Dear OHRP,
Thank you for your invitation for suggested improvements to the OHRP website. Before making any suggestions, I must first thank you for the existing website, which contains a great deal of extremely valuable information. As a historian, I particularly appreciate the historical material, including the Belmont Report oral history section, and the compilation of key notices from the Federal Register dating back to 1973.
With this in mind, let me suggest some additional material that would be helpful.
1. Responses to calls for comments
When OHRP issues calls for comments in the Federal Register, it routinely advises that "comments received within the comment period, including any personal information provided, will be made available to the public upon request." While I am grateful to OHRP staff for sending me electronic versions of these comments in replies to my requests, I suggest that all comments be posted on the OHRP website as well. The comments I have seen constitute thoughtful, informed positions on the regulation of human subjects research and mark significant contributions to the debate on the subject. They have been the subject of reporting in the press, suggesting the wide interest in them.
Placing the comments on the website would insure equal access to those comments by all concerned, and would solve the problem of electronic files that are too big for easy transmission by e-mail. Posting would also preserve the comments for future readers, a key concern given that many issues crop up repeatedly. For example, in 2007, OHRP requested comments on expedited review. Anyone responding to that call would have benefited from access to the comments received in reply to the similar call of 1997. But those earlier comments seem to have been lost to history.
2. Reports to which OHRP has contributed
In June 2008, the Human Subjects Research Subcommittee published a report called "Expedited Review of Social and Behavioral Research Activities." Perhaps this is not technically an OHRP report, but the Subcommittee was co-chaired by the acting director of OHRP, and both he and Mr. Drew of OHRP were members of the working group that produced the report. Yet there is no link to the report on the OHRP website, nor did I receive notice of it from the OHRP-L@LIST.NIH.GOV mailing list. When OHRP staff, acting in their official capacities, contribute to a report like this, it should be announced on the list and a link added to the OHRP site.
3. A complete copy of the Bell Report
Your current page, http://www.hhs.gov/ohrp/related.html, includes a copy of "Evaluation of NIH Implementation of Section 491 of the PHS Act, Mandating a Program of Protection for Research Subjects," published in 1998. But it does not include the technical appendices mentioned on page ii of that report, nor have I been able to locate a copy of those appendices. Posting them would be of value.
4. A link to OPRR Reports
The section on "Historical Documents" on the page http://www.hhs.gov/ohrp/related.html does not mention the OPRR Reports posted at http://www.hhs.gov/ohrp/dearcoll.htm. As the latter page indicates, most of these documents exist "solely as a reference for historical purposes." I am very glad that these documents are online, but I suggest that as historical documents, they deserve a link under the "historical documents" section. For that matter, I'd like to see the "Historical Documents/Information" section, including the Federal Register notices, given its own page, but I realize this wish may reflect my unusual perspective as a historian. I would also like a note added clarifying if the OPRR Reports now online represent all or just some of the OPRR Reports sent out during that office's existence.
Thank you again for this opportunity to comment on the website. If I think of additional suggestions, I will be sure to send them in.
Sincerely,
Zachary M. Schrag
Assistant Professor of History, George Mason University
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