ACHRE Report

Part III

Chapter 18

Recommendations 1 - 6

Recommendations 7-12

Recommendations 13-16

Chapter 18: Recommendations 13-16

Recommendation 13

The Advisory Committee recommends that the Human Radiation Interagency Working Group take steps to improve three elements of the current federal system for the protection of the rights and interests of human subjects--oversight, sanctions, and scope.

1. Oversight mechanisms to examine outcomes and performance. In most federal agencies, current mechanisms of oversight of research involving human subjects are limited to audits for cause and a review of paperwork requirements. These strategies do not provide a sufficient basis for ensuring that the current system is working properly. The adequate protection of human subjects requires that the system be subjected to regular, periodic evaluations that are based on an examination of outcomes and performance and that include the perspective and experiences of subjects of research as well as the research community. The Committee recommends that the Human Radiation Interagency Working Group consider new methods of oversight that focus on outcomes and performance of the system of protection of human subjects. The Committee's Subject Interview Study and Research Proposal Review Project, for example, yielded important and heretofore unavailable information about the current status of human subjects protections that could never be obtained from either an oversight policy that audits only "for cause" or a review that determines only whether paperwork requirements have been satisfied.

We realize that resources available for oversight are limited and that there may be real constraints on what, practically, can be achieved. At the very least, we urge that in the setting of priorities for limited oversight dollars, a premium be placed on methods that permit an examination of what the system is actually producing with respect to the outcome of human subjects protections, in contrast to methods that focus on process.

2. Appropriateness of sanctions for violations of human subjects protections. The Committee recommends that the Human Radiation Interagency Working Group review and evaluate the options available to the government when it is determined that there has been a violation of the Common Rule in the conduct of federally sponsored research involving human subjects. The object of this review is to determine whether the current structure of sanctions that can be imposed on investigators and grantee institutions is appropriate to the seriousness with which the nation takes violations of the rights and interests of human subjects. This structure includes mechanisms for detecting violations (including issues of oversight discussed above), severity of sanctions, and dissemination of policies on sanctions to investigators and institutions. We are particularly concerned that, even in the absence of research-related injury, there be clear and severe penalties for investigators who use human subjects without their consent. Although at least one state authorizes civil and criminal penalties for failure to obtain a subject's consent,[8] in most jurisdictions civil litigation is unlikely to result in penalties to investigators for failing to obtain consent from subjects if the subjects have not been physically injured. The Committee is aware that the Common Rule provides for sanctions of violations of its provisions, including the withdrawal of multiple project assurances and, with that action, research funding. It is not clear, however, that this system of sanctions functions well; nor is it clear that it adequately addresses the public's concerns that those who abuse the trust of research subjects be dealt with accordingly.

3. Extension of human subjects protections to nonfederally funded research. While some nonfederally funded research is performed voluntarily in accordance with the Common Rule, there is a need to assess the level of research performed outside its requirements and to consider action to ensure that all subjects are afforded the protections it offers. The Committee was charged with reviewing only federally funded research, and we limited our inquiries accordingly. However, we are aware that important areas of research are conducted largely independently of federal funding--for example, some research on reproductive technologies. We recommend that the Human Radiation Interagency Working Group take steps to ensure that all human subjects are adequately protected.

Recommendation 14

The Advisory Committee recommends that the Human Radiation Interagency Working Group review the area of compensation for research injuries of future subjects of federally funded research, particularly reimbursement for medical costs incurred as a result of injuries attributable to a subject's participation in such research, and create a mechanism for the satisfactory resolution of this long-standing social issue.

A system of compensation for research injuries has been contemplated since at least the late 1940s, when the Army debated, but ultimately rejected, suggestions to establish a "uniform" program for compensating prisoner volunteers who were injured during experiments involving malaria and hepatitis. Beginning in the 1970s, a number of government-sponsored ethics panels endorsed the provision of compensation for research injuries, culminating with the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (President's Commission) in 1982. Since then, experts and commentators have continued to support this position.[9]

In our deliberations concerning retrospective remedies for injured research subjects, the Advisory Committee was unable to reference a federal policy or guide for a fair system of compensation of research subjects, as no policy exists even today. So that years from now others do not have to revisit and struggle with this issue, the federal government must take steps now to address the issue of compensation for injured research subjects. These steps should include consideration of the approach recommended by the President's Commission in its report, Compensating for Research Injuries: The Ethical and Legal Implications of Programs to Redress Injured Subjects.[10]

The President's Commission summarized the basic argument for compensation as follows:

