Outside academia and the departments that run Institutional Review Boards, the issues surrounding these changes may seem arcane. But as my letter documents, the issues on protection of human subjects in federal funded experiments touches on some of the most important issues of our time, not least the torture program ran by the CIA and Department of Defense in the past 15 years. Other comments can be read at the link provided above. My very modest contribution in no way touches many of the important issues raised by these proposed changes, and interested readers should peruse the comments of others to get a fuller picture of the stakes involved in these proposed changes.
Note: Rather than embed links, I have provided endnotes with links, which reproduces how I sent the letter to HHS. One interesting side benefit of drafting and posting this letter was that it allowed me to update old links that had gone missing or dead over the years. Sadly, the links to much of the relevant material (Project Shad, for instance), had changed or disappeared, as public interest in the subject waxes and, sadly, wanes.
Date: January 6, 2016
To: Jerry Menikoff, MD, JD
Office for Human Research Protections (OHRP)
Department of Health and Human Services (HHS)
1101 Wootton Parkway, Suite 200
Rockville MD 20852
The Department of Health and Human Services (HHS) and other relevant agencies
From: Jeffrey S. Kaye, Ph.D.
xxxxxxxx, CA xxxxx
Re: Notice of Proposed Rule Making (NPRM), Docket ID HHS-OPHS-2015-0008
(CFR Citation: 45 CFR 46)
HHS has asked for public responses to changes proposed in law regarding Federal Policy for the Protection of Human Subjects, also known historically as the “Common Rule.”
In particular, my comment is related to proposed exceptions to protections under federal law for human subjects on matters related to “intelligence surveillance” and “criminal justice activities.” In addition, I address suggestions of weakening protections related to Subpart C of the Common Rule, which covers research on prisoners.
Currently, the Department of Justice, the Central Intelligence Agency, the Department of Homeland Security, the High-Value Detainee Interrogation Group (HIG), and the intelligence agencies that operate under the umbrella of the Department of Defense, are all regulated by 45 CFR 46, and protection of human subjects falls under the Common Rule. There is good reason historically for this, as government agencies, often under the auspices of “national security,” failed to protect human beings who were harmed significantly under experiments undertaken by such agencies.
These agencies act under a veil of secrecy, and safeguards on potential misuse of actions considered research, as defined, or even potentially close to research, should be strengthened, not weakened.
As Jay Katz said in a 1994 review of the history of human experimentation:
“In my review on the regulations on the conduct of research, I have tried to demonstrate that medical science's commitment to individual autonomy continues to remain ambiguous.Lack of Research Protections in the DoD and CIA
“The call for balancing the need to advance science for mankind's benefit and to protect the inviolability of subjects of research all too commonly tilts in favor of progress….
“As you know, I do not believe that the current federal regulations on the protection of subjects of research go far enough.”1
Failures to protect are not instances of the distant past. According to a 2010 investigatory report by Jason Leopold and Jeffrey Kaye2:
“In January 2004, the Director of Defense Research and Engineering (DDR&E) initiated a DoD-wide review of human subjects protection policies. A Navy slide presentation at DoD Training Day (PDF)3 on Nov. 14, 2006, hinted strongly at the serious issues behind the entire review.This review was ordered in late January 2004, only a few months after the Supreme court had agreed to hear the case later known as Rasul v Rumsfeld, which would decide that the Guantanamo detainees had a right to challenge their detention. The DoD-wide review came over two years after a DoD directive authored by Paul Wolfowitz had indicated such procedures should be in place. As a result, none of the required assurances by the different Defense Department components regarding their human subjects protection policies had been filed with DDR&E. In effect, there was little or no oversight over DoD research policies at exactly the time when both DoD and CIA were engaged in an experimental torture program, or using detainee prisoners as human guinea pigs for the study of the effects of torture and harsh detention (about which more below).
“The Navy presentation framed the problem in the light of the history of U.S. governmental ‘non-compliance’ with human subjects research protections, including ‘U.S. Government Mind Control Experiments – LSD, MKULTRA, MKDELTA (1950-1970s)’; a 90-day national ‘stand down’ in 2003 for all human subject research and development activities ‘ordered in response to the death of subjects," as well as use of "unqualified researchers.’
The Training Day presentation said the review found the Navy ‘not in full compliance with Federal policies on human subjects protection.’ Furthermore, DDR&E found the Navy had ‘no single point of accountability for human subject protections.’”
