Remedies for the Top 10 Stalls in the IRB New Protocol
Submission Process
University of Indianapolis IRB
February 24-25, 2010
University of Indianapolis IRB Members
Dr. Donna Konradi, IRB Chair (Nursing)
Dr. Matthew Beekley (Kinesiology)
Cory Clasemann, Human Protections Administrator
Dr. Lucinda Dale (Occupational Therapy)
Tracy Marschall (Social Sciences)
Dr. Fred May (Nursing)
Dr. Peter Rundquist (Physical Therapy)
Dr. John Somers (Teacher Education)
Dr. Jacqueline Wall (Psychology)
Alan Witchey (Community Member)
*Greg Manship
*Alternate member for Cory Clasemann)
UIndy IRB, February 24-25, 2010
IRB Review
• The purpose of IRB review is
to maximize research
participant benefit and
minimize risk.
• Using the information in the
protocol submission
documents, the IRB reviewers
weigh the benefits of
participation against
research-related risks for the
prospective research
subjects.
UIndy IRB, February 24-25, 2010
The Purpose of the Forum….
• Describe common problems that lead to “stalls”
and delays in the IRB approval process
• Describe remedies for resolving common
problems
• Provide resources from the Department of
Health and Human Services (DHHS), Office for
Human Research Protections (OHRP) and
other Federal Agencies regarding the criteria
for IRB approval & the scope of the IRB’s
obligations & responsibilities.
UIndy IRB, February 24-25, 2010
10 Stalls
1.
2.
3.
4.
5.
Incomplete protocol submission
Clarity issues
Incomplete &/or missing requests for waivers
Information inconsistencies
Inability to determine based on the information provided if the
research related activities are consistent with Uindy Policies and
Procedures
6. Concerns about data security measures
7. Research team member roles and responsibilities are not clearly
described.
8. Concerns about the research design
9. Research related activities are not clearly described
10. Submitted documents are not “research-ready.”
UIndy IRB, February 24-25, 2010
#1: The Incomplete Submission
•
•
When required information is missing from the initial protocol submission,
the IRB staff will contact the researcher with requests for additional
pieces of information. The IRB will not distribute an incomplete protocol to
committee members for review.
Carefully review your institution’s submission checklist and make sure
that all required elements are included with the protocol submission
a) Description of the informed consent process
b) Letters of informed consent / assent
c) Letters of cooperation / agreement
d) Recruitment materials
e) Verification of Human Subjects’ Protections Training
f) Data collection tools
UIndy IRB, February 24-25, 2010
a) Informed Consent / Assent Process
Elements
WHO will be responsible for obtaining the informed consents?
WHO will answer the prospective participants questions about the
research study?
WHERE will informed consent take place?
WHAT information will be provided to each participant?
HOW will participants receive information about the study?
HOW will the members of the research team verify that participants
understand the essential informed consent elements?
WHEN will the participants provide their informed consent.?
UIndy IRB, February 24-25, 2010
b) Informed Consent Document Elements
Include all of the required elements on the informed
consent document.
Provide the IRB with an exact copy of all consent / assent
documents. After the IRB has approved the protocol,
any & all changes to the letter of informed consent
must be submitted as a project “revision” for approval.
Develop the Informed Consent document on institutional
letterhead.
UIndy IRB, February 24-25, 2010
Resources for Developing the Informed Consent
Document
Institutional Review Board Guidebook Chapter 3, Basic
IRB Review (Section B Informed Consent). United
States Department of Health and Human Services
(DHHS), Office for Human Research Protections
(OHRP)
General Requirement for Informed Consent, Protection of
Human Subjects Title 45 Code of Federal Regulations
§46.116
OHRP Informed Consent Frequently Asked Questions,
United States Department of Health and Human
Services (DHHS), Office for Human Research
Protections (OHRP)
UIndy IRB, February 24-25, 2010
c) Letters of Agreement / Cooperation
Include with the protocol submission signed letter(s) of
agreement or cooperation.