Medical and scientific experimentation, even if carefully and cautiously conducted, carries certain inherent dangers. Experimentation has its victims, people who would not have suffered injury and disability were it not for society’s desire for the fruits of research. Society does not have the privilege of asking whether this price should be paid; it is being paid. In the absence of a program of compensation of subjects, those who are injured bear both the physical burdens and the associated financial costs. The question of justice is why it should be these persons, rather than others, who are to be expected to absorb the financial, as well as the unavoidable human costs of the societal research enterprise which benefits everyone.[11]

The Advisory Committee urges not only consideration of a compensation policy for physical injuries attributable to research but also that consideration be given to appropriate remedies for subjects who have suffered dignitary harms, even in the absence of physical injury. Subjects so wronged have little recourse in the current system; litigation in the absence of physical injury is unlikely to provide relief to people who have been used as subjects without their adequate consent. If it is determined that financial compensation is not generally an appropriate remedy in the absence of physical injury, consideration should be given to other remedies that would be fitting.

Recommendations for Balancing National Security Interests and the Rights of the Public

Recommendation 15

15a: The Advisory Committee recommends to the Human Radiation Interagency Working Group the adoption of a federal policy requiring the informed consent of all human subjects of classified research and that this requirement not be subject to exemption or waiver. In all cases, potential subjects should be informed of the identity of the sponsoring federal agency and that the project involves classified information.

15b: The Advisory Committee recommends to the Human Radiation Interagency Working Group the adoption of a federal policy requiring that classified research involving human subjects be permitted only after the review and approval of an independent panel of appropriate nongovernmental experts and citizen representatives, all with the necessary security clearances. This panel should be charged with determining (1) that the proposed experiment has scientific merit; (2) that risks to subjects are acceptable and that the balance of risk and potential benefit is appropriate; (3) that the disclosure to prospective subjects is sufficiently informational and that the consent solicited from subjects is sufficiently voluntary; and (4) whether potential subjects must have security clearances in order to be sufficiently informed to make a valid consent decision, and if so, how this can be achieved without compromising the privacy and voluntariness of potential subjects. Complete documentation of the panel's deliberations and of the informed consent documents and process should be maintained permanently. These records should be made public as soon as the national security concern justifying secrecy no longer applies.

Although the Advisory Committee believes that the interests of both science and potential subjects are best served when research involving human subjects is conducted in the open, a public policy prohibiting the conduct of human subject research in secret is unwise. Important national security goals may suffer if human subjects research projects making unique and irreplaceable contributions were foreclosed. More citizens may suffer harms for lack of such information than would be harmed if adequately safeguarded human subjects research was conducted in secret.

It also is possible that a prohibition on classified human subjects research would be circumvented through redefinition of activities or disregarded outright. If this were to occur, the participants in such activities could end up less well protected than if they were bona fide research subjects.

The Advisory Committee believes, however, that the classification of human subject research ought properly to be a rare event and that the subjects of such research, as well as the interests of the public in openness in science and in government, deserve special protections. The Advisory Committee does not believe that continuing with the current federal policy governing the protection of human subjects, which does not provide any special safeguards or procedures for classified research, is adequate.

In the current political context, classified human subjects research occurs relatively rarely. Existing policy may prove an inadequate safeguard of individual rights and welfare, however, if in the future national security crises occur that generate a perceived need for classified research. The history of human experimentation conducted in the interests of strengthening and protecting national security that the Advisory Committee has examined demonstrates how the rights and interests of citizens can be violated in secret research. The convergence of elements of secrecy, urgent national purposes, and the essential vulnerability of research subjects, owing to differentials in information and power between those conducting research and those serving as subjects, could again lead to abuses of individual rights and, upon subsequent revelation, the erosion of public distrust in government.

The Advisory Committee is particularly concerned about two aspects of current policy--exceptions to informed consent requirements and the absence of any special review and approval process for human research that is to be classified. The current requirement for the informed consent of research participants is not absolute, leaving open the possibility that subjects may serve as mere tools of the state in the interests of national security if consent is waived. A strengthened requirement for the informed consent of research subjects in classified research should safeguard against the merely instrumental use of individual people to serve national purposes.

Institutional review boards of government agencies are not sufficiently independent of the interests of the organizations of which they are a part to set aside considerations of organizational mission when considering research construed as having the greatest national priority. Thus, determination by an agency IRB that a waiver of informed consent is warranted, or that sufficient information about a study remains in a censored protocol description for a potential subject's review, inadequately protects subjects' interests and rights and does not adequately safeguard the public's trust. By contrast, an independent panel should be less subject to unintended bias than that of an IRB of a federal agency whose mission is to protect and promote national security.

