Healthcare Compliance Risk Areas Flashcards

Question

How are compliance risks addressed for Human Research Protections in Clinical Research?

Answer 1

Establish Effective Oversight of Clinical Research Institutions must establish comprehensive oversight for clinical research occurring at the organization, taking into consideration the complexity of the research, involvement of multiple sites or institutions, and use of external or central IRBs. Regulatory, funding, or sponsor requirements must be met, and the rights, safety, and welfare of research participants must be adequately protected. Attention should be paid to the evolution of the research portfolio and researchers over time as new risks may emerge. Considerations for effective institutional oversight include the following: Institutional Human Research Protection Program Governance Ensure programs are appropriately structured and include the following elements: Oversight by a centralized institutional program and administrator with a compliance oversight function that is supported by leadership and operates under organization-wide policies and procedures. If an institution has an internal IRB, the process for review and approval of human subject research is clear and supported by policies and procedures. Institutions that receive federal support for research must register their IRBs with OHRP and obtain an FWA. Ensuring that appropriate agreements are in place if using external or central IRBs and external investigators or facilities. Oversight programs should coordinate with multiple departments throughout the organization. The program can also evaluate any concerns; unanticipated problems; noncompliance issues; or concerns reported internally, from research participants, sponsors or funding agencies, private or government entities, or the public. Institutional Review of Clinical Research Reviews should be comprehensive to ensure any federal, state, and institutional requirements are met prior to and during the research. Considerations include: Establishing a review process that ensures, but is separate from, IRB review and approval. Other regulatory requirements and areas that may directly or indirectly affect human research protections should be reviewed prior to implementation. Examples of other areas include ClinicalTrials.gov registration, financial conflicts of interest disclosure and management, device or electronic system information technology security reviews, export controls, biosafety and radiation safety measures or risk assessments, grant or contracted related requirements, research billing or compensation-related reviews, and international research where other regulations and local rules apply or other areas. Ensuring that individuals involved in the research have the appropriate qualifications and level of experience and training. Allocating appropriate staff and resources to perform the work. Obtaining any necessary facility, ancillary department services (e.g., pharmacy or lab), and local community approvals. Organizational Standards Policies and procedures pertaining to clinical research should be easily accessible and available to researchers. They should be updated regularly and include regulatory, local, and institutional requirements. Information about clinical research requirements and reporting should also be included in the code of ethical conduct. Regular education regarding these standards can help enhance awareness and promote overall compliance. Develop and Provide Ongoing Education and Training Effective education and training are necessary to reduce the risk of research noncompliance. There should be ongoing education and training efforts on regulations, policies, and best practices, as well as new or emerging topics that are relevant to the clinical research community. An online learning management system can be used to disseminate and track training and education throughout the organization. Provide Support for FDA-regulated Research or Activities FDA-regulated activities can be complex and researchers and clinicians at healthcare organizations often require additional support to navigate regulatory requirements. Additional education and training may be necessary to ensure the research is conducted in accordance with FDA rules and GCP. The following are compliance risk areas. Investigational New Drug (IND) Applications and Investigational Device Exemptions (IDE) Certain clinical research studies for both marketed and experimental products may require an IND application or an IDE, preliminary evaluation and review of requirements, and monitoring to ensure compliance. Sponsor-Investigators Investigators that hold an IND application or an IDE are also considered sponsors and take on additional responsibilities. They will often need supplementary education and training to ensure they fulfill sponsor responsibilities such as monitoring, safety reporting, and other requirements. Expanded Access/Compassionate Use and Emergency Use Investigational (or non-FDA-approved) drugs, biologics, or devices used for treatment of a patient with a serious disease or condition outside of a clinical trial must meet certain criteria. FDA and IRB review and reporting at certain time points are required. Safety Monitoring and Reporting Documenting adverse events, reporting any considered serious, and ensuring adherence to the data and safety monitoring plans are key elements to ensuring safety of research participants. FDA Inspections The FDA’s Bioresearch Monitoring Program (BIMO) conducts routine and for-cause inspections of clinical investigators and committees that review FDA-regulated research such as IRBs and Radioactive Drug Research Committees (RDRCs). Regular internal reviews should be done to ensure compliance with FDA regulations and prepare for external inspections. Any observations cited by the FDA will require appropriate corrective and preventive actions and an effective response strategy. Implement a Compliance and Integrity Program Institutional compliance oversight is necessary not only to ensure that organizational obligations are met and human research participants are adequately protected, but also to guard against more serious issues such as fraud and research misconduct. A comprehensive compliance program for human research protections should encompass the following: Compliance Oversight Establish an independent group that performs regular audits and reviews of ongoing clinical research to evaluate compliance of clinical research investigators and IRBs. The group should maintain an independent reporting structure and report to the highest levels of management. Regular risk assessments should be conducted and annual work plans developed that incorporate clinical research reviews. Routine Compliance Reviews Establish reviews that are conducted on a routine basis. Reviews can be risk-based to balance resources against research volume and can be comprehensive or focused on a particular area. This allows evaluation of investigator compliance with IRB approvals and reporting, the protocol, any conflict of interest management plans, obtaining informed consent from research participants, drug or device accountability, safety reporting, regulatory documentation, and any other applicable requirements. Higher-risk areas tend to be research: Conducted by new or inexperienced researchers Involving interventional procedures or products that have a higher risk profile In early phase or a complex study Of FDA-regulated products Involving sponsor-investigator IND/IDE trials Involving researchers with prior compliance issues Involving vulnerable or critically ill populations Nonretaliatory Reporting Allow multiple ways to report noncompliance concerns (even anonymously) through a phone or web-based hotline, supported by institutional nonretaliation policies to ensure an open and safe environment. Noncompliance Investigations and Reporting Allegations of noncompliance, research misconduct, or complaints from clinical research participants must be investigated promptly and handled in accordance with institutional policies and applicable federal or state rules. Required reporting should be made within the time period based on any federal assurances and grant or contract requirements. Organizational Communication Serious or continuing noncompliance and research misconduct will require communication with other departments, such as legal affairs, human resources, risk management, or other groups. Institutional officials, research integrity officers, management, executive leadership, and the board should be appropriately informed of any issues. Manage Privacy and Security Healthcare organizations, which are considered covered entities, must pay attention to HIPAA rules and ensure privacy protections, security requirements, and breach reporting are met. International research requires special attention to local privacy and data protections requirements. This requires coordination with privacy boards, privacy officers, and chief information security officers at an organizational level. Clinical research should be incorporated into larger organizational privacy and security risk assessments, policies and procedures, and breach management and reporting. The following are areas to pay attention to: Privacy Boards for Research Ensure one is appointed (which can be the IRB) that issues waivers or alterations of HIPAA authorization requirements where appropriate. Agreements Appropriate agreements for covered entities should be in place when researchers propose use of certain data sets containing PHI, such as data use agreements, and when working with business associates that provide services that involve creating, receiving, maintaining, or transmitting PHI. This ensures that certain safeguards are in place when handling PHI. Security of Research Information Ensure that the appropriate controls and systems are in place to secure research data and ensure confidentiality of the information. This includes controlling access to research information, providing HIPAA-compliant tools and platforms for researchers to use, and ensuring appropriate security controls for research charts and devices where research participant information is stored. This can become more complex with increased use of mobile devices, cloud-based storage, and database applications. Handling and Reporting Privacy and Security Breaches Incidents must be investigated promptly and reported in accordance with federal and local requirements. Breaches will require notification to the affected research participants, IRB, institutional officials, the Office for Civil Rights, and any other federal or state agencies.

