IRB: Scene 2
Elizabeth A. Buchanan, Ph.D.
Endowed Chair in Ethics
Center for Applied Ethics
University of Wisconsin-Stout
buchanane@uwstout.edu
7152325184
Follow-Ups and Reminders
• One-person IRBs: Not boards, offices; boards
must have 5 members per regs
• The sessions are recorded; we will need to
determine if/how to share.
• Ask questions at any time!
In the News:
• http://www.research.umn.edu/news/docume
nts/final_report.pdf
Today’s Topics
• Processes
– Retention
– Dating
• Reviewing protocols
– Exempt
– Expedited
– Full Board
• Consent
• Modifications
– Significant versus minor modification
• Special Topics: SOTL
Recall an Important Contextual Point:
• Regs
• Institutional specificity
In order to contextualize today’s
session, a few things about us at Stout:
• We review all research, student, classroom projects,
campus research (we think!), etc
• Our process entails:
• Researcher submits PDF; documents are checked in by
administrative staff; routed to a board member; review
conducted and results sent back to admin staff;
notification of review status sent via email to
researcher; we do not use an IRB management system
• 10 working day turnaround for exempt/expedited;
• Pilot test this semester: 5 day turn-around for class
submissions
Retention of Records
It is more than keeping records three years. Protocol files need to be kept for three
years after completion of the research. Current and previous written procedures
required by the regulations need to be retained until all research ever reviewed under
under an procedure has been closed for three years. A similar retention requirement
applies to current and previous lists of IRB members (rosters), minutes of IRB
meetings, and correspondence between the IRB and the investigator. For example, if
you had a protocol open in 2000, and close in 2012, then you would have to keep all
versions of written procedures, rosters, and minutes back to 2000 until at least 2015.
If you retain records longer than required by the regulations, OHRP and FDA can ask
for any records in your possesion and you have to hand them over. I have had a
number of clients over the years that were unhappy when they found this out by
direct experience. If OHRP or FDA ask you for records and you destroyed them as part
of a systematic records destruction process, OHRP and FDA will acknowledge that and
leave you alone. If you destroy records en masse the day after you get a notification of
an audit, you are in a heap of trouble. If you keep an electronic copy and destroy the
paper copy, FDA will consider that to be a retained record that they can ask to inspect.
If you destroy records, you must destroy all versions, electronic, paper, including
backup files and tapes.
Retention and Destruction: Jeff Cooper
4.1. Review the study files that can be destroyed.
4.1.1.
Omit destruction of records on a legal hold.
4.1.2.
Previously approved non-exempt studies: Three years after the date on which all
research sites overseen by the [Organization]’s IRB have been completed either through
closure, <Termination of IRB Approval>, disapproval, or lapse of approval
4.1.3.
Non-exempt studies never approved and exempt studies: Three years after the
last IRB action or after withdrawal by the submitter
4.2. Shred paper documents and dispose the shredded materials securely.
4.3. Notify information technology to destroy electronic documents by either deleting the
files or replacing the files with stub files documenting the date of deletion.
4.4. Document your name and the date of destruction with the following for each study
file destroyed:
4.4.1.
Study title
4.4.2.
IRB ID
4.4.3.
Date of completion
4.4.4.
Paper, electronic, or both
Dating
• No regulatory requirement to put date stamps on
consent forms, survey documents, etc. BUT: for
good housekeeping:
• OHRP recommends that IRBs consider using
methods that will allow the IRB to readily
recognize the most current version of the IRBapproved informed consent document, for
example, using date stamps, version numbers, or
initialing and dating documents to indicate when
a version was approved.
Models of/for Reviewing Protocols
• Pre-review by admin/IRB coordinator/IRB analyst
• Review by Chair
• Sent to a decentral reviewer
– Expert review?
• Sent to board members
• Full board
– QUESTION: WHEN DO YOU DETERMINE A PROTOCOL
MUST GO TO FULL BOARD? PLEASE DESCRIBE
Protocol Review:
Always Begin at the Beginning:
• Is it research?
– Consider if a main goal of the activity is to learn something for
the purpose of benefitting people other than the research
subjects
– Are the study aims clear?
– Is there appropriate justification for the project?
– What is the primary intent of a project?
– What’s NOT research?
• Innovative therapy, nonvalidated practices, QI (aimed at improving
local systems, not generalizable); public health surveillance, public
health program evaluation
• Does it involve human subjects?
