In the areas of biomedical and behavioral sciences, research can only be considered reliable when it's based on proper protocols, accurate readings, and honest reporting. The Office of Research Integrity (ORI) works to set and enforce proper standards for research. When allegations of research misconduct arise, the Office of Research investigates the allegations, often placing university grad students, research assistants, professors, and other health science researchers under scrutiny. The decisions rendered by the ORI can have serious implications on the careers of these students and professionals. For this reason, it's essential to hire an experienced attorney to advise and represent your interests during any misconduct investigation being conducted by the ORI.
What Is the Office of Research Integrity?
The Office of Research Integrity (ORI) is a government agency within the Department of Health and Human Services (HHS), acting on behalf of the Secretary of Health and Human Services. The job of ORI is to provide accountability for all research activities falling within the scope of Public Health Services (PHS), not only within federal agencies themselves, but also with “extramural” organizations which receive PHS research funding, including colleges, universities, medical schools, research institutes, etc. The ORI reviews and investigates claims of research misconduct that take place within any school or facility that receives or has applied for research funding.
Why the ORI Exists
The entire essence of research is based on accuracy, integrity, and honesty. Decisions based on inaccurate findings can yield tainted results, and in some cases, this may result in dire consequences, especially in the area of public health. That's why university grad students, research assistants, professors, and other health science researchers are held to such strict academic and professional standards. When protocols are breached, or data is handled and reported dishonestly or recklessly, the research becomes corrupted. The ORI assumes responsibility to ensure all research facilities follow accepted protocols and that all students, professors, research assistants, and others within those facilities follow those protocols accurately and honestly.
How the Office of Research Integrity Handles Misconduct Claims
The ORI prescribes a fairly standard process for handling claims of research misconduct. The process starts when a complainant (whistleblower) reports alleged acts of research misconduct, either to the institution authorities or to the ORI directly. From there, the allegations go through a set of steps before being submitted to ORI for review. The steps are as falls.
Preliminary assessment. The institution first evaluates the allegation against certain criteria to make sure it falls within PHS jurisdiction, namely:
- Does the research and facility in question receive PHS funding, or has it applied for such funding?
- Does the allegation meet the established definitions for misconduct according to PHS policies? And
- Is there enough information within the allegation to move forward with an inquiry?
Inquiry. If the allegation warrants further review, there will be an inquiry into the matter—to evaluate the existing information and gathered evidence to decide whether to launch a full investigation. The respondent(s) (those who have been accused of research misconduct) may, at this point, be notified of the case and asked for their testimony on the matter.
Investigation. The investigation phase examines the alleged misconduct in detail “to determine specifically whether misconduct has been committed, by whom, and to what extent.” The investigation may also expand its reach to see whether other incidents of misconduct have occurred, particularly in matters where the alleged misconduct involves clinical trials or human subjects who may have been harmed.
Institutional Decision. After the investigation, the institution's deciding official makes a final decision whether to accept the findings of the investigation. At this point, the institution will notify the respondent(s) in writing of the decision and submit a report to ORI for review.
ORI Oversight Review. When the ORI receives an investigation report, the office reviews the report to ensure it is thorough, competent, objective, and timely. It also examines the conclusions to determine if the evidence supports them. From there, the ORI makes recommendations to the PHS/HHS as to which administrative actions are appropriate for the case.
PHS/HHS Decision. The Assistant Secretary for Health makes a final determination on which actions should be taken against the respondent based on the ORI recommendations and sends the respondent a copy of the final report. The respondent then has 30 days to request a hearing to appeal the decision, if he/she so desires.
Hearing (Appeal). A hearing only takes place if the respondent wishes to appeal the decision in the final ORI report. The hearing takes place before the HHS Departmental Appeals Board with an Administrative Law Judge presiding. The respondent may have an attorney to serve as legal counsel.
What Are the Penalties (Administrative Actions) for Research Misconduct?
Being found guilty of research misconduct can have far-reaching implications for students, researchers, and professors accused of such misconduct. The penalties (which are called Administrative Actions) may include any/all of the following:
- Correction of the research record
- Letters of reprimand
- Suspension/termination of PHS funding
- Restrictions of activities involving PHS funding
- Debarment/exclusion—in which the respondent (or institution) is prohibited from participating in federally funded research for a set period.
What Is a Voluntary Agreement?
In many cases, a person found to have committed research misconduct may enter into a voluntary agreement with the Office of Research Integrity to show good faith as well as to avert the most severe administrative actions. For example, a voluntary agreement may involve debarment for a lesser period, or an agreement to continue research under prescribed supervision.
Why You Need an Attorney for Research Misconduct Cases
While allegations of research misconduct generally don't involve law enforcement or criminal charges, they can have serious repercussions for students and researchers seeking a career in the biomedical or behavioral research professions. An experienced research misconduct attorney or attorney-advisor can offer critical guidance at important stages of the investigations, help you gather evidence to defend your actions, represent your interests during an appeal, and negotiate for the best possible outcome. In many cases, the involvement of an attorney can save your career.
Attorney Joseph D. Lento and the Lento Law Firm have many years of experience handling misconduct cases, including those involving the Office of Research Integrity. If you're facing research misconduct allegations, call 888-535-3686 to see how we can help.