This was recently circulated and sums up the problems at CUNY's 23 or
so  units, which I am sure have similar issues elsewhere.

September, 9, 2011

To: Dr. Gillian Small, Vice Chancellor for Research, CUNY;  Dr.
Jeffrey Cohen, CEO, HRP Consulting Group; Ms. Cheryl Savini,  COO, HRP
Consulting Group
Town Hall Meeting, Human Research Protection Programs & Institutional
Review Boards at CUNY September 9, 2011, Hunter College

Re: Reforms of CUNY's IRBs Regarding Social Science Research

I am a professor in the Sociology Department at Queens College and the
Graduate Center. I am a longtime member of the faculty deeply
committed to CUNY's mission and strong tradition of intellectual
freedom.  I am very happy to learn that CUNY is planning on
restructuring and hopefully seriously reforming its Institutional
Review Boards.

I wish to encourage those who are restructuring and reforming CUNY's
IRBs to pay close attention to the question of the powers of IRBs over
those of us who do social science and humanistic research.  In
particular, I hope they will look hard at issues about research which
is not conducted in laboratories, hospitals, and medical offices with
patients in experiments -- that is, at most routine, common, social
science and historical research, much of which simply involves talking
with other people.
As a growing literature documents, there have long been serious
problems with the expansion of IRB review to the social sciences.
These problems have increased enormously since about the year 2000,
and it is fair to say there is a now a growing national crisis about
the way that IRBs have intruded upon, interfered with, and often
stopped ordinary social science research, and about the disrespectful,
rude, high-handed way that IRBs have sometimes treated professors,
instructors, and even students . This has happened at many U.S.
universities and colleges.  And it has happened at the City University
of New York.

In the case of Hunter College professor Bernadette McCauley, CUNY has
been singled out in national news stories and scholarly publications
as an especially outrageous violator of long-standing, sensible
procedures for professional research and for routine information
gathering for classes.  A number of other CUNY faculty and students
have been likewise investigated, subjected to arbitrary orders, and
denied any appeal of the IRBs actions, decisions, and orders. This has
happened to colleagues of mine, and in the last year it has happened
to me.

For professors, their research and scholarly work is central to their
professional identity and position.  For professors, IRB allegations
of unethical conduct are deeply embarrassing and humiliating.  Not
surprisingly, unlike Professor McCauley, faculty usually do not make
public what has happened to them, or even discreetly tell many of
their colleagues. Rather, they usually try to get through their ordeal
in private and hopefully put the unpleasant and disturbing experience
behind them. As a result, those of us who are willing talk about what
has happened to us have learned about only some of the other cases
nationwide and at CUNY. No doubt the records of CUNY's various IRBs
tell many of these stories.

I hope that those restructuring CUNY's IRBs will make more
opportunities for individual faculty and their departments to present
suggestions and even tell what has happened to them at the hands of
CUNY's IRB beyond this single "Town Hall" meeting.  In this document,
I want to call attention to a few published works which discuss the
problems with IRBs and the social sciences generally. I have brought
copies of these for you, and I have pdf versions of them that I can
submit as well.  In addition, I have a few general recommendations and
one very specific suggestion about IRB policy.

WORKS ABOUT IRBS AND THE SOCIAL SCIENCES TO INCLUDE IN DISCUSSIONS AND
CONSIDERATIONS ABOUT REFORMING CUNY'S IRB SYSTEM.

• Zachary M. Schrag. Ethical Imperialism: Institutional Review Boards
and the Social Sciences, 19652009. Johns Hopkins University Press,
2010. This is the new and now definitive work on the history of IRBs
and the social sciences. It is cited and referenced in the July 26,
2011, official HHS announcement in the Federal Register of proposed
changes in rules governing "Human Subjects Research Protections."
(endnote 20 in:
http://www.federalregister.gov/articles/2011/07/26/2011-18792/human-subjects-research-protectionsenhancing-protections-for-research-subjects-and-reducing-burden
) I have brought a copy of the book's introduction which begins with
the story of Bernadette McCauley and the Hunter College IRB. Two
paragraphs of that are also featured prominently on the book's back
cover.  I hope that you will be able to get and closely read the whole
book.

