Does Originalism Profit by the Lack of Advanced Degree Programs in Constitutional History?

I wonder why I see no LLM programs in constitutional law, or even 18th century British constitutional history, on the AALS website. The latter would help contribute to the debate about living constitutionalism versus originalism in American constitutional interpretation. Is your answer that "there is no British constitution"? 

(I should add that I have spoken to three scholars on this subject in the past week or so: James Leonard, professor emeritus at The University of Alabama School of Law; Joel Richard Paul, professor of law at the University of California Hastings [and author of ‘Without Precedent: Chief Justice John Marshall and His Times’]; and Mark Wojcik, professor of Anglo-American and Comparative Law at the University of Lucerne in Switzerland. I also looked at several books by British legal scholars on ‘the British Constitution’ in 2015, the 800th anniversary of Magna Carta).

Au contraire! according to Walter Bagehot (who inherited ‘The Economist’ from his father-in-law and went on to lead the moderate journal to market saturation)

“There is a great difficulty in the way of a writer who attempts to sketch a living Constitution-a Constitution that is in actual work and power,” wrote Bagehot in his book the English Constitution.

True, some say that the British constitution is different from that of the US in two important ways: first, it is not to be found in one document, but instead is composed of multiple sources, including written texts such as Magna Carta (1215), the Petition of Right (1628)  and the Bill of Rights (1689).

Text there is to be sure, but critics also say that British Constitution differs from the American one in another way: the former lacks any greater authority than any act of British parliament (which makes sense in that it is a limitation on the monarch, not on the legislature); Parliament doesn’t need anything by way of a super-majority to change the law. 

In fact, it is sometime said that most of the founding documents of what is today a nominal or de facts British democracy have been long ago repealed.

To me, this remark misses the point: what I after is not British jurists today think of the notion of a “living” constitution or a static “original” constitution, but what they would have thought of our contemporary question in 1789.

Furthermore, if the British constitution is easier to change than that of the U.S., as has been argued, that seems to me to suggest that the former would be less static and even more “fluid” and “alive” than the latter.

I would be interested in studying this matter. Does anybody know differently?

And I return to my main point: why is no LLM in constitutional law, or British constitutional history, listed on the AALS website? Would it accomplish too much by way of refuting the notions of originalists currently in vogue?

#AALS

#Originalism

#LivingConstitution

I hope you'll review this working draft of my law review article on child suicide and the common rule

Hello readers, what follows is a working draft of my law review article on child suicide, human research law and ethics, and the massacres crisis that so effects our schools and society. I would like to revise, refine and complete it. Encouragement is welcome and appreciated. I am presently seeking funding or appropriate employment that would allow me to finish and submit the article. My contact info is available on this site or on LinkedIn. Thank you for reading, ~John Otrompke

All contents (c) 2018 John J. Otrompke, JD

Why The Common Rule Should Permit Universal Psychological Autopsy Studies of Child Suicides and ‘School Shooters’ 

The Proposed Revisions to the Common Rule Could Allow Two Badly-Needed Prospective Studies of Child Suicide and Mass Shootings, but Investigators Should Proceed Gingerly Because Subjects May Be Vulnerable

by John Otrompke, JD1

This paper proposes two universal prospective studies, utilizing a technique called the psychological autopsy, one of all child suicides, and another of all school massacre assailants, in the U.S. This article argues that provisions contained in the 2015 proposal to revise the federal Common Rule governing human subjects protection  would make these studies more feasible, especially provisions concerning public health surveillance and certain interview procedures, as well as a provision for centralized IRB review. However, such research is associated with more than usual hazard, and should be conducted with great care.

   Introduction

Between 1993 and 2014, 750 children between the ages of five and 11 years old committed suicide.2 Among certain subcategories of children, such as African-American children and caucasian girls, the rate of suicide has been increasing.3 Some scientists would like to be able to conduct a procedure known as the psychological autopsy, to learn why the rate has been increasing.4 However, they feel that the technique, in which scientists interview surviving family members and analyze other sources of information about the deceased child,5 cannot be conducted universally in cases of child suicide, because of cost and because ethics approval is required by the institutional review board (IRB) in each case.

However, such a universal project of psychological autopsies in all cases of child suicide was recently carried out in Norway, in 2012, with the benefit of centralized ethical approval by the Norwegian government. 

In July 2011, the Department of Health and Human Services (HHS) issued advance notice of its intent to amend the longstanding requirements of the Common Rule, which governs ethics review of many such projects.6 Following a notice-and-comment period, the agency issued a second document, a Notice of Proposed Rulemaking (NPRM) in September 2015.7 

The proposal contains changes that would make it easier to engage in public health activity,8 in the form of an ‘exclusion’ of public health surveillance activities from the requirements of the Common Rule.9 If a project involves “the collection, analysis, and use of data to target public health prevention” by a public health agency “in the context of a domestic or international public health emergency,” or  “during the course of an event or crisis that threatens the public health, such as a natural or man-made disaster,” then “they will not be required to receive any form of determination or IRB approval,” and “statements of purpose, benefit, and voluntariness as well as consent are not required.

The proposal also contains a provision exempting certain interview procedures. If IRB review is necessary, the proposal would also make a universal psychological study easier, by mandating single IRB review for multi-institutional cooperative studies. 

Discussion in Congress of the 21st Century Cures Act, which would make additional changes to human studies, may lead to another round of notice-and-comment, and another proposed rulemaking.

Therefore, this article proposes two studies: a universal prospective study of child suicides utilizing the psychological autopsy technique, which could serve as a pilot study for a similar universal study of all school shooters. It is important that the study be 

universal, because child suicide research suffers statistical problems relating to low incidence, while school shootings can be spoken of an an epidemic. Insight into causes of or changes in the prevalence of child suicide could give insights into the more sensational problem of mass shootings. Because such a project is of national scope, and related to an ongoing public health emergency in which many lives have been lost, this pilot project should be conducted by the U.S. Public Health Service.10

In the absence of IRB review, the studies should be designed and conducted with great care. They may be fraught with hazard, because knowing someone who has committed suicide is a heightened risk factor for a subject’s own suicide. The projects may also carry with it the danger of legal liability or social stigma. Investigators should also take pains to ameliorate the danger of research bias.

Child Suicide- A Constant Social Ill Which is Increasing in Some Populations

According to a poster presented at a psychiatric meeting  in 2016, there were 744 suicides among children in the U.S. between the ages of five and 11 years old between 1993 and 2014. The rate of suicide in that age group is increasing among some populations, such as African-American children, and according to some statistical measures, among caucasian girls, according to the study, which analyzed data from the Centers for Disease Control (CDC).11 

Other scientists have found increased prevalence in other subgroups, such as juvenile defenders (suicide attempt rate of 61%) and troubled adolescence (33% attempt rate).12

According to one article, suicide is the third leading cause of death among American youth ages 10–14 (accounting for 7.2% of deaths in 2005).13 Among children in the U.S. between five and 14, the suicide rate was 0.7 per 100,000 in 2009, according to another article, again citing the CDC14; by comparison, the rate in Norway was 1.3 per 100,000 in the same year, but it decreased to 0.3 per 100,000 in 2010.

The latter statistic illustrates one of the problems with the study of child suicide: while the phenomenon occurs consistently, the rate of occurrence is subject to great fluctuation, and the statistically small occurrence rate makes the phenomenon difficult to study in a scientifically valid way.

There has also been some controversy in the medical literature over potential misidentification of child suicides. Because some scientists question the ability of very young children “to grasp the finality and permanence of death,” a 2012 survey of medical examiners found that more than two-thirds of respondents indicated that they would never classify a child’s death as suicide if the child’s age was below a certain threshold (ranging from two to 12 years old, average 7.8 years old).15 Another complicating factor is that asphyxiation games are played among children.

