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Spotlight on Reporting Compliance Concerns
Supporting compliant practices involves more than just following “the rules.” It requires each of us to accept the responsibility of ethical behavior and to hold one another accountable for our actions and decisions. This includes reporting any compliance concerns you may have, so let’s address some common questions about reporting those concerns:
To whom do I report the issue?
• Management
• Entity Compliance Liaisons
• Office of Corporate Compliance • Compliance Helpline
What information should I provide?
• It is important to give as much detail as possible in order to address your concern. For example: study IDs, names of parties involved, location where events took place, and names of person(s) you’ve reported the concern(s) to prior to reporting to compliance.
Can I keep my identity a secret?
• Yes, you can remain anonymous. Keep in mind that this could limit the extent of the inquiry/investigation undertaken to address your concern.
Will I get in trouble?
• BSWH policy prohibits retaliation against staff who report compliance concerns in good faith, but reporting a concern does not absolve you from wrong doing if you are involved.
• Review the below policies for more information:
~ BSWH Non-Retaliation/Non-Retribution Policy ~ BSWH Research Misconduct Policy 
Ask the Auditor:
What kinds of issues does the FDA cite investigators for when they audit?
There are several common FDA findings that show up time and time again, and learning from other site’s mistakes is a great way to make sure your study is ahead of the curve. Here are some common findings and things to remember:
• Failure to ensure the investigation was conducted according to the investigational plan.
~ Remember, the investigational plan is more than just the approved protocol. It also includes the study application, the investigator agreement, the lab manual, clarification memos, and any other approved document that indicates how a study should be conducted.
• Failure to maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation.
~ Recordkeeping in general is extremely important in a research study, but remember that everything that happens to a subject during their participation must be supported by verifiable source.
• Failure to obtain informed consent in accordance with the provisions of 21 CFR part 50.
~ Perhaps the most important step in any human subject research is the process of informed consent. Unless a waiver has been approved by the IRB, extreme care should be taken to ensure subjects are fully informed and provide legally effective, written informed consent prior to any research procedures.
Follow the study plan, document thoroughly, and obtain consent appropriately These three steps can go a long way in keeping your study audit ready. 
New Infographic from ORI
Plan on publishing?
Then check out the Office of Research Integrity's new infographic on good authorship practices. This is available on their website along with a little video.
Whether you’re publishing the results of a retrospective research project, an editorial article on your research experience or
a soon-to-be best selling novel, they have a few important reminders to help you avoid some publication party fouls.
Publishing your work is a great accomplishment, and these tips will help prevent disputes that could hinder the celebration!
Don’t Forget!
Have a concern? Need to report a compliance prob- lem but don’t know how to go about it? Call the
confidential Compliance HelpLine at 1-866-245-0815 or go online to: http://ComplianceHelpLine.BSWHealth.com
We’re here for you!
ResearchCompliance@BSWHealth.org
Research Compliance Webpage on BSWConnect
Research Integrity Officer:
Stephanie Worley Office: 254-215-9025
Corporate Compliance Consultants:
Jennifer Gibbons-Ramirez Office: 254-215-9027
Lindsey Estep Office: 254-215-9028
Michelle Edens Office: 214-820-6524
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