• C. Kristina Gunsalus et. al. "The Illinois White Paper – Improving
the System for Protecting Human Subjects: Counteracting IRB Mission
Creep".  The University of Illinois College of Law, 2006, 32 pages.
This report was the result of a two-year investigation by the
University of Illinois and its law school. The report begins with the
following three paragraphs:
Our system of research self-regulation, designed to provide internal
checks and balances for those who participate in research involving
human subjects, is under considerable stress. Study after study
recently has reported that this is a system “in crisis,” “in
jeopardy,” and in need of thoughtful re-examination.

Much of this crisis has been caused by what we call mission creep, in
which the workload of IRBs has expanded beyond their ability to handle
effectively. Mission creep is caused by rewarding wrong behaviors,
such as focusing more on procedures and documentation than difficult
ethical questions; unclear definitions, which lead to unclear
responsibilities; efforts to comply with unwieldy federal requirements
even when research is not federally funded; exaggerated precautions to
protect against program shutdowns; and efforts to protect against
lawsuits.

Honest IRB specialists admit that they operate under constant concern
about the one case in a thousand that might slip through review — with
the consequence that the other 999 receive exaggerated reviews and
risk rejection in an effort to err on the side of caution. As a
consequence, mission creep is causing IRBs to lose the respect and
“buy-in” of the very people they are meant to regulate; they are
misdirecting their energies, threatening both academic and first
amendment freedoms; and most importantly, mission creep is taking
needed resources from the most risky research, which truly does need
IRB oversight.
I have brought you a copy of the report.

• Jack Katz, "Ethical escape routes for underground ethnographers."
American Ethnologist, 2008. Katz is a distinguished professor of
sociology at UCLA, with PhD and law degrees. He written several
articles about IRBs including this one which describes well the
impossible binds that IRB frequently put on ethnographic and interview
research, and how IRB rules could be changed to make them more
workable. It is at:
http://papers.ssrn.com/sol3/papers.cfm?abstract_id=902995 The paper's
abstract reads:
Campus committees for supervising research ethics have developed rules
and procedures that are indifferent to the emergent nature of
ethnographic research. As a result, participant-observing fieldworkers
have appreciated that, independent of their ethical commitments, they
cannot comply with official regulations. Resolution of the
fieldworker’s dilemma requires limiting review jurisdiction to funded
studies; articulating the meaning of regulatory language defining
auspices, exemptions, waiver, and research; and, above all, developing
a culture of legality in campus ethics administration.

I have brought a copy for you.
RECOMMENDATIONS
\• The University of Illinois report on "IRB Mission Creep" ends with
several pages of explicit recommendations about reforming IRB rules
and processes to make them serve faculty, students, and interview
subjects better. I urge they be taken very seriously.
• The article by Professor Jack Katz makes more general
recommendations about reform that include what he terms developing "a
culture of legality about IRBs."  These too seem essential to me for
reforming CUNY's IRBs.
• The book Ethical Imperialism by Zachary M. Schrag also make numerous
suggestions for alternative policies for governing IRBs and their
handling of social science research.  As I indicated, this is an
essential work.

• In the July 26, 2011 announcement of proposed changes to U.S.
government rules regarding human subject protection, a paragraph
explicitly summarizes some common criticisms of IRB governance of the
social sciences. Though not explicit recommendations, they do point in
the direction of needed reforms. In the beginning section called "I
Background" the announcement says: Questions have been raised about
the appropriateness of the review process for social and behavioral
research. The nature of the possible risks to subjects is often
significantly different in many social and behavioral research studies
as compared to biomedical research, and critics contend that the
difference is not adequately reflected in the current rules. While
physical risks generally are the greatest concern in biomedical
research, social and behavioral studies rarely pose physical risk but
may pose psychological or informational risks. Some have argued that,
particularly given the paucity of information suggesting significant
risks to subjects in certain types of survey and interview-based
research, the current system over-regulates such research. Further,
many critics see little evidence that most IRB review of social and
behavioral research effectively does much to protect research subjects
from psychological or informational risks. Over-regulating social and
behavioral research in general may serve to distract attention from
attempts to identify those social and behavioral research studies that
do pose threats to the welfare of subjects and thus do merit
significant oversight. (emphasis added) At:
http://www.federalregister.gov/articles/2011/07/26/2011-18792/human-subjects-researchprotections-enhancing-protections-for-research-subjects-and-reducing-burden

• In addition I encourage you to formally solicit comments from CUNY
faculty about possible reforms. The current U.S. government
announcement about proposed changes in federal IRB regulations is one
example of how this can be done.