(Note, however, that another 2012 study in Norway concluded that “the extent of mislabeling between suicide and accident was small” even though 19% of the parents of the suicide victims “were uncertain as to whether their child’s death was a suicide or an accident”).16

The Psychological Autopsy: A Technique Originated to 

Distinguish Accidental from Intentional Child Deaths

These factors make it important to study suicide. While fluctuation and the statistically low rate of occurrence complicate study, there are tools available. For example, the National Violent Death Reporting System (NVDRS) is a surveillance tool established by the CDC which some scientists use, in addition to the National Vital Statistics System, and the Web-based Injury Statistics Query and Reporting System (WISQARS).17 Other psychologists have created tools such as the Death Investigation Checklist, which incorporates elements of an intent-based classification system to attempt to separate suicides from accidents.18 Additionally, all 50 states and the District of Columbia have multidisciplinary Child Death Review (CDR) teams.19

Another tool sometimes used to study child suicide is the psychological autopsy, which was “developed originally as a means of resolving equivocal deaths.”20 

The nature of killing oneself, while explained by psychological theory, is rooted in a most personal experience base (phenomenological), one that is rarely knowable to others. Preventing suicide, therefore, requires an in-depth understanding of the person at risk. To accomplish this goal, a developmental perspective is invaluable to, but rarely possible for, researchers and counselors.21

The procedure is used with the intent of discovering “the state of mind of an individual at the time of death,”22 and while “no standardized procedures exist,” the technique usually involves interviews with family members among other individuals, and the gathering of documents such as police reports, medical records, suicide notes, and artwork, sometimes in conjunction with standard psychological tools such as the Diagnostic and Statistical Manual of Mental Disorders.

For example, in one Norwegian study, scientists “obtained from the parents their description of the death scene, the method of death, where and when it took place (time of day, day and month), who found the deceased and whether the deceased was alive when found.”23 One product of a thorough psychological autopsy can be “a timeline of significant events across the life of the subject.”24

Notwithstanding the apparent utility of the psychological autopsy, a number of factors converge to make the tool sometimes impractical to use. For example, “conducting psychological autopsies of suicide victims is an expensive endeavor in terms of time and money.”25 

Note that in the Cross article, the procedure “was conducted over a 4-year period from 1997 through 2001.” Additionally, the deceased young person was 21-year-old Reed Ball, the study was conducted at Ball State University in Indiana, one of the co-authors was P. Bonny Ball, the mother of the deceased, and the lead author was “the George and Frances Ball Distinguished Professor of Gifted Studies.”26 While the study was useful, both in terms of its detailed analysis of Reed Ball’s suicide, the collection of background psychological theories and other information, and its references to additional case studies, it nonetheless seems likely that most psychological autopsies can be done in a more scientific and economical manner.

That said, another reason some feel that psychological autopsies cannot be conducted universally is that some researchers feel that ethics review is required.27 While a more detailed review of American regulations concerning human subjects research begins in the next section, one reason that some institutional review boards (IRBs) may feel that psychological autopsies require IRB approval is that they involve intimate interviews with surviving family members of the deceased.

“Asking parents to recall and talk about their deceased child, regardless of the cause of death, can be upsetting and can reactivate grief. We asked them to participate without being able to assure them that the data they provide will actually help prevent new deaths.”28 (Additionally, participating in a psychological autopsy could theoretically trigger criminal liability in some cases, or give rise to other problems, such as child custody issues).

The Feasibility of Universal Psychological Autopsies in Cases of Child Suicide

While complicating factors exist, there is scientific precedent for the conducting of a universal series of psychological autopsies in Norway. Initial data were gathered fro, Statistics Norway; the number of autopsies was moderate (84 children 15 or younger who committed suicide in Norway between 1993 and 2004); in fact, the scientists were even able to perform psychological autopsies on a control of young people who died accidentally.29 The researchers noted that “participation has commonly been perceived as a ‘positive’ experience and many of the interviewees seem to benefit from the interview.”30

While ethics approval was required, “[a]ll required permissions were obtained from the Norwegian Directorate for Health and Social Affairs,” among other agencies, and the “Regional Committees for Medical and Health Research Ethics approved the study.”31

In this regard, it should be noted that recent regulations have created a mechanism for centralized IRB review for clinical trials all over the European Union.32 The rule doesn’t go into effect next year, and may not include psychological autopsies or other studies which involve interviews, but it does suggest a way forward. The recent notice of proposed rulemaking (NPRM) to amend the U.S. common rule also includes a provision for centralized IRB (though it is not nearly as centralized as the rules in Norway and the EU described above). 

What role the NPRM plays in making the universal application of psychological autopsies more feasible is what this article shall discuss next.

What is the ‘Common Rule’ and How Might It Apply to Psychological Autopsies?

Most scholars, of whatever kind, have heard of the Common Rule, it seems, and know that it creates restrictions which can seem unpleasantly burdensome. 

This section will briefly summarize what sorts of activity are subject to the Common Rule’s requirements, and what the regulation entails. The next section will examine public health activity in particular, and efforts to relax the effect of the ‘common rule’ on public health activity. It will then examine whether a proposed exemption in the notice of proposed rulemaking (NPRM) would make it easier to conduct psychological autopsies.

History of Common Rule

It is sometimes said that the evolution of human subjects ethics has been reactionary in nature. The ‘Common Rule’ (so-called because it is codified with variations in the regulations of some 16 federal agencies)33 developed in reaction to research tragedies and scandals of the 20th century. 

The federal “Common Rule” governing science using human subjects, which is codified in federal regulations in the codes of numerous federal agencies (sometimes with various changes according to the agency), developed as bioethicists and federal agencies reacted to tragedies and scandals of the 20th century. One of its main predecessors was the 1949 Nuremberg Code, which followed the trial of some 23 Nazis, researchers and scientists for cruel and unethical experiments during the Nazi persecutions.    

Many bioethical scandals also occurred in the U.S., even after the Nuremberg code was created, leading to the creation and release of the Belmont Report in 1979, which recognized values such as autonomy, beneficence, and justice as essential to human science ethics.34

The Common Rule came into existence somewhat late in the century, when in 1991, the federal government followed the Belmont Report (and a related document, the Declaration of Helsinki35), by 

attempting to codify the three principles mentioned above.36

What is the ‘Common Rule’ and What Does it Require?

The common rule applies to “research” conducted on “human subjects.”37 “Research” is defined by the Common Rule as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."38 

A “human subject” is defined as “a living individual about whom a researcher obtains (1) data through intervention or interaction with the individual; or (2) individually- identifiable health information.”

Initially, the Common Rule applied to any research for which an application must be submitted to the Food and Drug Administration (FDA), or any research funded by an agency of the federal government. 

However, the application of the Common Rule has grown expansively in the past years. Today, the federal government encourages research institutions which receive any federal funding to agree to what is known as a ‘federal-wide assurance,’ meaning that the institution vows to subject any research it undertakes to the requirements of the Common Rule, even if that particular research does not receive federal funding, or require an FDA application.

If the ‘Common Rule’ applies to a given scientific undertaking, certain requirements come into play, perhaps most notably mandatory prior approval by an institutional  review board (IRB), which is intended to protect the goal of beneficence. Additionally, the goal of autonomy or respect for person’s is advanced by the Common Rule’s requirement that the research can only be carried out on people who have given their informed consent. The goal of justice is served by the requirement that any risks the humans are exposed to must be proportionate to the potential benefits of the research.

If the Common Rule applies to the research, federal regulations require “advance review by an IRB [institutional review board] or medical ethics board in compliance with various specifications,”39 including an assessment as to “(1) whether there is appropriate individual or guardian consent for data collection; (2) the privacy of identifiable information is protected; (3) there exists a sound, safe, and effective research design; (4) research subjects are equitably selected; (5) appropriate data safety monitoring is provided; and (6) vulnerable populations (e.g., children, prisoners, mentally-disabled) are protected.”40 

Some would say that the Common Rule has become the ‘gold standard’ for human research compliance and ethics, and many institutions would be reluctant to permit human research to take place without an analysis of the Common Rule’s protections and their application.

The Scope of the Common Rule’s Application can be Unexpectedly Wide

Seen from another perspective, however, the application of the common rule to unanticipated fact patterns can lead to counter-intuitive or undesirably burdensome results.

For example, the Common Rule can be seen as coming into play any time a human being is interviewed, or the behavior of human beings is studied.41 For example, some IRBs have viewed the requirements of the Common Rule to activities even entirely outside the biomedical context, such biography, oral history, journalism, or even historical scholarship.42

A determination that a particular project is ‘research’ on a ‘human subject,’ and that therefore an IRB must review the project to ensure that the other requirements of the common rule are met, can have profound implications for the fate of the idea. For example, determination that a “multi-state project constitutes human subjects research may trigger review by a relatively large number of state and local IRBs, which can lead to the sort of inconsistent treatment across sites widely reported in the case of multi-center clinical research.”43

Some reason that even activities such as the observation of public behavior “may present actual or potential risks to participants (e.g., privacy violations, discrimination, injuries, coercion, anxiety).” 

