This history of the Common Rule was written by Norman Rabin in arguments to a Federal Rulemaking Challenge to argue the inadequacies of human research protections within the Common Rule and specifically challenge a capricious clause in the “Final Rule” published January 18, 2017, that went into effect on July 19, 2018. This capricious clause and other loopholes allow ongoing non-consensual human experimentation without informed consent on any human subject on which experimentation began prior to enactment of the Final Rule. In addition, the Final Rule codifies items that appear to be contrary to the 4th (unreasonable search) and 5th (due cause and self- incrimination) Amendments “in cases of National Security and Intelligence,” which are vaguely defined.
For details on the Common Rule, see: Search Results for common rule | HHS.gov
Regulatory History of the Predecessor Rule, the June 1991 Common Rule1
1. Two Laws enacted after the Tuskegee Experiment Scandal Resulted in The Enactment of Common Rule:
The governmentwide federal Policy for the Protection of Human Subjects (the ‘Common Rule’) resulted from two federal laws which were enacted after, and whose passage was precipitated by, the U.S. Government Tuskegee Experiment scandal, which together with other improper federal governmental, or other, improper or disturbing human experiments which illustrated the need for such legislation. The two enacted laws were: the National Research Act of 1974 [‘Act’] (Public Law 93-348, of July 1974); and Public Law 95-622, of November 1978.
Title II of the 1974 Act was entitled: “Protection of Human Subjects of Biomedical and Behavioral Research” and created the “National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research” [“National Commission”, or “1st Commission”]. And, Title III of Public Law 95-622, of 1978, created a follow-up Commission, the “President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research” [“President’s Commission” or “2nd Commission”] The government-wide policy came about from a two-step process: 1) In late January 19812, each of [DHEW/] HHS and the FDA separately enacted improved Human Subjects Protections, in response to the many recommendations of the National Commission to DHEW; and, 2) In June 1991, 16 federal Agencies and Departments jointly adopted a “common core” policy for human subject protections, mainly based upon the January 1981 HHS policy, in response to the 2nd Commission’s Recommendation that all agencies “adopt as a common core the regulations governing research with human subjects issued by” HHS.
The 1st Commission’s primary jurisdiction was to perform studies, and make finding and recommendations, which would be implemented to create a high-quality system, and policy, for the protection of human subjects at DHEW (U.S. Department of Health, Education, and Welfare, which is now HHS). However, the Commission’s scope was not just DHEW human research. The Commission was given wider authority to obtain information from any government agency in its pursuit of its mandates, which notably included “to determine the need for a mechanism to assure that human subjects in biomedical and behavioral research not subject to regulation by the [HEW] Secretary are protected”, and to make recommendations to Congress, if needed, concerning that.
Related: United Nations Studies Neurotechnology to Protect Human Rights and Promote Fundamental Freedoms – Interest-Driven
Related: U.N. Questionnaire: Questionnaire Neurotechnology_EN
Related: Inside America’s Torture and Mind Control Program – Interest-Driven
Related: A Chronological History of Torture and Assaults from U.S. Government Targeting – Interest-Driven
Related: Texas Group, Targeted Justice, Inc., Sues FBI, DHS, and high-ranking U.S. Officials for $1.3 Billion – Interest-Driven
2. The National Research Act of 1974: its Legislative History, and its Mandates
In late-July 1972, the Tuskegee Experiment of the U.S. Public Health Service was exposed by the national press. In late August 1972, DHEW (under Secretary Casper Weinberger) empaneled an Ad Hoc Commission on Tuskegee. In October 1972, the 9-person panel recommended that the Tuskegee experiment be stopped immediately. In late April 1973, the panel’s final report recommended to DHEW that Congress establish a permanent ‘board’ with authority to regulate all federally supported research involving human subjects, whether “intramural or extramural”, “sponsored by DHEW or other government agencies, such as the Department of Defense”, and that the ‘board’ be “independent of DHEW”.3
In 1973, the U.S. Senate Committee on Labor and Public Welfare’s Subcommittee on Health under Senator Edward Kennedy held about 12 hearings, from February through July, mainly concerned with human experimentation. The topics of these Hearing included: unapproved use of FDA-approved drugs [such as Depo-Provera birth control medication]; psychosurgery; abuse of “supercoil”, an intrauterine device; the Tuskegee Experiment; other experiments, and related ethical issues; and, on feedback from very prominent persons about the two Senate bills at issue: regarding “National Research Service Awards”, and “Human Subjects Protections”. Hearings on March 8, and April 30, 1973 focused on Tuskegee, with the witnesses including: the attorney for the Tuskegee victims, accompanied by 2 different subjects/victims of Tuskegee [four total]; 2 of the 3 medical doctors from the DHEW Ad Hoc Panel on Tuskegee; and, (on April 30) the former Public Health Service employee whose disclosure to the AP news service brought about the press exposure of Tuskegee. Also, one of the Ad Hoc Panel doctors testified again in late June.4
In late May 1973, the House passed their H.R. 7724, the “National Research Training Act”, which also contained a brief provision entitled “Limitations on Research”: “The [DHEW] Secretary may not conduct or support research in the United States or abroad which violates any ethical standard respecting research adopted by the [NIH], [NIMH], or their respective research institutes.” The House Committee Report [H. Rprt. 93-224] gave no specifics about human research other than mentioning concerns about research on living human fetuses. In late May 1973, the House considered the bill. One U.S. Representative wanted to be assured that the prohibition would prevent ‘a repeat of Tuskegee’; and another mentioned Tuskegee in the context his objecting to research on living fetuses. The bill’s Sponsor stated: “This bill covers that problem [research on living fetuses], as well as the Tuskegee problem, as well as the improper research on prisoners, as well as the improper research on persons who have not been advised of their rights. I believe we should not simply single this out at this time, because it might negate the broad general approach of the committee.” 5 The bill was passed overwhelmingly, 374 to 5 (by roll call vote) [but after a fetal research amendment].
In September 1973, the U.S. Senate passed their amended version of h.r. 7724, to which the Senate added the text which had been introduced in bill S.2072, under the title of “Protection of Human Subjects”. In presenting the bill up for vote, Senator Kennedy stated:
“The Senate Health Subcommittee was both shocked and saddened by the testimony it received on abuses in the field of human experimentation. The sad facts concerning the Tuskegee syphilis study, the Montgomery sterilization cases. the use of Depo-Provera for unapproved purposes, the unregulated performance of psychosurgery, are well known. The Protection of Human Subjects Act is designed to minimize the possibility of such events occurring again.”
The bill passed the Senate 81 – 6.
After the bill was delayed by the House not choosing Conferees until late-March 1974, and after reportedly a “long and difficult conference” process, the Senate considered the Conference-amended bill in late June 1974 and passed it 72-14.
