UAB Policy on Compliance with Human Subjects Regulations or the Requirements of the IRB - IRB POL028

UAB Policy on Compliance with Human Subjects Regulations or the Requirements of the IRB - IRB POL028

Abstract:
This policy describes the process of reporting, investigating and deciding upon non-compliance as it relates to Human Subjects Regulations.
Effective Date:
2/16/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     POL028
Effective Date:   3/30/07
Revision Date:  2/16/10
Subject:  UAB Policy on Compliance with Human Subjects Regulations or the Requirements of the IRB  

POLICY STATEMENT

UAB policy requires that any serious or continuing non-compliance with federal regulations affecting human subjects research or the requirements or policies of the UAB IRB be promptly reported to the IRB, UAB, the sponsor, if any, and appropriate federal agencies, if required (see 45 CFR 46.103(b)(5)(i); 45 CFR 46.116(b)(5); 21 CFR 50.25(b)(5); 21 CFR 56.108(b)(2); 10 CFR 745, DOE O 443.1A. and DOE O 443.1A, and DOE P 443.1A; 32 CFR 219, DODD 3216.2, and SECNAVINST 3900.)

The UAB IRB is responsible for deciding whether serious or continuing non-compliance has taken place under this policy. The IRB shall publish a list of the types of information which the IRB must consider to determine whether serious or continuing non-compliance has occurred. The IRB will publish the criteria used to determine serious or continuing non-compliance. (See PRO128 Procedure for Compliance Issues with Human Subjects Regulations or the Requirements of the IRB.) Investigators are responsible for reporting the information listed by the IRB as soon as they learn of such information but in no event later than 10 days. In conjunction with the OIRB, the IRB will establish procedures to receive, evaluate, gather additional information, as necessary, and render decisions (see PRO128 Procedure for Compliance Issues with Human Subjects Regulations or the Requirements of the IRB). Pertaining to non-compliance, the IRB will promptly communicate its findings and any actions taken to the investigator and the Institutional Official. The Institutional Official is responsible for promptly communicating IRB decisions of serious or continuing non-compliance to the appropriate federal agencies and sponsors.

DEFINITIONS

Allegation of non-compliance: An unproven assertion of non-compliance.

Compliance Review Subcommittee: A standing subcommittee established to provide a thorough factual basis and recommendations in response to allegations or reports of noncompliance before the matter is presented to the convened IRB. The subcommittee will consist of at least three IRB members nominated by the IRB Chair and confirmed by the IRB and the Regulatory Compliance Manager of the OIRB. Appointments are for 2-year renewable terms.

Continuing Non-compliance: A pattern of repeated non-compliance actions or omissions that, if unaddressed, may compromise the integrity of the UAB human research protection program. The pattern may reflect a lack of knowledge on the part of the investigator or a lack of commitment by the investigator and/or research team to human subject’s protection. Non-compliance may be both serious and continuing.

Finding of non-compliance: non-compliance that is proven by substantial evidence.

Non-compliance: Failure of an investigator or member of the research team to adhere to the terms of IRB approval or other requirements or determinations by the IRB; or failure to abide by applicable laws or regulations or UAB policies, including failure to submit research for IRB review and approval before initiating research.

Non-serious, non-continuing (NSNC) non-compliance:Non-compliance which is neither serious nor continuing. NSNC non-compliance if repeated may result in continuing and possibly serious non-compliance.

Serious Non-compliance: Failure to comply with laws or regulations, UAB policies, or the requirements or determinations of the reviewing IRB when that failure increases the risk to subjects or adversely affects the rights and welfare of the subjects. A single instance of non-compliance may be serious. Examples of serious non-compliance may include the following:

  • Falsification of IRB documents
  • Human subjects research conducted without IRB approval
  • Deviation from the IRB approved protocol or consent process
  • Modification of protocol without prior IRB approval
  • Failure to maintain regulatory documents
  • Inadequate oversight of research

Approved on March 1, 2010, by:

Richard B. Marchase, PhD
Vice President for Research and Economic Development

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director