Each letter should include:
• Name, position, and scope of authority for the individual
granting the research team access to the recruitment &/or data
collection site and/or study sample.
• Language affirming that the signatory understands the nature
of the research, understands any site responsibilities and
agrees to provide access.
• The dates of facility involvement in the research
UIndy IRB, February 24-25, 2010
d) Recruitment Materials
Provide the IRB with exact
copies for all recruitment
documents & scripts (e-mails,
phone scripts, announcement
postings, in-person
announcement scripts, etc).
Provide the IRB with detailed
information about your
recruitment procedures and
strategies.
UIndy IRB, February 24-25, 2010
d) Required Recruitment Elements
1. Name and address of the researchers and the
research facility
2. Purpose of the research
3. Eligibility criteria for participation
4. Anticipated participant benefits (if any)
5. Time or other commitments required of the participant
6. Location of the research
7. Individual to contact for additional information
Resource Recruiting Study Subjects, United States Food and Drug
Administration (FDA).
UIndy IRB, February 24-25, 2010
e) Human Subjects’ Protections Training
Provide the IRB with verification
of human subjects
protections training for all
members of the research
team.
Resource OHRP Investigator
Responsibility Frequently Asked
Questions, United States
Department of Health and Human
Services (DHHS).
UIndy IRB, February 24-25, 2010
f) Data Collection Tools & Measures
• Provide the IRB with all study-related tools,
measures, surveys, and data recording forms.
The IRB must receive these tools and
measures in the exact form that they will be
used in the research and distributed to the
research participants.
• If participants will be accessing a survey or
other measures electronically (ie. from an
online survey hosting service), provide the IRB
with a live link to the online survey.
UIndy IRB, February 24-25, 2010
Stall #2: The Confusing Submission
The protocol does not include a clear explanation &/or
description of all research process elements
When the information provided by the researcher is
confusing or unclear, the IRB will contact the
researcher with requests for clarifications.
• Significant and distracting grammar errors that result in
unclear communication
• Spelling errors and lack of precision with “word choice”
• Missing, confusing &/or inaccurate information
• Use of jargon
UIndy IRB, February 24-25, 2010
Stall #3: Incomplete &/or Missing Requests for
Waivers
IF….
• Federal waiver criteria are met but a waiver has not been
specifically requested by the researcher OR
• A waiver is requested by the researcher but the Federal waiver
criteria have not been met
THEN…..
• The IRB will ask the researcher to add or revise the Request for
Waiver documentation. The IRB can not approve a protocol
unless requests for waivers meet the criteria described in the
Federal Guidelines.
UIndy IRB, February 24-25, 2010
Stall #3: Requests for Waivers
Types of waivers
• Waiver of documentation of informed consent
§46.117c
• Waiver of informed consent §46.116c, §46.116d
The IRB will review all waiver requests based on
evaluation of the criteria for waiver or alteration, and
will approve, modify or deny each request.
The Waiver of Informed Consent document is available
from the UIndy IRB website
UIndy IRB, February 24-25, 2010
Resources for Additional Information about Waivers
Code of Federal Regulations Title 45 Public Welfare Department of
Health and Human Services Part 46 Protection of Human
Subjects §46.116 & §46.117
Protecting Personal Health Information in Research: Understanding
the HIPPA Privacy Rule. Department of Health and Human
Services (DHHS), National Institutes of Health (NIH)
Instructions for Waiver of Authorization or Altered Authorization:
When may an application for IRB Waiver of Authorization or
Altered Authorization be Approved by an IRB under HIPAA
privacy rules? HIPAA Privacy Rule Research Guidance,
Frequently Asked Questions
Institutional Review Boards and the HIPPA Privacy Rule, Department
of Health and Human Services (DHHS), National Institutes of
Health (NIH).