• Institutions that receive federal monies are not required under
current regulation to apply U.S. government rules to unfunded research
or to research with non US government funding. The University of
Chicago and a number of other institutions have removed unfunded
social research from most or all IRB supervision, especially when the
work does not collect personal information, or is based on
confidentiality or anonymity. There is also now considerable
discussion nationally about exempting all or most social science
research that involves interviews or questionnaires, whether funded or
not, when the research does not collect or retain personal
information.  Certainly all anonymous and most confidential research
should require little or no IRB supervision or review.

• As many have noted, there is currently no appeal of IRB decisions
beyond the IRB itself. This is a serious violation of due process,
basic rights, and intellectual freedom.  There must be some authority
– possibly external – to which researchers can appeal the decisions of
CUNY's IRBs.

• Unlike some other prominent universities, CUNY's current IRB
materials do not distinguish or in any way refer to research which
involves human beings, including talking with them, which is "not
human subjects research."  This is a serious omission and should be
addressed in the restructuring and reform of CUNY's IRBs. The
University of Southern California is a leader in creating material for
its faculty and students to help them understand and deal with IRBs.
Its publications are also used by other colleges and universities.
Their materials do distinguish and discuss research with human beings
that is not human subjects research. As part of a broader rewriting
and reimagining of CUNY's IRB publications and rules, I encourage you
to consult USC's documents, and to develop thoughtful descriptions and
discussion of social research that involves talking with people, which
is defined by CUNY as not research with human subjects.

• Finally, CUNY's IRBs and its publications must recognize that
conversations and interviews with people that cover only what the
people know about institutions and social processes – and which do not
collect information about the person's life, values, feelings and
beliefs – is NOT research with "human subjects" as defined by the U.S.
government, by IRBs at other colleges and universities, and by
widely-used IRB training materials, including the CITI program used by
CUNY.  I will submit separately some documents about this point which
I discovered because of my own IRB case. But the basic point can be
made here.

U.S. government language defines a human subject as "a living
individual about whom an investigator conducting research obtains
identifiable information." Central to this definition is the phrase
"about whom."
CUNY requires training through the Collaborative Institutional
Training Initiative (CITI) at: https://www.citiprogram.org where one
can log in. All the modules can be seen by clicking the "Optional
Modules" link. The third module in the series, by Lorna Hicks from
Duke University, is titled "Defining Research with Human Subjects. "
Point 2.0 discusses the definition of a human subject and point 2.2 is
titled "About whom." It reads:
2.2 "About whom" :  Most research in the social and behavioral
sciences involves gathering information about individuals. However,
some research that involves interactions with people does not meet the
regulatory definition of research with human subjects because the
focus of the investigation is not the opinions, characteristics, or
behavior of the individual. In other words, the information being
elicited is not about the individual ("whom"), but rather is about
"what". (emphasis added)
The CITI training notes that researchers can elicit information from
an individual but about something else other than that individual.
Such research, the CITI training says, does not meet the regulatory
definition of human subjects. In the next paragraph, the CITI training
gives an example:

For example, if a researcher calls the director of a shelter for
battered women and asks her for the average length of stay of the
women who use the shelter, that inquiry would not meet the definition
of research with human subjects because the information requested is
not "about" the director. If the researcher interviewed the director
about her training, experience, and how she defines the problem of
battering, then the inquiry becomes about her - and thus "about whom."
(emphasis added)
Other universities recognize this distinction, but CUNY does not do so
in its IRB publications, and its IRBs personnel do not either, at
least they did not in the case of my unfunded project.  I strongly
urge you to revise CUNY's rules, procedures, and publications to
reflect this critical distinction in the meaning of human subjects
research. Again, I will submit additional materials on this point.

