UAB Policy on Determination of Human Subject Research and Research Exempt from Federal Human Subjects Protection Regulations; IRB Review of Exempt Research - IRB POL017

Abstract:
This policy describes the IRB's process of determining human subjects research and research exempt from Federal Human Subjects Protection Regulations. This document lists what the IRB is authorized to determine and includes multiple definitions related to the review process for research involving human subjects.
Effective Date:
1/27/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

 

HRPP Document:     POL017
Effective Date:   3/30/07
Revision Date:  1/27/10
Subject:  UAB Policy on Determination of Human Subject Research and Research Exempt from Federal Human Subjects Protection Regulations; IRB Review of Exempt Research

POLICY STATEMENT

When UAB engages in research, 1 the UAB IRB is authorized to make the following determinations for research involving humans:

  1. Whether or not the proposed research satisfies the definition of human subjects research; and
  2. Whether or not the proposed research is exempt from federal human research subjects protection regulations.2

Only the IRB can make a authoritative determination as to whether an activity is human subjects research. No investigator is authorized to determine that his or her human subjects research is exempt. Determinations of whether research involving humans constitutes research in human subjects under, or is exempt from, federal human subjects protection regulations may be delegated by the IRB to an experienced IRB member or to a member of the OIRB administrative staff knowledgeable about this area of federal regulation. All determinations must be made in accordance with applicable federal regulations and guidance and be ratified by the IRB. UAB does not consider research involving only coded private information or coded human biological specimens to involve human subjects as described by OHRP guidance.3 Only federal exemptions may be recognized by the IRB. Each determination and its basis must be documented and communicated to the investigator.

For research involving humans that is determined to be exempt from, or not human subjects research under, federal human research subjects protection regulations, the IRB is authorized to review any proposed or implemented change(s) to the research to determine whether it alters the previously assigned status of the research. For research that is determined to be exempt or not human subjects research, the IRB is authorized to review the research to determine if the research meets UAB’s ethical standards. UAB has adopted the principles of the Belmont Report as its ethical standard for research involving humans unless some other appropriate ethical standard controls the research. Ethical review may be accomplished by expedited review procedures or a convened IRB meeting. UAB, upon recommendation of the UAB IRBs or of its own accord, may designate classifications of research involving humans for IRB review in addition to those required by federal regulations.

DEFINITIONS

See also: Definitions in POL001.
Coded means that:

  1. Identifying information including all 18 HIPAA identifiers listed in 45 CFR 164.514 has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); and
  2. A key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.

Interaction includes communication or interpersonal contact between the investigator and subject.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject environment that are performed for research purposes.

Individually identifiable refers to private information or specimens that can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems. Private information or specimens are not considered to be individually identifiable when they cannot be linked to specific individuals by the investigator(s) either directly or indirectly. For research covered by HIPAA privacy regulations, research information comprising protected health information will be considered not to be individually identifiable if it does not contain any identifiers in accordance with HIPAA standards.

Investigator means anyone involved in conducting the research. Individuals who provide coded information or specimens to investigators for research and collaborate on other activities related to the conduct of the same research with the investigators who received such information or specimens are considered to have involvement with the conduct of research. Examples of such additional activities include, but are not limited to: (1) the study, interpretation, or analysis of the data resulting from the coded information or specimens, and (2) authorship of presentations or manuscripts related to the research.

Private information includes information about behavior that occurs in a context in which the individual can reasonably expect that no observation or recording is taking place, and information or a biological specimen(s) which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., a medical record, biopsy tissue). Private information or specimens must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) or, if the research information is protected health information (PHI) under HIPAA, the PHI must be considered identifiable under HIPAA standards.

Research using coded private information or coded biological specimens does not constitute human subjects research as defined under the OHRP definition above if both of the following conditions are met.

  1. The private information or specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals; and
  2. The investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain because, for example
    1. The key to decipher the code is destroyed before the research begins;
    2. The investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstance, until the individuals are deceased;
    3. There are IRB-approved written polices and operating procedures for a repository or data management center that prohibits the release of the key to the investigators under any circumstances, until the individuals are deceased; or
    4. There are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased.

Test article means any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the FD&C Act, as amended, or under Sections 351 or 354-360f of the Public Health Service Act, as amended.

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

_______________________________________________

1 OHRP Guidance: Engagement of Institutions in Research.
2The term federal human research subjects protection regulations refers to 45 CFR Part 46 and 21 CFR Parts 50 and 56. Exemptions from all or part of the federal human research protections regulations are listed at 21 CFR Sec. 56.104, 45 CFR Sec. 46.101(b)(1) – (6), 45 CFR 46.101 (i), 45 CFR 46.301(a), 45 CFR 46.401(b), DoD Directive 3216.1 E2.1.1., DOJ 28CFR 12.10
3 OHRP Guidance: Guidance on Research Involving Coded Private Information or Biological Specimens.