The House considered the Conference version of the bill the next day, with the detailed Human Subjects Protections section added versus the original house bill. In presenting the bill to the House, the original bill’s sponsor stated:
After a long and difficult conference, the conferees emerged with a workable report to continue the program of research training support and authorize a 2-year study commission designed to assist the [DHEW] Secretary in identifying basic ethical principles which should underlie the conduct of research with human subjects, to make recommendations to the secretary for administrative and legislative action, and which would cease to exist following submission of its final report.
The Secretary is required to respond in writing to these recommendations, but he is not required to implement them.7
The House passed the Conference bill 311 – 10. President Nixon signed the bill into law a few weeks later, on July 12, 1974.
3. National Research Act of 1974 – and its Mandates
The National Commission created by the 1974 Act had several congressional mandates. The fulfillment of those mandates resulted in (among other things): the 1981 revision of HHS Human Subjects Protections policy, as enhanced by the Commission’s recommendations; and, the April 1979 Belmont Report, which fulfilled a mandate “to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects”.
The Act also created an Ethics Guidance Program within HHS [now at 42 U.S. Code 289(b) ] “under which requests for clarification and guidance with respect to ethical issues raised in connection with biomedical or behavioral research involving human subjects are responded to promptly and appropriately”.
The Act also required that HHS Human Subjects Protections regulations require each Human Research Project to be reviewed by an Institutional Review Board, “to review biomedical and behavioral research involving human subjects conducted at or sponsored by such entity in order to protect the rights of the human subjects of such research.” [ 42 U.S. Code 289(a) ] The Commission’s mandated report on IRBs resulted in many of the still current rules which govern the system of IRB review, and its localized oversight, of human research projects. IRB review includes: review of Research Proposals; and also, appropriately frequent ‘continuing review’ of the human research while the human study is still ongoing.
4. The Public Law 95-622, Title III (President’s Commission), its Legislative History, and its Mandates
The Senate bill which proposed the President’s Commission, S.2579 (proposed in February 1978), was the result of follow-up work on Human Research Protections and Bioethics by the Health Subcommittee chaired by Senator Kennedy. The Senate Report on the 1978 bill listed all of the 1973 Hearings, and additional hearings in: September 1975 (2 hearings on Army drug testing, including testing of LSD); November 1975 (1 hearing on Department of Defense and CIA drug testing); and, August-September 1977 (3 hearings on C.I.A. drug testing, including non-consensual testing of LSD).
The Committee’s Report on the bill stated:
.. The need to expand the scope and jurisdiction of the National Commission was made evident by the hearings conducted with respect to drug testing by the CIA and the Defense Department. In those hearings, the Committee learned that both the CIA and the Defense Department had been involved in the widespread testing of hallucinogenic drugs on unsuspecting citizens, servicemen, and employees of the agencies. These experiments, which were perceived to be necessary to meet the needs of national security, violated the basic principles of biomedical and behavioral research with human subjects and their rights…
In considering the testimony at these hearings, the Committee became convinced that all human subjects who participate in bio medical or behavioral research programs under the auspices of any Federal agency deserve protection.8
When Senator Kennedy presented the legislation to the Senate, he presented the human research abuses, leading off with (referring to) Tuskegee, and concluding with mention of “[w]idespread abuses in the human research programs of the Department of Defense; The inexcusable, intolerable abuses of human rights by the Central Intelligence Agency’s testing of hallucinogenic drugs on unwitting Americans on both coasts, of all social classes;”.
“.. S. 2579 gives the [then-proposed President’s] Commission the authority to review the adequacy of the guidelines for the protection of human subjects of all agencies that conduct research on human subjects.” .. “It is the goal of this legislation to establish a system for the protection of human subjects of biomedical and behavioral research second to none.” 9
In late June 1978, after Amendments unrelated to the human subjects protections provisions, the bill (S.2579) was passed by the Senate (by a vote of 68 to 10). The bill was then added an as Amendment to another health-related bill, S.2450, which was then passed without a roll call vote. In the Senate bill, the Commission was to biennially review the “rules, policies, guidelines, and regulations of each department or agency (including the Department of Defense and the Central Intelligence Agency)” to determine whether human subjects are “adequately protected”.
In mid-October 1978, the House voted upon a Senate-House negotiated com-promise version of S.2450. The House has no comparable legislation related to the President’s Commission. There was no House debate on the compromise bill. The House passed the bill without a roll call vote. In the House-Senate compromise bill, the Commission was to biennially review “the adequacy and uniformity” 10
.. of: “the rules, policies, guidelines, and regulations of all Federal agencies regarding the protection of human subjects”; and, their implementation.
The “Joint House-Senate Comparative Summary And Explanation”, which Senator Kennedy stated sets forth “the legislative intent and history of S. 2450” 11, stated that: “the House amendment adopts a provision similar to that in the Senate bill requiring that a report on the protection of human subjects be issued every two years and shall include a review of the adequacy and uniformity of (1) the rules, policies, guidelines and regulations of all Federal agencies (including the Central Intelligence Agency and the Department of Defense) regarding the protection of human subjects”,.. “and (2) their implementation.”[12] Plausibly, the Senate version’s mention of those two agencies by name in the bill text was viewed as redundant, and was deleted, but the intent was preserved by the “Explanation” text.
The bill/law made special provisions [under section: “Administrative Provisions”, 1803(d)(2), that: “The Commission shall promptly arrange for such security clearances for its members and appropriate staff as are necessary to obtain access to classified information needed to carry out its duties under this title.” This clearly indicates that Congress sought to assure that human subjects were adequately protected regarding all human research, including classified human research.
The Senate passed the compromise bill without a roll call vote later the same day.
5. The Two Commissions’ Recommendations and the so-called “Forcing Clause”
For each of these ‘two laws enacted after Tuskegee’, each of the respective commission’s Recommendations to DHEW (or HHS), or to any Agency or Agencies, respectively: 1) were to be published in the Federal Register, upon which Public Comment would be sought; and, 2) each Recommendation was subject to a so-called “forcing clause”. A forcing clause means that the applicable Agency was legally obligated to either adopt the Recommendation [“as expeditiously as is feasible”], or else to publish in the Federal Register an “adequate statement of the reasons” as to why the recommendation was not appropriate.
6. The 2nd Commission’s Recommendation for a Common Policy and the Details of the Agencies’ Public Acceptance
The 2nd Commission’s 1st Biennial Report [of December 30, 1981; March 21, 1982, 47 Fed. Reg. 13271, at: 13294] recommended to the Agencies, similarly as the 1st Commission had recommended to Congress: that all Federal departments or agencies adopt as a common core the regulations governing research with human subjects issued by the Department of Health and Human Services (codified at 45 CFR Part 46), as periodically amended or revised, while permitting additions needed by any department or agency that are not inconsistent with these core provisions 13
In June 1986, OSTP [the White House Office of Science and Technology Policy] published a response to the above recommendation (and to the other recommendations in the 2nd Commission’s 1st Biennial Report) [51 Fed. Reg. 20204, June 3, 1986], “on behalf of all affected federal departments and agencies”.