What sorts of activities do public health entities engage in?

Public health agencies, including departments of the state and federal government and academic institutions, have traditionally engaged in a variety of activities such as disease surveillance designed to benefit not a single individual, but the “public health patient”- that is, the population as a whole. 

The first public health agency of the federal government, the U.S. Public Health Service, was founded in 1798,44 but the scope of activities engaged in by public health agencies has been expanding. 

“Traditionally, disease surveillance largely consisted of legally mandated reporting of selected ‘notifiable’ diseases by health care providers, but in recent times surveillance has expanded to encompass activities ranging from anonymous testing of stored blood specimens through analyses of insurance claims to interviews about highly personal health-related behaviors.”45 

“Public health agencies collect and analyze significant identifiable health data from health care providers, insurers, other agencies, or individuals to perform an array of public health activities. These activities include surveillance (e.g., reporting requirements, disease registries, sentinel networks), epidemiological investigations (e.g., to investigate disease outbreaks), and evaluation and monitoring (e.g., public health program development and analysis, oversight functions).”46

The fact that public health activities are intended to benefit the population at large makes some such activities resemble research intended to produce generalizable knowledge. 

However, the application of the common rule to public health activities has been complicated because the division between public health research and practice has been especially complex and controversial.47

Some scholars have argued that “[t]he primary intent of non-research in public health is to prevent or control disease or injury and improve health, or to improve a public health program or service”48, because "the intent of public health practice is always to prevent or control disease and improve health or to improve a public health program or service in a specific population (i.e., the 'public health patient').” 

In other words, according to some scholars, public health activity that resembles research, because its purpose is to prevent disease in the general population, is nonetheless ‘treatment’ for purposes of the common rule, because the ‘patient’ in public health practice is not a single individual, but always the general population.

(It should be noted that the argument that research-like studies are undertaken to discover how to improve public health activities benefitting the general population begins to resemble the arguments advanced to craft an exemption for quality assurance programs.49

Historically, What Sorts of Public Health Activities 

Might Be Research Governed by the Common Rule?

Notwithstanding the arguments crafted regarding the intent of public health programs to serve the health of the general population, and the longstanding blessing of historical practice, some public health activities nonetheless grew to be viewed as coming under the purview of the common rule.51 

“Public health practice involves the application of proven methods to monitor the health status of the community, investigate unusual occurrences of diseases or other conditions, and implement preventive control measures based on current understanding within public health sciences. Research involves testing new, unproven treatments or strategies that are not known to be efficacious. As such, research entails rigorous monitoring of potential adverse, unexpected consequences to selected human subjects in the application of new, often unproven interventions.52

“A public health agency may, for example, conduct a double-blinded, controlled study to assess the efficacy of a new vaccine among a randomly-selected group of persons within the affected population. The study's hypothesis, methods, and underlying intent substantiate that the activity is research.”53

Additionally, “if any activity involves introduction of non-standard or experimental procedures, the activity is more likely research rather than public health practice...[I]f an activity utilizes control groups or randomly selects its participants to eliminate bias, the activity is likely research rather than public health practice.”54

As noted, above, the recently-released NPRM proposing to modify the common rule has crafted language relaxing the application of the regulation to public health, quality assurance activities and other situations. A section below will explore those changes; but next, this article will explore whether the historical application of the common rule might apply to psychological autopsies conducted in the wake of child suicide, and why.

The psychological autopsy resembles ‘research’ concerning a ‘human subject’

Putting aside for a moment the NPRM, which will be discussed below, is the psychological autopsy governed by the common rule, given the simplified conceptual outline described above? When institutions are involved that have received federal funding, this paper concludes that psychological autopsies are governed by the regulation’s historical requirements.

For scientific purposes, the universe of young children (between the ages of 5 and 11) who committed suicide in the U.S. between 1993 and 2014 is relatively limited (only 750). Therefore, it would seem possible for investigators to embark upon the project of conducting psychological autopsies in all such cases. If scientists were to begin a prospective study, consisting of psychological autopsies of all young children who commit suicide, with the goal of identifying causes for any increase in subgroups, that research would be “a systematic investigation...designed to develop or contribute to generalizable knowledge."55 

Who would be the subjects of the research? Not the deceased child, because a ‘human subject’ is defined as “a living individual about whom a researcher obtains (1) data through intervention or interaction with the individual; or (2) individually-identifiable health information.”

Therefore, the subjects of a psychological autopsy would likely be living persons who are studied by the investigators, as they seek clues as to the causes and methods of the child’s suicide. Such subjects would likely include any person who is interviewed, such as the child’s surviving family members. Even living individuals who are not interviewed, however, might be ‘human subjects’ for purposes of the Common Rule, if the researchers obtain “individually-identifiable health information” about them, for example by reviewing records such as a coroner’s report or public school records.

Given the fact that the psychological autopsy is not necessarily an interventional study, why would ethicists be concerned about such a study? It is thought that scientific inquiry into a child’s suicide could reawaken trauma. Additionally, such inquiry could lead to adverse consequences for family members or other individuals such as stigma, family or marriage disruption, or in some cases even criminal liability or the loss of custody of other children.

These considerations do not indicate that such activity would be entirely banned by the historical regulation; they just mean that scientists would have to comply with the common rules requirements, such as IRB approval and informed consent, among others. 

A full consideration of whether a study consisting of psychological autopsies should be approved by any particular IRB may be fact-dependent and is beyond the scope of this paper. 

Next, this paper will describe the potential deregulation for public health and other activities contained in the NPRM, and whether they make it easier to conduct the psychological autopsy.

      How Do the Proposed Revisions Affect the Application of the 

      Common Rule to the Two Proposed Psychological Autopsy Studies?

Research utilizing the psychological autopsy is regulated by the Common Rule, ab initio; but that doesn’t mean that the Common Rule explicitly forbids such studies. Instead, viewed historically, the Common Rule would leave to the discretion of an IRB whether such studies could go forward.

The inquiry is covered by the Common Rule because it may be intended to lead to generalizable knowledge, and is conducted on humans (such as the surviving interview subjects, for example).

Historically, in determining whether to allow the study, an IRB would consider a number of factors, such as the opportunity of the subjects to consent, whether the selection of participants was equitable, and whether the risk of harm was fairly balanced against any potential benefit to the individual subjects, or to society as a whole. (Note that the possibility of public benefit turns in part on whether the study design is scientifically and statistically valid). Another factor considered by IRBs is whether the activity includes provisions for the privacy of the subjects.

Psychological autopsies don’t subject the participants to physical risk of intrusion, and present the prospect of serving the public good by reducing the factors that lead children to take their lives. These factors could weigh heavily in favor of the project, in comparison to potential harms, such as the prospect of reawakening grief, or the potential for legal liability, on the part of the interviewees. 

Therefore, it seems that some psychological autopsy studies could go forward, even under the historical version of the Common Rule. But because such studies are expensive, may involve multiple IRBs generating conflicting rulings, and are sometimes controversial (particularly in the context of firearms), inquiry is sometimes stymied. 

The proposed revisions to the Common Rule would make it easier to conduct the two nationwide prospective psychological autopsy studies. The NPRM discusses two proposed deregulated categories that would be among the most helpful changes: the exclusion for public health surveillance, and the exemption for interview procedures. 

The studies could go forward without any Common Rule requirements, such as IRB review or informed consent if conducted by a public health agency. Even when conducted by investigators outside a public health entity, the revisions could allow interview procedures to take place without IRB review or informed consent, if certain record-keeping and privacy standards are observed. When IRB review is nevertheless required, the NPRM also contains a provision providing for centralized IRB review for cooperative research, which could be important for a nationwide prospective study like those proposed by this article.

However, researchers should be cautioned to conduct the two proposed studies gingerly, because a psychological autopsy is probably not a minimal risk project. The living subjects may be vulnerable, because the possibility of psychological harm is a hallmark of these psychological autopsies. Knowing someone who has committed suicide is a factor putting the individual subjects at increased risk for committing suicide themselves.

This article will proceed with a brief overview of the NPRM.