UIndy IRB, February 24-25, 2010
Stall #4: Protocol Inconsistencies
The description provided for participant research related activities is
not consistent across all protocol documents
–
–
–
–
–
Protocol description of research activities
Informed consent document(s)
Protocol description of informed consent processes
Recruitment materials
Letter of cooperation/agreement
When the information provided in the protocol is contradictory &/or
inconsistent, the IRB is unable to evaluate participant risks and
benefits.
UIndy IRB, February 24-25, 2010
Stall #4: Common Inconsistencies
The amount of time required for study participation is not
the same on all study-related documents. Example:
Identifies in the protocol that the focus groups will
meet for 90 minutes; identified in the letter of consent
that the focus groups will meet for 60 minutes.
The number of individuals needed for research study
participation is not the same on all study documents.
Example: Identifies a projected sample size of 50
participants in the protocol; identifies a projected
sample size of 65 on the letter of informed consent.
UIndy IRB, February 24-25, 2010
Stall #4: Common Inconsistencies
• The words anonymous and confidential are used
interchangeably.
– Anonymous means that there is no link between the
participants and the data they provide.
– Confidential means that there is a link between participants
and the data they provide.
Example: Describes a procedure for coding data that includes
using a key to link individual participants to the information
they provide on a survey document; States on the letter of
informed consent that the method of data collection is
anonymous.
UIndy IRB, February 24-25, 2010
Stall #4: Common Inconsistencies
Once involved in the research process, participants are
asked to provide personal information beyond the
scope of what was described during the recruitment
process or during informed consent processes.
Example: Participants are informed that they will be
completing a functional assessment tool for range of
motion. After signing the letter of informed consent,
participants are asked to provide information about
their workman’s compensation status.
UIndy IRB, February 24-25, 2010
Suggestions for Identifying and Resolving
Inconsistencies
• If the protocol is developed by a group, then a
final meeting should be scheduled to reconcile
all parts of the protocol prior to submission.
• Content expert review
• Peer review
• Reasonable person standard: Review by a
reasonably intelligent individual who is not
content expert
UIndy IRB, February 24-25, 2010
Stall #5: Unable to Verify if Research Procedures are
Consistent with UIndy Policies
Based on the information provided in the
protocol submission documents, the IRB
is unable to determine if the research
procedures will be consistent with
appropriate UIndy policies related to
research and data access.
UIndy IRB, February 24-25, 2010
Policy and Procedure Documents
1. Policy on Medical Emergencies and Accidents
Incurred by Individuals Participating in
University of Indianapolis Research Projects
on Campus
2. Use of Professional Research Methods in the
Classroom
3. University of Indianapolis Students as
Research Participants
4. Procedures & Guidelines for access to the
SOPS Research Pool
UIndy IRB, February 24-25, 2010
Stall 6: Data Security Concerns
Data security measures (or the explanation of data
security measures) are insufficient and/or not
adequate based on the type of data collected.
According to the NIH Policy for Data and Safety
Monitoring:
1. Monitoring & data security should be
commensurate with risks
2. Monitoring & data security should be
commensurate with project size and complexity
Resource: NIH Policy for Data and Safety Monitoring, NIH Guide
(July 10, 1998). National Institutes of Health.
UIndy IRB, February 24-25, 2010
Stall #6: Data Security Concerns
Specific IRB Concerns
• Data security measures are insufficient for the type of data
collected.
• Procedures for data storage, retention, and security are not
described.
• Procedures for data storage, retention and security are not
appropriate for the type or format of the data.
• Procedures for data coding are not addressed or insufficiently
described.
• Does not correctly differentiate between de-identified, coded and
anonymous data.
• Does not include sufficient data security strategies for protecting
the data “key” (the information that matches the participant
identifiers to the coded data).
UIndy IRB, February 24-25, 2010
Stall #7: Research Team Member
Responsibilities & Qualifications
To ensure that participant risks are minimized,
investigators must provide evidence that they are
sufficiently qualified to perform their research-related
tasks and responsibilities.
If information about the researchers’ qualifications &/or
credentials is unclear, the IRB will ask the investigators
to provide this data.
