SOP

Data Sets Not Requiring NBER IRB Review

 

 

 

This document describes the procedures for adding a data set to the NBER IRB-maintained List of Data Sets Not Requiring IRB Review.

Policy:

The NBER Institutional Review Board recognizes that certain data sets are considered to not involve “human subjects”, as defined by federal regulations and guidance. The research use of such data sets does not require IRB review or a determination of exempt status. As a service to researchers, the NBER IRB maintains a list of data sets it has evaluated as not involving human subjects and provides the process described here for adding other data sets to the list. The list is maintained at the end of GUIDANCE: Data Sets Not Requiring IRB Review.

Definitions:

Publicly available: The general public can obtain the information. Data sets are not generally considered publicly available if access to the data is limited to researchers.

De-identified: The data do not contain information that can be used to readily ascertain the identity of the individuals, nor to associate an individual with the information. This includes data that are anonymous or coded (when the user has no access to the link between the code and the identifiers, and when the code is not derived from or related to information about the individuals).

Procedure:

Nominating a data set
Researchers send an email to irb@nber.org with:

  • Request to evaluate the data set for inclusion on the list
  • Name of the data set
  • Name of the host/holder archive or institution
  • The following information or web site addresses (URLs) where the following information can be obtained:
  1. The data set contents, including the variables;
  2. The identifiability of the data;
  3. The subject populations, how the data were collected, by whom, and when;
  4. How the data set is obtained by researchers, any conditions or restrictions, and copy of any agreement that a researcher or institution must sign in order to obtain the data

IRB members are encouraged to nominate data sets (for example, when they encounter a likely candidate while screening an IRB application).

Evaluating the data set. The evaluation is conducted by the Research Compliance Manager, the Chair of the IRB and the Director of Research and Grants Management using the CHECKLIST: Data Sets Not Requiring IRB Review. The nomination will then be sent to the IRB for review and approval. Majority vote determines the outcome. If the nominator was a member of the IRB, the nominator will recuse him or herself from the deliberations.

Documentation and communication. The decision is communicated by the Research Compliance Manager to the nominator. The Research Compliance Manager creates an office file to document the nomination, evaluation, and outcome, containing:
The nomination (e.g., email request)
The CHECKLISTS from each evaluator
The communication of the decision
Any other relevant material

Forms and Regulatory Help:

45 CFR 46.102(f), definition of human subject:

http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/#46.102

OHRP Guidance on Research Involving Coded Information or Biological:

http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/#46.102