The ABCs of IRBs

Monday, August 25, 2014
By Lenis L. Archer, J.D., M.P.H., The Health Law Firm

The field of scientific research presents many challenges to academics.  When research is performed on human subjects in a health care setting, the stakes are even higher.  

Allegations of research misconduct can throw academic researchers into a tangled web of institutional and legal challenges.  University policies, federal regulations, and legal concerns overlap in ways that may become quite frustrating for a health practitioner and researcher devoted to clinical care.


Governing Bodies of Scientific Research.

Research involving human subjects at a hospital or university is governed by an Institutional Review Board (IRB).  An IRB is responsible for the review and approval of all research proposals and protocols submitted by a researcher.  

An IRB can exhibit a great deal of power over academic research.  An IRB can audit an already approved research protocol at any time outside of a scheduled continuing review, if any person brings a complaint of alleged noncompliance or misconduct in research.

Research funded by federal entities such as the National Institutes of Health (NIH), the Department of Health and Human Services (HHS), or the Food and Drug Administration (FDA) are also subject to reviews by the Office of Human Research Protections (OHRP).


Tips for Staying in Compliance.

Here are some tips to make sure you are in compliance and prepared for inquiries and investigations into research involving human subjects:

1.  Know your research parameters: Make sure you and your staff are fully cognizant of the limits on your research.  You and your team need to know what types of procedures are permitted.  Know your research protocols and review them regularly.  If you need to modify your research, seek approval from your IRB immediately.

2.  Know IRB policies and procedures:  Make sure that you and your staff are familiar with your institution's IRB policies and procedures, including current Collaborative Institutional Training Institute (CITI) continuing education.  Afford your staff every opportunity to refresh their knowledge.  Conduct a self audit on your laboratory or research team, so you can be aware of any noncompliance issues. You are ultimately responsible for your staff's documentation and the propriety of their research policies.

3.  Know your due process rights:  If an IRB finds noncompliance, you may have limited ability to respond.  In many situations, an IRB's notice of inquiry or investigation can lead to the seizure of laboratory equipment and records.  

4.  Know the effects on your employment:  You may be placed on administrative leave.  Be aware of the additional institutional entities that may act, and be prepared to defend yourself.  Be familiar with the terms of your employment contract, and tenure, if applicable.

If an IRB audit's preliminary findings allege noncompliance or even misconduct, an IRB may report their findings to OHRP.  Your research funding may be halted.  If you published any of your findings in a peer-reviewed journal, you may have to retract your article.  This will lead to the submission of your name to the infamous "Retraction Watch, Wall of Shame," an internet site devoted to posting information on discredited and retracted research and researchers.

Don't let allegations of research noncompliance or misconduct derail your career.


Comments?

How do you ensure compliance with IRB standards? Would you be prepared for inquiries and investigations into you research? Please leave any thoughtful comments below.


Contact Health Law Attorneys Experienced in Representation for Clinical Research Fraud and Misconduct.

In order to combat such destructive accusations and avoid major punishments, it is critical to have a legal representative present on your behalf in an effective manner that does not compromise a legal defense. The Health Law Firm attorneys, through years of experience, have obtained the knowledge and skills necessary to navigate research misconduct cases. An accusation of research misconduct, even if later proven to be incorrect, may unfairly tarnish your professional reputation. Legal guidance and experienced insight are invaluable when it comes to protecting the time and efforts you have put forth in building a sustainable and impacting career.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.


About the Author: Lenis L. Archer is as attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.


Tag Words: research misconduct, institutional review board, IRB, IRB audit,  National Institutes of Health, NIH, Department of Health and Human Services, HHS, Food and Drug Administration, FDA, Office of Human Research Protections, OHRP, research parameters, IRB policies and procedures, Collaborative Institutional Training Institute, CITI, self audit, employment contract, IRB attorney, IRB lawyer, defense attorney, defense lawyer, health law firm, The Health Law Firm
"The Health Law Firm" is a registered fictitious business name of George F. Indest III, P.A. - The Health Law Firm, a Florida professional service corporation, since 1999.
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Lenis L. Archer 8/25/2014

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