New Protocols

The NIEHS IRB reviews all NIEHS intramural studies involving human subjects research.

Scientists with new protocols involving human subjects research should consult the NIEHS IRB Administrator, Jane Lambert (lambert@niehs.nih.gov),
530 Keystone, Room 2019, 541-5047, Craig Wladyka (cwladyka@niehs.nih.gov), 530 Keystone, Room 2023, 541-3822, and or the NIEHS IRB Chair,
David B. Resnik.(resnikd@niehs.nih.gov)

Paperwork Required:

• All new protocols require the Initial Review Application (NIH form 1195) (http://www.niehs.nih.gov/about/orgstructure/boards/irb/docs/1195.pdf)   (673K). This is a multi-copy form; originals can be obtained from Jane Lambert. It is suggested that you fill out a COPY of form 1195 as best you can with pen and paper, and bring that to your meeting with Jane Lambert. For details of how to fill out this form click on this link (http://www.niehs.nih.gov/about/orgstructure/boards/irb/paperwork.cfm). This is not to be used for final submission. The multi-copy form is required.

• NIH Conflict of Interest Review Requirement
  Effective May 2, 2008, the NEW Personal Finance Forms must be submitted for approval for all New and Continuing Review protocols as well as with amendments where an investigator is added. IRB approval cannot be given until the NIH Ethics Office has approved the form.
  • A Guide to Preventing Financial and Non-Financial Conflicts of Interest in Human Subjects Research at NIH (March 2008) (http://www.niehs.nih.gov/about/orgstructure/boards/irb/docs/coi-guide-march2008.pdf)   (104KB)
  • Clearance OF NIH Investigator Personal Financial Holdings Form or PFC (3/19/08) (http://www.niehs.nih.gov/about/orgstructure/boards/irb/docs/pfc-form.pdf)   (100KB)
  • Guide for Completing PFC (http://www.niehs.nih.gov/about/orgstructure/boards/irb/docs/guide-complete-pfc.pdf)   (38KB)
  • Conflict of Interest Statements for NIH Protocol Consent Forms (http://www.niehs.nih.gov/about/orgstructure/boards/irb/docs/coi-nih-consentforms.pdf)   (17KB)
  
  

• All new protocols must be put into the NIEHS IRB Standard Format   Word Version (http://www.niehs.nih.gov/about/orgstructure/boards/irb/docs/niehs_irb_standard_format_04.doc)   (25K)   PDF Version (http://www.niehs.nih.gov/about/orgstructure/boards/irb/docs/irb_stan_format_04.pdf)   (25K).

• All protocols require documentation of Scientific Review.
  • The Deputy Scientific Director's Office (Bill Schrader)
  • The Epidemiology Branch Chief's Office (Dale Sandler, Room A304, 541-4668) handles NIEHS Internal Scientific Review for Epidemiology Branch protocols.
  
  

• The Initial Review Application and its numerous attachments should be submitted in complete form at least 4 weeks prior to the regularly scheduled IRB meeting dates to be considered for review. See NIEHS IRB Meeting Schedule (http://www.niehs.nih.gov/about/orgstructure/boards/irb/meetings.cfm) for specific due dates.

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