I appreciate the opportunity you have created today to hear about the
plans for restructuring CUNY's IRB. I wish you the best of luck in
your work. Please let me know if I can help you in any way.

Sincerely,
Harry G. Levine Professor

President, Social Explorer, Inc
50 Merriam Ave
Bronxville, NY 10708
Phone 1-888-636-1118
Mobile 914-522-4487
FAX 1-888-442-1117
andy@socialexplorer.com
www.socialexplorer.com
Become a fan on Facebook!
http://www.facebook.com/pages/Social-Explorer/110325499019530
Follow us on Twitter @socialexplorer

Prof of Sociology Queens College and Grad Ctr CUNY
Chair Queens College Sociology Dept
Office:  718-997-2852
Email:  andrew.beveridge@qc.cuny.edu
233D Powdermaker Hall
65-30 Kissena Blvd
Flushing, NY 11367-1597

Dear Andy and Colleagues,

I'm very appreciative of the correspondence on IRB's and this long overdue discussion. At the two-year colleges this simple process alongside what Andrew describes as "mission creeps" often makes research impossible for faculty already overwhelmed with teaching and committee responsibilities. I served on the IRB for about five years. Over and over again, I have watched projects, including harmless undergraduate projects with no potential for generalization, demolished by the IRB. At the CUNY Online, I finally moved student capstone projects to topics that involve either content analysis of published media or data from data banks (and even the latter can require IRB approval under some circumstances) to avoid the IRB process, which can result in delays of up to a semester for degree completion. My own IRB proposals have been held up for weeks -- often months -- by requests for revisions, such as putting information regarding how subjects would be recruited (subjects were a handful of community leaders -- the response was "by making interviews through their secretaries") in VIII 1. as well as VIII 2. on the automated form. We are required to attach a description of the U.S. Census if we use census data. I know that everyone is familiar with Donald Black's The Behavior of Law, but a "for instance" here is probably worth a thousand words in terms of how what you witness on the four-year campuses plays out on the margins. I've watched colleagues tear apart the design quality of modest unfunded efforts to see how students in their classes respond to Power Points; others spend hours and hours reviewing and correcting grammar in proposals from high school Intel students -- a requirement if you want to be on the IRB. Each college has a special idiosyncratic requirement for Exempt research -- it's in the culture. The IRB members "learn" it when they join.

We need a revision, and one that separates on the front end research that involves human subjects from what cannot, under the code, be classified as such. There is in CUNY a form for this: the Research Determination Form. And, way too much time is wasted reviewing Exempt Research. If it's Exempt -- and most sociology research falls into this category -- it's Exempt. Just implementing these two changes would be transformative.

Thanks again to everyone. I'm happy to see this finally happening.

Barbara

Barbara Walters, Ph.D.
Academic Director, SPS Online Baccalaureate in Sociology
CUNY School of Professional Studies
101 31st Street, Suite 733
Phone/Voicemail: 646-344-7327
E-mail: bwalters@kbcc.cuny.edu

-----citasa-bounces@list.citasa.org wrote: -----> To: section asa <citasa@list.citasa.org>

From: "Andrew A. Beveridge"
Sent by: citasa-bounces@list.citasa.org
Date: 09/27/2011 07:04AM
Subject: [CITASA] IRB Mission Creep and the Social Sciences

This was recently circulated and sums up the problems at CUNY's 23 or
so units, which I am sure have similar issues elsewhere.

September, 9, 2011

To: Dr. Gillian Small, Vice Chancellor for Research, CUNY; Dr.
Jeffrey Cohen, CEO, HRP Consulting Group; Ms. Cheryl Savini, COO, HRP
Consulting Group
Town Hall Meeting, Human Research Protection Programs & Institutional
Review Boards at CUNY September 9, 2011, Hunter College

Re: Reforms of CUNY's IRBs Regarding Social Science Research

I am a professor in the Sociology Department at Queens College and the
Graduate Center. I am a longtime member of the faculty deeply
committed to CUNY's mission and strong tradition of intellectual
freedom. I am very happy to learn that CUNY is planning on
restructuring and hopefully seriously reforming its Institutional
Review Boards.

