected fabrication, falsification, or plagiarism (FFP) Institutional research integrity officer, then the Office of Research Integrity Per the institution’s own inquiry and investigation policy 42 CFR Part 93
    European Union (trials under the Clinical Trials Regulation) A “serious breach” likely to affect participant safety, rights, or data reliability Concerned Member States via the Clinical Trials Information System (CTIS) Without undue delay, no later than 7 calendar days of becoming aware Regulation (EU) No 536/2014, Article 52
    United Kingdom A “serious breach” of the protocol or the regulations The Medicines and Healthcare products Regulatory Agency (MHRA) Within 7 days of becoming aware Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended), Regulation 29A

    Two consequences follow directly from this table. First, sponsors running the same trial across the US and EU cannot rely on a single reporting clock: the EU’s 7-day “serious breach” deadline is explicit and calendar-driven, while the FDA standard is outcome-driven and tied to specific triggering events such as investigator termination. Second, if the trial is PHS-funded, a sponsor’s obligations sit alongside — not instead of — the awardee institution’s separate duty under 42 CFR Part 93, which applies to the institution employing the researcher rather than to the commercial sponsor itself.

    How Does Reporting Interact with Regulatory Inspections?

    A misconduct report rarely closes the matter quietly — it frequently opens the door to a “for-cause” regulatory inspection. Regulators treat a sponsor’s own disclosure as both a compliance signal and a lead worth following up directly at the site.

    In the US, the FDA’s Bioresearch Monitoring (BIMO) programme conducts for-cause inspections when a sponsor, IRB, or whistleblower flags data integrity concerns, independent of the routine, risk-based inspection schedule. In the EU and UK, a notified “serious breach” is a documented input into the GCP inspectorate’s risk assessment, and can trigger an unannounced inspection of the sponsor, CRO, or investigator site. Sponsors that self-report early and demonstrate a documented corrective action plan are generally viewed more favourably during inspection than those where a breach surfaces only through external whistleblowing or routine monitoring.

    What Happens After a Sponsor Reports Suspected Misconduct?

    Reporting is the start of a defined sequence, not the end of the sponsor’s obligation. Under 21 CFR 312.56, once a sponsor discovers an investigator is not complying with the signed investigator statement (FDA Form 1572), it must secure compliance or discontinue that investigator’s participation and shipment of investigational product, then notify the FDA of the termination.

    1. Sponsor performs an initial assessment and, where warranted, a root cause analysis of the suspected misconduct.
    2. Sponsor notifies the relevant regulator(s) and ethics committee/IRB within the applicable jurisdictional deadline.
    3. Sponsor implements corrective and preventive actions (CAPA), which may include investigator termination, site closure, or data exclusion.
    4. Where PHS funding is involved, the awardee institution runs its own inquiry/investigation under 42 CFR Part 93, independent of the sponsor’s regulatory notification.
    5. Findings are documented for the trial master file and made available to inspectors on request.

    Common Questions About Clinical Research Misconduct

    What are some examples of research misconduct?

    The recurring examples in clinical trials are data fabrication, falsification of records or results, plagiarism in reporting, informed consent violations, and undisclosed conflicts of interest. ORI case summaries also document backdated visit records and fabricated subject interviews as recurring fact patterns in confirmed findings.

    What are the five unethical practices most often cited in research?

    Commonly cited categories are falsification of data, failure to credit others (plagiarism), conflicts of interest, and biased design or interpretation driven by outside influence, alongside fabrication. These sit on a spectrum with lesser “questionable research practices” that fall short of formal misconduct.

    What are the three recognised types of research misconduct?

    US federal policy defines research misconduct as fabrication, falsification, and plagiarism — often abbreviated FFP. This is the operative definition ORI applies under 42 CFR Part 93 when assessing PHS-funded research allegations.

    What is clinical misconduct specifically?

    Clinical misconduct is misconduct occurring within a trial’s conduct rather than its publication: consent breaches, fabricated case report forms, or falsified eligibility data. The UK Medical Research Council and Wellcome historically defined it as fabrication, falsification, plagiarism, or deception in proposing, conducting, or reporting research.

    Implications for Sponsors and CROs

    The practical takeaway for sponsors and CROs is that “report it eventually” is not a defensible standard in any jurisdiction. A written misconduct-escalation procedure needs a named responsible officer, a fixed internal assessment window shorter than the EU’s 7-day external deadline, and a clear map of which regulator, IRB, ethics committee, or funder must be notified for each trial in the portfolio. Institutions receiving PHS/NIH funding additionally need their own 42 CFR Part 93 assurance and inquiry procedure, run independently of the sponsor’s regulatory notifications.

    As trials increasingly span the US, EU, and UK under a single protocol, the sponsors best placed to withstand scrutiny will be those who treat suspected misconduct as a multi-jurisdictional reporting event from the first credible signal, rather than a single notification to a single regulator. Research administration teams coordinating multi-site, multi-country trials are well positioned to own this escalation map, since they already sit at the interface between investigator sites, sponsors, and regulatory affairs.