The response was:
The Ad Hoc Committee agreed in principle with this recommendation and developed a Model Federal Policy (Model Policy) statement based upon adaptations of HHS regulations for the protection of human subjects involved in research (45 CFR Part 46). The Office of Science and Technology Policy has made several modifications to increase uniformity of procedures among the federal departments and agencies and to increase compatibility with other current federal policies.
The Model Policy document has been drafted in the form of a policy statement rather than in the form of a regulation so that it may be referenced by departments and agencies that will implement the Policy within a reasonable time and in a manner customary to each department or agency. In the future, department or agency heads may amend their policies so long as they note in advance in the Federal Register or other appropriate publications the way in which their amendments relate to provisions of the Model Policy. 14
Assuming a department or agency adopts the Model Policy, it will retain the flexibility to waive individual requirements if waiver decisions are published in advance in the Federal Register or other appropriate publication. The Ad Hoc Committee believed that instances of waiver will be infrequent, and the requirement that each waiver be published will prevent inappropriate use of the waiver authority. 15
In November 1988, [53 Fed. Reg. 44660, November 10, 1988] OSTP together with 15 federal government agencies, published an NPRM [Notice of Proposed Rulemaking] which: responded to public comments to the June 1986 Model Policy; and presented a lightly modified version of the Model Policy as their formally proposed “common Federal Policy for the Protection of Human Subjects”.
In June 1991, [ 56 Fed. Reg. 28001-28023, June 18, 1991 ] OSTP and 15 agencies issued their Final Rule on the NPRM proposed policy and responded to public comments. The OSTP ‘header page’ for the Final Rule (and the prior NPRM) stated: “Note that the Central Intelligence Agency is required by Executive Order 12333 to conform to the guidelines issues by [HHS]”. That requirement applies to all components of the U.S. Intelligence Community (including, for example, the intelligence components of the FBI).
7. Existing Legal Analysis of the Common Rule
We non-lawyer Appellants (Pro Se in this Brief) were able to find [via internet search ] only 1 legal analysis concerning the legal basis for the Common Rule. The finding/opinion of that one analysis was to the effect that: because Congress created a process by which the Revised Common Rule was substantially based upon an HHS or other Agencies Public Response to formal policy related Recommendations of those 1974-1978, and 1979-1983, Commissions, via the 2 ‘forcing clauses’, Agencies cannot make policy changes which are inconsistent with those Recommendations without formally and Publicly: presenting their rejection of a not previously rejected Recommendation; and, publishing an “adequate statement of the reasons” for that rejection.
Summary/Overview of the Common Rule – the Federal Policy for the Protection of Human Subjects[17]
Under the federal Policy for the Protection of Human subjects: a proposal for a Human Research project (study) is proposed by an Investigator. The Investigator conducts his/her work at, or in formal association with, an Institution. Each Institution conducting human research has one or more (internal or external) IRBs – Institutional Review Boards. Each Institution which conducts human research submits an Assurance to HHS, or to the sponsoring federal agency, that: the Institution and the IRBs upon which it relies will abide by the federal common Policy; and, that the Institution has adopted a statement of principles (typically: the Belmont Report) as guiding the institution in achieving its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution. 18
The Policy specifies the rules for IRBs (e.g., rules for IRB membership) and for IRB review of research, and specific requirements for Informed Consent of the human subject. Besides from these ‘most substantive’ parts of the policy, much of the policy defines how the policy is applied to different types of human research. Such as: what types of research-like activities qualify as human research which is subject to the policy; possible (‘rare’) Agency Head Waiver of part or all of the policy; what types of human research are exempt from the policy, typically due to their being very low risk activities; what types of projects are eligible for expedited IRB review (applicable to some minimal risk research); criteria for IRB waiver of Informed Consent (applicable only to some special cases of minimal risk); or [in the Revised Common Rule] limited IRB review (for research where the main risks are related to safeguarding privacy, or data security). Also, the Revised Common Rule allows researchers to offer human subjects the option to give “broad consent” to retain their identifiable private information and identifiable biospecimens, to better enable research from data banks, thereby respecting the autonomy of the [potentially identifiable] human subjects.
The Belmont Report, and 2 of its Absolutes: Informed Consent; and, No Brutality;
The Belmont Report [September 30, 1978; 44 Fed. Reg. 23192 – 23197, April 18, 1979] identified three basic ethical principles, in its fulfillment of its first mandate of the 1974 Act “to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects” and to “develop guidelines which should be followed in such research to assure that it is conducted in accordance with such principles,” and to make Recommendations to the DHEW/HHS Secretary for Administrative action [as per the above described ‘forcing clause’]. [section 202, a)1)A), Public Law 93-348]
The three basic principles are: Respect for Persons (Autonomy), Beneficence [an “obligation” to “do not harm” and to “maximize possible benefits and minimize possible harms”]; and Justice [fair distribution of the benefits and burdens of research]. In the Belmont Report, at the start of its “Applications” section, the Belmont Report clearly identifies the Informed Consent of each human research subject as absolutely required [for conscious persons]:
“1. Informed Consent. — Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied.”
Also, the Belmont Report states, as an Application of Beneficent: when reviewing the Risks and Benefits of proposed research: “Finally, assessment of the justifiability of research should reflect at least the following considerations: (i) Brutal or inhumane treatment of human subjects is never morally justified“; ..
The 1982 Agency Head Waiver Clause; and the 1986 Model Policy and
Commun Rule version of the Agency Head Waiver Clause – The Source of Mischief
“The January 26, 1981 HHS Human Subjects Policy allowed an HHS Department Head Waiver of the Policy for particular human research but required that such Waiver action be published in the Federal Register [thereby providing the Public with the possibility of receiving Notice].” [AC, at 32.] [at .101(e), 46 Fed. Reg. 8387, January 26, 1981:]
(e) The Secretary may also waive the applicability of these regulations to specific research activities or classes of research activities, otherwise covered by these regulations. Notices of these actions will be published in the Federal Register as they occur.”
However, when the Model Policy [for a governmentwide policy] was proposed in June 1986, the wording was changed [AC, at 35.], probably to accommodate the fact that Classified matters could not be disclosed in the Federal Register; however, failing to create any ‘equitable’ accommodation so as to potentially provide Notice to prospective human subjects, and so as to assure any reasonable degree of Public scrutiny. (This exact wording was retained in the subsequent August 1988 NPRM, and the June 1991 Common Rule as well:)
“(i) Unless otherwise required by law, department or agency heads may waive the applicability of some or all of the provisions of this policy to specific research activities or classes of research activities otherwise covered by this policy. Except when otherwise required by statute or Executive Order, the department or agency head shall forward advance notices of these actions to the Office for Protection from Research Risks, Department of Health and Human Services (HHS), and shall also publish them in the Federal Register or in such other manner as provided in department or agency procedures.” [51 Fed. Reg. 20211, June 3, 1986]
“The major practical consequence of this was that Classified Human Research projects could Waive part or all of the federal Policy, including Informed Consent, without the Public receiving Notice about such Human Research.” [AC, at 35.]