I wish to encourage those who are restructuring and reforming CUNY's
IRBs to pay close attention to the question of the powers of IRBs over
those of us who do social science and humanistic research. In
particular, I hope they will look hard at issues about research which
is not conducted in laboratories, hospitals, and medical offices with
patients in experiments -- that is, at most routine, common, social
science and historical research, much of which simply involves talking
with other people.
As a growing literature documents, there have long been serious
problems with the expansion of IRB review to the social sciences.
These problems have increased enormously since about the year 2000,
and it is fair to say there is a now a growing national crisis about
the way that IRBs have intruded upon, interfered with, and often
stopped ordinary social science research, and about the disrespectful,
rude, high-handed way that IRBs have sometimes treated professors,
instructors, and even students . This has happened at many U.S.
universities and colleges. And it has happened at the City University
of New York.

In the case of Hunter College professor Bernadette McCauley, CUNY has
been singled out in national news stories and scholarly publications
as an especially outrageous violator of long-standing, sensible
procedures for professional research and for routine information
gathering for classes. A number of other CUNY faculty and students
have been likewise investigated, subjected to arbitrary orders, and
denied any appeal of the IRBs actions, decisions, and orders. This has
happened to colleagues of mine, and in the last year it has happened
to me.

For professors, their research and scholarly work is central to their
professional identity and position. For professors, IRB allegations
of unethical conduct are deeply embarrassing and humiliating. Not
surprisingly, unlike Professor McCauley, faculty usually do not make
public what has happened to them, or even discreetly tell many of
their colleagues. Rather, they usually try to get through their ordeal
in private and hopefully put the unpleasant and disturbing experience
behind them. As a result, those of us who are willing talk about what
has happened to us have learned about only some of the other cases
nationwide and at CUNY. No doubt the records of CUNY's various IRBs
tell many of these stories.

I hope that those restructuring CUNY's IRBs will make more
opportunities for individual faculty and their departments to present
suggestions and even tell what has happened to them at the hands of
CUNY's IRB beyond this single "Town Hall" meeting. In this document,
I want to call attention to a few published works which discuss the
problems with IRBs and the social sciences generally. I have brought
copies of these for you, and I have pdf versions of them that I can
submit as well. In addition, I have a few general recommendations and
one very specific suggestion about IRB policy.

WORKS ABOUT IRBS AND THE SOCIAL SCIENCES TO INCLUDE IN DISCUSSIONS AND
CONSIDERATIONS ABOUT REFORMING CUNY'S IRB SYSTEM.

• Zachary M. Schrag. Ethical Imperialism: Institutional Review Boards
and the Social Sciences, 19652009. Johns Hopkins University Press,
2010. This is the new and now definitive work on the history of IRBs
and the social sciences. It is cited and referenced in the July 26,
2011, official HHS announcement in the Federal Register of proposed
changes in rules governing "Human Subjects Research Protections."
(endnote 20 in:
http://www.federalregister.gov/articles/2011/07/26/2011-18792/human-subjects-research-protectionsenhancing-protections-for-research-subjects-and-reducing-burden
) I have brought a copy of the book's introduction which begins with
the story of Bernadette McCauley and the Hunter College IRB. Two
paragraphs of that are also featured prominently on the book's back
cover. I hope that you will be able to get and closely read the whole
book.

• C. Kristina Gunsalus et. al. "The Illinois White Paper – Improving
the System for Protecting Human Subjects: Counteracting IRB Mission
Creep". The University of Illinois College of Law, 2006, 32 pages.
This report was the result of a two-year investigation by the
University of Illinois and its law school. The report begins with the
following three paragraphs:
Our system of research self-regulation, designed to provide internal
checks and balances for those who participate in research involving
human subjects, is under considerable stress. Study after study
recently has reported that this is a system “in crisis,” “in
jeopardy,” and in need of thoughtful re-examination.

