Determination of Human Subject Research on Cell Lines- POL042   

 

 

Abstract: 
This policy outlines UAB's approach to determining whether use of commercially available cell lines is defined as human subjects research.

Effective Date: 5/9/2011

 

Review/Revised Date: 9/9/2019

 

Category: Research

 

Policy Owner: Vice President for Research

Policy Contact:

 
   
 
 

 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.

POLICY STATEMENT

UAB’s human research protection program has adopted a policy regarding the use of commercially available cell lines, based on the Guidance for Investigators and Institutional Review Boards Regarding Research Involving Human Embryonic Stem Cells, Germ Cells and Stem Cell-Derived Test Articles issued by the Office for Human Research Protections (OHRP) March 19, 2002.

HHS-conducted or supported research that involves neither interactions nor interventions with living individuals or obtaining identifiable private information is not considered human subjects research. Accordingly, in vitro research and research in animals using already derived and established human cell lines, from which the identity of the donor(s) cannot readily be ascertained by the investigator, are not considered human subject research and are not governed by the HHS or FDA human subject protection regulations appearing at 45 CFR Part 46 and 21 CFR Parts 50 and 56. IRB review is not required for such research.

Research that proposes the use of human cell lines commercially procured from the American Type Culture collection (ATCC) or a similar repository is not considered human subjects research because the cells are publicly available and all of the information known about the cell lines (perhaps, including the donor) is also publicly available.

In vitro research or research in animals using a human cell line that retains a link to identiable private information ordinarily would not be considered human subjects research if:  

  1. The investigator and research institution do not have access to individually identifiable private information related to the cell line or the code; and
  2. A written agreement, including published written policies and procedures, is obtained from the holder of the identifiable private information related to the cell line providing that such information will not be released to the investigator under any circumstances. In this case, the research may be considered to not involve human subjects because the identity of the donor(s) could not be “readily ascertained” by the investigator or associated with the cell line. Under such circumstances, an institution or an IRB could determine that IRB review of the research using the cell line was not needed (see POL017).

If the two criteria above are not true, then the investigator must submit a Not Human Subjects Research application to the IRB for review and approval.

Research using established cell lines with identifiers meet the definition of human subjects research and the investigator must submit an HSP application to the IRB for review and approval.