Answer 2

Noncompliance with human research protection requirements by investigators may result in suspension or termination of the research by the reviewing IRB, special conditions imposed by the funding agency or sponsor, citations, or debarment by federal agencies. For example, the FDA will issue an observation or warning letter as a result of an inspection, and for more egregious cases will initiate clinical investigator disqualification proceedings. Depending on the severity, this may mean that they are not eligible to conduct FDA-regulated research, engage in product development activities, or may be restricted from receiving investigational products. PHS will take administrative actions against individuals found to have engaged in research misconduct, including debarment from eligibility to receive federal funding, prohibition from service on PHS advisory committees and grant review panels, supervision by the institution, submission of corrections or retraction of published articles, and other actions. More serious noncompliance that is fraudulent in nature may result in fines and penalties. Violation of the False Claims Act (which qui tam or whistleblower lawsuits are often brought under) can result in civil and sometimes criminal liability for individuals and institutions. This can also lead to reputational harm for the institution or researcher and loss of public trust. Serious or systemic issues at organizations with an FWA could also lead to a halt of all research (or those that are federally funded) occurring at an institution. Institutional-level sanctions may include limiting an investigator’s ability to conduct research at the organization. The type of sanctions will depend on the seriousness and severity of the noncompliance, taking into account the reasons for noncompliance, whether it is continuing noncompliance, and the impact to research integrity and research participants. Remedial measures can include retraining, increased monitoring of the investigator’s research, or disciplinary measures on the individual level.

