Human Subjects Involvement Codes

See also: Human Subjects Inclusion Codes.

NIH uses this list of codes to indicate the extent of Human Subjects involvement within a grant application. The codes can refer to exemptions, missing information, insufficient procedures, reviewers concerns, or the fact that all issues have been resolved and the award can be processed. They appear on the summary statements grantees receive, and also on the grants management and program officer worksheets in IMPAC.

The current codes are:

• Code 10 -- Award can be processed, no human subjects involved.
• Codes E1-E6 -- Award can be processed, human subjects involved, designates an exemption.
  • Code E1 -- Exemption category 1 -- research is conducted in an educational setting involving normal educational practices.
  • Code E2 -- Exemption category 2 -- research uses cognitive, diagnostic, aptitude, or achievement tests; interviews; or observations of public behavior, unless subjects are identifiable and disclosure could place them at risk.
  • Code E3 -- Exemption category 3 -- research is covered by (2) and is not exempt, if the subjects are public officials or candidates or the law requires that confidentiality be maintained.
  • Code E4 -- Exemption category 4 -- research involves the collection or study of existing data, documents, records, or pathological or diagnostic specimens, if the sources are publicly available or the information is recorded so subjects cannot be identified.
  • Code E5 -- Exemption category 5 -- research involves research and demonstration projects to study public benefit or service programs.
  • Code E6 -- Exemption category 6 -- research evaluates taste and food quality or consumer acceptance of certain foods.
• Code E7 -- Human subjects involved -- multiple exemption categories designated.
• Code E8 -- Human subjects involved -- applicability of human subjects regulations waived by the Secretary, HHS.
• Code 20 -- Award cannot be processed, human subjects involved and no appropriate exemption designated.
• Code 30 -- Award can be processed, human subjects involved, no scientific review group (SRG) human subjects concerns*.
• Code 44 -- Award cannot be processed, human subjects involved, SRG human subjects concerns.
• Code 48 -- Award can be processed, human subjects involved, SRG human subjects concern, restricted from enrolling subjects until resolved.
• Code 54 -- Award can be processed, previously Code 44, now resolved.

*Concerns: Any actual or potential unacceptable risk or inadequate protection against risk to human subjects. It will need to be resolved before we award the grant.

See also: Human Subjects Inclusion Codes and Human Subjects.