UIndy IRB, February 24-25, 2010
Stall #8: Scientific Design
Examples of Design-Related Problems
• The relationship between the current study and previous research
is not established.
• The links between the research questions (hypotheses
statements); the research design; the specific types of data
collected; the data collection tools or measures, and the data
analysis procedures are unclear, inconsistent, &/or inaccurate.
• The link between the type of qualitative methodology (grounded
theory, ethnography, focus group, etc) and specific research
procedures is not clearly described.
• The researcher does not differentiate between inclusion criteria
and research-related interventions.
UIndy IRB, February 24-25, 2010
Stall #8: Scientific Design
Examples of Design-Related Problems
• Rationale for collecting specific pieces of personal
information is not provided.
• Rational for sample size is not provided.
UIndy IRB, February 24-25, 2010
Considerations of Research Design
IRB Guidebook, Chapter 4
• The value of research depends upon the integrity of study results.
One of the ethical justifications for research involving human
subjects is the social value of advancing scientific understanding
and promoting human welfare by improving health care. But if a
research study is so methodologically flawed that little or no
reliable information will result, it is unethical to put subjects at risk
or even to inconvenience them through participation in such a
study.
• One question that every IRB member asks is "To what degree is it
our responsibility to review the underlying science of the proposed
research?" Clearly, if it is not good science, it is not ethical.
UIndy IRB, February 24-25, 2010
Considerations of Research Design
IRB Guidebook, Chapter 4
• The federal regulations under which IRBs operate, however, do
not clearly call for IRB review of the scientific validity of the
research design. Nonetheless, they do require that IRBs
determine whether "[r]isks to subjects are reasonable in relation
to...the importance of the knowledge that may reasonably be
expected to result" [Federal Policy §___.111(a)(2)]. If the
underlying science is no good, then surely no important
knowledge may reasonably be expected to result.
UIndy IRB, February 24-25, 2010
Considerations of Research Design
IRB Guidebook, Chapter 4
• Left without clear direction on this point, most IRBs appear to take
the following approach, which has been described approvingly by
Robert Levine (1986, p. 21): Where the investigator conducting
the research under review is seeking funding from the federal
government or other extramural funding agency, rigorous review
of the science is left to the agency's peer review process. The IRB
provides a less detailed examination to satisfy itself that there are
no obvious flaws that would place subjects at unnecessary risk.
UIndy IRB, February 24-25, 2010
Considerations of Research Design
IRB Guidebook, Chapter 4
• Where the protocol will not receive such detailed scientific review,
IRBs review the research design with much more care, perhaps
with the assistance of consultants, if the IRB itself does not
possess sufficient expertise to perform such a review. Levine
suggests that IRBs should establish their authority to criticize the
scientific merits of protocols and to exercise that authority to
require that investigators correct design flaws identified by the IRB
before receiving IRB approval, but that IRBs should recognize
their limits in this regard as well. [See also Commentary by Levine
following McLarty (1987), p. 3.
UIndy IRB, February 24-25, 2010
Considerations of Research Design
IRB Guidebook, Chapter 4
• Benjamin Freedman suggests that research must be both valid
and of value [Freedman (1987b)]. Although IRB members do not
need to be experts in scientific methodology or statistics, they
should understand the basic features of experimental design, and
they should not hesitate to consult experts when aspects of
research design seem to pose a significant problem.
• The purpose of this chapter of the Guidebook is to provide some
basic background information on scientific research design, some
of the research techniques used by scientists, and some ethical
considerations raised by these designs and techniques.
Resource: Institutional Review Board Guidebook Chapter 4,
Considerations of Research Design, United States Department of
Health and Human Services (DHHS), Office for Human Research
Protections (OHRP).
UIndy IRB, February 24-25, 2010
Biomedical and Behavioral Research
IRB Guidebook, Chapter 5
•
Most behavioral research involves no physical intervention and no
physical risk. However, some studies do present a risk of social harm
(e.g., harm to a subject's reputation, which is sometimes a danger if
confidentiality is not maintained) or psychological harm, which may
occur if the research involves deception or provides subjects with
unwelcome and disturbing information about themselves. When
deception is involved, the IRB needs to be satisfied that the deception is
necessary and that, when appropriate, the subjects will be debriefed.