Answer 3

Clinical trial billing is one of the highest priorities for research sites that are doing therapeutic trials. This process is defined as a review of all documentation to create a coverage analysis to validate what can be billed out to commercial and government payers on a claim. It includes the coverage analysis with a convergence of documentation within the budget, contract, and consent. After a patient is identified as one who has consented to a particular study, tracking that patient throughout the life cycle of the study to ensure proper billing within the clinical trial policy and rules is best practice. The clinical trial policy was enacted by President Bill Clinton in October 2000 to enable seniors to have more opportunity to participate in clinical trials. Information gained from important clinical trials is used to inform coverage decisions, so Medicare was instructed to revise rules to expand benefits for qualifying clinical trials. The types of trials that are of highest importance for compliance are the investigational device exemption (IDE); drug; and coverage with evidence development (CED) studies. The role of the Medicare’s National Coverage Determination (NCD) and how it affects a site varies among different institutions. Because of the variety of tasks and responsibilities related to the clinical trial billing process, institutions often need several specialized individuals to maintain all aspects of compliance in billing Medicare and other types of health insurance. Establishing a billing compliance program takes not only expertise in the Centers for Medicare & Medicaid Services’ (CMS) National Coverage Determination for Routine Costs in Clinical Trials (NCD 310.1), but also a significant commitment.[3] Finding expertise in this area can be extremely difficult. The breadth of employees who are involved in the process reach across an institution or site. It will include a principal investigator and research team, the finance staff, and coding department. Formulations of how this work is performed at each site are based on the electronic medical record, physician–investigator relationship to the site and practice group ownership, a clinical trials management system, the institutional review board’s views on identifying costs to patients, and the varying risk profile of the research portfolio. Staff must dedicate significant focus to billing compliance: by not having a solid program, a site can have true risks. By not having an effective program fully implemented, those risk increase. The roles and responsibilities defined by the U.S. Department of Justice Criminal Division’s Evaluation of Corporate Compliance Programs in June 2020 should be configured by solid policies, procedures, and defined responsibilities of the compliance team. NCD 310.1 is an established policy that even after 20 years can be difficult to absorb. In order to cover conventional care, and the expanded benefits to monitor and prevent toxicities, one must understand the type of trial that is being done. Sites must designate who will perform the qualifying status and billing nature of the tests and procedures on the schedule of events in a clinical trial protocol. It takes careful review to ensure that all of the items eligible for billing Medicare and commercial insurance are correct and validated. This tedious process is called a coverage analysis. Within the study calendar, the items must be itemized as they will show up on a claim for justification of billing. Reviewing published evidence-based guidelines provides direction on the billing process before the study starts and helps ensure compliant billing once patients are enrolled. The risk of not providing a coverage analysis and review can lead to liability under the False Claims Act. These risks were brought to national attention when Rush University Medical Center entered into a million-dollar settlement agreement with the Department of Justice in 2005 for clinical trial billing errors in cancer research. This included overpayments related solely to the NCD 310.1. Rush’s settlement with the federal government was the first to focus on a clinical trial policy.[6] The potential for noncompliant billing in clinical research became noticeable for sites across the country after the Rush settlement. Many sites began conducting more intense evaluations of qualifying status and determining routine costs. The risks of vague budgets without coverage analysis guidance became more evident as auditing moved forward. The coverage analysis became a powerful, necessary tool. Recognizing the application of NCD 310.1 to research studies as a priority in the study start-up process has become increasingly more important throughout the last 20 years.