Although the Advisory Committee acknowledges that both the formation of an independent review panel and an absolute informed consent requirement create opportunities for information leaks or security breaches and delays in the progress of urgent research, these disadvantages are surmountable and are more than balanced by the increased vigilance afforded the rights and interests of citizens and the safeguarding of the public's trust in government.

Recommendation 16

The Advisory Committee recommends to the Human Radiation Interagency Working Group that improvements be made in the protections of the public's rights and interests with respect to intentional releases.

16a. The Advisory Committee recommends to the Human Radiation Interagency Working Group that an independent review panel review any planned or intended environmental releases of substances in cases where the release is proposed to take place in secret or in circumstances where any aspect of the environmental review process required by law is conducted in secret.

In conducting its review, the independent panel should ensure that (l) secrecy is limited to that required for reasons of national security; (2) records will be kept on the nature and purpose of the release, the rationale for not informing the public (including workers and service personnel, as well as affected citizens), and alternative means of gathering data that were considered; (3) actions to mitigate risk were considered and will be taken; and (4) actions will be taken to measure the actual effect of the release on the environment and human health and safety, to the extent that measurements are deemed needed and feasible. The panel should also review the conditions on which any information kept secret should be made public, with a view toward ensuring the release of information as soon as practicable, consistent with any legitimate national security restrictions. The panel should report to Congress periodically on the number and nature of releases it has reviewed.

The Advisory Committee does not conclude that intentional releases can never be conducted in secret. It does conclude that, to the extent that the government proposes to conduct an intentional release that involves elements of secrecy, there must be independent review to ensure that the action is needed, that risk is minimized, and that records will be kept to make sure a proper accounting is made to the public at the earliest date consistent with legitimate national security concerns.

The Advisory Committee found that the government has sponsored numerous intentional environmental releases of radiation for research purposes. In many cases these releases were conducted in secret, without warning to the surrounding populations. While the risks posed by these releases appear to have been relatively small, in many cases little data remain on the precise measure of these risks or on actions taken to minimize risk and to ensure that unknowing citizens did not inadvertently expose themselves to greater risks than necessary. In addition, the Committee found that the risks and concerns posed by intentional releases for research purposes--in terms of both the magnitude of radiation exposure and the consequences of secret keeping--sometimes did not differ qualitatively from those posed by "routine" operational releases of radiation. Most notably, the radiation risk posed by the Green Run, a relatively large intentional release, was a fraction of that posed by radiation released in the normal course of operation of Hanford in the mid-1940s.

This recommendation is intended to apply to all secret releases of substances into the environment, not merely to substances determined to be hazardous. The Committee believes that the operative concern is secrecy; even if the substance released is entirely harmless, the backdrop of secrecy is sufficient to create a climate of distrust. The Committee did not have the expertise, however, to determine whether so broad a sweep was feasible. At minimum, the Committee recommends that any secret release of a substance that would necessitate an environmental impact statement be required to have a review by an independent panel.

Today, federal environmental laws and rules provide for environmental impact statements, which are subject to review, in instances in which the federal government proposes actions with a substantial effect on the environment. However, the rules also provide that part--or even all--of such reviews may be conducted in secret. In fact, reviews that are secret in whole or part do take place.

The Environmental Protection Agency has the authority and responsibility to oversee all environmental impact reviews, including those conducted in secret. However, the Advisory Committee's inquiries indicate that EPA's role in the review of secret impact statements has been limited. Moreover, the decades of secret keeping regarding intentional releases have created a basis for distrust, particularly among those living in potentially affected communities. Even today, there is little practical means by which the public can know the full extent (whether or not great) of environmental decision making and action that is being kept secret. The location of responsibility for review of these activities in a single panel that is itself accountable and that is independent of agencies that conduct releases should be a means to restoring lost trust.

16b. The Advisory Committee recommends to the Human Radiation Interagency Working Group that an appropriate government agency, currently the Environmental Protection Agency, maintain a program directed at the oversight of classified programs, with suitably cleared personnel. This program should maintain critical records, such as environmental impact statements and environmental permits, permanently. The agencies subject to regulation should ensure the timely consideration of environmental impacts and oversight and the timely provision of all necessary clearances. EPA should provide regular unclassified reports to Congress describing the extent of its activities as well as any significant problems.

The requirements of environmental law apply to activities of the federal government, regardless of whether those activities are classified. However, classification complicates the process of regulatory oversight by the EPA or any other regulatory agency and limits the ability to report to the public and for the public to express its own concerns. Furthermore, secrecy has been used to shield activities that raise public health concerns.

