1 / 55

ORD Common Findings

ORD Common Findings. K. Lynn Cates, M.D. Assistant Chief Research & Development Officer Director, PRIDE May 30, 2012. ORD Policies. ORD is responsible for 1200 series handbooks PRIDE is responsible for 1200.05 content Interpreting 1200.05

mervyn
Download Presentation

ORD Common Findings

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. ORD Common Findings K. Lynn Cates, M.D. Assistant Chief Research & Development Officer Director, PRIDE May 30, 2012

  2. ORD Policies • ORD is responsible for 1200 series handbooks • PRIDE is responsible for • 1200.05 content • Interpreting 1200.05 • See FAQ on PRIDE web site at http://www.research.va.gov/resources/policies/FAQs-for-researchers-research-offices.pdf

  3. VA Research

  4. Which of the following is not a factor in determining whether or not a project is VA Research? • Source of funding • Whether or not subjects are Veterans • R&D Committee approval • All of the above • None of the above

  5. VA Research A project is VA Research if • It has been approved by the R&D Committee • It uses any VA resources, such as • VA funding • VA time • VA equipment • VA property

  6. A VA investigator uses non-VA funding to conduct research entirely at a non-VA facility with Veteran subjects. Is this VA Research? • Yes • No • It Depends

  7. VA Research What other information do you need?

  8. VA Research Is the VA investigator working on VA time or using other VA resources (e.g., VA laptop, VA office space, etc.)? • If YES, then it is VA Research • If NO, then it is not VA Research

  9. If research is being conducted at a non-VA facility and the participants are not Veterans, does the investigator need to use a VA informed consent form (VA Form 10-1086)? • Yes • No • It Depends

  10. VA Research • YES – if it is VA Research • NO – if it is not VA Research

  11. VA Research A VA investigator is conducting non-VA funded research at a non-VA facility, on her affiliate time, and she is using no VA resources. The non-VA facility’s IRB has approved the study. The subjects include Veterans and non-Veterans. More

  12. Should the VA R&D Committee review her study? • Yes • No • It Depends

  13. VA Research VA R&D Committee approval makes the study “VA Research” and obligates VA to provide care for research-related injuries

  14. Does VA permit its R&D Committees to approve studies in which the VA’s sole involvement is to solicit participation of Veterans in research conducted by non-VA personnelat a non-VA entity? • Yes • No • It depends

  15. “Recruitment Only” Studies VA R&D Committees may only approve research that supports VA’s mission to advance the health care of the Nation’s Veterans, and VA R&D Committee approval makes the study “VA Research” and obligates VA to provide care for research-related injuries

  16. Does VA permit fliers, advertisements, or other recruitment materials for research studies to be posted on VA premises? • Yes • No • It Depends

  17. Advertising • YES for VA studies • NO for non-VA studies

  18. Advertising “Posting” includes • Announcing • Distributing electronically (e.g., email) or in hard copy • Advertising electronically or in hard copy • Tacking up on bulletin boards • Setting out materials in waiting rooms • Putting on web sites

  19. Can VA clinicians discuss non-VA research studies with their patients and refer them to non-VA investigators for more information about these studies? • Yes • No • It Depends

  20. Advertising YES – the clinician • May tell a patient about a non-VA study • May give a patient contact information for a non-VA study However – the clinician • May not recruit patients for a non-VA study • May not obtain informed consent for a non-VA study • May not put out recruitment flyers for a non-VA study

  21. Advertising VA staff can only provide the patient’s protected health information to a non-VA investigator if there is • A signed release form, and • A signed HIPAA authorization, and • He/she adheres to local requirements for release of medical information

  22. If the IRB determines a study is exempt from IRB review, is the study overseen by any committee or subcommittee? • Yes • No • It Depends

  23. Exempt Studies The R&D Committee is the review and approving committee of record. It performs • Initial review • Continuing review • Amendment review • Oversight VHA Handbook 1200.01, subparagraph 10c

  24. Research Protocol An investigator has a project that involves a research intervention in cancer patients who require many medications and interventions. More

  25. Does she have to do anything special in preparing her IRB application? • Yes • No • It Depends

  26. Research Protocol She must clearly differentiate the research activity from the usual care in • The protocol, and • The informed consent form VHA Handbook 1200.05, paragraphs 9, 10, 17

  27. Future Use of Data & Specimens A VA investigator wants to use data and specimens for future research. He clearly spelled this out in the protocol and HIPAA authorization. More

  28. Is there anything else he needs to do? • Yes • No • It Depends

  29. Future Use of Data & Specimens The informed consent form The protocol, informed consent form, and HIPAA authorization must be consistent with each other

  30. An investigator wants to collect information on the pregnant partner of a research subject. He will need to obtain consent from: • The subject • The pregnant partner • Both

  31. Pregnancy The collection of information about her makes her a subject and this requires IRB approval of the information to be collected and the informed consent form

  32. Does the investigator need a waiver from the Chief Research & Development Officer (CRADO) to collect information about this couple’s baby? • Yes • No • It Depends

  33. Pregnancy YES – collecting information on the baby is considered research involving children and requires a waiver from the CRADO VHA Handbook 1200.05, paragraph 48

  34. Pregnancy The investigator has already finished collecting her data on the children of the subjects but forgot to get a CRADO waiver. More

  35. Can she request a waiver as long as it is before she publishes her results? • Yes • No • Maybe

  36. Pregnancy CRADO waivers cannot be granted retroactively What will happen to the results? See FAQ at http://www.research.va.gov/resources/policies/FAQs-for-researchers-research-offices.pdf

  37. Continuing Review Expiration of IRB Approval An investigator was out of town and missed the deadline for continuing review. All his research activities stopped. More

  38. Does the IRB have to perform a full initial review before the study can be re-started? • Yes • No • It Depends

  39. Continuing Review Expiration of IRB Approval It may require continuing review or initial review depending on • How long the study has been expired (e.g., long enough for something to have changed that would necessitate a new initial IRB review?) • The nature of the study (especially the risks) • Local SOPs VHA Handbook 1200.05, subparagraph 22g

  40. HIPAA Authorization A study is coming up for continuing review. Its informed consent form and HIPAA Authorization are combined into one form. More

  41. Will the investigator have to split them into two documents to obtain IRB approval? • Yes • No • It Depends

  42. HIPAA Authorization • YES – if • Local SOPs call for the two forms to be separated at the time of continuing review, or • The IRB determines the two forms should be separated • NO – if neither of the above conditions apply VHA Handbook 1200.05, paragraph 27

  43. Multi-Site Studies A VA facility will be one of 6 sites in a multi-site NIH study. Since the IRB of one of the other sites has already approved the study… More

  44. Can the VA facility’s IRB use expedited review? • Yes • No • It Depends

  45. Multi-Site Studies • YES – if the study meets the criteria for expedited review • NO - if it doesn’t

  46. Who decides whether or not a local site is engaged? • The PI’s IRB of record • ORD • ORO • Any of the above

  47. EngagementMulti-Site Studies For most projects, the PI’s IRB of record should be able to make this determination. If there are any questions, ORD & ORO can provide assistance

  48. When the research will involve a site(s) that is not engaged, the PI has to obtain permission from the non-engaged facility’s director to perform the research at that site • True • False

  49. Multi-Site Study Responsibilities Principal Investigator (PI)* The PI just has to notify the Director of the non-engaged facility. He does not have to obtain permission VHA Handbook 1200.05, Paragraph 52a(1)

  50. Local RCOs, Privacy Officers, and ISOs should treat the study at the local site like any other study no matter which of its IRBs of record approved it. • True • False • It Depends

More Related