§46.118 Applications and proposals lacking definite plans for involvement of human subjects.

46.118 Determinations can be granted to satisfy federal sponsor requirements (e.g., Just-In-Time) to allow investigators to have access to funding to begin aspects of the project that do not involve human subjects.  Human subject research activities cannot begin until a full application and all applicable material (e.g., consents, surveys, tools) have been developed, submitted, and IRB approval (§46.111) has been obtained.

Under the federal regulations (§46.118) certain types of applications for grants are submitted with the knowledge that subjects may be involved, but definite plans would not normally be set forth in the application or proposal. These can fall under three categories:

  • institutional type grants when selection of specific projects is the institution’s responsibility;
  • research training grants in which the activities involving subjects remain to be selected; and,
  • projects in which human subjects’ involvement will depend upon completion of instruments, prior animal studies, or purification of compounds.

Many of the request for a .118 determination will fall under the third category. Research instruments refers to measurement devices and can include surveys, tests, questionnaires, etc. It is important to distinguish if the release of funds are required for the completion of instruments, prior animal studies, or purification of compounds.