The Endocrine Society, founded in 1916, consists of over 9,500 scientists and physicians who are dedicated to basic and clinical research, and the teaching and practice of endocrinology, the chemical regulation of cellular processes. We are aware of the fact that this provision was enacted without debate and that the OMB must write rules for what has the potential of seriously and adversely affecting research involving human beings and their tissues, including studies of their genetic makeup. As befits a law made without proper debate and consideration, it is unconscionably vague and will inevitably be the subject of endless and expensive litigation, which in itself can seriously inhibit the scientific process that so greatly benefits us all. The mischief occasioned by this rule is easily demonstrated by example.
Researchers publish a paper indicating that a highly touted treatment is no better than placebo.
The major corporation that has invested much capital in that treatment demands all the primary data under the FOIA in order to demonstrate that the study was incorrect. The core statistical data have already been published. What the company needs is to identify the individual characteristics of the participants so as to determine which ones may have been mischaracterized. Obtaining characteristics such as age, sex, blood pressure, cholesterol, and medical conditions, in addition to the location, permits the company to identify each individual and even to contact them for further information. Not only will this violate the promise of confidentiality accorded to the patients, should the investigators refuse to provide the information the subsequent lawsuit could deplete personal and institutional resources.