The DoD directive (3216.02), authored by Paul Wolfowitz, mentioned in the paragraph above, was titled “Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research,” and released in March 2002. The directive was updated in 2011. But in its 2002 version, and for many years, it represented a significant weakening of human subjects protections, making waivers of informed consent the responsibility of lower-level heads of DoD divisions, and weakening protections that had been in place for decades by limiting research safeguards to “prisoners of war.” There had never been such loose rules on informed consent ever explicitly allowed in the history of military research.4 While protections against use of research on detainees, such as those held at Guantanamo, supposedly now restrict research or experiments on that population,5 the history of attempts by DoD officials to push back against such restrictions should not allow for further weakening of any protections now in place.
There are a number of other instances of lack of protection of research subjects under the Department of Defense. One of the most egregious, which like so many of these abuses, took decades to come to light, concerned the military’s Project Shad.
Project Shad was a DoD experiment that exposed at least 4,000 Navy men to various chemical agents and decontaminant chemicals, "including Bacillus globigii (BG), Coxiella burnetii [which causes Q fever], Pasteurella tularensis [which causes tularemia or 'rabbit fever'], Zinc Cadmium Sulfide, Beta-propriolactone, Sarin, VX, Escherichia Coli (EC), Serratia Marcescens (SM), Sodium Hydroxide, Peracetic acid, Potassium hydroxide, Sodium hypochlorite, ‘tracer amounts’ of radioactivity and asbestos, [and] Methylacetoacetate."6 The existence of these experiments was denied by the U.S. government for 35 years, until Congressional hearings were finally held in 2002.7 While back in 2002, there were major news reports on the subject, today the story has dropped off the radar. Nevertheless, the government website, Health.mil, still has a webpage dedicated to information on the subject.8
The history of abuses surrounding Project Shad, and other similar instances of dangerous military research, e.g. projects Copper Head, Flower Drum, Shady Grove, Autumn Gold, among others undertaken from 1963-1970, argue strongly against any lessening of human subjects protections when it comes to military research.
Finally, on the subject of military research, it is worth noting the warnings aired in a National Research Council (NRC) 2008 report on a conference on “Emerging Cognitive Neuroscience and Related Technologies.”9 Participants concluded, “On the whole… the system of protections for human research subjects is not well designed to capture instances of intentional wrongdoing,” providing “rather… guidance for well-motivated investigators who wish to be in compliance with regulatory requirements and practice standards.”
While some find the current “formal procedures in place for the use of military personnel in medical experiments” are “stringent,” that doesn’t imply “that no abuses can occur, nor that convenient alternative frameworks (such as field testing) cannot be used to circumvent the research rules, but only that the official policies and procedures in the military are rigorous.” (bold emphasis added)
But even with such supposedly “rigorous” policies, the report’s authors see a problem. They ominously ask whether “classified research can ever be ethically sound inasmuch as it lacks transparency, such as in the form of public accountability. For example, if a member of an ethics review board disagrees with a majority decision involving a classified human experiment, that member would be unable to engage in a public protest of that decision.”
I think the questions raised in the NRC 2008 report are germane and vital to the issue of NPRM changes on matters related to “intelligence surveillance” and “criminal justice activities.” In particular, the kinds of artifice that can be engaged in relation to what exactly constitutes research is precisely what makes changes in these sensitive areas of high concern.
One such instance where the issue of using field testing or adjustment of technique and program assessment vs. formal research, i.e., to test areas of generalized knowledge, concerns charges of experimentation by the CIA and DoD in regards to the application of interrogation techniques on prisoners captured in the “war on terror,” prisoners which the U.S. government removed from coverage by the “prisoner of war” provisions of the Geneva Conventions.
Research done by the government in relation to interrogation or detainees was usually couched in terms that the research was only program evaluation, as in the case of the Behavioral Science Consultation Teams at Guantanamo, or involved only research related to improvement of conditions for individual detainees, or response to specific applications of an interrogation technique, as when the CIA monitored the oxygenation level of a waterboarding victim.
The point is that in the case of intelligence or national security agencies, especially those aspects covered by secrecy and classification, or that are “covert,” determinations of what is and what is not research, i.e., what can be covered or monitored by the Common Rule, what the “exceptions” are, is actually nonsensical. Either the coverage is complete and total, or it is not.
Charges of CIA Experiments in Torture
In the case of the CIA experimental torture or “enhanced interrogation” program, OHRP referred any research misdeeds back to the agency itself, in this case, back to the CIA. Such is their policy, which is in this case is shown as grossly inadequate.
The fact remains, as documented in the recent release of the Executive Summary of the Senate Select Committee Intelligence report on the CIA’s torture program, that the plans for the “enhanced interrogation” program were formed in the same division of the CIA that ran the MKULTRA program.10
Do we really want less, not more, safeguards on “intelligence surveillance” activities?