The Three 1995 to 1997 Government Findings or Actions
re: Classified Human Research 19
Starting with the findings and recommendations of the President-created Advisory Committee on Human Radiation Experiments [ACHRE] Final Report of October 1995, followed by findings and a proposed bill by Senator Glenn in January 1997; and followed by an Administrative Order by President Clinton in March 1997, the 1991 Common Rule policy was found to not adequately protect citizens from non-consensual classified human testing. (Senator Glenn publicly began his review of human experimentation in January 1994, as then Chairman of the U.S. Senate Governmental Affairs Committee.)
ACHRE’s October 1995 Final Report clearly stated that:
“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.”
and Recommendation 15a of their Final Report stated that:
“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.” [ UL here added ]
[ see: https://ehss.energy.gov/ohre/roadmap/achre/chap18_3.html ]
On January 22, 1997, Senator Glenn proposed legislation to improve human research subjects protections, and his bill (S.193) included a special section [“Title II”] for classified human research to codify into law the ACHRE Recommendation 15a via a federal funding restriction. In the Introductory Remarks to his bill, Senator Glenn stated his finding that: “Under current rule and executive order, it is possible to waive informed consent and IRB review for classified research.” [20]
In March 1997, President Clinton issued an Administrative Order which sought to implement ACHRE’s Recommendations for human subjects of classified research, and ordered multiple agencies to jointly conduct rulemaking to enact revisions of the Common Rule accordingly, including to “prohibit waiver of informed consent for classified research”. The Order directed the agencies to promulgate a final rule on this within 1 year. [21]However, for reasons unknown, this President ordered policy change [which in effect sought to safeguard basic, physical, bodily, U.S. Constitutional Rights from federal government violation] was never agreed upon by all required agencies. (In 2016, U.S. Dept. of Energy on its own adopted the ‘Clinton Memo’ safeguards through agency directives.)
Plaintiffs believe that the above findings represent a strong factual finding that human subjects protections under the Common Rule, concerning classified human research, were inadequate. Plaintiffs also believe that these findings primarily, but not only, implicate the Agency Head waiver clause of the Common Rule. This is because the Common Rule only contains two mechanisms for Waiving of Informed Consent for human research involving interventions upon the physical human body. The most general mechanism is the Agency Head Waiver of Informed Consent [under .101(i)], which may be with or without a waiver of the usually protective IRB [Institutional Review Board] Review requirements. The second, and more narrowly applicable mechanism, is the IRB Waiver of Informed Consent for some minimal risk research [under .116(f)(c)], but which contains the safeguarding requirement [at .116(f)(c)(iv)] that: “(iv) The waiver or alteration will not adversely affect the rights and welfare of the subjects.”![22] Therefore, Plaintiffs’ believe that the above described findings primarily implicate the Agency Head Waiver clause [.101(i)] as putting citizens at risk to non-consensual human research programs which involve interventions upon the physical human body (or brain).
Plaintiffs also believe that the above findings have found that human subjects of classified research are, in effect, a vulnerable population, for which special added protections are appropriate.[23]
Components/Stages of the Rulemaking for the Revised Common Rule
The rulemaking challenge here consists of: a (‘preliminary stage’) July 26, 2011 ANPRM [Advance Notice of Proposed Rulemaking] (3 month Public Comment period); a September 8, 2015 NPRM [Notice of Proposed Rulemaking] (4 month Public Comment period); a January 19, 2017 Final Rule; a January 22, 2018 re-scheduling Interim Final Rule [IFR] (2 month Public Comment period); an April 20, 2018 re-scheduling NPRM (1 month Public Comment period); and, a June 19, 2018 re-scheduling Final Rule.
Victims’ Participation in the Rulemaking
Administrative Record (Even Predating the ANPRM)
During a January to September 2011 President ordered review of human subjects protections by the Presidential Commission for the Study of Bioethical Issues [PCSBI], about 20 victims of non-consensual human testing presented their Spoken [oral] Public Comments, complaining of the inhumane wrongdoing, at each of the March 1, 2011 (in Washington, D.C.), and the May 18, 2011 (in New York City) meetings of the Commission. (This was likely a Historically rare if not first occurrence of such a presentation [and plea for relief], in U.S. history.) Additionally, about 50 to 75 victims submitted written materials to PCSBI, during, or shortly before or after, a Public Comment period of March 2 – May 2, 2011, regarding human subjects protections. [ AC, 12-13, 53-54; AMFR, p. 10-11 ] [24]
The subsequent July 26, 2011 ANPRM [AC, 11.], as well as the September 8, 2015 NPRM [at 80 Fed. Reg. 54033-54034], formally admitted the “deliberations of the PCSBI and the “public comments received on the request for information issued by” PCSBI to the rulemaking record. [25]
About 20 – 25 alleged victims submitted 25 Public Comments in response to the July 2011 ANPRM, and about 70 – 75 alleged victims submitted about 99 Public Comments to the NPRM. In total, about 75 to 80 victims submitted ANPRM and/or NPRM Public Comments.
In May 2012, by telephone inquiry to OHRP about victims ANPRM Public Comment, Plaintiff Rabin was told by OHRP that ‘they’re going through the [ANPRM] comments, and they did notice that there were some comments regarding Classified Human Research. [26] [This was not presented to the District Court.]
In May 2016 (in person and by email), and with an improved Victims- Comments version in September 2016 (by email), Plaintiff Rabin and victim-citizen ‘K.’ submitted to OHRP a 2-part Summary of: Victims’ NPRM and ANPRM Comments; and, Non-Victims NPRM Comments mainly regarding the NPRM-proposed “Intelligence Surveillance Activities” exclusion [adopted in a different form, in the January 2017 Final Rule]. [AC, at 25;]
The A.P.A. Law Governing Reviewability of Rulemaking Actions
Section 704 [5 U.S.C. 704] authorizes judicial review only of “[a]gency action made reviewable by statute and final agency action for which there is no other adequate remedy in a court,” and specifies that a “preliminary, procedural, or inter-mediate agency action or ruling [such as the July 26, 2011 ANPRM, and the September 8, 2015 NPRM] not directly reviewable is subject to review on the review of the final agency action.” (14, CHARLES ALAN WRIGHT & ARTHUR R. MILLER, FEDERAL PRACTICE AND PROCEDURE § 3659 (4d ed. 2023) [AMRC, p. 4]
The ANPRM Text, NPRM Text, and Final Rule Text or Rule Text, At Issue in Plaintiffs’ Claims [27]
Overview of the Contents of the (20-page, 3-column) ANPRM, and Identification of the Case-Relevant Sections[28]
The ANPRM consisted of: a Background section (Introduction) [Section I]; Seven [7] suggested areas for policy change, which comprised the main contents of the ANPRM [Sections II through VIII]; and, a request for: general input; input about improving the efficiency of the policy; and input regarding any areas where existing Protections of human subjects are inadequate. [Section IX]. The table of contents, and notations of relevancy to Plaintiffs’ Claims, are as follows:
I. Background – the stated purposes and intents of the ANPRM, and the presented History, are relevant to this case, as presented below.