For these reasons, the responsibility for environmental oversight is magnified for secret programs. There is no fundamental barrier to effective oversight--at least some regulators can be given the necessary clearances. However, ensuring timely and effective oversight requires cooperation between the regulated agency and the regulatory agency to establish the necessary oversight procedures. These mechanisms are not fully in place. For example, the EPA office with the statutory responsibility to review environmental impact statements maintains no records of classified environmental impact statements and has not historically had individuals cleared to review the most highly classified defense programs. The EPA office responsible for overseeing federal compliance with environmental regulations has just begun to establish mechanisms for overseeing secret programs.

Recommendations on Openness

Recommendation 17

The Advisory Committee recommends that the Human Radiation Interagency Working Group take steps to ensure the continued application of the lessons learned from the Human Radiation Interagency Working Group's efforts to organize and make accessible to the public, and the government itself, the nation's historical records.

The Committee's experience confirms that with presidential directive and the strong and continued support of a multiagency records search team, substantial amounts of the nation's documentary heritage can be located and retrieved. Through the research process, important lessons were learned about ways in which to improve the accessibility and usefulness of this documentary record to both the public and the government.

We are aware that government resources are stretched thin and may well be diminishing. However, the nation's records are a precious asset that the government created, and holds in trust, for its citizens. This asset, and the commitment made to the public through the enactment of the Freedom of Information Act, is of limited value if the government itself cannot access its records as citizens rightfully expect it should. The Committee's experience confirms that there is an intense public interest in using these records, a public willingness to volunteer time and intelligence needed to help organize and research them, and great opportunity to make them available in ways that will permit citizens to do so.

The Committee recommends that the Human Radiation Interagency Working Group effect the following five steps to increase both government and citizen access to information about the past. The implementation of these steps might best be accomplished by the designation of an individual or entity with responsibility and appropriate authority for their effectuation.[12]

1. The most important historical collections should be entrusted to the National Archives. The agencies and the National Archives should review the extent to which this is now being done and develop policies to hasten the transfer of agency records to the National Archives.

Federal law basically requires that permanent records be transferred to the National Archives when (1) they are more than thirty years old; or (2) earlier if the originating agency no longer needs to use the records for the purpose for which they were created or in its regular current business, or if agency needs will be satisfied by use of the records at the National Archives.

Nonetheless, many portions of older collections have been appraised as permanently valuable but are not at the National Archives. For example, the Committee found that a great number of AEC headquarters records of substantial interest to the Committee and the public are still held by DOE either at its headquarters or at the Washington National Records Center (these include the only collection of general manager files, the post-1958 Executive Secretariat files, virtually all the Division of Military Application files, and most of the files of the Division of Biology and Medicine). In the case of the Department of Defense, the records of the Office of the Secretary of Defense largely remain at the Washington National Records Center or with the Office of the Secretary of Defense.[13]

The public's ability to access records held by agencies is limited because (1) most agencies do not know in detail what records they still hold, and even if folder listings exist, they are not publicly available for the most part; (2) there has generally been little declassification review of these records; (3) there is no requirement that agencies permit access to even completely unclassified or declassified collections; and (4) most agencies have very limited facilities to accommodate researchers. The public's ability to gain access to documents in federal records centers is also limited because (1) the task of examining the basic inventory forms (SF-135s)[14] to determine what is in a record group is time-consuming, and in many cases, the SF-135s do not adequately describe the records; (2) there has generally been very little declassification review of these records; and (3) permission must be obtained from the appropriate agencies to review even completely unclassified or declassified collections; this permission process can be time-consuming and agencies can impose restrictions, such as permitting review but not copying.

Locating records at the National Archives has the following advantages: (1) there is generally at least some type of finding aid and, in some cases, folder listings prepared by the National Archives or the agencies when the records were sent; (2) archivists are available to assist researchers; (3) there is complete access to unclassified and declassified collections (unless Privacy Act or similar restrictions apply); and (4) many classified records at the National Archives (among the exceptions are Restricted Data records and records dealing with intelligence) are properly the subject of an informal and usually very quick in-house declassification review process called Special Declassification Review. Under Special Declassification Review, records are often reviewed within months, versus the years it takes under the Freedom of Information Act or Mandatory Declassification Review.

2. Agencies should make readily available all existing inventories, indices, folder listings, and other finding aids to record collections now under agency control. Classified finding aids should undergo declassification review, and declassified versions of these finding aids should also be made available.

Finding aids or indices to federal government records holdings are an invaluable tool, without which it would be practically impossible to locate documents of interest from among the hundreds of thousands of boxes of records maintained by the government.

Many collections of records still held by agencies have finding aids or indices that have been inaccessible to the public, either because they simply have never been made available or because they are classified. Finding aids should be made available to the public in a headquarters office, regional offices (including all field site reading rooms), and ultimately, on the Internet. (This recommendation does not call for the creation of indices where they do not currently exist.)

