Information Concerning the Sunshine Project's Survey of Compliance with the Public Access Provisions of the NIH Guidelines
On 28-31 January, the Sunshine Project has sent letters to Institutional Biosafety Committees. Pursuant to the NIH Guidelines, these letters request copies of Institutional Biosafety Committee meeting minutes. The letters also request that the institution indicate whether or not it is registered to handle select agents.
This page provides answers to questions you may have and information to assist institutions with their response.
Question: Who is getting these letters?
Answer: Institutional Biosafety Committees registered with NIH. As of 31 January, 396 IBCs have received a fax. This constitutes 90% of the 439 registered IBCs. The 396 contacted as of today are the survey group.
Question: Why did you send the fax to this particular person/address/number?
Answer: The letters are sent to the IBC contact addresses and fax numbers on file at the NIH Office of Biotechnology Activities. In some instances (about 35%), NIH OBA has no fax number or a bad fax number on file. In these cases, we have looked up the appropriate fax number on the internet.
Question: Why are you doing this?
Answer: As the letter indicates, the Sunshine Project is conducting a national survey of compliance with the public access provisions of the NIH Guidelines.
Question: I've heard about these letters; but I haven't seen one. What, exactly, did you ask for?
Answer: An example of the form letter is provided at the bottom of this page.
Question: Am I required to provide the IBC Minutes?
Answer: The language of the NIH Guidelines is unequivocal. In order to remain in compliance with the NIH Guidelines, you must provide the minutes.
Question: I have been told / read e-mails that state that the Bioterrorism Act and/or CDC regulations prohibit answering the question about select agent registration.
Answer: You have been misinformed. Unless you are responding on behalf of a federal IBC, neither the Bioterrorism Act nor CDC regulations prohibit answering. If you have questions about this issue, please contact the CDC Office of General Counsel at 404-639-7200.
Question: Can I fax or e-mail my reply?
Answer: Please do not fax or e-mail your reply. We request that you please send it by US mail.
Question: What is the Sunshine Project?
Answer: This website contains an "About" section and all of our publications. Please feel free to browse.
Question: My question isn't answered here. Who do I contact?
Answer: You may send e-mail to Edward Hammond at hammond@sunshine-project.org.
[Sunshine Project Letterhead]
[28, 29, or 30] January 2004
[NIH-registered IBC contact]
[address]
By fax: [number]
Dear Dr. [name],
Pursuant to the National Institutes of Health Guidelines on Research Involving Recombinant DNA Molecules (NIH Guidelines), Section IV-B-2-a-(7),* the Sunshine Project hereby requests copies of the Minutes of the two (2) most recent meetings of the [institution name] Institutional Biosafety Committee (IBC).
Please send the Minutes to the address above. I request that you please mail your reply by 1 March 2004.
This letter is sent to you because IBC registration records of the National Institutes of Health Office of Biotechnology Activities indicate that you are responsible for the [institution name] IBC.
This letter is sent to you as part of a national survey of compliance with the public access provisions of the NIH Guidelines.
When you respond, I would appreciate your taking the time to answer the following question (please circle one):
[Institution name] IS / IS NOT registered to handle select agents.
Please feel free to attach any additional explanatory materials that you feel are appropriate.
Thank you very much for your attention to this request.
Sincerely,
[signature]
Edward H. Hammond
Director
*Section IV-B-2-a-(7). Upon request, the institution shall make available to the public all Institutional Biosafety Committee meeting minutes...