II. Ensuring Risk-Based Protections – this human subjects protections concept has relevance to this case, as presented below.
III. Streamlining IRB Review of Multi-Site Studies
IV. Improving Informed Consent [e.g., improving Consent forms ]
V. Strengthening Data Protections To Minimize Information Risks
VI. Data Collection To Enhance System Oversight
VII. Extension of Federal Regulations
VIII. Clarifying and Harmonizing Regulatory Requirements and Agency Guidance – this section has some relevance to Plaintiffs’ Claims as noted below, but [mention of Guidances] was missing from Plaintiffs’ Amended Complaint
IX. Agency Request for Information – this Section is relevant to this case, as presented below;
ANPRM Text at Issue in Plaintiffs’ Claims
A) The lead Summary statement for the July 2011 ANPRM was:
“[The Office of the HHS Secretary, in coordination with OSTP] is issuing this advance notice of proposed rulemaking (ANPRM) to request comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. This ANPRM seeks comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.” [76 Fed. Reg. 44512] [partly mentioned at AC, 1.]
Plaintiffs here observe that: while regulations which promote advances in the arts and sciences, and regulations which are easy to work with, are likely valid and desirable governmental interests, the existing Congressional mandates for human subjects protections focus on: assuring that human subjects are at least “adequately protected”, and that there is “uniformity” at least for the basic policy. [29]
B) The ANPRM introductory text mentions that the HHS/DHEW regulations were first issued in 1974, and then were further improved in response to abuses:
In the United States, a series of highly publicized abuses in research led to the enactment of the 1974 National Research Act (Pub. L. 93–348), which created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission). .. Based on the Belmont Report and other work of the National Commission, HHS revised and expanded its regulations for the protection of human subjects in the late 1970s and early 1980s. [ [76 Fed. Reg. 44512] [ AC, at 1. D), 31., 46., 56.; re: Tuskegee ]
C) After summarizing seven suggested areas of policy change [which comprised the main contents of the ANPRM] , the ANPRM stated: “Comment is now sought on these proposals and on the broader question of how to modernize, simplify, and enhance the current system.” [76 Fed. Reg. 44514 ]
D) As noted above, the ANPRM [at 76 Fed. Reg. 44514] admitted the PCSBI items as noted above.
E) After presenting 74 numbered questions for Public Comment on details related to their 7 suggested areas of policy change, the ANPRM presented an unnumbered question ’75’:
IX. Agency Request for Information
When submitting responses to the specific questions asked in this notice, please cite the specific question by number.
In addition to the specific solicitation of comments throughout this ANPRM, general comment is invited on the current system of protections for human research subjects as implemented through the Common Rule, the HIPAA Privacy and Security Rules, and any other rules, regulations, or guidance documents. In particular, comments are sought not only on ways to improve the efficiency of the current system, but about circumstances in which the protections provided by the current system might be inadequate and in need of supplementation or change in order to make sure that subjects are receiving appropriate protections. [76 Fed. Reg. 44512, 44529 ] [ highlighting below heading was here added ] [OMtd, p. 10-11] [30]
Plaintiffs note that this unnumbered question ’75’ is closely related to the interests or requirements of previous, or yet applicable, Congressional Mandates, which desired that all human subjects be at least “adequately protected”.
Overview of the Contents of the (129-page, 3-column) NPRM, and Identification of the Case-Relevant Sections [31]
The lengthy-in-size 129-page NPRM consisted of:
– an Introductory section (1-paragraph Summary; a 1 1/2 page Table of Contents; a 1-page “Purpose of the Regulatory Action” [which the APA requires for a Final Rule, but for an NPRM]; a 1-page “Summary of the Major Provisions of the Proposed Regulatory Action” ); 1-paragraph statement citing “legal authority”; and, a 1/2 page Summary of “Estimated Costs and Benefits”); and, a 4-page section describing “I. The Rationale for Modernizing the Common Rule”;
– “II. Major Proposals To Modernize the Common Rule” (sections A through I (50-pages), with sections A through G each organized by Policy subject category, and section H comprising “Other Changes” (nd a 1-page Section I covering Effective and Compliance Dates and Transition Provisions [including ‘Grandfathering’ proposals]); and sections III through VII (III. Regulatory Impact Analyses [32-pages]; IV. Environmental Impact [1-paragraph]; V. Paperwork Reduction Act [8-pages]; VI. Summary of Comments Received on the 2011 Common Rule ANPRM (11-pages); VII. Regulatory Text (11-page full Regulatory Text for the proposed amended Common Policy; and, 5-pages displaying the CFR Policy Parts and Subparts; the legal authority; and, the signature official;, for each of the 16 NPRM Agencies/Departments).
The subheading of the table of contents, and notations of relevancy to Plaintiffs’ Claims, for the substance of the NPRM proposals, contained in the above noted Section “II. Major Proposals To Modernize the Common Rule” (sections A through I) are as follows:
II. Major Proposals To Modernize the Common Rule
A. Proposed Changes to the Scope and Applicability of the Regulations
1. Expanding the Definition of Human Subject to Cover Research With Nonidentified Biospecimens [not adopted]
2. Explicit Exclusion of Activities From the Common Rule
a. Exclusion of Activities That Are Deemed Not Research
i. Program Improvement Activities
ii. Oral History, Journalism, Biography, and Historical Scholarship Activities (NPRM at § _.101(b)(1)(ii))
iii. Criminal Justice Activities (NPRM at § _.101(b)(1)(iii))
iv. Quality Assurance and Quality Improvement Activities
v. Public Health Surveillance
vi. Intelligence Surveillance Activities (NPRM at § _.101(b)(1)(vi)) – Case Relevant – subject of Claim 3 (AC at 72.) [and AC Relief item 3.] (and also possibly related to Claim 2, AC at 71. [and AC Relief Item 2.])