For example, folder listings (which provide the titles of records files) exist for many of the AEC headquarters record collections that are still at DOE or at the Washington National Records Center. These include, among others, the only known collection of general manager's files from 1947 through 1974, all of the Division of Military Applications files from 1947 through 1974, all of the Executive Secretariat files from 1959 through 1974, and most of the Division of Biology and Medicine files from 1947 through 1974. Without the folder listings it would have been difficult for the Advisory Committee to locate particular collections of interest and, even if located, to determine the documents to be reviewed. The folder listings, however, have not been generally available to the public.

Similarly, the DOE's Oak Ridge Operations Office vault contains more than 7,000 cubic feet of classified records. The Committee found that the Records Holding Task Group (RHTG) collection in this vault (about 300 cubic feet) contained many documents of interest to the Committee, which were typically readily declassifiable. This collection has an index; however, the index is classified.

In the case of the National Archives, finding aids are generally available. However, there are fifteen National Archives facilities around the country. Currently, the only means of determining exactly what records are at a particular branch is to contact that branch directly. This is a time-consuming process, and there are understandable limits on the number of pages of finding aids archivists can copy and send to any person (a single finding aid can total hundreds of pages). It would be much simpler and easier for the public to be able to review the finding aids from all fifteen branches at any one of them.

3. The Human Radiation Interagency Working Group should ensure the development of policies to improve public access to records held by agencies or deposited in federal records centers.

In the case of a vast amount of records, particularly those not yet transferred to the National Archives, the available descriptions are often too broad or incomplete to provide meaningful clues to the contents of boxes. Thus, a Freedom of Information Act request that seeks all information on a given topic may well receive a response that ignores information located in boxes or files that are not clearly labeled or indexed. Under these circumstances, searches may be more fruitfully conducted by citizens with an interest in, and understanding of, the subject of the search. However, because so many of the nation's records collections are off-limits to the public, even citizens who are willing to help are often precluded from lending a hand.

Many collections of interest to citizens contain no classified documents and can be made directly accessible to them. However, the Committee reviewed collections, particularly those containing decades-old records, where the entire collection was classified because it housed a small number of classified documents. For example, Record Group 326 at the College Park National Archives has approximately 160 feet of Metallurgical Laboratory/Argonne National Laboratory documentation that should be of significant historical interest. The collection itself is classified and currently inaccessible to citizens. The Committee's examination of large portions of the collection found very few classified documents, and when found, these documents were immediately declassified.

Executive Order 12958, issued by President Clinton on April 17, 1995 ("Classified National Security Information"), provides broadly for the automatic declassification (with specific exceptions) of all records that are more than twenty-five years old. In implementing the order, agencies should target collections that can be relatively quickly reviewed and made available to the public in their entirety.

4. Agencies should maintain complete records, available to the public, of document destruction.

Government records management rules provide for the destruction at varying dates in the future of all records that are appraised as temporary (that is, nonpermanent). They also provide that records be kept where certain collections, including classified records, are destroyed. But the Committee found that records of destruction are themselves routinely destroyed.

For example, upon Committee inquiry, DOE investigation revealed that the files of the AEC's Intelligence Division had been substantially destroyed during the 1970s and as late as 1989. (These files may have contained data on intentional releases, experimentation performed by the AEC for other agencies, and on the rules and practices of secret keeping regarding human data gathering). The DOE's inquiry found individuals who stated that they destroyed substantial records and that records of destruction were made. However, in accordance with DOE rules, the "certificates of destruction" were themselves later destroyed.[15] As another example, documents provided by the Department of Veterans Affairs and the Department of Defense indicate that, in 1947, the government contemplated the keeping of secret records in anticipation of potential liability claims from service personnel exposed to radiation and that some such records were kept. However, despite substantial search efforts by the DOD and the VA, the specific identity of the records referred to has not yet been determined.[16]

The Committee presumes that the vast majority of these records were destroyed in the routine course of business. Nonetheless, where records recording the destruction of important collections of records are themselves destroyed, the public cannot know whether important records have been destroyed (or merely are lost) and cannot be easily assured that destruction was in the routine course of business.

5. The Human Radiation Interagency Working Group should review and develop policies concerning public access to records generated or held by private contractors and institutions receiving federal funding.

Since World War II, the government has relied on contractors and grantees to perform an increasing number of governmental activities, including government-sponsored biomedical research. When the Advisory Committee undertook to locate information on particular government-sponsored radiation experiments, it was often told by federal agencies that, if such information was created, it would have been maintained only by nonfederal entities or investigators and not the government itself.