Answer 4

False Claims Act, 31 U.S.C. §§ 3729–3733 To mitigate the risk of billing errors, sites need to be aware of the laws that govern clinical trial billing and the False Claims Act. The False Claims Act basically states that if an individual or group knowingly submits a false claim for payment of government funds, they are liable for up to three times the government’s damages plus civil penalties. Although the False Claims Act uses the term “knowingly,” proof of specific intent to defraud is not required.[7] A coverage analysis is the source of truth for billing to all payers and will help in mitigating billing issues if errors occur. Centers for Medicare & Medicaid Services Centers for Medicare & Medicaid Services, “National Coverage Determination (NCD) for Routine Costs in Clinical Trials (310.1),” transmittal, July 2007 Centers for Medicare & Medicaid Services, “Clarification of Medicare Payment for Routine Costs in a Clinical Trial,” MLN Matters, SE0822 Revised, May 16, 2018 Centers for Medicare & Medicaid Services, “Chapter 15: Covered Medical and Other Health Services,” Medicare Benefit Policy Manual, Pub. 100-02, revised July 12, 2019 Centers for Medicare & Medicaid Services, “Chapter 14: Medical Devices,” Medicare Benefit Policy Manual, Pub. 100-02, revised November 6, 2014 Centers for Medicare & Medicaid Services, “Chapter 32: Billing Requirements for Special Services,” Medicare Claims Processing Manual, Pub. 100-04, revised July 21, 2020 The clinical trial policy, or NCD 310.1, is the indication of the terms and conditions for coverage. Effective for items and services furnished on or after July 9, 2007, Medicare covers the routine costs of qualifying clinical trials, which are defined in NCD 310.1, as well as reasonable and necessary items and services (such as a physical exam on day one of a treatment cycle for a patient with cancer, or a glucose lab for a patient with diabetes) used to diagnose and treat complications arising from participation in all clinical trials. It is important to remember that all other Medicare rules apply and that NCD 310.1 does not stand alone among Medicare rules. CMS has many billing guidance documents that guide billing for IDE, drug, and CED trials. The coverage requirements for routine costs of qualifying clinical trial services and how to submit claims lie within the various manuals. Medical Services Coverage Decisions That Relate to Healthcare Technology, 42 C.F.R. §§ 405.201–405.215, 411 .15, and 411.406 (for device trials) Device trial coverage rules lie within the Code of Federal Regulations in 42 C.F.R. §§ 405.201–405.215, 411 .15, and 411.406 and are partially dependent upon action by the Food and Drug Administration (FDA).[8] The FDA provides the category status for devices under an IDE of either a Category A (experimental) or Category B (nonexperimental/investigational) study. Understanding the FDA categorization of an IDE device is necessary to know how to bill not only the investigational device, but also the likelihood of CMS approval of the study for billing. CMS must approve billing for an IDE study, which is notated on the approved IDE trial website ClinicalTrials.gov, which is maintained by CMS.

Answer 5

Billing for an Item or Service that a Sponsor or Grant Has Paid for or Funded If a sponsor provides a payment in a budget for a service, you cannot submit that item or service on a claim or you may have double billed. Billing for an Item that is Being Performed for Research Only Validating all research-related items or services that do not meet the guidelines and identifying them as paid by the sponsor or as a patient liability is important to ensure that you do not bill inappropriately or violate the False Claims Act. Billing for an Item or Service that is Promised “Free” in the Informed Consent Form Billing for an item or service that has been identified to a patient in a consent form as “free” or “at no cost” must be provided and not charged to their payer or you may violate the False Claims Act. Billing Medicare Advantage Plans for an Item or Service that Should Be Billed to and Paid for by the Medicare Administrative Contractor Medicare has rules surrounding billing drug trials to regular Medicare, while Medicare Advantage plans should cover IDE approved studies. Knowing the particular payer is recommended. Unknowing Stakeholders Who Can Displace the Process by Not Following Billing Rules in Ordering and Documentation in the Medical Record The removal of codes, modifiers, national clinical trial number, or an IDE number is sometimes found when coding teams are not provided adequate information on clinical trial billing and coverage analysis. Allowing Principal Investigators to Assert Standard of Care Services as the Same as Routine Costs in a Qualifying Trial and Not Validating the Billing Status of Protocol Events with a Coverage Analysis “Standard of care” is not a term that Medicare uses. It covers routine costs in a qualifying trial and items and services that are medically necessary to diagnose or treat illness or injury. Not Knowing All of the Study Portfolio Occurring and Not Managing All Study-related Activity from a Billing Compliance Perspective The possibility that research is ongoing in a facility can lead to unknown claims being submitted without the rigorous review against the coverage analysis. This can lead to improper billing to all payers.