The NPRM is a Laissez-Faire Deregulatory Document That Introduces Moral Relativism as Well as Several Categories of Excluded Conduct and Eight Exemptions

As mentioned above, the NPRM was issued in 2015, and followed the 2011 release of the ANPRM by HHS. The 131-page NPRM is a vast document, containing changes almost as far-flung as the universe of scientific inquiry itself, which would wreak profound changes in the Common Rule, twenty-five years since it was first created in 1991.56 

Although the comment period for the current proposal has passed, the current moment (I write this on the eve of 2017) may be an opportune time to advocate for reform in the spirit of the NPRM. This is because, two separate notice-and-comment periods having elapsed, two drafts of proposed regulations having been promulgated, Congress is now considering the 21st Century Cures Act, which would make additional changes in the regulation of scientific inquiries involving human subjects. Therefore, a third round of notice-and-comment seems possible.

This article will briefly discuss the tenor of the NPRM, and mention a few of its provisions in the following paragraphs. Except for those relevant to the psychological autopsy studies, however, a full analysis of the the NPRM is beyond the scope of this article.

The NPRM expresses regulatory regard for the study of human subjects, and describes general public enthusiasm for such studies as well as confidence in investigators.57 Then, the NPRM re-introduces a powerful element of moral relativism into bioethical considerations in support of the sweeping changes it would make:

The three ethical principles of the Belmont Report often cannot all be fulfilled at the same time. In many cases, it will be necessary to choose which of those principles will deserve the greatest adherence.58

Note that these three principles are respect for persons, beneficence, and justice59 In recent years, privacy has been described as a fourth important ethical factor, and is a theme repeated throughout the NPRM. Scientific validity of study design is also an important factor in determining the justness of a trial, because if a scientifically flawed study presents risk to an individual, such risk cannot be justified by the potential for public good. The NPRM continues:

If a reasonable balance is struck between protecting human research subjects, minimizing the administrative burden of the system, and engendering public trust, this should maximize beneficence and raise all ships.60

In pursuit of this deregulatory motive, the NPRM crafts various forms of exceptionalism favoring many categories of scientific inquiry, whose proponents have long maintained that the Common Rule was overbroad, Scientists who might benefit from the NPRM include geneticists and oncologists, and others who wish to see easier access to biospecimens, among many others. To be sure, the NPRM also contains more protection-oriented reforms such as universal coverage of clinical trials, the public availability of informed consent documents, and others.

In carving out its deregulated categories of inquiry, the NPRM makes adjustments modifying application of the Common Rule for certain categories, which all happen to start with an ‘E’: ‘Excluded’ categories, which are not covered at all by the Common Rule61; exempt activities subject only to certain privacy and/or documentation requirements, but not IRB review62; an expedited category for certain ‘minimal risk’ activity63; and an excused category.

For the first time, some categories of scientific inquiry are placed wholly outside the reach of the Common Rule, as they are “deemed non-research” by  the NPRM.64 

None of the Common Rule’s requirements apply, including IRB review, informed consent, documentation, or privacy safeguards.

Beneficiaries include social scientists and even journalists, who have long expressed shock and opposition to the regulation by IRBs of activity which consists merely in the observation of public behavior.65 Another area of inquiry which would enjoy deregulation under the NPRM, inter alia, is quality assurance and quality improvement.66 Also deemed non-research are some forms of social science inquiry, such as biography and oral history.

But the category of “non-research” activity most relevant to the proposed psychological autopsy studies is the exclusion for public health surveillance.

In addition to the exclusions, the NPRM also proposes eight exemptions, which qualify for reduced regulation, and which are grouped into three categories, according to the level of risk they are perceived to carry. The three categories have different regulatory burdens.

The most relevant exemption for this paper is for interview procedures, which most closely resemble psychological autopsies.67 This category of activity would be exempt from the Common Rule’s requirements for IRB review and informed consent, but subject to certain record-keeping and privacy safeguards.

Interviews fall into a seemingly-motley assortment of activities, “Educational Tests, Survey Procedures, Interview Procedures, or Observation of Public Behaviors.” The application of the Common Rule to even non-invasive forms of scientific investigation, including the mere observation of public behavior, has been a source of longstanding controversy.

The federal government is currently mulling whether “interview procedures” qualify for an exemption, even when children are interviewed.

Public Health Surveillance Enjoys the Strongest Form of Deregulation in the 

NPRM, Which Would Permit the Proposed Psychological Autopsy Studies

Public health advocates have long struggled with the application of the Common Rule to the activities of public health agencies. If the entire notion of public health is predicated upon the treatment of general populations, not individuals, then when is public health activity practice, and therefore not governed by the Common Rule, even though it resembles research designed to discover generalizable knowledge?

The NPRM answers this question by creating a new category of excluded activity for ‘Public Health Surveillance.’ The exclusion refers to ‘biospecimens’ necessary to “identify, monitor, assess, or investigate potential public health signals or the onset of a disease outbreak, including trends, or signals, and patterns in diseases, or sudden increase in injuries,” but the net cast by the NPRM is wider:

“Public health surveillance refers to the collection, analysis, and use of data to target public health prevention. It is the foundation of public health practice. Surveillance uses data from a variety of sources, including mandatory reporting of certain conditions, routine monitoring, vital records, medical billing records, and public health investigations in response to reports of potential outbreaks.”

Hence, the exclusion for public health surveillance seems almost tailor-made for scientific inquiry into mass shootings, because the text of the preamble contains a reference to a “sudden increase in injuries from using a consumer product,” and to surveillance conducted “during the course of an event or crisis that threatens public health, including natural or man-made disasters.”

The scientific literature tells us that scientific investigation into child suicide is statistically hindered by low prevalence, raising the question of whether child suicide is an “emergency.” How, then, does the NPRM make it easier to conduct the two proposed psychological autopsy studies? 

The careful reader will recall that child suicides are on the rise in some groups. One could argue that the problem is “epidemic.” One wants to ask, how many is too many?

Given the consistent recurrence and prevalence of massacres in the U.S. since Columbine, events like school massacres constitute a public health emergency. The problem seems to have increased since 1999, as assailants make reference to one another in writings, video and social media statements. The unacceptable prevalence of atrocities in the U.S. must have a seriously deleterious effect on the overall well-being and psychological health of our society. 

In that light, an investigation into child suicide could produce invaluable information to help solve the problem and determine what is behind the uninterrupted stream of bloodshed that has come to plague our society. Perhaps a prospective study of child suicides could be a pilot project for a somewhat wider study of mass shootings.

The Second-Most Important Deregulated Category in the NPRM is for 

Interview Procedures, Which Closely Resemble the Psychological Autopsy

The concept of “interview procedures” is one of the most important concepts in the entire NPRM for our purposes, and it would make it substantially easier to conduct the psychological autopsy studies.

The discussion of the concept of “interview procedures” is complex, because the category can be either an exclusion68, or an exemption.69 Theoretically, it seems that some psychological autopsies might qualify as excluded conduct, while some might qualify as exempt, and some might not qualify for either category of deregulation.

Because either category may be relevant, the differences will be described below. Data privacy is a critical concern for both categories. Also, the investigator may enjoy a certain amount of discretion as to whether the project qualifies for deregulation under either the excluded or exempt category.

The most important difference, however, is that the NPRM disqualifies interviews of children from the excluded category, in its discussion of the subparts. Therefore, this paper concludes that it is the exempt type of interview procedure that may be most relevant to psychological autopsies (depending on the content of the Final Rule).

Excluded Interviews

Interviews that fall into the excluded category of activity are “deemed non-research,” like public health surveillance, and therefore enjoy the broadest protection from regulation under the NPRM, meaning that the Common Rule simply does not apply.

One main difference between the excluded and exempt category of interviews is that in an interview that qualifies for the exclusion, “[t]he information is recorded by the investigator in such a manner that human subjects cannot be identified, directly or through identifiers linked to the subjects[.]”70

Another difference is that the NPRM explicitly states that the excluded form of interview cannot involve an “intervention.” Exactly what constitutes an “intervention”? 

An exempt category, “Benign Interventions in Conjunction With the Collection of Data From an Adult Subject,” gives a curious description of some interventions, such as puzzle-solving, and is discussed briefly later in this paper. 