• Are you engaged?
• Does it fall under an exempt category?
What is Exempt?
• Research activities in which the only
involvement of human subjects will be in one
or more of the exempt categories defined by
the federal regulations, will be given an
exempt determination, rather than IRB
approval. Exempt studies are so named
because they are exempt from some of the
federal regulations. However, they are not
exempt from state laws, institutional policies,
or the requirements for ethical research.
Who may determine that research is
exempt?
• The regulations do not specify who at an
institution may determine that research is
exempt under 45 CFR 46.101(b). However,
OHRP recommends that, because of the
potential for conflict of interest, investigators
not be given the authority to make an
independent determination that human
subjects research is exempt.
Who Decides Exemptions?
• Persons making an exemption determination should have access to sufficient
information to make a correct determination. Evaluation tools and resources may
take a variety of forms, including but not restricted to: checklists, Standard
Operating Procedures, or specialized training for individuals authorized by the
institution to make an exemption determination.
• When an exemption determination is made, the specific exemption category or
categories should be included in the record and this information should be
available for oversight and audit purposes.
• Institutional policies and procedures should identify clearly who is responsible for
making exemption decisions. This may be done in a variety of ways, including
delegation by name, role, or position.
• Institutions should make policy and procedure information addressing exemption
determination readily accessible to investigators and others involved in the
conduct and administration of human subjects research.
Category 1
• Research conducted in established or commonly
accepted educational settings, involving normal
educational practices, such as: (i) research on regular
and special education instructional strategies, or (ii)
research on the effectiveness of or the comparison
among instructional techniques, curricula, or classroom
management methods.
• Examples:
– Evaluating the use of accepted or revised standardized
tests
– Testing or comparing a curriculum or lesson
– A program evaluation of pharmacy continuing education
Category 2
•
Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public
behavior, unless: (i) information obtained is recorded in such a manner that human
subjects can be identified, directly or through identifiers linked to the subjects;
and (ii) any disclosure of the human subjects' responses outside the research could
reasonably place the subjects at risk of criminal or civil liability or be damaging to
the subjects' financial standing, employability, or reputation.
•
Note: The section of this category pertaining to standardized educational tests may
be applied to research involving children. This category may also apply to research
with children when the investigator observes public behavior but does not
participate in that behavior or activity. This section is not applicable to survey or
interview research involving children.
•
Examples:
– Surveying teachers, nurses, or doctors about a technique or an outcome
– Interviewing managers about a management style or best practice
– Conducting a focus group about an experience or an opinion of a community program
Can We Use Exempt 2 with Children?
• Kelly from UW-O, do you remember??
• IRB Bible: NO
• But:
• From IRB Forum:
“In fact, OHRP notes that a particular research activity may be found to be exempt if it
the activity meets the criteria for any one of the exempt categories of research
described under HHS regulations at 45 CFR 46.101(b). Therefore, if an activity is found
to be meet the criteria for exemption under 45 CFR 46.101(b)(1), it does not need to
be evaluated with respect to any other exempt category (such as that category under
45 CFR 46.101(b)(2)). OHRP further notes that some research activities that involve
individually identifiable data about student performance reasonably may be found to
be exempt under HHS regulations at 45 CFR 46.101(b)(1). Accordingly, in the example
given, if an institution determined that the student survey (and the rest of that study)
met the requirements for exemption under 45 CFR 46.101(b)(1), then the survey
would be exempt, and it would be irrelevant whether or not it met the requirements
for exemption under 45 CFR 46.101(b)(2).” Elyse Summers
Category 3
• Research involving the use of educational tests (cognitive,
diagnostic, aptitude, achievement), survey procedures,
interview procedures, or observation of public behavior
that is not exempt under paragraph (2) of this section, if: (i)
the human subjects are elected or appointed public
officials or candidates for public office; or (ii) Federal
statute(s) require(s) without exception that the
confidentiality of the personally identifiable information
will be maintained throughout the research and thereafter.
• Example:
– Interviewing public officials about a local or global issue.
Category 4
• Research involving the collection or study of existing* data,
documents, records, pathological specimens, or diagnostic
specimens, if these sources are publicly available or if the
information is recorded by the investigator in such a manner that
subjects cannot be identified, directly or through identifiers linked
to the subjects.
• *Note: "Existing" means existing before the research is proposed to
the institutional review board to determine whether the research is
exempt.