Answer 6

Billing for an Item or Service that a Sponsor or Grant has Paid for or Funded Perform a coverage analysis and ensure that the budget and contract are consistent with it. Then, once a service is performed, ensure that the charges are segregated appropriately against the coverage analysis. Billing for an Item that is Being Performed for Research Only Identify services by reviewing the protocol for all items and services being done within the trial that are research driven while removing them from the claim consistent with the coverage analysis. Billing for an Item or Service that is Promised “Free” in the Informed Consent Form Understand the “Expected Cost” section of the consent when the patient is consented. Confirm that anything promised at no cost is not submitted on a claim or sent to a patient for payment. Billing Medicare Advantage Plans for an Item or Service that Should Be Billed to and Paid for by Medicare Fee-For-Service Recognize a clinical trial patient’s payer. If the patient is enrolled in a Medicare Advantage plan, ensure that the routine costs of the clinical trial services are diverted to the site’s regular Medicare administrative contractor for payment when they are participating in a drug clinical trial. Bill any remaining amount after Medicare pays to the Medicare Advantage plan to make the patient “whole.” Unknowing Stakeholders Who Can Displace the Process by Not Following Billing Rules in Ordering and Documentation in the Medical Record Conduct compliance training on the clinical trial billing process. Training is the only method for ensuring that all stakeholders are aware of the clinical trial billing process. From the principal investigator to the coder who releases a claim, all must understand and appreciate the correct billing process, which helps avoid errors in an intended workflow. Allowing Principal Investigators to Assert Standard of Care Services as the Same as Routine Costs in a Qualifying Trial and Not Validating the Protocol with a Coverage Analysis Principal investigators should be a part of the billing process. They should provide input and approve the coverage analysis as a commitment to bill all subjects consistently. By permitting them to just provide what they feel is standard of care does not guarantee that what they order is billable within the guidelines or coverage decisions. The only sure method to validate the items in a study is to do a thorough coverage analysis. Inappropriately billing Medicare for items or services in a clinical trial that are ineligible for coverage might constitute a false claim if the claim should not have been submitted in the first place. Not Knowing All of the Study Portfolio Occurring and Not Managing All Study-related Activity from a Billing Compliance Perspective Have a complete itemized list of ongoing studies at the site. If a site does not have a complete itemized list of the studies ongoing at a site, then it does not have the capability to safeguard all claims to be placed in a “hold” status or a work queue for the appropriate codes and modifiers to be added. This also warrants that the proper payer is billed for each encounter.

Answer 7

The potential penalties for noncompliance with the Medicare clinical trial policy can be significant. National Coverage Determination (NCD) for Routine Costs in Clinical Trials (310.1) If a site does not follow the NCD 310.1, errors in billing to Medicare can occur, which may violate the False Claims Act. Those items include: Billing for the investigational item or service itself if it is not covered outside the study; Items and services provided solely to satisfy data collection; Items and services that are not used in the direct clinical management of the patient (e.g., monthly CT scans for a condition usually requiring only a single scan every six months); and, Items and services customarily provided by the research sponsors free-of-charge for any enrollee in the trial. While there is no single correct way to develop process compliance controls to meet federal clinical trials billing regulations around Medicare, standardization of the entire billing process is key. Establishing standards around a comprehensive clinical trial billing compliance program will help mitigate billing non-compliance risks. The risks of not complying with federal clinical trial billing regulations can lead to research suspension, fines, and/or the imposition of corporate integrity agreements. False Claims Act The False Claims Act prohibits filing or causing the filing of false claims or creating a false record to get a claim paid.[13] The core of a false claims case is that the government was cheated in one form or another—hence the false claim. This is typically due to double-billing or improper billing in a clinical research study. The benefits of self-disclosure (e.g., a speedy resolution, lower multiplier, and an exclusion release without integrity agreement obligations) depend on the disclosing party’s willingness to work cooperatively with the Office of the Inspector General (OIG) throughout the process.[14] Depending on the facts, OIG “believe[s] that individuals or entities that use the SDP [self-disclosure protocol] and cooperate with OIG during the SDP process deserve to pay a lower multiplier on single damages.” OIG will attempt to process the issue faster due to streamlined processes and turnaround times.[15] The False Claims Act is a punitive statute enforced by the Department of Justice and qui tam relators. For civil violations, its penalties provision authorizes fines of three times the amount the government paid for each false claim, plus an additional penalty of up to $11,000 per false claim.