b. Exclusion of Activities That Are Low Risk and Already Subject to Independent Controls
iii. [sic] Educational Tests, Survey Procedures, Interview Procedures, or Observation of Public Behaviors
iv. Research Involving the Collection or Study of Information That Has Been or Will Be Collected
v. Research Conducted by a Government Agency Using Government-Generated or Government-Collected Data
vi. Certain Activities Covered by HIPAA
c. Applicability of Exclusions to the Subparts
3. Proposed Exemptions
a. Making Exempt Research Determinations
b. Exemptions Subject to the Documentation Requirements of § _.104(c) and No Other Section of the Proposed Rule
i. Research Conducted in Established or Commonly Accepted Educational Settings
ii. Research and Demonstration Projects Conducted or Supported by a Federal Department or Agency
iii. Research Involving Benign Interventions in Conjunction With the Collection of Data From an Adult Subject
iv. Taste and Food Quality Evaluation and Consumer Acceptance Studies
c. Exemptions Subject to the Documentation Requirements of § _.104(c) and the Privacy Safeguards Described in § _.105
ii. [sic] Research Involving Educational Tests, Surveys, Interviews, or Observation of Public Behavior if the Information Is Recorded With Identifiers and Even if the Information Is Sensitive
iii. Secondary Research Use of Identifiable Private Information
d. Exemptions Subject to the Documentation Requirements of § _.104(c), the Privacy Safeguards Described in § _.105, Limited IRB Review as Described in § _.111(a)(9), and Broad Consent in Accordance With § _.116(c)
(1) Exemption for the Storage or Maintenance of Biospecimens or Identifiable Private Information for Secondary Research Use
(2) Exemption for Secondary Research Use of Biospecimens or Identifiable Private Information Where Broad Consent Has Been Sought and Obtained
e. Applicability of Exemptions to the Subparts
B. Proposed Changes To Obtaining, Waiving, and Documenting Informed Consent (§§ _.116 and_.117)
1. Required Elements of Informed Consent (NPRM at § _.116(a), (b))
2. Broad Consent to the Storage, Maintenance and Secondary Research Use of Biospecimens and Identifiable Private Information (NPRM at § _.116(c), (d))
3. Waiver of Informed Consent or Documentation of Informed Consent (NPRM at §§ _.116(e), (f) and _.117) [minor changes, and not related to this Plaintiffs Claims];
4. Posting of Consent Forms [not specifically ‘case relevant’, but the adopted posting of (non-FDA) Clinical represents the first time that Common Rule research makes publicly available details about the [non-FDA] Human Research Process. The IRB-based system of Human Subjects Protections had been criticized by multiple Presidential Bioethics Commissions as being lacking in data and feedback which enable measurement of: how well are human subjects being protected and treated (based upon data from: the human subjects; IRBs; and, others involved in a research study); and, what factors lead to successful, or less than ideal, IRB review and IRB oversight.
Before the 1981 HHS regulations were put into practice, the 1974-created National Commission did a study to assess the then-effectiveness of IRBs. ]
C. Proposed Changes To Protect Information and Biospecimens
D. Harmonization of Agency Guidance [ not related to Plaintiffs’ Claims, but possibly related to Plaintiffs’ OMtd proposed Discovery Item 5 [p. 7, OMdt], and related to a possible claim that may or may not be added to a future Amended Comment ].
E. Cooperative Research and Proposal To Cover Unaffiliated IRBs Not Operated by an Institution Holding a Federal-wide Assurance.
F. Changes To Promote Effectiveness and Efficiency in IRB Operations
1. Continuing Review of Research
2. Expedited Review Procedures and the Definition of ‘‘Minimal Risk’’
G. Proposed Changes to IRB Operational Requirements
1. Proposed Criteria for IRB Approval of Research (NPRM at § _.111)
2. Proposed Revisions To IRB Operations, Functions, and Membership Requirements
H. Other Proposed Changes
1. Proposal To Extend the Common Rule to All Clinical Trials (With Exceptions)
2. Changes to the Assurance Process [ not related to Plaintiffs’ Claims, but the enacted change at .103(a)(1) committed a not well-justified removal of the requirement that an Institution’s Assurance contains: “A statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research …” [32]].
3. Department or Agency Discretion About Applicability of the Policy (NPRM at § _.101(c), (d), (i)) and Discretion Regarding Additional Requirements Imposed by the Conducting or Supporting Department or Agency (NPRM and Current Rule at § _.124) – Changes to .101(i) are Case Relevant – subject of Claim 1 (AC at 69.) [and AC Relief item 1.], and AC Relief Items 4. and 5.
4. Research Covered by This Policy Conducted in Foreign Countries
I. Effective and Compliance Dates of New Rule (NPRM at § _.101(k))
1. Effective Dates
2. Transition Provisions
a. Research Initiated Prior to the Effective Date of This Subpart (NPRM at § _.101(k)(1)) – these very specific, enumerated, Publicly Proposed NPRM Transition Provisions are Case Relevant – Subject of Claim 1 [and AC Relief 1.], and also AC Relief Item 5;, because: these Transitions Provisions provided: no Notice and Comment, and no foreseeability whatsoever, for the Final Rule enactment of a .101(i) [Agency Head Waivers] related Grandfather Clause.
b. Use of Prior Collections of Biospecimens
—— end of NPRM Policy Change Proposals, from NPRM Table of Contents, from section: “II. Major Proposals To Modernize the Common Rule” ———–
NPRM Text at Issue in Plaintiffs’ Claims, and the corresponding Final Rule Regulatory (where changed) and Final Rule(s) [33] Explanatory Text
A) The NPRM (and the Final Rule) Summary Text
The leading Summary text of the NPRM and the Final Rule contained the following text: [ AC at 1., 1.E), 49.]
This NPRM seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. This proposed rule is an effort to modernize, simplify, and enhance the current system of oversight. [ p. 1, 80 Fed. Reg. 53933 ]
This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are an effort to modernize, simplify, and enhance the current system of oversight. [ p. 1, 82 Fed. Reg. 7149 ]
B) The NPRM Preamble Text
The main required contexts of an NPRM under the APA [at 5 U.S.C. 553(b)] is: 1) the legal authority for the proposal; 2) “either the terms or substance of the proposed rule or a description of the subjects and issues involved”; and, 3) the opportunity for Public Comment. Although a preamble is not required at the NPRM stage, Plaintiffs here briefly describe or quote from it. Plaintiffs believe that the Preamble text has some legal relevance because: 1) rulemaking is required to be a reason-based process; and, 2) a rulemaking should be an honest process.
Mention of the preamble (except for the NPRM’s leading Summary statement above), was not presented in the District Court, because the NPRM is a basic, case-cited, part of the Public administrative record to be Court reviewed.
In contrast to the ANPRM, the NPRM’s brief regulatory history [p. 3, 53935] makes no mention of: the policy’s scandal based origin; and, the policy’s Congressionally mandated origin.