Where an activity is conducted by government employees (for example, researchers working in the facilities of the National Institutes of Health's Clinical Center), citizens have a right to seek access to information relating to that activity under the Freedom of Information Act. A similar right of access often does not apply, however, where a similar or even identical activity is conducted, also on federal funds, at nonfederal facilities.[17]

From the citizen's vantage point, the right to know about a government-funded activity should not depend on whether that activity is conducted directly by the government or by a government-funded private institution. At the same time, nonfederal institutions are not governmental agencies, and there may be good reasons they should not be burdened with identical obligations to retain records and to provide information to the public.

Rules are needed that accommodate both the citizen's right to know about the conduct of the government and the relevant differences between nonfederal and federal institutions with respect to duties to create and maintain publicly accessible records.[18] To ensure consistent and informed governmentwide treatment of the question, the Human Radiation Interagency Working Group may wish to call on the Office of Management and Budget (OMB) and the Office of Federal Procurement Policy (OFPP) to review the current right of members of the public to gain access to the records of government grantees and contractors.

Recommendation 18

18a: The Advisory Committee recommends to the Human Radiation Interagency Working Group that the CIA's record-keeping system be reviewed to ensure that records maintained by that agency are accessible upon legitimate request from the public or governmental sources. This review could be performed by the CIA inspector general or an oversight panel.

18b: The Advisory Committee recommends that all records of the CIA bearing on programs of secret human research, such as MKULTRA and the related CIA human behavior projects from the late 1940s through the early 1970s, including Bluebird, Artichoke, MKSEARCH, MKDELTA, Naomi, Chance, Often, and Chickwit, become a top priority for declassification review with the expectation that most, if not all, of these documents can be declassified and made available to the public.

These recommendations are intended to ensure that the public and the government have practical access to historical records of the CIA (where access is otherwise appropriate) and to address long-standing public interest and concerns regarding secret human experiments conducted or sponsored by the CIA.

The framework of the records collections of all the Human Radiation Interagency Working Group agencies, save the CIA, is visible to the public. This is the case even in agencies, such as the Defense Nuclear Agency, where historical research records are largely classified.

While documents showing CIA participation in midcentury DOD-sponsored discussions of human experimentation were obtained from DOD, DOE, and the public National Archives, the CIA was not able to locate such documents in its own files and states that the CIA's role in these discussions was sufficiently minor that such records would not have been kept. The Advisory Committee also notes the recent report to the attorney general of the BNL Task Force, which was investigating a bank-related scandal: "While we benefited from extensive cooperation and assistance from the CIA's Office of General Counsel, the CIA's ability to retrieve information is limited. Records are 'compartmentalized' to prevent unauthorized disclosure; only some of those records are retrievable through computer databases; no database encompasses all records; and not all information is recorded. In the course of our work, we learned of 'sensitive' components of information not normally retrievable and of specialized offices that previously were unknown to the CIA personnel assisting us."[19]

In addition, while the Advisory Committee has found no evidence to show that the CIA conducted or sponsored human radiation experiments, numerous documents, some of which remain partially classified, make reference to possible CIA interest in this area. Although Advisory Committee staff has reviewed all of the available classified information concerning human radiation experiments and requested that it be declassified, the public does not as yet have the benefit of such access.

Twenty years after they were first revealed to the public, there continues to be a strong public interest in the CIA's "mind control" programs. The Advisory Committee received numerous queries about MKULTRA and the other related programs from scholars, journalists, and citizens who have been unable to review the complete record. Although these CIA projects were the subject of significant governmental inquiry in the mid to late 1970s--by the Senate and House committees and by the presidentially appointed Rockefeller Commission--and a substantial portion of the records have been declassified and released to the public, a number of documents remain classified, and many of the documents that have been released contain numerous redactions. This has made it extremely difficult to understand the full context of the activities or to clarify discrepancies or uncertainties in the record.

A number of the declassified documents make reference to radiation experiments. However, because of the redactions, it is impossible for the public to determine from these documents whether there is additional, secret information about radiation activities. (Advisory Committee staff have reviewed the full text of these documents.) For example, the 1963 CIA inspector general report on the inspection of MKULTRA, which was declassified in redacted form in 1975, stated that "radiation" was one of the avenues explored under MKULTRA. But because so much of that document was redacted, the public reader might reasonably suspect that there is more information about radiation in the report. At the request of the Advisory Committee, the CIA re-released this document, and a handful of others, with minimal redactions.

However, few other such documents have been re-reviewed for declassification in almost twenty years. Since most of the classified CIA documents concerning MKULTRA and related programs that Advisory Committee staff reviewed were declassified upon request, the Advisory Committee believes that if the rest of these records were reviewed for historical declassification, most, if not all, of the records could be declassified without harming the national security.