On January 15, 2015, two United Nation Special Rapporteurs wrote an official letter to the U.S. government expressing their concern over “the role of health professionals in the Central Intelligence Agency (CIA) interrogation program, between 2001 and 2009, and the subsequent lack of investigation into these allegations.”11
The letter was prompted by new information released when in December 2014 the Senate Select Committee on Intelligence released a redacted version of its Executive Summary of its report on the CIA “enhanced interrogation” program. One section of the letter contained charges and concerns about the research component aspect of the CIA program.
I reproduce that section of their letter in its entirety, as it helps explain my contention that the secrecy of the intelligence and covert operations world cannot allow any weakening of research or informed consent protections, as the agencies involved are without moral scruple, and have a long and even recent history of covering up misdeeds.
From the Special Rapporteurs’ letter:
3. Engaging in potential human subjects experimentation to provide legal cover for tortureThere was no known response to this letter.
From the SSCI summary it can be inferred that the OMS officers played an active role in determining, along with the DoJ lawyers, what techniques would be considered authorised for the CIA to employ. The 2004 OMS Draft Guidelines stated “in order to best inform future medical judgments and recommendations, it is important that every application of the waterboard be thoroughly documented”. The OMS personnel analysed data previously collected from the detainees during torture to make generalized conclusions about the techniques. In 2004 and 2005, this data and analysis was provided to the DoJ’s Office of Legal Counsel to determine what techniques and applications would be legitimate under their interpretation of U.S. laws.
On at least two occasions, CIA personnel expressed concerns that this process would amount to human experimentation. Similarly, on 11 April 2005, OMS personnel expressed such concern when stating that the “OMS did not review or vet these techniques prior to their introduction, but rather came into this program with the understanding… that they were already determined as legal, permitted and safe. We see this current iteration as a reversal of that sequence”.
However, despite these concerns, the 2005 Office of Legal Counsel memos (known as the Bradbury memos) reveal that the final determinations on the legality and safety of the techniques relied heavily on OMS data and analysis.12
A Mysterious Use of Research Regarding the Department of Justice and the HIG
The NPRM states that the suspension of the common rule for “intelligence surveillance” includes “interviews, surveillance activities and related analyses... where these activities are conducted by a defense, national security, or homeland security authority solely for authorized intelligence, homeland security, defense, or other national security purposes.”13
The proposed Criminal Justice exclusion from the Common Rule involves “data collection and analysis that enables the uniform delivery of criminal justice. The scope of this exclusion is collection and analysis of data, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes. The activities excluded are necessary for the operation and implementation of the criminal justice system.”14
How does this look in light of the reality of research undertaken within the arcane workings of the criminal justice system? One example occurred during the interrogation of accused would-be assassin Manssor Arbabsiar. Under interrogation after arrest in 2012, a “research psychologist,” Susan Brandon, unknown to Arbabsiar was making observations and notes on defendant Arbabsiar. The research appears to have been for the FBI-led High-Value Detainee Interrogation Group, or HIG, for whom Dr. Brandon worked as “Chief of Research.”
According to another psychologist contracted to the government, Gregory H. Saathoff, Brandon was present during all of Arbabsiar’s post-arrest questioning, viewing him via closed-circuit camera, where she “closely monitored and documented Mr. Arbabsiar’s behaviors.”15
She produced a 21-page document, which has been withheld from public view, the subject of a court protective order.16 Brandon’s document, and hence her research, became part of the prosecution’s case against Arbabsiar, and was apparently part of the process of reaching a plea bargain with him and his attorneys. How did a secretive research protocol become part of a prosecutor’s evidence against a defendant?
As I wrote at the time: “So what was the administration’s top interrogation researcher doing at Arbabsiar’s interrogation? And if she was doing research, was Arbabsiar so informed? And whether he was or not, what in her role as researcher later led Brandon to file a report with the court? These are all important questions....” (see endnote vi)
In the context of the new proposed changes in the Common Rule, the questions involved are vital to the workings of both science and of a democratic society.
Research on Prisoners
Related to the Criminal Justice and Intelligence Agency exclusions are calls for weakening the protections regarding use of prisoners in research, which currently fall under Subpart C of the Common Rule. The very way this is brought up in the call for discussion is insulting: “The subpart was written in the wake of harsh criticism regarding research abuses involving prisoners that occurred or became public in the 1960s and 1970s.”
This was not simply “harsh criticism,” but well documented instances of horrific abuse of prisoners. The classic work in this field was Allen Hornblum’s book, Acres of Skin: Human Experiments at Holmesburg Prison, published by Routledge in 1998. There is no reason to lighten the restrictions against such research, which was the result of decades of abuses. Whatever positive results regarding such lightening of restrictions on consent in this case are outweighed by the dangers of unchecked power over a vulnerable population, the examples of which ruined untold number of lives.