Answer 8

Research misconduct (sometimes called scientific misconduct) is one of several behaviors related to research activities that are generally considered to be unethical or dishonest. Most people learn early in life that these behaviors are unacceptable. Nevertheless, rules exist to draw a distinct line separating allowable research behavior from research misconduct. Research misconduct is limited to the following three behaviors: (1) fabrication, (2) falsification, and (3) plagiarism. There are many other unethical or incorrect behaviors that a researcher may engage in, such as noncompliance with research protocols or failing to disclose a significant financial interest with a research sponsor. These and many other fraudulent behaviors, however, are dealt with through other regulatory or administrative mechanisms. There are any number of reasons why research misconduct might occur, but some of the most common motivators are pressure to publish or the desire for professional recognition or money. Another reason for misconduct may come from failures at the site level, such as lack of resources, staff turnover, lack of training, or absence of policies and procedures that should be in place to protect both the institution and the researchers. It is important to remember that research misconduct is narrowly defined. It does not include honest differences of opinion among scientists, inadvertent errors, or disputes about the order of appearance in a list of authors’ names. Likewise, the use of sloppy research techniques or suboptimal record keeping, even the republishing of an author’s original or collaborative work (so-called “self-plagiarism”), are not considered instances of research misconduct. These activities, however, do represent inappropriate and sometimes unethical behavior, and institutions may choose to develop policies or procedures that address these behaviors, although they are not under the purview of the federal Office of Research Integrity (ORI).[3] The ORI oversees and directs research integrity activities of the U.S. Public Health Service (PHS) on behalf of the Secretary of the U.S. Department of Health & Human Services (HHS), with the one exception: the regulatory research integrity activities of the U.S. Food and Drug Administration (FDA). Organizationally, the ORI is located within the Office of the Assistant Secretary for Health (OASH), which is in Office of the Secretary of Health and Human Services (OS) in HHS.[4] According to its website,

Answer 9

Fabrication is making up data or results and, subsequently, recording or reporting them. Fabrication is perhaps the most serious form of research misconduct because it is outright deception—the results are conjured up from the deceiver’s imagination. It is science fiction posing as fact because the empirical work from which results have been reported either (1) was never conducted or (2) bore out results that were contrary to and replaced by those reported. Falsification is 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. Falsification is similar to fabrication inasmuch as it is a form of deliberate deception, but different in its magnitude and often its subtlety. For example, a study that yields merely promising results can be made to look like a major breakthrough by selectively removing data points that are not consistent with the desired outcome—an act of falsification. Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit. Plagiarism differs from fabrication or falsification in that results or reports may be entirely accurate and true, except for the matter of who actually did the work. Plagiarism is a deception and more; the plagiarist commits a form of theft by taking credit for the work of others.

Answer 10

A significant departure from accepted practices of the relevant research community occurred; The misconduct was committed intentionally, knowingly, or recklessly; and The allegation be proven by a preponderance of the evidence

Answer 11

This article focuses on standards codified in HHS from 42 C.F.R. § 93, which details PHS Policies on Research Misconduct, and the National Science Foundation (NSF) regulation of 45 C.F.R. § 689, which explains Policies on Scientific Misconduct. Note that the ORI is responsible for oversight of misconduct for PHS agencies, including the National Institutes of Health (NIH). [7][8] The NSF Office of Inspector General is responsible for NSF-funded research.[9] The Department of Justice (DOJ) and the FDA may also investigate research misconduct related to research supported or funded by those agencies. Institutions that seek PHS funding are required to have an assurance certifying that the institution has (1) policies and procedures to manage allegations of research misconduct and (2) a designated RIO to implement and manage the process.[10] Prior to 1996, this process required an “initial assurance” form; however, as of 1996, the act of signing the face page of a grant application constitutes a deemed assurance. It is important to note that compliance with these regulations is required when an application for funding is submitted and is not contingent upon receiving funding.[11] There also is an annual reporting requirement that describes any allegations and how they were managed in the previous year.