Much of this crisis has been caused by what we call mission creep, in
which the workload of IRBs has expanded beyond their ability to handle
effectively. Mission creep is caused by rewarding wrong behaviors,
such as focusing more on procedures and documentation than difficult
ethical questions; unclear definitions, which lead to unclear
responsibilities; efforts to comply with unwieldy federal requirements
even when research is not federally funded; exaggerated precautions to
protect against program shutdowns; and efforts to protect against
lawsuits.

Honest IRB specialists admit that they operate under constant concern
about the one case in a thousand that might slip through review — with
the consequence that the other 999 receive exaggerated reviews and
risk rejection in an effort to err on the side of caution. As a
consequence, mission creep is causing IRBs to lose the respect and
“buy-in” of the very people they are meant to regulate; they are
misdirecting their energies, threatening both academic and first
amendment freedoms; and most importantly, mission creep is taking
needed resources from the most risky research, which truly does need
IRB oversight.
I have brought you a copy of the report.

• Jack Katz, "Ethical escape routes for underground ethnographers."
American Ethnologist, 2008. Katz is a distinguished professor of
sociology at UCLA, with PhD and law degrees. He written several
articles about IRBs including this one which describes well the
impossible binds that IRB frequently put on ethnographic and interview
research, and how IRB rules could be changed to make them more
workable. It is at:
http://papers.ssrn.com/sol3/papers.cfm?abstract_id=902995 The paper's
abstract reads:
Campus committees for supervising research ethics have developed rules
and procedures that are indifferent to the emergent nature of
ethnographic research. As a result, participant-observing fieldworkers
have appreciated that, independent of their ethical commitments, they
cannot comply with official regulations. Resolution of the
fieldworker’s dilemma requires limiting review jurisdiction to funded
studies; articulating the meaning of regulatory language defining
auspices, exemptions, waiver, and research; and, above all, developing
a culture of legality in campus ethics administration.

I have brought a copy for you.
RECOMMENDATIONS
\• The University of Illinois report on "IRB Mission Creep" ends with
several pages of explicit recommendations about reforming IRB rules
and processes to make them serve faculty, students, and interview
subjects better. I urge they be taken very seriously.
• The article by Professor Jack Katz makes more general
recommendations about reform that include what he terms developing "a
culture of legality about IRBs." These too seem essential to me for
reforming CUNY's IRBs.
• The book Ethical Imperialism by Zachary M. Schrag also make numerous
suggestions for alternative policies for governing IRBs and their
handling of social science research. As I indicated, this is an
essential work.

• In the July 26, 2011 announcement of proposed changes to U.S.
government rules regarding human subject protection, a paragraph
explicitly summarizes some common criticisms of IRB governance of the
social sciences. Though not explicit recommendations, they do point in
the direction of needed reforms. In the beginning section called "I
Background" the announcement says: Questions have been raised about
the appropriateness of the review process for social and behavioral
research. The nature of the possible risks to subjects is often
significantly different in many social and behavioral research studies
as compared to biomedical research, and critics contend that the
difference is not adequately reflected in the current rules. While
physical risks generally are the greatest concern in biomedical
research, social and behavioral studies rarely pose physical risk but
may pose psychological or informational risks. Some have argued that,
particularly given the paucity of information suggesting significant
risks to subjects in certain types of survey and interview-based
research, the current system over-regulates such research. Further,
many critics see little evidence that most IRB review of social and
behavioral research effectively does much to protect research subjects
from psychological or informational risks. Over-regulating social and
behavioral research in general may serve to distract attention from
attempts to identify those social and behavioral research studies that
do pose threats to the welfare of subjects and thus do merit
significant oversight. (emphasis added) At:
http://www.federalregister.gov/articles/2011/07/26/2011-18792/human-subjects-researchprotections-enhancing-protections-for-research-subjects-and-reducing-burden

• In addition I encourage you to formally solicit comments from CUNY
faculty about possible reforms. The current U.S. government
announcement about proposed changes in federal IRB regulations is one
example of how this can be done.

