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07/07/2017

The 2017 Common Rule and the Clinical Ethics of Prolixity

Some bioethicists link the beginnings of our field to the Nazi Medical experiments and the Nuremberg Trial (Annas). Whether this is the beginning of bioethics is debatable, but without a doubt, research ethics has been a central topic in the field. In fact, the very first federal bioethics commission laid out the principles of research ethics in the Belmont Report. Later, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recommended to the President and Congress that a uniform framework and set of regulations should govern human subjects research.  This effort reached fruition under The Federal Policy for the Protection of Human Subjects or the “Common Rule” that was issued in 1991.  Since then, there have been no major changes to the regulations – until now.  After a five-year process and thousands of comments, the new “final rule” was released on January 19th, 2017.  The July 2017 issue of the American Journal of Bioethics addresses these changes.  In addition to our usual open peer commentaries, we are posting a number of blog posts written in response to the AJOB target article.

The following is a re-post of Steven Mile’s original February 2017 post.


by Steven H. Miles, MD

The new Common Rule to protect human subjects has an extraordinarily large and diverse audience.[i] The new Rules defines the obligations of an enormous number of personnel at the National Institutes of Health as well as virtually any other government agency engaged in research with human subjects. The Rules define the requisite knowledge, training, and work of staff who oversee and conduct clinical research in the United States. The Rules are a template for institutions in other countries, including those that don’t use English as a primary language. They are the template for interpretative guidelines and curricula produced by and for persons at all levels of the clinical research enterprise. The Rules are the platform upon which commercial electronic IRB programs and interfaces are designed. In sum, its words directly and indirectly teach people with immense variation in expertise and familiarity with the history and aims of oversight of research with human volunteers. For many of these persons, The Common Rule will be the only ethics text that they ever read. The Nuremberg Code, Belmont Report, and popular books like Bad Blood: The Tuskegee Syphilis Experiment or The Immortal Life of Henrietta Lacks will remain outside their ken.

For these reasons, the readability of The Common Rule is an ethics issue. The massive size of the regulation, the organization and indexing of its provisions, the complexity of the grammar, and the choice of vocabulary affect who will be able to comprehend the text of these regulations. The complexity of the text affects the ability to discern and address contradictions between parts of the document. The clarity of the language affects the design of interpretive curricula, the consistency of rulings, and even software design for the electronic IRB. The burdens of the text will be reflected in the size of administrative staff needed to interpret and implement the text.

The best measurement of the success of the Common Rule is its clarity to clinical investigators. Regulations are prosaic but The Common Rule goes to the heart of a common, publicly scrutinized relationship between a clinical investigator and a person who is invited or who elects to serve in creating new clinical knowledge. To that end, The Common Rule must be lucidly and transparently written. It should minimize jargon. It should not be obscured with prolixity, circumlocutions, or redundancy.

The Common Rule fails this assay. Its 12,000 plus words are dense nests of meandering sentences. The length deters the reader. I assessed the readability of The Common Rule by rewriting a portion of it. To do so, I used an online random number generator to select one if it’s twenty-three sections. It came up with Section 117: Documentation of Informed Consent. Table 1 shows my rewrite of the text, aiming to accurately match the regulation. An apparently misplaced clause in the regulation (in italics) was moved to what struck me as a more fitting location in my rewrite of Section 117.

Table 2 displays differences between the texts. The number of words for Section .117 fell by 25% and the use of the passive voice decreased by 40%. The sentence length decreased from 26 to 21 words but remained long because I did not tamper with outline style lists that were built from compound sentences. Flesch–Kincaid” (F–K) reading grade level as measured by Microsoft Word fell from 14.2 to 12.5, although it would have fallen more had I converted the outline lists to simple sentences.

Based on this short exercise, one could imagine that The Common Rule could be shortened by about 3,000 words. Also based on this exercise, I believe that much of the verbiage cut away is misplaced, redundant, and even contradictory.

The 2017 edition of the Common Rule is the end result of an enormous effort. The updating of The Common Rule was long overdue. Now, there should be an effort to make this critically important ethics document transparently accessible to the non-specialized audiences who most directly rely on it to guide their work. These are the researchers and their staff who recruit and follow human volunteers, and also the dedicated personnel who work in IRB offices.