Most importantly, the NPRM proposes that activity cannot be excluded from regulation under the Common Rule if it involves the interviewing of children.71 

It seems conceivable that some psychological autopsies could be completed without interviewing children (for example, if the project was a case study of the suicide of an only child), so some such studies could be considered excluded from the Common Rule, if the data was not identified and did not involve an intervention. 

But it seems likely that nationwide prospective psychological autopsy studies like the two proposed by this article (involving child suicides, or school shooters) would necessarily involve the interviews of children.

Exempt Interviews

Interviews can also fall under an exemption category described in the NPRM, even if the research includes sensitive information recorded with identifiers.72 Even so, privacy was an important consideration for the drafters of the NPRM, and the research is exempt only if certain privacy safeguards are observed,73 and documentation requirements are fulfilled.74

One interesting question is whether exempt interviews can involve an “intervention.” The section on excluded interviews explicitly states that they cannot involve an intervention; but the section on exempt interviews is silent on the matter. The most important question is whether interviews with children can be exempt; that question is being considered following the notice-and-comment period75, and if the exemption is allowed in such cases, it seems that the two proposed nationwide prospective studies could go forward, without IRB review or informed consent, subject only to certain documentation and privacy safeguards.

A Note on Self-Determination by Investigators

The NPRM gives investigators conducting either category of interview some degree of autonomy in determining whether the activity qualifies for deregulation.

 Of the two categories, such autonomy may be much greater for those conducting the excluded kind.

 For the exempt category, self-determination may amount only to autonomous data entry into a decisional tool, resembling a flow-chart or a computer algorithm, and which will itself determine whether the interviews are exempt.

Deregulation could make this category especially especially attractive for investigators. If given such autonomy, researchers could decide themselves whether the prospect of beneficent discovery outweighs the danger of psychological harm, interview subject liability, potential skewed science or other risks.

 Therefore, such autonomy seems to make it more likely such investigation could go forward.

In its discussion of the excluded category of research, however, the NPRM gives explicit consideration to the possibility that interviews may present the possibility of psychological injury.

 The possibility of emotional harm is a hallmark of these psychological autopsies, especially because the suicide of a family member or knowing someone who has committed suicide is a factor putting an individual at increased risk for suicide on their own part.

Therefore, this paper considers the greater degree of discretion entrusted to investigators conducting the excluded form of interviews to be another factor suggesting that it is the exemption, not the exclusion, that is most appropriate for psychological autopsies.

The NPRM Contains a Proposal for Centralized 

IRB Review That May be Of Critical Importance

Even where such a prospective study as I propose is fully regulated under the Common Rule, the NPRM contains a provision that might make it more feasible.

One difficulty with such a nationwide study is that the geographical breadth of the research might mean that multiple institutions and IRBs will be involved, leading to conflicting outcomes and variations in study design. 

This problem is ameliorated by the NPRM, which would mandate that U.S. institutions engaged in cooperative research rely on a single IRB, with certain exceptions (discussed below).

 “The federal funding agency would select the reviewing IRB for federally funded research... For research not funded by a federal agency, the lead institution conducting the research would select the reviewing IRB.”

 The provision would go into effect three years from the issuance of a final rule.

The NPRM gives a suggestion of how the government feels about centralized IRB review:

The evaluation of a study’s social value, scientific validity, and risks and benefits, and the adequacy of the informed consent form and process generally do not require the unique perspective of a local IRB....Relevant local contextual issues (e.g., investigator competence, site suitability) pertinent to most studies can be addressed through mechanisms other than local IRB review.

It also should be noted that the proposal for centralized IRB review has been floated by many agencies, and may be a fait accompli in many contexts.

 The EU has even created a system of centralized IRB review.

Bearing in mind that the nationwide psychological autopsy study of child suicides in Norway was made possible by the use of a system of national ethics review, the proposal for centralized IRB review contained in the NPRM may be critical to the two proposed studies.

One interesting question is whether the requirement for centralized IRB review applies only to clinical research, such as drug and device trials, or also to social science research, like the psychological autopsy. The NPRM explicitly addresses this question:

Support was especially strong for single IRB review for cooperative clinical trials for which the evaluation of a study’s social value, scientific validity, and risks and benefits, and the adequacy of the informed consent form and process generally do not require the unique perspective of a local IRB.

The NPRM continued:

Those who expressed concern about the use of a single IRB said some studies, especially in the behavioral and social sciences, might involve significant contextual issues reflecting community norms, standards, and practices, or local culture and customs. Use of a distant IRB might not consider and best protect subjects based on community norms.

Here, note again the introduction of relative standards of morality: what is considered benign or just in one region may be deemed unethical in another.

It seems that this question is up for grabs following the notice-and-comment period.

The Exclusion for Oral History and Biography 

is Another Noteworthy Deregulated Category 

Certain activities comprising “Oral History, Journalism, Biography, and Historical Scholarship Activities” are deemed not research and therefore excluded from the requirements of the Common Rule. Under some limited circumstances, practitioners should consider whether a psychological autopsy resembles these activities.

While this category does not much resemble a universal, nationwide prospective study like the two I propose, one might consider whether the terms ‘biography’ or ‘oral history’ describe limited research like an inquiry into an individual massacre, or a case study like the article describing the psychological autopsy of Reed Ball, above. If so, the activity may enjoy the greatest deregulatory status contained in the NPRM. 

According to the NPRM:

In the kinds of activities referred to here, the ethical requirement is to provide an accurate and evidence-based portrayal of the individuals involved, and not to protect them from public scrutiny...Additionally, these fields of research have their own codes of ethics, according to which, for example, consent is obtained for oral histories.

“Benign Interventions in Conjunction With the Collection of Data 

From an Adult Subject” is Also a Potentially-Relevant Category

Another, more minor exempt category discussed in the NPRM is for “Research involving benign interventions in conjunction with the collection of data from an adult subject.”

 Here, the exemption means that the research is subject only to certain record-keeping requirements, and no other burdens of the Common Rule.

Because some psychological autopsies could conceivably be done without involving living children (for example, in a case study of an only child), it seems possible that some such studies could be designed as “benign interventions.” 

This type of research permits “interventions,” and gives some examples, including “certain types of well-understood interactions with subjects (e.g., asking someone to watch a video and then conducting word association tests),” or asking subjects “to read materials, review pictures or videos, play online games, solve puzzles, or perform cognitive tasks.”

The NPRM explicitly refers to the low-risk nature of the studies under this exemption, whereas the risk for psychological harm would seem to be a hallmark of psychological autopsy studies.

It seems that both the information gathering, and the intervention aspects of this exempt category must be low-risk, because the techniques governed by this category “are known to involve virtually no risk to subjects,” and “[a]ny disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation.”

Whether this exemption would be very useful in the two proposed studies seems doubtful, especially because a psychological autopsy may present the hazard of reawakening grief, even when conducted in an adult.

Notwithstanding the Extent of Deregulation, Investigators Should       Nonetheless Proceed Gingerly with the Proposed Studies

Thus, the proposed revisions to the Common Rule ought to make it easier to conduct a study consisting of universal psychological autopsies in cases of child suicide. Such studies ought to be conducted, subject only to the caveat that investigators should proceed gingerly, because they present significant potential for injury to the subjects, notwithstanding their presumed non-invasive, non-interventional nature. 

The subjects may be vulnerable, and the studies involve more than minimal risk. Additionally, those involved in study design must ensure that they do not involve the potential for research bias, especially because issues related to firearms may be involved.

Subjects being interviewed or otherwise participating in the psychological autopsy of a deceased child are vulnerable, because knowing someone who has committed suicide is a risk factor for one’s own suicide. 

Notwithstanding the NPRM, Psychological Autopsy Subjects are Vulnerable

Therefore, investigators should consider the subjects “vulnerable,” notwithstanding certain seemingly contrariwise provisions in the NPRM. The NPRM discusses the concept of vulnerable subjects in the context of proposed IRB operational requirements.

According to the proposal, IRBs are to weigh the vulnerability of subjects in determining whether research is equitable.

The NPRM proposes to define vulnerable populations as “subjects who are vulnerable to coercion or undue influence,” and gives examples, such as “children, prisoners, pregnant women, physically or mentally disabled persons, or economically or educationally disadvantaged persons.”

The NPRM also mentions vulnerable populations in its discussion of IRB membership, and proposes that members of vulnerable populations serve on an IRB that regularly reviews research involving vulnerable populations.