So long as documents about secret human experiments are withheld from the public, it will be impossible to put to rest distrust with the conduct of government. The rapid, public release of the remaining documents about MKULTRA and other secret programs would be a fitting close to an unhappy chapter in the nation's history.


The Advisory Committee's charter requires that we consider the issue of notice to experimental subjects of potential health risk and the need for medical follow-up:

If required to protect the health of individuals who were subjects of a human radiation experiment, or their descendants, the Advisory Committee may recommend to the Human Radiation Interagency Working Group that an agency notify particular subjects of an experiment, or their descendants, of any potential health risk or the need for medical follow-up [Sec. 4.c.].

The basic intent of this provision is not directed at subjects who have already died, or at subjects who have already become ill and been treated. It is primarily aimed at asymptomatic subjects who remain at significant risk for the development of radiation-induced cancers. Because at least two and as many as five decades have passed since the experiments took place, most of those who may eventually develop cancer as a result of the experiment will already have developed symptoms and sought treatment. However, some subjects may still be at risk and thus arguably might benefit from medical follow-up.

The initial consideration in deciding whether to implement a program of active notification and medical follow-up is the identification of populations of subjects who have been put at significant risk for the development of radiogenic cancers. The magnitude and focus of these risk estimates are driven by the specific organs placed at highest risk from the particular radiation exposure (for example, thyroid being the organ at greatest risk in the iodine 131 experiments, testes in the Oregon and Washington prisoner experiments, and the brain for the nasopharyngeal radium experiments). Risk estimates are calculated for each target organ according to a number of assumptions that may include adjustments for variables such as age at exposure, sex, or type of radiation (isotope vs. external beam) and are generally expressed in terms of excess cancer incidence/mortality for a given population over a specified period at a specified dose.

The Advisory Committee adopted an excess site-specific cancer mortality (death) greater than 1 case in 1,000 (lifetime) as a criterion for determining that a subject had been placed at increased risk. However, because of the substantial passage of time since the initial exposure, the criteria for consideration of active notification were set at 1/1,000 future or remaining lifetime risk and an excess relative risk of greater than 10 percent (organ specific). This level of risk was arbitrarily chosen by the Advisory Committee. When compared with the normal risk of developing cancer (220 out of 1,000), this level of risk is small. The Advisory Committee chose this small remaining lifetime risk as a reasonable initial criterion to decide if a more in-depth analysis of the effectiveness of screening and intervention was needed.

Once a population has been determined to have an increased remaining lifetime risk for radiogenic cancer mortality, a second criterion must be satisfied before a government-funded medical follow-up program is recommended, namely whether the exposed individuals would likely benefit from a program of early detection or early treatment of the malignancy. Effective screening procedures for the detection of an early-stage cancer exist only for a limited number of cancer sites. Moreover, the lack of specificity of all diagnostic screening tests results in a significant number of "false positives" (a positive test result in an individual who in truth is not affected), resulting in unnecessary and potentially hazardous medical procedures that may cause health problems in and of themselves. On the other hand, most diagnostic tests are also imperfectly sensitive, meaning that some individuals who actually have the disease will be falsely reassured that they are cancer free and may thereby delay seeking attention when it becomes symptomatic. To this end the Advisory Committee has adopted the following criteria for assessing the value of screening, preventive, or therapeutic measures for exposed subjects of biomedical experiments:[20]

  1. The condition must have a significant effect on the quality or length of life.

  2. The condition must have an asymptomatic period during which it can be detected by available screening methods.

  3. These screening methods must have high sensitivity and specificity.

  4. Treatment in the asymptomatic phase must yield a therapeutic result superior to that obtained by delaying treatment until symptoms appear.

  5. The medical benefits of screening and early treatment must outweigh any detrimental medical effects or risks.

These criteria were applied to each exposed population at significant risk for development of a malignancy and evaluated according to the organ(s) at risk from radiation exposure. In each case, the conditions enumerated above must be satisfied before specific medical follow-up would be recommended.