Answer 12

Treating Allegations Properly Allegations of research misconduct generally fall into one of three categories: (1) good-faith allegations raised by individuals who have credible evidence for research misconduct; (2) good-faith allegations made by individuals who may be confusing honest disagreement or sloppy research practices with actual misconduct; or (3) allegations not made in good faith. [12] The last is very difficult to prove, therefore, the best practice is to treat all allegations as though they were brought in good faith. Having Policies and Procedures Not having policies and procedures in place can put an institution’s PHS funding at risk and create an environment ripe for noncompliance. Each institution that seeks PHS funding should have written policies and procedures to handle allegations of research misconduct that are consistent with the federal regulations. The ORI has published a model policy that can be accessed on its website.[13] The sample policy and procedures can be tailored to fit any research institution to outline the process that it will undertake when an allegation of research misconduct arises. The sample policy and procedures also define the individual roles involved in the handling of research misconduct. Having the Proper Officials Assigned Institutions must have individuals assigned to investigate allegations of research misconduct to fulfill part of the ORI’s requirement to have policies and procedures in place to conduct an inquiry and, if needed, an investigation of the allegation. In an investigation, the complainant is the person who brings forward the allegation of research misconduct. The respondent is the person accused of the misconduct. The RIO is the institutional official assigned the responsibility for carrying out the process described herein for the handling of allegations of research misconduct. The deciding official (DO) is the institutional official who makes the final determination on the allegation. The RIO and the DO should be two different individuals, because the RIO is responsible for carrying out the procedures involving the inquiry and investigation of the allegation of research misconduct and the DO, who is a higher-level official, is able to review the outcomes of both the inquiry and investigation and make a decision based on the facts alone. Determining the Credibility of an Allegation Not all allegations are credible, and the RIO needs to perform due diligence to determine which allegations should be pursued. The pursuit of a false one could be quite costly to the institution and the researcher alike. Such inquiries and investigations have the potential to damage careers and reputations, and neither should be taken lightly. Once an institution receives an allegation of research misconduct, it must first determine whether the allegation is sufficiently credible and specific so that evidence of the misconduct can be identified. If so, the RIO should initiate an official Inquiry and designate an Inquiry Committee. The Inquiry Committee reviews available evidence to determine whether an official Investigation is warranted and then prepares a report for the DO. The DO makes the final determination on whether a formal investigation will be conducted.[14] If the inquiry advances to the investigation stage, a formal examination is conducted and a factual record is created that will result in a determination (1) not to make a finding of research misconduct or (2) to recommend for a finding of research misconduct that may include other administrative actions. The investigation ends when an Investigation Report is provided to the DO, who then decides what administrative action(s) to take.[15] There are specific points throughout this process at which the institution is obligated to report its activities and findings to the ORI.

