Human Subject: An Investigational Memoir

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8. Getting the Goods

“Celui qui ne connaît pas les tourments de l'inconnu doit ignorer les joies de la découverte qui sont certainement les plus vives que l'esprit de l'homme puisse jamais ressentir.”

On May 9, I received another postcard from InfoGuard. The documents I had requested were ready. I could either pay $32.40 to have them mailed to me or pick them up myself and pay $29.10. The card didn’t say where I should pick up the documents, but the return address was just a few blocks from where I lived, so the next morning I walked down there.

The office was on the third floor of a building that housed several other Big U divisions. After looking in vain for a staircase, I took the elevator up two flights. I wondered why a university that promoted wellness and fitness for its employees would hide the stairs.

The InfoGuard office had a locked glass door with a doorbell to ring for admittance. I rang. After a few seconds a somewhat harried-looking middle-aged woman opened the door part-way.

“Can I help you?” she asked, eyeing me suspiciously.

“I got this card saying that some documents were ready,” I said, showing her the card, “and this was the only address I could find on it.”

She looked at the card, looked again at me, and said, “You can come in.”

I entered a vast and sparsely furnished common area, with a few offices adjoining it. There didn’t seem to be anyone else working in the whole suite. The employee opened a tall storage cabinet and removed a white 10” x 12” envelope and brought it to me.

It didn’t look like $30 worth of photocopies, so I said, “I guess there’s some other charge besides copying . . . ?”

“Oh, no,” she said. “We’re only allowed to charge for copying. Fifteen cents a page. Plus packaging.”

Packaging? When I later counted the pages, there were about 175. At 15 cents each, that came to $26.25. So the flimsy white envelope was worth more than $3. Or maybe the charge included the time required to slide the photocopies into the envelope and seal it.

I left InfoGuard and wandered the halls of the third floor until I found a stairway. A sign on the door read “To Street Level Exit Only.” It was a door of no return, set to lock behind whosoever dared descend the stairs. I’ve had a fear of locked stairway doors ever since I got stuck in a stairwell once in high school and had to shout and pound on the door for what seemed hours (but may have been mere minutes), so it was with some trepidation that I closed the door behind me. At the bottom I found a door to an alley, not the street. Thankfully, the door was unlocked, but it locked behind me as I exited. So it looked like Big U didn’t entirely discourage physical fitness; it just limited employees to the cardiovascularly inferior exercise of going down, rather than up, the stairs.

Back home I eagerly inspected my treasure. I had specified in the request that I would prefer to get the documents electronically, but I had figured this wouldn’t be possible due to the redaction that would be required. Based on Dr. Veatch’s experience, I had expected that certain sensitive data, like budget figures or specific experimental procedures, would need to be blacked out. As it turned out, nothing was censored, so I guess the documents were available only in hard copy. And apparently Big U did not believe in making two-sided copies. I felt a twinge of guilt at the waste, especially knowing that NIA would be sending me a similarly hefty (and costly) package. Public records

The first item in the pile was a cover letter, signed by someone with the title Legal Assistant. It stated: “This concludes the University’s response to your Public Records request.” That sounded ominously final, but it was kind of a relief to know I wouldn’t be getting another bill.

The application for IRB approval of the study was submitted on August 16 and approved on September 28. It had multiple attachments and appendices, including consent forms, a study flow chart, and descriptions of tests to be administered. There was no document that was clearly labeled “protocol,” but the application packet included a copy of the NIA grant application, which had a protocol section.

These were the items that I found most interesting:

  1. The application said, “A taxi will be provided for participants who do not have someone available to take them home.” In the grant application two reviewers had disapproved of this plan. They stated that someone familiar with the patient’s condition needed to accompany him/her home. The investigators had therefore amended the protocol to say that if the subject’s caregiver did not drive, a taxi or bus fare would be provided; if the subject had no caregiver, the study coordinator (Lisa) would accompany the subject home by taxi. This was all news to me. When I had told Lisa I would be walking or riding the bus alone, she had said that was fine.
  2. Question 3 in the application asked, “Is it possible that you will discover a subject’s previously unknown condition (disease, suicidal intentions, genetic predisposition, etc.) as a result of study procedures? If yes, explain how you will handle this situation.” The investigators had checked the No box. This seemed really odd, and not just to me: A later document revealed that before giving final approval, the review committee had required that several things be changed, including the answer to Question 3. “Because you are conducting physical and cognitive testing during screening,” the committee chairman had written, “the Committee feels it is possible you could discover a previously undiagnosed condition.” The question was dutifully re-answered, stating that if a condition were found, the investigators would “refer the subject to an appropriate source for treatment.” Oddly enough, this vague answer was good enough for the committee.
  3. I learned that the test where I had to keep my hand in cold water for as long as possible was called a cold pressor test. And I learned that the temperature of the water had been between 1 and 3 degrees Centigrade, i.e., barely above freezing, just as I’d thought. I also learned that there was a part of the script that Lisa had never recited to me: “Immediately after removing their hand from the cold water ask subjects to rate their experience of both pain and bothersomeness on a ten point scale. ‘ “0” is not at all [painful] [bothersome] and “10” is [pain as bad] [as bothersome] as it can be.’ After subjects give a whole number answer to bothersomeness, they can place their hand back in the warm water bath for a maximum of two minutes.” I was glad I hadn’t been deprived of the warm water while being forced to rate the bothersomeness of having a near-frozen hand, but I wondered why this step had been omitted.
  4. I learned that there was indeed pulse oximetry as part of the protocol. I wondered why this hadn’t been performed. Or were they recording it each time they took my blood pressure and pulse? Would I have to request my records next, to see if these data had been fabricated? Did I really care? By this time I really didn’t.
  5. Nowhere in the voluminous collection of application materials and correspondence was there any discussion of qualifications required to perform the various tasks in the study. But I did find one discrepancy between what actually occurred and the division of labor mandated by the protocol: “Research nurses will perform venipuncture, obtain blood samples, pulse oximetry and pupillometry. A study coordinator/research assistant will perform all other duties including, pain stimulus, side effect observation and recording, administration of psychometric tests.” Lousy grammar and punctuation aside, it had been Lisa, not the nurses, who performed the pupillometry. Still, she was authorized to do it all, according to the job description I’d seen for people of her ilk.