At its page 4 [53936], the NPRM articulated a policy making concept which had been articulated in the ANPRM, and which is consistent with the 1st Commissions’ Recommendations, notably in their Report on IRBs, which among numerous other sections of that Report, were adopted in the 1981 HEW/HHS Policy and the subsequent Common Rule based upon that HHS Policy. That is, the concept/idea that the ‘level of [IRB] review’ (and level of IRB responsibility for the well-being of even normal adults) be proportional to foreseeable possible risks[34]:
“The NPRM also attempts to strengthen the effectiveness and efficiency of the oversight system by making the level of review more proportional to the seriousness of the harm or danger to be avoided. Research that poses greater risk to subjects should receive more oversight and deliberation than less risky research. The NPRM seeks to avoid requirements that do not enhance protection and impose burden, which can decrease efficiency, waste resources, erode trust, and obscure the true ethical challenges that require careful deliberation and stakeholder input. .. The result of these types of changes, as the NPRM proposes to implement them, is that some studies that currently require IRB review would now become exempt. Some that are currently exempt would specifically be declared as outside the scope of the regulations (‘‘excluded’’) and thus would not require any administrative or IRB review.“
At its page 5 [93537], the NPRM, in concluding its “Summary of Major Provisions”, states its adherence to the Belmont Report ethical principles:
“In sum, the proposed modifications [selectively-] described above are designed to continue to uphold the ethical principles upon which the Common Rule is based, as applied to the current social, cultural, and technological environment.”
The NPRM preamble describes the changing landscape of much research. Among its multiple areas of focus, one major area of focus of the NPRM is perhaps well-depicted at its page 6:
“As technology evolves, so does the nature of the risks and benefits of participating in certain types of research. Many studies do not involve interaction with research subjects, but instead involve, for example, analyzing information obtained from medical records, administrative claims data, education records, criminal justice records, research data shared through data repositories, and existing biospecimens stored in repositories. Risks related to these types of research studies are largely informational, not physical; that is, harms could result primarily from the inappropriate release of information and not from the research interventions themselves. Nonetheless, those harms can be significant. [p.6, 53938]
At its page 7 [53939], the NPRM states: “The revisions to the Common Rule proposed here are based upon a variety of sources of public, stakeholder, and expert comments and advice.”
At its page 8 to (top of) page 10 [53940-53941], the NPRM reviews the Belmont Report’s three basic ethical principles as “Guiding Principles for the Pro-posed Changes”. It depicts a context sensitive ‘balancing’ of the three principles. (However, it neglects to acknowledge that there are some absolutes, such as: informed consent is required for research involving interventions on the human body.)
C) The NPRM’s ‘Standalone” Summary of ANPRM Public Comments
After presenting the NPRM policy proposals, the NPRM presented a ‘stand-alone’ Summary of the ANPRM Public Comment, [p. 101 – 112; 54033-54044] without reference to the specific NPRM proposals.
On its page 101 [54033], the NPRM clearly stated:
“In addition to reviewing the public responses to the ANPRM, in preparing the NPRM, the deliberations of the Presidential Commission for the Study of Bioethical Issues (the Commission) were taken into account. Consideration was also given to public comments received” on the PCSBI’s 2011 Public Comment period on human subjects protections. However, the NPRM did not mention any issues presented by the PCSBI Public Comments. [OMtd, p. 10] [35]
And, the NPRM’s Summary of Public Comments did not include any mention of ANPRM Comments in response to the ANPRM’s unnumbered question ’75’ [presented above, re: ANPRM], regarding “inadequate” protections of human subjects that need to be addressed by the policy. [OMtd, p. 10]
Both of these omissions in the NPRM appear arbitrary. In the context of this particular rulemaking for this particular federal policy, considering all of the facts and also the policy’s legal history, Plaintiffs believe that the rulemaking cannot arbitrarily ignore, and not openly attempt to address, areas of inadequate human subjects protections which are presented to this rulemaking at each such time when the Common Rule policy is “periodically amended”.
Additionally, each of NPRM’s Agency Head Waiver clause (.101(i)) related proposal, and the NPRM’s Intelligence Surveillance Activities ‘Exclusion’ proposal, are related to these not discussed items. By the NPRM discussing the ANPRM Public Comments, it provided the Public with ‘additional thoughts’ related to some of the NPRM proposals. The NPRM acted arbitrarily by omitting any discussion, or even any mention of the ANPRM or PCSBI Public Comments, which might reasonably have enhanced Public thinking about these two [‘victims related’] NPRM Proposals; and, the Plaintiffs (and other victims’ stakeholders) were likely adversely affected by these 2 omissions.
D) The NPRM, and Final Rule Exacted, New Requirements that .101(i) Agency Head Waivers, and .101(c), Agency Head Determinations, be Consistent with Belmont Report Principles
The NPRM proposed [p. 114, 80 Fed. Reg. 54046], and the Final Rule enacted [p. 111; 82 Fed. Reg. 7259], the following changes to the previously unrestricted: Agency Head Waiver clause at .101(i), and the Agency Head ‘Determinations’ Clause at .101(c): (For simplicity: the new Added Requirement text is simply presented as underlined text below; and, changes between the NPRM text and the Final Rule text are indicated in square brackets.)
“.101 .. (c) Department or agency heads retain final judgment as to whether a particular activity is covered by this policy and this judgment shall be exercised consistent with the ethical principles of the Belmont Report. “
“.101 .. (i) Unless otherwise required by law, department or agency heads may waive the applicability of some or all of the provisions of this policy to specific research activities or classes of research activities otherwise covered by this policy [” ” –> “,”], provided the alternative procedures to be followed are consistent with the principles of the Belmont Report. Except when otherwise required by statute or Executive Order, the department or agency head shall forward advance notices of these actions to the Office for Human Research Protections, Department of Health and Human Services (HHS), or any successor office, or to the equivalent office within the appropriate Federal department or agency, and shall also publish them in the Federal Register or in such other manner as provided in department or agency procedures. The waiver notice must include a statement that identifies the conditions under which the waiver will be applied and a justification as to why the waiver is appropriate for the research, including how the decision is consistent with the principles [“in” (sic) –> “of the”] of the Belmont Report. [“Each Federal department or agency conducting or supporting the research must establish, on a publicly accessible federal Web site, a list of the research for which a waiver has been issued.” –> ” “]
For these changes to part .101(c), and part .101(i): the NPRM text appears at NPRM, p. 60; 80 Fed. Reg. 53992; and, the Final Rule text appears at p. 9-10, 82 Fed. Reg. 7157-7158, and “Explanation of the Final Rule” text for these included the following text, respectively: [ underline here added: ]
“.. Although some commenters were opposed to ever granting departments or agencies the authority permitted by §__.101(c), we believe requiring that these decisions be consistent with the principles of the Belmont Report is an approach that promotes accountability while still giving federal departments and agencies the necessary flexibility to achieve their respective missions. .. these judgments in consideration of the ethical protection of human research subjects.” [7157]
“.. The final rule thus formally codifies in §__.101(c) and (i) the general practice that the ethical standards articulated in the Belmont Report are the ethical standards that Common Rule departments or agencies will use in determining whether an activity is covered under this policy or whether to grant a waiver of the applicability of some or all of the provisions (unless otherwise required by law). The addition of the reference to the Belmont Report makes explicit the ethical basis underpinning how waiver decisions have and must be considered.” [ 7158 ] [36]
In the June 19, 2018 Rescheduling Final Rule, in response to victims stakeholders concerns and objections to the Final Rule’s enactment of a Grandfather Clause for ongoing projects approved under the unrestricted 1991-based Agency Head Waiver cause, the June 2018 Rule text wrote:
“As with the comments on the interim final rule, a few comments expressed concern with the waiver provision at § .101(i) allowing federal departments and agencies to waive some or all provisions of the Common Rule (which could allow research to be conducted on people without their informed consent).”