• Institutions that receive federal monies are not required under
current regulation to apply U.S. government rules to unfunded research
or to research with non US government funding. The University of
Chicago and a number of other institutions have removed unfunded
social research from most or all IRB supervision, especially when the
work does not collect personal information, or is based on
confidentiality or anonymity. There is also now considerable
discussion nationally about exempting all or most social science
research that involves interviews or questionnaires, whether funded or
not, when the research does not collect or retain personal
information. Certainly all anonymous and most confidential research
should require little or no IRB supervision or review.

• As many have noted, there is currently no appeal of IRB decisions
beyond the IRB itself. This is a serious violation of due process,
basic rights, and intellectual freedom. There must be some authority
– possibly external – to which researchers can appeal the decisions of
CUNY's IRBs.

• Unlike some other prominent universities, CUNY's current IRB
materials do not distinguish or in any way refer to research which
involves human beings, including talking with them, which is "not
human subjects research." This is a serious omission and should be
addressed in the restructuring and reform of CUNY's IRBs. The
University of Southern California is a leader in creating material for
its faculty and students to help them understand and deal with IRBs.
Its publications are also used by other colleges and universities.
Their materials do distinguish and discuss research with human beings
that is not human subjects research. As part of a broader rewriting
and reimagining of CUNY's IRB publications and rules, I encourage you
to consult USC's documents, and to develop thoughtful descriptions and
discussion of social research that involves talking with people, which
is defined by CUNY as not research with human subjects.

• Finally, CUNY's IRBs and its publications must recognize that
conversations and interviews with people that cover only what the
people know about institutions and social processes – and which do not
collect information about the person's life, values, feelings and
beliefs – is NOT research with "human subjects" as defined by the U.S.
government, by IRBs at other colleges and universities, and by
widely-used IRB training materials, including the CITI program used by
CUNY. I will submit separately some documents about this point which
I discovered because of my own IRB case. But the basic point can be
made here.

U.S. government language defines a human subject as "a living
individual about whom an investigator conducting research obtains
identifiable information." Central to this definition is the phrase
"about whom."
CUNY requires training through the Collaborative Institutional
Training Initiative (CITI) at: https://www.citiprogram.org where one
can log in. All the modules can be seen by clicking the "Optional
Modules" link. The third module in the series, by Lorna Hicks from
Duke University, is titled "Defining Research with Human Subjects. "
Point 2.0 discusses the definition of a human subject and point 2.2 is
titled "About whom." It reads:
2.2 "About whom" : Most research in the social and behavioral
sciences involves gathering information about individuals. However,
some research that involves interactions with people does not meet the
regulatory definition of research with human subjects because the
focus of the investigation is not the opinions, characteristics, or
behavior of the individual. In other words, the information being
elicited is not about the individual ("whom"), but rather is about
"what". (emphasis added)
The CITI training notes that researchers can elicit information from
an individual but about something else other than that individual.
Such research, the CITI training says, does not meet the regulatory
definition of human subjects. In the next paragraph, the CITI training
gives an example:

For example, if a researcher calls the director of a shelter for
battered women and asks her for the average length of stay of the
women who use the shelter, that inquiry would not meet the definition
of research with human subjects because the information requested is
not "about" the director. If the researcher interviewed the director
about her training, experience, and how she defines the problem of
battering, then the inquiry becomes about her - and thus "about whom."
(emphasis added)
Other universities recognize this distinction, but CUNY does not do so
in its IRB publications, and its IRBs personnel do not either, at
least they did not in the case of my unfunded project. I strongly
urge you to revise CUNY's rules, procedures, and publications to
reflect this critical distinction in the meaning of human subjects
research. Again, I will submit additional materials on this point.

I appreciate the opportunity you have created today to hear about the
plans for restructuring CUNY's IRB. I wish you the best of luck in
your work. Please let me know if I can help you in any way.

Sincerely,
Harry G. Levine Professor

President, Social Explorer, Inc
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Prof of Sociology Queens College and Grad Ctr CUNY
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Email: andrew.beveridge@qc.cuny.edu
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