 

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Table 1.  Section .117

Published Regulation Regulation as rewritten by SHM
Documentation of informed
consent.
Documenting informed consent.
(a) Except as provided in paragraph (c) of this
section, informed consent shall be documented by the use of a written
informed consent form approved by the IRB and signed (including in an
electronic format) by the subject or the subject’s legally authorized
representative. A written copy shall be given to the person signing the
informed consent form.
(a) Informed consent shall be documented on a written form
approved by the IRB and signed (in writing or electronic form) by the subject
(or legally authorized representative). A printed copy shall be given to the
person signing the form.
(b) Except as provided in paragraph (c) of
this section, the informed consent form may be either of the following:
(1) A written informed consent form that meets the requirements
of Sec. __.116. The investigator shall give either the subject or the subject’s
legally authorized representative adequate opportunity to read the informed
consent form before it is signed; alternatively, this form may be read to the
subject or the subject’s legally authorized representative.
(2) A short form written informed consent form stating that the
elements of informed consent required by Sec. __.116 have been presented
orally to the subject or the subject’s legally authorized representative, and
that the key information required by Sec.  __.116(a)(5)(i) was presented
first to the subject, before other information, if any, was provided. The IRB
shall approve a written summary of what is to be said to the subject or the
legally authorized representative. When this method is used, there shall be a
witness to the oral presentation. Only the short form itself is to be signed
by the subject or the subject’s legally authorized representative. However,
the witness shall sign both the short form and a copy of the summary, and the
person actually obtaining consent shall sign a copy of the summary. A copy of
the summary shall be given to the subject or the subject’s legally authorized
representative, in addition to a copy of the short form.
The investigator shall give the subject (or legally
authorized representative) adequate opportunity to read or have the informed
consent form read to them before signing.
(b) The consent form may be either:(1) A written consent form meeting the requirements of Sec. __.116.

(2) A short written consent form stating that a concise summary
of the trial (See Sec. __.116(a)(5)(i)) and that the elements of consent (see
Sec. __.116) have been orally presented to the subject (or legally authorized
representative). The IRB shall approve the wording of that oral presentation.
A witness shall observe such oral presentations and shall sign the short
consent form and a copy of the summary. The subject (or legally authorized
representative) need only sign the short form. The person obtaining consent
shall sign a copy of the summary. A copy of the summary and a copy of the
short form shall be given to the subject (or legally authorized
representative).

(c)(1) An IRB may waive the requirement for the investigator to
obtain a signed informed consent form for some or all subjects if it finds
any of the following:(i) That the only record linking the subject and the research
would be the informed consent form and the principal risk would be potential
harm resulting from a breach of confidentiality. Each subject (or legally
authorized representative) will be asked whether the subject wants
documentation linking the subject with the research, and the subject’s wishes
will govern;(ii) That the research presents no more than minimal risk of
harm to subjects and involves no procedures for which written consent is normally
required outside of the research context; or

(iii) If the subjects or legally authorized representatives are
members of a distinct cultural group or community in which signing forms is
not the norm, that the research presents no more than minimal risk of harm to
subjects and provided there is an appropriate alternative mechanism for
documenting that informed consent was obtained.

(c)(1) An IRB may waive the requirement for a signed consent
form for some or all subjects if it finds any of the following:(i) That the form would be the only record linking the subject
to the research and that a breach of confidentiality is the principal risk of
harm. Each subject (or legally authorized representative) must explicitly consent
to persistence of documentation linking the subject to the research; or(ii) That the research presents no more than minimal risk of
harm and involves no procedures for which written consent is normally
required outside of a research context; or

(iii) That the subject (or legally authorized representative) belongs
to a cultural group in which signing forms is not a norm, that the research
presents no more than minimal risk and that the IRB has approved an
alternative for documenting the obtaining of informed consent.

 

(2) In cases in which the documentation requirement is waived,
the IRB may require the investigator to provide subjects or legally
authorized representatives with a written statement regarding the research.
(2) If the requirement to document consent is waived, the IRB
may require the investigator to give subjects (or legally authorized
representatives) a written statement about the research.

 

 

 

 

Table 2. Comparisons between 2017
Regulation and SHM rewrite.

Regulation Regulation by SHM
Words 500 375
Words per Sentence 26.2 21.0
Passive Voice 53% 21%
Flesch-Kincaid Grade Level 14.2 12.5

[i] Department of Health and Human Services. Federal Policy for the Protection of Human Subjects. 45 CFR Part 46.117 (2017) https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/html/2017-01058.htm

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