Human Research Protection Program

HITECH Act

Compliance

Frequently Asked Questions

What is Noncompliance?

All Investigators are required to conduct research projects in accordance with the approved IRB protocol, federal regulations, state law, and University policy. Failure to do so will constitute noncompliance in the research endeavor. Noncompliance can be minor, serious or continuing as below:

Noncompliance: Any action or activity associated with the conduct or oversight of research involving human subjects that fails to comply with the research plan as approved by a designated IRB or federal regulations or institutional policies governing such research. Non-compliance may range from minor to serious, be unintentional or willful, and may occur once or several times.

Minor Noncompliance: Any action or omission in the conduct or oversight of research involving human subjects that deviates from the approved research plan, federal regulations or institutional policies but because of the nature of the deviation, research project or subject population does not place, or have the potential to place, participants at greater risk than previously anticipated. Examples of minor non-compliance include, but are not limited to:

  • Changing study personnel without notifying the IRB
  • Shortening the duration between planned study visits
  • Implementing minor wording changes in study questionnaires without first obtaining IRB approval

Serious Noncompliance: Any action or omission in the conduct or oversight of human research that has been determined to affect the rights and welfare of participants, increases risks to participants, decreases potential benefits or compromises the integrity or validity of the research. Examples include, but are not limited to:

  • Conducting non-exempt research that requires direct interaction or interventions with human subjects without first obtaining IRB approval;
  • Enrolling subjects who fail to meet the inclusion or exclusion criteria in a protocol that involves greater than minimal risk and that in the opinion of the IRB Chair, designee, or convened Committee, places the participant(s) at greater risk;
  • Failure to adequately provide informed consent as described in the IRB approved protocol;
  • Inadequate supervision in research involving experimental drugs, devices or procedures;
  • Failure to follow recommendations made by the Committee to ensure the safety of subjects;
  • Failure to report appropriate adverse events, unanticipated problems, or proposed protocol changes to the Committee or
  • Serious protocol deviations that place, or have the potential to place, participants at increased risk from the research.

Continuing Noncompliance: A pattern of non-compliance that, in the judgment of the IRB Chair, designee, or a convened Committee, indicates a lack of understanding or disregard for the regulations or institutional requirements that protect the rights and welfare of participants, compromises the scientific integrity of a study such that important conclusions can no longer be reached, suggests a likelihood that non-compliance will continue without intervention, or frequent instances of minor non-compliance. Continuing non-compliance may also include failure to respond to a request from the IRB to resolve an episode of non-compliance.

I think I may be out of compliance, what should I do?

Investigators, research personnel, or other individuals who believe that an incident of non-compliance has occurred must report the incident to the IRB within 48 hours of their becoming aware of the incident as required by regulatory and institutional policies for the protection of human subjects. Please call (203) 785-4688 to report such incidents. If you’re unsure about whether or not the incident meets any of the definitions above, please contact us as soon as possible and we will work with you to determine the best course of action.

I’ve received notification that my study is going to be audited. What does this mean?

The Compliance Office has begun a program of random reviews to ensure compliance with ethical standards and human subjects protection. The selection of your study was done randomly and doesn’t mean you are out of compliance. The Compliance Manager will come to your office for a brief introductory meeting to explain what will happen during the audit and then will schedule a full day to perform the audit. During the audit the Compliance Manager may talk with research staff, tour your facility, review study records, and IRB records. This process should be collaborative and helpful with the end goal of facilitating your research and the protection of your participants.

What are my responsibilities and how do I stay in compliance?

The most important way you can stay in compliance is to follow your protocol as it has been approved by the IRB. If you make ANY changes to the protocol, it MUST be approved by the IRB before you implement those changes. Additionally, make yourself familiar with the University policies and federal regulations governing human subjects research. Links to these are on our website. Also remember, your primary responsibility as an investigator is the protection of the human subjects who have volunteered to participate in your studies.