1. Delayed Onset Human Research formerly Limited Activities Determination (LAD) Karen Moe, Director Human Subjects Division

2. Release of federal funding for Human Subjects Research requires: IRB approval Exempt status or Limited Activities Determination (LAD) – New name: DOHR

3. What is the DOHR ? (formerly LAD) A way to release funds for grants that: Will be doing (or funding) human subjects research, but There are not yet any definite, detailed plans for human subjects research, but the

4. How is it changing? Expanded to include other sources of funding Expanded to include other types of awards New name

5. Change #1: New Name Delayed Onset Human Research Determination (DOHR) Why a new name? NIH Notice August 2, 2012 NOT-OD-12-130 “Prior NIH Approval of Human Subjects Research in Active Awards Initially Submitted without Definitive Plans for Human Subjects Involvement (Delayed Onset Awards)” Goal: use terms familiar to NIH & thereby increase acceptance by NIH

6. DOHR Opening the door to the funds

7. Change #2: Expanded to additional funding entities Federal funding NEW Awards from non-federal entities (except when not allowed by the award conditions)

8. Change #3: Expanded to other types of awards CRITERIA for granting DOHR status: The research requires significant development work that doesn’t involve human subjects NEW Grants whose only human subjects research is funding for small projects or trainees that will be selected and funded by the awardee – Institutional Training grants (NIH “T” awards) NEW Grants for clinical research networks or consortia that will create protocols over the course of the award. – Most NIH “P” awards

9. Grants that do not meet any of these criteria are not eligible for DOHR status. Most grants are not eligible. This is a special status for special circumstances only.

10. Important Caveat NIH does not always accept this as a mechanism for funding release of Training grants or Program/Center grants, even though: It is a federally recognized process. NIH identified it as a legitimate process in a guidance document last summer.

11. What if NIH doesn’t accept it? Use the Center/Training/Program grant application. DOHR is preferred because: – More consistent and compliant with regulations. – Annual renewal does not require listing the individual projects and their IRB numbers and approval dates.

12. The DOHR Process Same as the LAD process PI completes DOHR form, sends to HSD HSD makes a determination HSD sends memo to PI PI gives memo to OSP, or OSP sees the DOHR “Study Status” in DORA Renew it annually with the same form: fast!

13. Impact on Researchers Clearer pathway to releasing funds for certain types of awards Easier, somewhat faster, process for gaining access to these types of new funding