The NPRM tells us that “the vulnerability of the populations in these research studies should be considered to be a function of the possibility of coercion or undue influence, and that this vulnerability alone should be the IRB focus of concern,”

 and mulls the question of whether pregnant women or individuals with physical disabilities also ought to have any vulnerability taken into consideration by IRBs.

But as discussed above, many studies will be outside the reach of IRB review, including public health surveillance and many interview procedures, such as psychological autopsies.

The Risk of Psychological Autopsies is More than Minimal

Nonetheless, investigators conducting psychological autopsies must bear in mind that the subjects participating are vulnerable, whether the study is deemed ‘research’ or not, and even if they don’t fall into the specified groups, and that the activity should not be characterized as “minimal risk.”

According to the proposal, investigation which is associated with only “minimal risk” qualifies for another category of deregulation, which, like excluded activity and exempt research, starts with an ‘e’: such research can be approved with only “expedited” review.

 Because this category does not apply to our projects, it will be discussed only briefly.

According to the proposal, “minimal risk” is comparable to the risk  ‘‘ordinarily encountered in daily life’’ or in ‘‘routine physical or psychological examinations.”

 However, the NPRM notes:

[T]he risks encountered in daily life can vary greatly depending on many factors, for example, where people live, what kind of work they are involved in, what their social and economic environment is, and their baseline health status. Thus, IRBs need to consider all of these issues in making a determination about the level of risk.

The NPRM proposes that such activity be limited to a list of forms of research promulgated elsewhere by the Secretary of Health and Human Services (last updated in 1998).

Regarding the psychological autopsy, the Norwegian study of children who committed suicide found that those survivors who took part in the research were happy to do so. However, another article pointed out that conducted such interviews poses the danger of reawakening grief. 

Because statements from the psychological literature are mixed, and because of the concern for psychological harm verbalized in the NPRM, this paper concludes that 

responsible investigators should not view most psychological autopsies of children who committed suicide to be “minimal risk.”

Studies Must be Scrupulously Designed to Eliminate the Danger of Research Bias

Finally, investigators should design their studies to peremptorily address another potential danger of unregulated investigation: scientific bias.

Scientific validity is important to considerations of beneficence and justice. Even a non-therapeutic study which presents more than minimal risk to the human subjects participating in it may nonetheless be considered ethically justified if it may promise a significant-enough benefit to society as a whole. That is abundantly true of psychological autopsy studies in children who committed suicide- but if the design of a study is scientifically or statistically flawed, any promise of social benefit may be illusory.

IRB review is thought to be a protection against scientific bias, and to ensure that the statistical design of studies is valid.

Another reason for investigators to take pains to ensure the scientific validity of their studies is that such projects may be unexpectedly controversial. For example, 

federally-funded scientific investigation which touches on handgun violence has been a volatile area of dispute for Second Amendment advocates.

Some commentators have perceived federal public health inquiry into handgun violence as unscientifically biased and part of a project favoring gun control.104 Since the Common Rule applies to federally-funded inquiry, perhaps this political perception would make it more difficult for an IRB to approve child suicide research. 

In the case of child suicide, perhaps such concerns are unfounded. Recall that the difficulty experienced by medical examiners in sorting out suicides in very young children from accidental child deaths was one motivating factor for the development of the psychological autopsy as a tool.

But it is hard to understand how a deliberate child death by firearm is more or less probative of the comparative virtues of gun rights versus gun control than evidence showing that the same death were an accident.

Indeed, if a psychological autopsy study were to prove that many child deaths by firearm that were initially classified as accidents were actually suicides, that might support some arguments of gun rights advocates, because merely removing firearms from the reach of a child bent on suicide might not prevent their death, since they may simply choose another method, such as asphyxiation.

Additionally, such concerns for scientific bias seem especially unfounded in the context of these proposed studies, because the studies would be examining all child suicides, not just those that occurred by firearm. The psychological autopsy is intended to uncover psychological factors that may be present in these tragic cases, which may be entirely distinct from the issue of gun policy.

Nonetheless, investigators planning the proposed psychological autopsy studies should be aware of all these hazards of the activity, especially in the absence of IRB review, and should design their studies and craft their arguments accordingly.

  Conclusion and Recommendations

This paper concludes that a prospective, universal study should be conducted of all child suicides in the U.S. Such a study would be important in its own right, and could serve as a pilot project for a similar universal psychological autopsy study of school shootings in the U.S. 

The experiment in Norway proves that is possible to conduct a universal survey of child suicide, by conducting psychological autopsies in all cases, prospectively and over a certain time frame, in a given country (although a small country).

Several proposals in the NPRM should make it easier to conduct such universal studies, without IRB oversight or the necessity of informed consent. The problem of massacres which has developed in the U.S. can be characterized as an epidemic, and so these studies could be carried out under the aegis of public health surveillance.

The two proposed studies could also be carried out under the exemption for interview procedures (assuming the Final Rule permits exemption for interview procedures which involve children).

Even in situations where the studies are subject to IRB review, the proposed revisions to the Common Rule include a measure that could be of critical assistance allowing for centralized review by a single IRB. (Recall that the Norwegian project benefitted from the fact that ethical permission was given by a centralized government agency).

However, investigators should proceed gingerly, even in the deregulated context, because of unique harms associated with the proposed studies, which will be associated with significant risks for subjects, since the suicide of a relative puts one at increased risk for one’s own suicide. Additionally, legal liability could conceivably flow from participating in the research.

Extreme care should also be taken from the point of view of scientific validity, especially because child suicide research is made statistically difficult due to low incidence. The danger is also present that the projects could become embroiled in political debate over gun policy.

In the absence of a universal prospective study, what should be done? Federal public health officers should be trained to conduct the psychological autopsy, and should universally make initial interviews soon after all suspect child death cases. The federal investigators should be no more required to get informed consent then state law enforcement agents are today. 

The federal officials should preserve as much as possible, so that if psychological researchers may later judge whether further interviews are warranted. Perhaps the psychological researchers could use psychological measures as a screen to determine whether family members would be disturbed, thereby warranting IRB review or other application of the Common Rule.

For those considering such projects, consideration in Congress of the 21st Century Cures Act, and the possibility of another proposed rulemaking, may provide an opportunity to advocate for reforms which will allow these studies to go forward.

If all of these proposals and reforms fail, what else is left to do to a conscientious social scientist whose beneficent activity is stymied? The NPRM leaves us with at least one remaining alternative: to write an oral history of a contemporary American catastrophe, as successive massacres and atrocities grip our schools in the 21st century, and nobody did anything about it.

*********

¹ The author possesses a Juris Doctor with s health law certificate from DePaul University, and was a 2015 faculty recruitment applicant at the Association of American Law Schools. He has never practiced law. Current contact information may be found on his website, www.otrompkescommentaries.blogspot.com 

² Logan, et al. “Suicide Trends Among Young Children in the United States from 1993 to 2014.” Poster 1.55, presented at the Annual Meeting of the American Academy of Child and Adolescent Psychiatry

Wednesday, Oct. 26, in New York City. The authors of the poster relied on data from the Centers for Disease Control from 1993 and 2014. 

³ Id.

⁴ Otrompke, “One Method of Researching Child Suicides, the Psychological Autopsy, May be Hindered by the Common Rule and IRB Requirements,” Nov. 5, 2016. http://otrompkescommentaries.blogspot.com/2016/11/one-method-of-researching-child.html (Accessed Dec. 26, 2016).

⁵ Franci Crepeau-Hobson (2010): The Psychological Autopsy and Determination of Child Suicides: A Survey of Medical Examiners, Archives of Suicide Research, 14:1, 24-34. http://dx.doi.org/10.1080/13811110903479011

⁶ Otrompke, J. “Significant Changes to Institutional Review Boards Proposed.”  IEEE Pulse, Nov.-Dec. 2012. http://pubget.com/paper/23247160/Significant_changes_to_institutional_review_boards_proposed__government_may_issue_first_changes_in_decades_to_the_common_rule_on_human_subjects_research

⁷ 80 Fed. Reg. 53933 et seq. (September 8, 2015) (hereinafter NPRM).

⁸ These proposed changes were apparently informed by advocacy which had been appearing in the literature for many years. See, for example, Burris, et al. “Applying the Common Rule to Public Health Agencies: Questions and Tentative Answers About a Separate Regulatory Regime.” Journal of Law, Medicine & Ethics,31 (2003): 638-653.