[at 83 Fed. Reg. 28502, 3rd column, 2nd full paragraph]
But after writing this, and admitting this, “the otherwise responsive scheduling final rule did not publish any Response!”. [AC, p. 27, at 69., item 5) ]
E) The NPRM Proposed (.101(k)), and Unforeseeably the Final Rule Enacted (.101(l)), Transition Provisions
Interfered-with, Pro Se Plaintiffs assumed [apparently incorrectly] that the idea of, or phrase, “grandfather clause”, was understandable, by context, as referring to SELECTED changes among the many changes which were NPRM proposed, or Final Rule enacted, for the Common Rule Policy. However, after the July 9, 2024 adverse ruling of the District Court (which uncritically adopted Defendants’ denial of this distinction), Plaintiffs stated in their Amended Motion for Reconsideration what a “grandfather clause” means in this context: (Note: text in double brackets “[[ ]]” below was added for apparent legal accuracy.)
“[The September 8, 2015 NPRM .. contained ..] a limited list of 10 or so .. Grandfathering provisions, basically saying: ‘Ongoing human research projects do not have to revise their procedures to comply with SOME of the NPRM proposed changes to the Common Rule, BUT for all other [[NPRM-proposed]] Changes to the Common Rule [[and for non-NPRM-proposed but enacted provisions which are not a ‘logical outgrowth’ of the NPRM-proposed Grandfathered provisions]], Ongoing human research projects DO have to revise their procedures in accord with the New Policy.’ The NPRM did NOT propose grandfathering Agency Head waivers under .101(i) for ongoing research projects.” [AMFC, at p. (13-) 14 ]
The NPRM proposal text for its transition provisions, and which contained, and which briefly-described each of, the NPRM ‘specific provisions based’ Grandfathering proposals, was as follows:
“a. Research Initiated Prior to the Effective Date of This Subpart (NPRM at § ll.101(k)(1))
.. Ongoing human subjects research initiated prior to the effective date of the final rule .. [need not] comply with additional requirements related to:
— Coverage of clinical trials (§ __.101(a)(2));
— Written procedures for documenting an institution’s reliance on an unaffiliated IRB (§ __.103(e));
— New exempt research categories and determination requirements (§ __.104(c)–(f));
— Information and biospecimen protection requirements (§ __.105);
— New IRB roster and written procedural requirements (§ __.108(a)(2));
— Continuing review requirements (§ __.109(f)(2));
— Additional IRB approval criteria for information safeguards and return of results plans (§ __.111(a)(7) and (8));
— Requirements for cooperative research (§ __.114);
— IRB recordkeeping requirements for documenting an institution’s reliance on an unaffiliated IRB and exemption determinations (§ __.115(a)(10) and (11)); and
— Requirements for obtaining and documenting informed consent (§§ __.116 and __.117)[;],
that become effective on the [effective] date of the final rule.”
The subitems for item 3 above, __.104(c) – __.104(f) above are as follows:
— § .104(c), re: a decision tool to assist with exemption determinations;
— § .104(d), re: exempt human subjects research which “generally involve a low-risk intervention with human subjects”;
— (d)(1) educational research;
— (d)(2) federal agency conducted or sponsored studies of public benefit or service programs;
— (d)(3) some benign interventions through verbal or written responses, or video recording, involving an adult subject;
— (d)(4) Taste and food quality, and consumer acceptance, studies;
.104(e), re: exempt human subjects research not including interventions, involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior; and secondary research use of identifiable private information that has been or will be acquired for non-research purposes
§ .104(f), re: exempt human subjects research involving biospecimens or identifiable private information;
Additionally, Plaintiffs here note that: the NPRM proposed changes to § .116 [‘requirements for obtaining informed consent’] (at item 10 in the list of ’10 bulleted items’ above), were all in the direction of improved and more informative consent forms, and other improvements upon existing informed consent procedures.
The Final Rule Transition Enactment
The enacted Transition provisions of the January 2017 Final Rule were very different from the NPRM proposal, as was renumbered as part .101(l). After a one-year delay of the Policy’s effective date, and a clarification about which exemption determinations were being referred to, the grandfathering clauses of the Transition provision of the June 19, 2018 Re-Scheduling Final Rule was as follows:
[ at subpart .101(l)]
“(l) Compliance dates and transition provisions:
(3) Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the following research, unless the research is transitioning to comply with the 2018 Requirements in accordance with paragraph (l)(4) of this section:
(i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019;
(ii) Research for which IRB review was waived pursuant to § 46.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the research was exempt under § 46.101(b) of the pre-2018 Requirements before January 21, 2019.
(4) Transitioning research. If, on or after July 19, 2018, an institution planning or engaged in research otherwise covered by paragraph (l)(3) of this section deter-mines that such research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination. ..”
The January 2017 Final Rule change in the transition provisions: 1) changed from a particular policy change-item oriented, and policy-meaning sensitive based, grandfathering rationale, to an ‘approval-based’ transition policy; 2) changed, perhaps illegally, from considering a research project to be Ongoing based, or a research project a particular human subject (or ‘next batch’) of human subjects: based upon when the human subject became involved in the research;, to being instead based upon when an IRB approved the research proposal, or when an Agency head Waived the requirement for IRB Review (Review of the Research Proposal, and appropriately-frequent Ongoing follow-up review). [ Could a ‘madmad’ Agency head dream up a proposal for a society-wide ‘human testing project’, to start 10 years from now, but where he “waived IRB review” on January 15, 2019, in advance of the new Policy’s effective date? ]
The January 2017 Final Rule text did not give a reasonable explanation of this change. It merely stated: “We note that ongoing research studies that were initially approved by an IRB, waived pursuant to §__.101(i), or determined to be exempt before January 19, 2018, will not be required to comply with the changes reflected in this final rule.” [82 Fed. Reg. 7161, 2nd column, end of first full paragraph]
The June 19, 2018 Final Rule text, in reviewing victims stakeholders’ Public Comments to the January 2018 Interim Re-Scheduling Rule, and the April 2018 Re-Scheduling NRPM [at 83 Fed. Reg. 28499-28500], stated that:
“Others [comments] discussed concerns with the waiver provision at §__.101(i) and suggested that this provision be strengthened such that departments and agencies are only permitted to waive the Common Rule with regard to certain research activities when such a waiver is consistent with the Belmont Report.”
But, the June 2018 Re-Scheduling Final Rule provided no reply. (The Belmont Report principles sounded ‘so important’ in the NPRM preamble, but concerning the Transition Provisions in the January 2017 Final Rule, and the June 2018 re-scheduling Final Rule text, the rulemaking text fell ‘silent’.)