I found it amazing that the protocol assigned so much responsibility to someone with one of two vague titles (“study coordinator/research assistant”), neither of which Lisa actually had. A research nurse is a fairly well-defined entity, presumably one with at least a bachelor’s degree in nursing. A research assistant or study coordinator could be anyone, and apparently anyone was good enough to gather data for this $371,250 study.

On June 4 I received a package from NIA that was about one-third the size of the one I’d gotten from Big U. It mainly contained just the grant application. A cover letter from the NIA FOI specialist explained that there was no charge for the materials, because the cost was “below the $25 minimum.” Her original letter to me had said that copies were 10 cents a page, with the first 100 pages free, which would have meant that $10 was the minimum, but maybe there was some complicated formula involving the various charges for research that she’d mentioned. I decided not to try to figure it out.

The letter also warned that it was HHS policy to expunge “percentage of effort, effort, entity identification number, evaluative information, references to unpublished material, private source of support, pending support, and proprietary information.” This zeal for secrecy seems to be fairly common in federal agencies. A few weeks later I came across an article that mentioned a federal public-records office that had this motto on its wall: “When in doubt, cross it out.”

Sure enough, when I compared the copy they sent me with the one I’d gotten from Big U, I found the following instances of censorship:

  1. On the first page, the Entity Identification Number had been replaced by a gray box with the word “EIN.”
  2. Wherever an investigator’s Biographical Sketch mentioned a private funding source (i.e., other than NIH), even for research that was completed years ago, the text had been replaced by a gray box with the words “Private Source.”
  3. Wherever a Biographical Sketch mentioned the percentage of time an investigator spent on anything that was funded by NIH, the text had been replaced by a gray box with the words “% Effort.” Maybe that was because NIH didn’t want anyone to know how much value they placed on different people’s time.
  4. The pages containing criticism from reviewers, and the investigators’ response to the criticism, were completely gray, with the words “Evaluative Info” at the top.
  5. Where the research assistant’s contribution was mentioned, the words “full time” had been replaced by a grey box with the word “EFFORT.” I never did figure out what that was all about.
  6. The Testing Protocol for Phase I, which listed Neuropsychological Tests, Subjective Side Effect Measures, and Physiological Measures, and almost the entire testing section for Phase II had been grayed out and designated as “Proprietary Info.” The only parts of the Phase II testing not considered proprietary were the vital signs and the blood test for oxycodone.
  7. In the Literature Cited section, wherever a reference was described as In Press, it had been grayed out and labeled accordingly.
  8. Two of the letters appended to the application had been completely grayed out as “Proprietary Info.” I suspected that NIH just wanted to spare me some really bad writing, since both letters began: “I am happy to serve as a member of the independent monitoring board (IMB) for you’re your project . . .”

I admired NIA’s restraint in using tasteful dove-gray bars and boxes rather than the menacing black rectangles that one usually sees on passages deemed (with apologies to Seinfeld) expunge-worthy.

For all its stonewalling, Big U apparently cared less than the federal government about protecting sensitive information, and it had helpfully shared with me the intimate details of an NIH grant application. I thought about writing to the FOI officer at NIA to let her know that Big U was divulging government secrets, but I decided it was best, in the interest of encouraging unfettered (or at least less fettered) public disclosure, to keep that information to myself.

I didn’t think I would ever hear from InfoGuard again. Then one afternoon, a month after I had picked up the photocopies from the oxycodone study, I got an anonymous, unsigned email from the generic InfoGuard email address, saying that in responding to my request, “a question has arisen.” This puzzled me, because the letter from the legal assistant had definitely said that they considered the case closed. Then the day’s mail brought a postcard from InfoGuard, acknowledging receipt of this so-called request that I had not submitted. Details on the alleged request and the ensuing battle over the release of allegedly public information appear in chapters 20 and 21.

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