1. Best Practices Reviewing Classified Human Subject Research at DOE Sites Terry Reser & Sherry Davis November 13, 2009

2. Do you know… • Is classified HS research being conducted at your site? • How confident are you of your answer? • How can you find out? • Who can you call? • If it is, do you know what to do? Best Practices – Classified HS Research

3. Federal Requirements Only 2 • 10 CFR 745 -- no Expedited review for classified research • DOE 443.1A – must notify DOE/NNSA Program Managers of classified research Best Practices – Classified HS Research

4. Background Last 12 years… • Clinton Memo of 1997 • Very prescriptive • No consensus • Never implemented • Only result: Common Rule amended to disallow expedited review for classified • No written guidance, no SOP • Starting point – what you ought to know Best Practices – Classified HS Research

5. Step 1 Is it classified? • Standard question on your IRB application • PI must make this call – not the IRB • What makes it classified? • Can study be fully described without that information? • If so, classified review may not be required • If not, classified review is the only option Best Practices – Classified HS Research

6. Step 1 (cont’d) What makes it classified? •  results • application/implementation •  sponsor •  purpose (implies deception) •  equipment or material or process involved •  everything Best Practices – Classified HS Research

7. Step 1 (cont’d) Is it Generalizable? • In classified research, “generalizable” may have a different connotation • By definition, classified information has a limited distribution • Need to Know (NTK), clearance level • IRB of Record must decide how that impacts “generalizable knowledge” Best Practices – Classified HS Research

8. Step 2 Handling Classified Information • What clearance level is required for review? • What training for Administrator, for IRB members? • Where can your IRB meet to discuss? • Where can you store records? • Who determines whether your meeting minutes & notes are classified? Best Practices – Classified HS Research

9. Step 3 What gets Reported? • Notify DOE HSR Program manager (and NNSA if applicable) about a classified study • Do not include classified studies in the annual HSRD database report • Report classified studies to DOE/IN via a secure method. Best Practices – Classified HS Research

10. Step 4 Which institutions are involved? • ID all institutions and the role of each • Does each have an IRB? • Do all agree on review? Who determines? • Who manages the overall study? • Who is directly involved with subjects? • If WFO, has DOE/IN reviewed the study? Best Practices – Classified HS Research

11. Step 6 Clarify Researcher roles • ID all researchers and the role of each • Are there multiple PIs? • Who will work with subjects (each site)? • Who will collect the data (each site)? • Who will analyze the data? Best Practices – Classified HS Research

12. Step 7 Where will study occur? • Domestic? Foreign? • What countries are involved? • If outside US, see the International Compilation of Human Subject Research Protections for country-specific laws • Are there multiple data collection sites? • Are there separate sites for data analysis? Best Practices – Classified HS Research

13. Step 8 Classified HTM or HSCB? • DOE and NNSA consider HTM and Human Social Cultural Behavior Modeling (HSCB) to be human subject research • The sponsor may not Best Practices – Classified HS Research

14. Step 9 Is Deception Involved? • Does anyone not receive full knowledge? • Is the deception justified? • Could concealed info affect subjects? • Will those deceived be briefed about the deception after the study? Best Practices – Classified HS Research

15. Step 10 Potential for Mischief • Identify any factors that might have the potential to adversely impact subjects, researchers, your institution, or DOE’s reputation • The potential for controversy might involve different considerations in a classified study than in a non-classified one Best Practices – Classified HS Research

16. Step 11 Identify issues specific to your site • Institutional policies • Export control issues • Additional approvals Best Practices – Classified HS Research