As Mr. Hornblum concluded at the end of his book:
"It couldn't happen in America" we reassured ourselves about medical practices in Nazi Germany. But intolerable medical practices were practiced on vulnerable populations in America, without the support of the political culture or the despotic leadership that captivated Germany under the Third Reich, without any protest from the AMA, which prides itself on its ability to regulate itself.In conclusion, I ask that the NPRM changes proposed for weakening of protections on issues related to “intelligence surveillance” and “criminal justice activities,” as well as weakening protections related to Subpart C of the Common Rule relating to research protections for prisoners, be soundly rejected.
History suggests that we are as susceptible to abusing our socially and economically disenfranchised citizens as any other nation. If, as many believe, a democracy is only as strong as the respect accorded its weakest members, we must work to assure that neither these abuses nor the "conspiracy of silence" that makes them possible ever happen again. We must do this not only for the benefit of the powerless, but also for the benefit of society as a whole.17
Jeffrey S. Kaye, Ph.D.
1Advisory Committee on Human Radiation Experiments, Public Meeting, Tuesday, July 5, 1994, Presentation by Jay Katz. URL: http://nsarchive.gwu.edu/radiation/dir/mstreet/commeet/meet4/trnsct04.txt
2Jason Leopold and Jeffrey Kaye, “Wolfowitz Directive Gave Legal Cover to Detainee Experimentation Program,” Truthout, Oct. 14, 2010. URL: http://www.truth-out.org/news/item/257:wolfowitz-directive-gave-legal-cover-to-detainee-experimentation-program
3“DON Human Research Protection Program: What’s New -14 November 2006.” URL: http://www.dtic.mil/biosys/docs/hu-navy_cs-2006.pdf
4See Jason Leopold and Jeffrey Kaye at i. above.
5See “New DoD Directive on Detainees Allows Sleep and Sensory Deprivation, Biometric IDs,” Invictus, September 17, 2014. URL: http://valtinsblog.blogspot.com/2014/09/new-dod-directive-on-detainees-allows.html?m=1
6“American Servicemen Used As Guinea Pigs - Tests Revealed DOD Releases Project SHAD Fact Sheets”, (no date, but first webpage circa 2002). URL: http://web.archive.org/web/20070221064138/http://www.testsubjects.net/shad.htm
7Hearing Before the Subcommittee on Health of the Committee on Veterans’ Affairs, House of Representatives, One Hundred Seventh Congress, Second Session, October 9, 2002, “Military Operations Aspects of SHAD and Project 112.” URL: http://web.archive.org/web/20090805150741/http://fhp.osd.mil/CBexposures/pdfs/oct9h02.pdf
8See “Project 112/SHAD,” (no date), URL: http://www.health.mil/Military-Health-Topics/Health-Readiness/Environmental-Exposures/Project-112-SHAD
9See Jeffrey Kaye, NRC on Research on “War on Terror” Detainees: “A Contemporary Problem,” February 12, 2011. URL: https://shadowproof.com/2011/02/12/nrc-on-research-on-war-on-terror-detainees-a-contemporary-problem/
Also National Research Council (NRC) 2008 , “Emerging Cognitive Neuroscience and Related Technologies”. URL: http://www.nap.edu/read/12177/chapter/6#118
10Jeffrey Kaye, “SSCI Report Reveals CIA Torture Program Originated in Same Department as MKULTRA,” The Dissenter (later changed name to Shadowproof), December 11, 2014,. URL: https://shadowproof.com/2014/12/11/ssci-report-reveals-cia-torture-program-originated-in-same-department-as-mkultra
11Dainius Puras and Juan E. Méndez, Letter to the U.S. Government, January 15, 2015, “Mandates of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health and the Special Rapporteur on torture and other cruel, inhuman or degrading treatment or punishment.”
12Ibid., pp. 3-4.
13Federal Register, Vol. 80, No. 173, Tuesday, September 8, 2015, Proposed Rules., p. 20. URL: https://www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-21756.pdf
14Federal Register, Vol. 80, No. 173, Tuesday, September 8, 2015, Proposed Rules., p. 18. URL: https://www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-21756.pdf
15Jeffrey Kaye, “Government’s Psychological Evaluation of Manssor Arbabsiar Fails to Impress,” The Public Record, October 10, 2012. URL: http://pubrecord.org/law/10586/governments-psychological-evaluation/
16U.S. District Court, Southern District of New York, Protective Order, 11 Cr. 897 (JFK), USA vs. Manssor Arbabsiar, August 15, 2012. URL: https://www.documentcloud.org/documents/459526-8-15-12-protective-order-manssor-case.html
17Hornblum, Allen M. (2013-05-13). Acres of Skin: Human Experiments at Holmesburg Prison (Kindle Locations 4625-4631). Taylor and Francis. Kindle Edition.