• Example:
– Analyzing existing tissue samples or data set which are recorded by
the investigator without identifiers
Types of Data
• Anonymous – the identity of the respondent cannot be determined;
no links exist between the data and the individual about whom the
data are recorded; ongoing debates about the reality of anonymity!
Is confidentiality where it’s at?
• De-identified – identifiers have been removed from the dataset
under consideration; links between the data and the individual
about whom the data are recorded exist but are not readily
accessible to the researcher at CU;
• Coded – identifiers have been removed from the dataset under
consideration but can readily be replaced through the use of a
master list that is accessible to the investigator;
• Identifiable or non-coded – the identity of the subject is
documented, linked or associated with the data.
Coded Data (SO MUCH TO COVER….!)
Lots of Discussion and Ambiguity
These Days, both SBER and Med/Bio
Category 5
• Research and demonstration projects which are
conducted by or subject to the approval of
department or agency heads, and which are
designed to study, evaluate, or otherwise
examine: (i) Public benefit or service programs;
(ii) procedures for obtaining benefits or services
under those programs; (iii) possible changes in or
alternatives to those programs or procedures; or
(iv) possible changes in methods or levels of
payment for benefits or services under those
programs.
Category 6
• Taste and food quality evaluation and consumer
acceptance studies, (i) if wholesome foods
without additives are consumed or (ii) if a food is
consumed that contains a food ingredient at or
below the level and for a use found to be safe, or
agricultural chemical or environmental
contaminant at or below the level found to be
safe, by the Food and Drug Administration or
approved by the Environmental Protection
Agency or the Food Safety and Inspection Service
of the U.S. Department of Agriculture.
– “The sauerkraut protocol”
Expedited Review
• Expedited reviews are conducted by at least one experienced
member of the IRB. In order to qualify for review via expedited
procedures, the research must not be greater than minimal risk and
fall into at least one of the expedited categories defined by the
federal regulations.
• The expedited review procedure may not be used where
identification of the subjects and/or their responses would
reasonably place them at risk of criminal or civil liability or be
damaging to the subjects financial standing, employability,
insurability, reputation, or be stigmatizing, unless reasonable and
appropriate protections will be implemented so that risks related to
invasion of privacy and breach of confidentiality are no greater than
minimal risk.
Full Board Review
• Research that is greater than minimal risk and/or does not
qualify for exempt or expedited review, as defined by the
categories, will be reviewed by the Full Board at a convened
meeting.
• Expedited review as defined by federal regulations allows
the IRB chairperson or one or more experienced reviewers
designated by the chairperson from among members of the
IRB to evaluate and approve specific types of research.
Reviewers conducting an expedited review may exercise all
of the authority of the IRB except that they may not
disapprove a study. When a subcommittee cannot approve
the research under expedited review, the study is referred
to the full Committee for review.
What Are Our Options?
•
•
•
•
•
Exempt
Approve
Defer with minor mods
Defer with major mods
Disapprove
• Share your experiences.
When is consent required?
Research
Involving human subjects
Conducted or supported by Common Rule
agency or covered by applicable FWA
 Not exempt
 Not eligible for waiver of informed consent
(Note: not available for FDA-regulated research except for emergency
research, and other life-threatening or military situations outlined in FDA
regulations at 21 CFR 50.23)
Consent Includes Subject Recruitment!
