For help to decide if your research involves human subjects:
Discuss it with your Section, Branch, or Laboratory Chief
Your IRB Chair, David B. Resnikresnikd(@niehs.nih.gov) (919) 541-5658 or 541-4265
Your IRB Administrator, Jane Lambert (lambert@niehs.nih.gov) (919) 541-5047
Your Acting Clinical Director, Darryl Zeldin (black009@niehs.nih.gov) (919) 541-1169
Call Office of Human Subjects Research (OHSR) (301) 402-3444
To determine whether your proposed research activity is exempt from the requirements of the NIH MPA:
Ask your IRB Chair, (David B. Resnik, 541-5658, or 541-4265) or IRB Administrators (Jane Lambert 541-5047, or Craig Wladyka 541-3822) for a copy of the OHSR form entitled "Request For Review Of Research Activity Involving Human Subjects", or print it from the following NIH site (http://ohsr.od.nih.gov/info/info.html). Please send this form through the NIEHS IRB Administrator, who will in turn forward it to the OHSR for determination of exempt status.
For assistance in formatting a research protocol for IRB submission:
The Clinical Center has a guide for preparation of research protocols for IRB submission, a booklet entitled Protomechanics. You can view Protomechanics online at the NIH Clinical Center Web site (http://www.cc.nih.gov/ccc/protomechanics/index.html).
Be aware that Protomechanics was developed for the NIH Clinical Center, and many parts of it are not applicable to research done at NIEHS.
For help in planning a research study with challenging or complex ethical considerations:
All NIEHS Investigators are asked to consult with the NIEHS Biomedical Ethicist (David Resnik (resnikd@niehs.nih.gov), 530 Keystone, Room 2022, ph (919) 541-5658) on matters of ethics and informed consent.
. Please send this form through the NIEHS IRB Administrator, who will in turn forward it to the OHSR for determination of exempt status.
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