Answer 13

It is important that the research compliance program has in place an adequate program to monitor and address research misconduct—and that it trains the research community on this process. This should be part of the ongoing training program, along with an annual review of the process to determine whether any revisions to the established policies and procedures are required. Once a legitimate allegation of research misconduct is found and the institution decides to investigate, the RIO and DO must ensure they take the following actions. Maintain Complainant Confidentiality and Ensure No Retaliation An institution is obligated to take reasonable efforts to keep the identity of the complainant confidential; however, this may not always be practical, depending upon the setting and circumstances. It is equally important to protect the complainant from retaliation. Once the respondent is made aware of the inquiry, the RIO should discuss the institution’s policy against retaliation with the respondent as well as any others who are involved, particularly those who are more senior in their roles than the complainant. This policy should reflect a zero-tolerance standard regarding retaliation. Preserve Respondent’s Reputation The institution also has an obligation to preserve the reputation of the respondent throughout the process and ensure that information about the case is shared only with those who have a need to know. Reputations can be damaged for years as a result of an investigation, even when the allegation is ultimately determined not to be research misconduct.[16] Therefore, the inquiry and investigation should be carried out with utmost care in preserving the confidentiality of both the complainant and respondent. Adhere to ORI Timelines Specific timelines exist for the inquiry and investigation phases, as well as for reporting to the ORI. This is important, not only from a regulatory perspective, but also from a fairness perspective. Wrapping up the inquiry and investigation in a timely manner will go a long way to protecting the confidentiality of the process, as well as protecting the identity of the complainant and the reputation of the respondent. The inquiry should be completed within 60 calendar days of its initiation, unless extended by the RIO in writing (up to an additional 60 days). The inquiry ends when the Inquiry Report is complete and the DO has decided whether or not to move forward with an investigation. If the DO decides to move forward with an investigation, the RIO must notify the ORI within 30 days of the completion of the inquiry. The investigation must also begin within those 30 days. The investigation, Investigation Report, and submission to ORI must be completed within 120 days. Any additional extensions must be requested from and granted by ORI.[17][18] Form an Impartial Committee Assembling an impartial committee can be a difficult task. No members of the Inquiry or Investigation Committee should have any personal, financial, or professional biases toward the respondent or the complainant.[19] The members should be acceptable to both sides and may be from within or outside of the institution. Conduct and Transcribe Interviews Conducting interviews can also present a challenge. Some interviewees, particularly the respondent, may request to have legal counsel present for the interviews. Since the interviews are not legal proceedings, the institution has no obligation to address counsel or permit that person to participate in the interview. Transcripts of the interviews should be provided to the interviewee(s) so that they may offer any corrections to the record or provide additional information. Transcripts are part of the official record and will also be submitted to the ORI as part of the Investigation Report.[20] Manage and Sequester Documentation Sequestering records and materials should start when the decision is made to move forward with an inquiry. The information being sequestered is important for determining whether or not the allegation has a basis in fact and, therefore, should be secured and chain of custody recorded and maintained. At this stage, there is a risk of breaching confidentiality as the physical process of collecting and sequestering documents and materials can be difficult, especially when there is a research team working with the respondent who will have questions and who will need access to some or all of the sequestered documents or materials to continue their work. The RIO will have to determine the best way to protect the documents and materials, while allowing sufficient access to the research team.[21] Record keeping will need to be complete, up to date, and kept in a secure chain of command. Most institutions allow the respondent and complainant a brief period to comment on the draft reports before they are finalized and submitted to the ORI. Respond Appropriately to ORI Review and Findings Once the ORI receives a report, it will examine the information to determine whether the institution’s findings are defensible, supported by evidence, and an acceptable outcome of the inquiry and investigation. During its review, the ORI may determine it agrees with the institution’s report; request additional information; initiate its own review of the allegation; or refer the case to the HHS Office of Inspector General for further investigation. At the end of its review, the ORI will send a copy of the report to the institution and request that the institution directly notify the respondent and whistleblower of the outcome of the investigation. If a finding of research misconduct is made, the ORI may negotiate with the respondent a voluntary exclusion agreement (VEA) in which the respondent accepts the imposition of PHS administrative actions, or, if no agreement is reached, then the ORI makes a finding of research misconduct and recommends to the Assistant Secretary for Health the imposition of administrative actions or submits a charge letter to the HHS Departmental Appeals Board.

Answer 14

Possible penalties for research misconduct are divided into three groups and range from minimal restrictions (Group I) to the most severe and restrictive (Group III). The possible penalties listed in the regulations are not exhaustive and do not include possible criminal or other administrative sanctions. Here are some examples of the penalties that may be directed to an individual or an institution within each of the three groups. Group I penalties include a letter of reprimand to the individual or institution; a condition of an award that for a specified period an individual or institution must obtain special prior approval from NSF for particular activities; or a requirement that, for a specified period, an institutional official other than those guilty of misconduct certify the accuracy of reports generated under an award or provide assurance of compliance with particular policies, regulations, guidelines, or special terms and conditions. Group II penalties include total or partial suspension of an active award or restriction of designated activities or expenditures under an active award for a specified period. All requests for funding from an affected individual or institution will require special reviews for a specified period to ensure that steps have been taken to prevent repetition of the misconduct—or will require a correction to the research record. Group III penalties include terminating an active award; prohibiting an individual from participating as an NSF reviewer, advisor, or consultant for a specified period; or debarring or suspending an individual or institution from participation in federal programs for a specified period, after further proceedings under applicable regulations. Factors that should be considered when determining the appropriate actions to be taken include the seriousness of the misconduct; the degree to which the misconduct was knowing, intentional, or reckless; whether it was an isolated event or part of a pattern; whether it had a significant impact on the research record, research subjects, other researchers, institutions, or the public welfare; and other relevant circumstances. Interim actions that may be taken include, but are not limited to, totally or partially suspending an existing award; suspending eligibility for federal awards in accordance with debarment-and-suspension regulations; proscribing or restricting particular research activities, as, for example, to protect human or animal subjects; requiring special certifications, assurances, or other, administrative arrangements to ensure compliance with applicable regulations or terms of the award; requiring more prior approvals by the NSF; deferring funding action on continuing grant increments; deferring a pending award; or restricting or suspending participation as an NSF reviewer, advisor, or consultant. For cases governed by the debarment and suspension regulations, the standards of proof in the regulations shall control. Otherwise, NSF will take no final action under this section without a finding of misconduct supported by a preponderance of the relevant evidence.