• OHRP considers subject recruitment part of informed
consent:
o Recruitment plan must receive IRB review/approval
prior to initiation of research
o This often poses challenges in classroom research:
o Dealing with “pre-recruitment”
o Convenience subjects/sampling
Required Elements of Consent
•
•
•
•
•
•
•
•
•
•
•
•
•
§46.116 Informed Consent Checklist - Basic and Additional Elements
A statement that the study involves research
An explanation of the purposes of the research
The expected duration of the subject's participation
A description of the procedures to be followed
Identification of any procedures which are experimental
A description of any reasonably foreseeable risks or discomforts to the subject
A description of any benefits to the subject or to others which may reasonably be expected from the
research
A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be
advantageous to the subject
A statement describing the extent, if any, to which confidentiality of records identifying the subject will be
maintained
For research involving more than minimal risk, an explanation as to whether any compensation, and an
explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist
of, or where further information may be obtained
Research, Rights or Injury: An explanation of whom to contact for answers to pertinent questions about the
research and research subjects' rights, and whom to contact in the event of a research-related injury to the
subject
A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits
to which the subject is otherwise entitled, and the subject may discontinue participation at any time
without penalty or loss of benefits, to which the subject is otherwise entitled
Waiver of informed consent
45 CFR 46.116(d)[not for FDA-regulated research]
• Waiver may be of some or all of the required elements,
or of requirement for consent in toto
• IRB must find and document:
– Minimal risk research;
– Waiver will not adversely affect subjects’ rights and welfare;
– Research could not practicably be carried out without waiver;
and
– When appropriate, subjects provided with additional pertinent
information after participation
Documentation required unless waived [waiver
not permitted in FDA-regulated studies]
 If documentation required, “long form” or “short form”
procedure (45 CFR 46.117)
 For waiver, IRB must find:
o Consent document would be only record linking subject to
the research and principal risk is breach of confidentiality,
and each subject must be asked if documentation wanted;
or
o Minimal risk research; no procedures requiring consent in
a non-research context
 IRB may require investigator to give subjects written
statement regarding the research
Continuing Review
• http://www.hhs.gov/ohrp/policy/continuingre
view2010.html
Electronic Signatures
Electronic signatures
Electronic signatures encompass a broad
gamut of technologies and methodologies,
ranging from an “I agree” button in a click-thru
agreement…
to an electronic tablet which accepts a
handwritten signature (oftentimes referred to
as an eSignature)…
to a digital signature cryptographically tied to
a digital ID or certificate
John B. Harris, Adobe Security blog entry
"So what is an electronic signature
anyway?",
http://blogs.adobe.com/security/2008/02/
Electronic signatures
OHRP FAQ:
 Does not require specific
method of electronic
signature
 Provides points to
consider for the IRB to
evaluate method of
obtaining electronic
signature
 Q: In what jurisdiction is
the research being
conducted?
Electronic Signatures
• Jurisdictionally-based
• Wisconsin laws at
http://docs.legis.wisconsin.gov/statutes/statut
es/137/II/15
• Discuss with your legal counsel
SOTL
• With eternal thanks to and sadness at the loss of DR. RENEE MEYER, UWM
• In 2007, Renee spearheaded a group to discuss SOTL and IRB concerns
• That document remains relevant today.
– SOTL researchers seek to advance the practice of teaching and learning
through scholarly inquiry into student learning.
• SOTL asks:
– How can an instructor help students learn to be more critical or reflective
thinkers?
– How can an instructor help students learn how to use feedback on their
assignments so as to make the subsequent assignments better?
– How do students view group participation, and how does that impact their
learning?
– How can instructors help students learn to think creatively?
– How do students draw on their prior knowledge to learn about new
information or ideas?
Particular Concerns with SOTL
• Student Coercion/Power differentials
• Waste of time? (not just SOTL research…)
Case Studies
A student PI contacted the IRB regarding a
proposed study in which they planned to
interview gang members about the meaning
behind their tattoos [a very valuable data point].
The IRB and the PI were concerned that a gang
member could disclose a past crime or a future
intent to harm, and wondered what legal
obligations the student would have should such
information be disclosed.
10-12 orphanages in Cairo, Egypt (near Tahir Square) and interviews
with government officials were undertaken by a student researcher
who had previously been told by his faculty advisor that he did not
need IRB review to conduct research for his dissertation. Questions
were personal and sensitive in nature, and ranged in topic from
perceptions of the orphanage system and solutions for improvement,
to how staff could be better trained, to the kinds of psychological
distress experienced by the children living there. Student collected data
about children using their experiences in directed art therapy. Data was
also collected by way of observation in order to describe day to day life.
Surveys are commonly used in social behavioral research.
To reach large numbers of people the field has moved to
vendors like mechanicalTurk, and Qualtrics to reach a
wide audience and provide an intermediary between
subject and researcher. MechanicalTurk is also a venue
for posting small jobs and processing the compensation
paid to individual account holders who perform the work.
A regular mechanicTurk user became disgruntled after a
75₵ payment was denied for completion of a survey. He
took his complaint to the president of USC. As in all big
institutions, the action to respond went through many
administrative layers, all of which passed the issue down,
but all of which needed to be informed of the resolution.
In other words, a major ruckus over 75₵
Next Session
• April 3, 2015, 2-4
• Topics: Internet/social media research, data
security, and emerging issues
• Send questions/cases!