⁹ “Public Health Surveillance (NPRM at § ll.101(b)(1)(v)),” NPRM at 53949

¹⁰ See, for example, Muchmore, S. “Democrats, doctors say mass shootings need public health approach,” Modern Healthcare, December 3, 2015.

http://www.modernhealthcare.com/article/20151203/NEWS/151209953

¹¹ Poster (supra, n. 2).

¹² Cross, T, et al. “A psychological autopsy of the suicide of an academically gifted student: Researchers' and Parents' Perspectives.” Gifted Child Quarterly (Fall 2002). Note that one of the authors on this case study was the mother of the deceased young adult. Nonetheless, this article is a useful contribution, even if it does not 100% comply with the scientific method.

¹³ Crepeau-Hobson (n. 5, supra) at 24.

¹⁴ Freuchen et al. “Suicide or accident? A psychological autopsy study of suicide in youths under the age of 16 compared to deaths labeled as accidents.”Child and Adolescent Psychiatry and Mental Health (2012), p. 9 http://www.capmh.com/content/6/1/30

¹⁵ Creapeu- Hobson (supra, n. 5) at 29.

¹⁶ Freuchen (supra, n 14), at 11

¹⁷ Crepeau-Hobson at 24.

¹⁸ Id at 31

¹⁹ Id at 29-30.

²⁰ Cross et al (supra n 12).

²¹ Id.

²² Crepeau Hobson (supra, n 5) at 26.

²³ Freuchen et al (supra, n 14) at 2-3.

²⁴ Cross et al (supra, n. 12).

²⁵ Id

²⁶ Id

²⁷ Blog post (supra, n 4).

²⁸ Freuchen (supra, 14), at 10-11

²⁹ Id at 1-2.

³⁰ Id at 10-11.

³¹ Id at 2-3.

³² “Is Europe ready for centralised ethical approval?” Cancer World No. 73-74 (Sept. 12, 2016).

http://cancerworld.net/spotlight-on/policy-is-europe-ready-for-centralised-ethical-approval/

³³ The United States Public Health Service, or the Food and Drug Administration are but two examples.

³⁴ Privacy, another bioethics norm that has grown in currency in recent years, is a recurrent theme in the NPRM, and is discussed in greater detail below.

³⁵ Toxicology Excellence for Risk Assessment (TERA), “Comparison of Common Rule with the Declaration of Helsinki and Good Clinical Practice,” (Chart) August 2002.

http://www.tera.org/Publications/comparisontable.pdf (Accessed Dec. 26, 2016).

³⁶ https://en.wikipedia.org/wiki/Common_Rule

³⁷ Hodge, J, “An Enhanced Approach to Distinguishing Public Health Practice and Human Subjects Research,” 33 J.L. Med. & Ethics 125 (2005) at 127

³⁸ Id, citing 32 C.F.R. 219 (1991).

³⁹ Id at 130, citing 45 C.F.R. 46.103 (1991).

⁴⁰ Id, citing 53. 45 C.F.R. 46.111(a)(4)-(5) (1991).

45 C.F.R. 46.111(a)(7) (1991).

45 C.F.R. § 46.111(a)(1)-(2) (1991).

45 C.F.R. § 46.111(a)(3) (1991).

45 C.F.R. 46.109(e) (1991); 46.111(a)(6) (1991).

45 C.F.R. 46.111(b) (1991); 45 C.F.R. 46.201 (1991); 45 C.F.R.

⁴¹ “Educational Tests, Survey Procedures, Interview Procedures, or Observation of Public Behaviors (NPRM at § ll.101(b)(2)(i)),” NPRM at 53951-53954.

⁴² “Oral History, Journalism, Biography, and Historical Scholarship Activities (NPRM at § ll.101(b)(1)(ii)),” NPRM at 53948.

⁴³ Burris (supra, n. 8) at 640

⁴⁴ https://en.wikipedia.org/wiki/United_States_Public_Health_Service

⁴⁵ Burris at 640

⁴⁶ Hodge (supra, n 39) at 125

⁴⁷ For example, the Cross article (supra, n. 12) which presented the case study of Mr. Ball’s suicide, may be viewed as blurring the boundary between research and practice. (See also discussion, notes 24-26 and accompanying text). The purpose of that work may have been as much to treat the subject (the co-author, Mr. Ball’s bereaved mother) as to produce generalizable knowledge. Indeed, the issue of producing generalizable knowledge from a case study is complex enough, that the question of whether a case study can ever be governed by the Common Rule is interesting enough that it may be suitable for its own article.

⁴⁸ Burris at p 639 

⁴⁹ Abbo E, “Promoting Free Speech in Clinical Quality Improvement Research,” 101 Nw. U. L. Rev. 575 (2007). See also Hodge (supra, n. 39) at 129 (n. 32), citing Casarett, D,  et al. “"Determining when

Quality Improvement Initiatives Should be Considered Research,” JAMA 283 (2000): 2275-2280:  “A quality-improvement initiative should be considered research if "(1) the majority of patients involved are not expected to benefit directly from the knowledge to be gained or (2) additional risks or burdens imposed make the results generalizable. Although these criteria refer specifically to quality improvement efforts in clinical settings, they have been applied more broadly by IRBs to distinguish research from public health practice.” (Internal quotations and citations omitted). 

⁵⁰ Some 16 agencies and departments have signed onto the Common Rule. The HHS regulations governing the ‘public health service’ contain their own version of the Common Rule: Department of Health and Human Services (45 CFR Part 46)

⁵¹ Such concerns about the bioethics of public health research are not entirely unfounded, given that the federal public health agency was the initiator of the Tuskegee syphilis study, one of the most unethical studies of the 20th century, which was indeed the origin of the common rule. Other public health bioethics controversies followed even after the creation of the common rule.

⁵² Hodge (supra, n. 39) at 126

⁵³ Id at 125

⁵⁴ Id at 138

⁵⁵ 45 C.F.R. 546.102(d) 

⁵⁶ The first American regulations for the protection of human subjects were published in 1974.

⁵⁷ Note that the NPRM defines some studies relevant to this paper as being “deemed non-research,” such as public health surveillance, and certain forms of social inquiry. Therefore, when this paper 

is referring to such “non-research” activity, I will use the terms “inquiry,” “investigation,” “study,” or the like, and use the term ‘research’ or ‘researcher’ only when I am referring to conduct which was not “deemed non-research.”

⁵⁸ NPRM at 53941

⁵⁹Id at 53938

⁶⁰ Id

⁶¹ “Exclusion of Activities That Are Low- Risk and Already Subject to Independent Controls (NPRM

at § ll.101(b)(2))”

⁶² “Exemptions Subject to the Documentation Requirements of § ll.104(c) and No Other Section of the Proposed Rule,” NPRM at 53955

⁶³ “Expedited Review Procedures and the Definition of ‘‘Minimal Risk’’ (NPRM at §§ ll.110 and ll.102(j)).”

⁶⁴ “Oral History, Journalism, Biography, and Historical Scholarship Activities (NPRM at § ll.101(b)(1)(ii)),” NPRM at 53948.

⁶⁵ “Observation of Public Behaviors (NPRM at § ll.101(b)(2)(i))”

⁶⁶ “Explicit Exclusion of Activities From the Common Rule; a. Exclusion of Activities That Are Deemed

Not Research; iv. Quality Assurance and Quality Improvement Activities (NPRM at § ll.101(b)(1)(iv)),” NPRM at 53948-9

⁶⁷ Some kinds of interview procedures are also deemed non-research, and therefore are excluded from Common Rule regulation; but as discussed below, interview procedures that involve children are more likely to be exempt, not excluded.

⁶⁸ “Exclusion of Activities That Are Low-Risk and Already Subject to Independent Controls (NPRM at § ll.101(b)(2)); iii. Educational Tests, Survey Procedures, Interview Procedures, or Observation of Public Behaviors (NPRM at § ll.101(b)(2)(i)),” NPRM at 53951: “The exclusion at § ll.101(b)(2)(i) is for research, not including interventions, that involves the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) uninfluenced by the investigators...”

