IRB: policies

2018 Policy Update Notice

The federal regulations and corresponding SJSU Policy for the Protection of Human Subjects in Research (HSR) have been revised and are effective January 2018. Links to the new policy and regulations are provided below.

The most significant change to the regulations is the expansion and clarification of exemption categories. A list of the exemption categories, how they apply to vulnerable groups, and the SJSU-specific consent requirements for each category are provided in the following Table of Exemption Categories (pdf).

Summary of Revisions to HSR Policy:

  • New exemption categories (e.g., benign behavioral interventions), clarification to existing categories, clarification on how new exemptions apply to vulnerable groups (see Table of Exemption Categories (pdf)).
  • Exemption categories apply to vulnerable groups in the same way as the federal regulations – previous SJSU policy was more restrictive.
  • Continue to apply more stringent consent requirements than the federal regulations for exempt research – most exempt research will only require a consent notice as opposed to a signed consent form, except when the subjects are minors or when the research is subject to other laws (e.g., FERPA) that require written consent.
  • No parental permission is required for college students under the age of 18 participating in school-based research.
  • Assent (verbal or written) is required, when appropriate, or researchers must provide an explanation for why assent is not appropriate.
  • No continuing review is required for research initially evaluated under expedited or exempt review.
  • Consent documents must make sense to the target population and the consent process must be comprehensible to prospective subjects; this includes minimization of situations that may cause undue influence or present a conflict of interest.
  • SJSU has chosen not to adopt the broad consent provisions and accompanying exemption categories outlined in the federal regulations (which enables the creation of databases that are primarily of interest to biomedical research).
  • Adopted single IRB mandate – only one IRB conducts a review when multiple institutions are engaged in collaborative research.

 

Regulations Related to Human Subjects Research Protections


SJSU Policy for Protection of Human Research Subjects (pdf)

Code of Federal Regulations for the Protection of Human Subjects

Family Educational Rights and Privacy Act (FERPA)

Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule

 

Regulatory Bodies

SJSU Academic Senate

Office of Human Research Protections (OHRP)