Details of the Advisory Committee's risk calculations can be found in chapters 7 and 9. To summarize, the Advisory Committee found no experiments involving iodine 131 administration to children that met our 1/1,000 criterion for remaining lifetime risk of dying of cancer; even in the most highly exposed individuals, risks were estimated to be 1/2,000 (remaining lifetime risk). In addition, the U.S. Preventive Services (USPS) Task Force concluded that "routine screening for thyroid disorders is otherwise not warranted in asymptomatic adults or children." Although it has been suggested that people placed at risk for development of thyroid carcinoma following high-dose external irradiation to the upper body may benefit from regular physical examination of the thyroid, there are no data to support a similar risk or benefit for those who have been exposed to diagnostic or therapeutic doses of iodine 131.[21]

The Advisory Committee recognizes that in addition to the very small risk of a fatal thyroid cancer, individuals exposed as children to iodine 131 also have a larger risk of a nonfatal thyroid cancer or benign tumor, a lifetime risk that in many of the experiments we considered exceeded 1/1,000 and in a few individuals exceeded 1/100. We recognize that such conditions may require medical treatment and may be associated with considerable anxiety and discomfort. After considerable discussion, however, the Committee concluded that notification was not warranted for the purpose of detecting such conditions early, on several grounds. First, the prognosis for such conditions under standard clinical care is excellent, and there is no evidence that early detection improves the outcome. Second, even among the subgroup of about 200 children exposed to this level of risk, the number of excess cancers expected is less than one, whereas the normal prevalence in an unexposed population is about 20 to 30 percent. Third, many thyroid cancers that are detectable by screening may have no clinical significance. Finally, the most effective means of screening for thyroid cancer remains palpation, which has low sensitivity and low specificity.

For the prisoners subjected to testicular irradiation, the Advisory Committee estimates that even the most heavily exposed individual (600 rad to the testicles) would have a risk of only 0.4/1,000[22] of developing a fatal cancer, which does not attain our stated criterion. Furthermore, the USPS Task Force has concluded that "there is insufficient evidence of clinical benefit or harm to recommend for or against routine screening of asymptomatic men [other than those with a history of cryptorchidism, orchiopexy, or testicular atrophy] for testicular cancer."[23] These considerations lead the Advisory Committee to recommend against any program of active notification of these subjects. However, subjects who voluntarily request medical check-up or counseling should have such provided in a standard clinical setting.

For the children who received nasopharyngeal radium treatments, the Advisory Committee has estimated that the lifetime risk of tumors to the central nervous system (brain), head, and neck regions is approximately 4.35/1,000 and the excess relative risk is about 62 percent, both with considerable uncertainties.[24] Although these experiments were conducted in the 1940s and much of the risk has probably already been expressed, it is still possible that the future risk is greater than or equal to our arbitrary 1/1,000 risk criterion. However, at greatest risk are the brain, and head and neck tissues, for which there is neither an accepted nor recommended screening procedure.[25] Thus, while the subjects in these experiments meet the Advisory Committee's arbitrary 1/1,000 criterion for consideration for notification and medical follow-up (criterion 1 in Recommendation 4, above), the utility of such a program has not been demonstrated, so criterion 2 of Recommendation 4 is not satisfied. Adult military personnel who participated in trials of this procedure received significantly lower radiation exposures, did not attain our arbitrary 1/1,000 criterion for risk, and would similarly fail to meet the criteria in guideline 2. Therefore, the Advisory Committee does not recommend notification and medical follow-up of children or adults in this group of experiments.

The Advisory Committee's charter also requires that we consider the need for notification of descendants of experimental subjects for purposes of health protection. The rationale for considering notification in this instance derived from the assumption that the offspring of former subjects might be at risk for disease or disability as a consequence of inherited mutations resulting from their parent's previous radiation exposure. The weight of evidence suggests that the risk of heritable genetic effects from the radiation exposures in the experiments we reviewed is very small, although it is possible that some offspring of exposed individuals might carry mutations that were caused by radiation.[26] Moreover, in most medical experiments involving external sources of radiation, efforts are made to shield the gonads (ovaries/testes) as much as possible. With the exception of the testicular irradiation experiments, where subjects agreed to undergo vasectomy to prevent transmission of any mutations that might have occurred, experiments involving external irradiation are likely to have produced relatively small gonadal doses, as would those experiments involving tracers. Even therapeutic studies involving internal radionuclides would generally involve only modest gonadal doses. Thus, in the vast majority of experiments, it is likely that the risk of radiation-induced mutations is small in relation to natural rates.

In addition to cancer and genetic effects, there are only a small number of well-established effects of radiation, including severe mental retardation among those exposed in utero (particularly between eight and fifteen weeks of gestation), sterility, cataracts, and hypothyroidism. Unlike cancer and genetic effects, however, these other endpoints appear to be "deterministic" effects that appear only after high doses that are unlikely to have been received by subjects in the experiments under consideration for notification. The Advisory Committee heard extensive public testimony about a range of other conditions that those testifying thought might be related to radiation exposures. However, the Advisory Committee believes that a program of active notification must be grounded on currently accepted scientific evidence concerning the conditions that are likely to be caused by radiation.

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