⁶⁹ “Exemptions Subject to the Documentation Requirements of § ll.104(c) and the Privacy Safeguards Described in § ll.105; ii. 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 (NPRM at § ll.104(e)(1)),” NPRM at 53961-53962: “Two exemption categories are proposed which will be subject to the documentation requirement and the new privacy safeguards. The first exemption category is for certain research involving educational tests, surveys, interviews, or observation of public behavior...The goal of the proposed exemption at § ll.104(e)(1) is to eliminate the need for IRB review of certain low-risk studies that involve collecting information by means of educational tests, surveys, interviews, or observation of public behavior.”

⁷⁰ NPRM at 53951

⁷¹ NPRM at 53954: “It is proposed that all of the exclusion categories in § ll.101(b)(2) apply to research subject to subpart D, with the exception that the exclusion proposed under § ll.101(b)(2)(i) would only apply to research involving educational tests or observations of public behavior when the investigator does not participate in the activities being observed. This limitation would maintain the protection currently provided by the similar application of the current exemption § ll.101(b)(2) to research involving children, and would continue to require IRB review under the Common Rule and additional IRB review under subpart D of 45 CFR part 46 when the research involves surveys or interview procedures with children or observation of public behavior when the investigator participates in the activities being observed.”

⁷² “Exemptions Subject to the Documentation Requirements of § ll.104(c) and the Privacy Safeguards Described in § ll.105; ii. 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 (NPRM at § ll.104(e)(1)),” NPRM at 53961-53962: “The goal of the proposed exemption at § ll.104(e)(1) is to eliminate the need for IRB review of certain low-risk studies that involve collecting information by means of educational tests, surveys, interviews, or observation of public behavior.”

⁷³ Eight exemptions are described in the NPRM. “The proposed eight exemptions are divided into three groupings according to the kind of risk.” The category of exempt interviews falls into the second group, “which will be subject to the documentation requirement and the new privacy safeguards.” Id.

⁷⁴ The documentation requirements, which are themselves complex, are described in the proposed regulations at § ll.104 (c) (“Exempt research”), NPRM at 54048. Likewise, the privacy safeguards are described at § ll.105 (“Protection of biospecimens and identifiable private information”), Id at 54049-54050.

⁷⁵ NPRM at 53962-53963: “5) Questions for Public Comment. 45. Public comment is sought on whether the proposed exemption regarding the use of educational tests, survey procedures, interview procedures, or observation of public behavior (§ ll.104(e)(1)) should be applied to research involving the use of educational tests with children and whether it should also be applied to research involving the use of survey or interview procedures with children. If so, for research involving children, should the permissible survey or interview topics be limited in some way?” See also NPRM at 53968: “e. Applicability of Exemptions to the Subparts (NPRM at § ll.104(b); Current Rule at Footnote 1) i. Current Rule

In the current Common Rule, the application of the exemptions articulated in the current Common Rule in § ll.101(b) to the subparts is specified through footnote 1 of the current Rule. It states that the exemptions do not apply to research involving prisoners, and are also limited in their application to research involving children. The current exemption at § ll.101(b)(2) for research involving educational tests, survey or interview procedures or observations of public behavior does not apply to subpart D, except for research involving educational tests or observations of public behavior when the investigator does not participate in the activities being observed.”

⁷⁶ “Educational Tests, Survey Procedures, Interview Procedures, or Observation of Public Behaviors (NPRM at § ll.101(b)(2)(i)),” NPRM at 53951: “Question 11. Public comment is sought regarding whether it is reasonable to rely on investigators to make self-determinations for the types of research activities covered in this particular exclusion category. If so, should documentation of any kind be generated and retained?”

⁷⁷ Id.

⁷⁸ NPRM at 53963: “Public comment is sought on whether it is reasonable, for purposes of this exemption, to rely on the exemption determinations produced by the decision tool where investigators themselves input the data into the tool, or whether there should be further administrative review in such circumstances?”

⁷⁹ “Whether and how the exclusion should be bounded so that the final rule achieves a balance among the principles of beneficence, autonomy, and justice is the subject of the request for comment on this proposed exclusion.”

⁸⁰ “Moses vs. Santa Claus,” Epic Rap Battles of History, 

http://epicrapbattlesofhistory.wikia.com/wiki/Moses_vs_Santa_Claus :”Who won? Who’s next? You decide!” (Accessed Dec. 26, 2016).

⁸¹ “[E]ven if the subject does not know that an investigator is watching his or her actions, the subject’s behavior is public and could be observed by others and thus the research observation is not inappropriately intrusive. However, there are situations in which this assumption would not always hold. For instance, administration of a questionnaire or participation in a focus group on a sensitive topic may induce significant stress in some individuals, or individuals approached about taking a survey may feel compelled to participate.”

⁸² “Cooperative Research (NPRM and Current Rule at § ll.114) and Proposal To Cover Unaffiliated IRBs Not Operated by an Institution Holding a Federalwide Assurance (NPRM at § ll.101(a))” NPRM at 53981

⁸³ Id at 53937

⁸⁴ Center P., “The Common Rule NPRM: Single IRB Review” (Blog post), Nov. 29, 2015. 

http://blogs.harvard.edu/billofhealth/2015/11/29/the-common-rule-nprm-single-irb-review/

(Accessed Dec. 26, 2016). (citing NPRM at 53933, 53984).

⁸⁵ NPRM at 53984

⁸⁶ For example, “In 2006, the FDA issued guidance intended to assist sponsors, institutions, IRBs, and clinical investigators by facilitating the use of a centralized IRB review process in cooperative clinical trials of investigational new drugs...” Center, P (Blog Post), (supra n. 93). See also Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research issued in December 2014 . Regarding the new EU policy, see Cancer World (supra, n. 32).

⁸⁷ Cancer World, supra.

⁸⁸ NPRM at 53982.

⁸⁹ Id at 53983

⁹⁰  “Explicit Exclusion of Activities From the Common Rule: a. Exclusion of Activities That Are Deemed

Not Research (NPRM at § ll.101(b)(1)(ii)),” NPRM at 53948

⁹¹ NPRM at 53948

⁹²  NPRM at 53960.

⁹³ As mentioned above (supra, n. 83), the NPRM proposes eight exempt categories of inquiry, divided into three groups, stratified according to the degree of risk they present. The exempt category of interviews, discussed above, falls into a group to which apply both documentation requirements and certain privacy standards. This exempt category, “iii. Research involving benign interventions in conjunction with the collection of data from an adult subject (NPRM at § ll.104(d)(3)),” falls into a different group, “Low-risk interventions that do not require application of standards for information and biospecimen protection,” to which only documentation requirements apply. NPRM at 53955; 53960.

⁹⁴ “G. Proposed Changes to IRB Operational Requirements; Proposed Criteria for IRB Approval of Research (NPRM at § ll.111),” NPRM at 53987.

⁹⁵ “Criteria for IRB approval of research. 111”

⁹⁶ “NPRM Common Rule: IRB Approval Criteria,” Human Research Protection Program, Mich. State University, http://hrpp.msu.edu/nmpr-common-rule-irb-approval-criteria . Accessed Dec. 26, 2016.

⁹⁷ “IRB membership. §107:2. Proposed Revisions to IRB Operations, Functions, and Membership Requirements,” NPRM at 53988: “The goal is to improve IRB operations and make relevant sections consistent with other areas of the NPRM.”

⁹⁸ NPRM at 53987

⁹⁹ Id at 53988

¹⁰⁰ “Expedited Review Procedures and the Definition of ‘‘Minimal Risk’’ (NPRM at §§ ll.110 and ll.102(j)),” NPRM at 53985

¹⁰¹ Id at 53951

¹⁰² 53986

¹⁰³ NPRM at § ll.102(j)); NPRM at 53986

¹⁰⁴ See Morse B., “Why Congress Cut The CDC’s Gun Research Budget,” Dec. 15, 2015 (Blog Post).

 http://thefederalist.com/2015/12/15/why-congress-cut-the-cdcs-gun-research-budget/ (Accessed Dec. 26, 2016).See also, “Flawed Study from the Prestigious Lancet Exposes Broader Problems in Anti-gun Research,” National Rifle Association Institute for Legislative Action, March 11, 2016. https://www.nraila.org/articles/20160311/flawed-study-from-the-prestigious-lancet-exposes-broader-problems-in-anti-gun-research  .    Accessed Dec. 26, 2016.

(c) 2018 John J. Otrompke