(Debriefing may be inappropriate, for example, when the debriefing itself
may present an unreasonable risk of harm without a counterveiling
benefit.) The IRB should also make sure that the proposed subject
population is suitable. [See Guidebook Chapter 3, Section A,
"Risk/Benefit Analysis.“]
UIndy IRB, February 24-25, 2010
Biomedical and Behavioral Research
IRB Guidebook, Chapter 5
• Some studies involve the possibility of a moral wrong, which is
what some commentators have labeled the ethical problems
posed by deception of subjects or invasions of their privacy.
• IRBs need to determine whether any deception or invasion of
privacy involved in a research protocol is justified.
Resource: Institutional Review Board Guidebook Chapter 5,
Biomedical and Behavioral Research: An Overview, United States
Department of Health and Human Services (DHHS), Office for
Human Research Protections (OHRP).
UIndy IRB, February 24-25, 2010
Stall 9: Insufficient Description of the
Research Activities
If insufficient or unclear information is provided
about the research-related activities or
interventions, the IRB is unable to evaluate
participant risk.
If the description of the research activities is
insufficient or unclear, the IRB will ask the
researcher to provide additional clarifying
information.
UIndy IRB, February 24-25, 2010
Clearly Describe All Research-Related
Activities
Where will the research be conducted?
Which members of the research team are involved in
each procedure?
What will each participant in the research study do?
How long will each research-related activity take?
What are the risks associated with each activity?
What are the specific participant benefits associated
with each activity?
UIndy IRB, February 24-25, 2010
Clearly Describe Compensation Procedures
(if appropriate)
IRBs must attempt to make sure that prospective subjects
realize that their participation is voluntary, and that
choosing not to participate will not adversely affect
their relationship with the institution or its staff in any
way. To make this determination, IRBs should know
who the subjects will be, what incentives are being
offered, and the conditions under which the offer will be
made.
IRB Guidebook Chapter 3, Basic IRB Review Section G,
Incentives for Participation
UIndy IRB, February 24-25, 2010
Clearly Describe Compensation
Procedures (if appropriate)
What type of compensation will be provided (money, gift
card, other tangible “benefit”)?
When will participants receive their compensation?
What activities do participants need to complete to be
eligible for compensation?
How will the participant receive compensation?
How much compensation will be provided?
Who will receive compensation for participation? If all
participants are not compensated equally, how will the
researcher(s) determine who receives what level of
compensation?
UIndy IRB, February 24-25, 2010
Stall 10: Research-Ready Documents
• Documents must be research-ready: If post-IRB
approval changes to the letters of informed
consent/assent and/or recruitment materials are
needed, a “Request for Revisions” must be submitted
to the IRB for approval before these documents can be
used in the research process.
• Active links to electronic surveys.
• Appropriate documents on letterhead.
• If survey data collection is anonymous or if there is an
intention to code the survey data, remove from the
survey documents requests for the participants’ names
and significant identifying information.
UIndy IRB, February 24-25, 2010
IRB Resources
The standards for IRB review are derived from Code of Federal
Regulations Title 45 Public Welfare Part 46 Protection of Human
Subjects (45 CFR 46).
A good resource for information about the IRB review process
standards is the Office for Human Research Protections (OHRP)
IRB Guidebook
IRB Guidebook Chapter 3, Basic IRB Review: Includes information
about informed consent, selection of subjects, privacy, &
incentives.
IRB Guidebook Chapter 4, Considerations of Research Design
IRB Guidebook Chapter 5, Biomedical and Behavioral Research
A comprehensive source of information about IRB guidelines and
processes: Bankert, E. & Amdur, R. (2005). Institutional Review
Board: Management and Function, Jones & Bartlett.
UIndy IRB, February 24-25, 2010