IRB: Scene 1
February 2015
Elizabeth Buchanan, Ph.D.
Endowed Chair in Ethics
Director, Center for Applied Ethics
IRB Leadership Director
UW-Stout
Objectives
• Review current regulatory requirements for
basic IRB considerations, including:
– IRB Scope
– Membership
– Procedures
– Regulations and Institutional Choices
– Plans for next two webinars
Limitations
• Restricted to HHS, not FDA regs
• I was specifically told NOT to spend too much
time on the history of research ethics
• I am NOT taking into consideration the proposed
rule changes (NPRM); this could have very
significant implications!
• Many topics to cover, for multiple audiences:
WHEN (not if) I don’t cover something, ask!
– Chairs versus admins versus IOs
– Regulatory versus extra-regulatory
Who am I and What Brings Me Here?
• 1998, found myself submitting protocols to a medical institution and
an SBER board: my dissertation research involved all online data (back
then, it was interesting and IRBs weren’t as comfortable with online
spaces)
• 1999: Became IRB member
• 2004: Became IRB member for medical board
• Edited a book about online research and IRBs; gave numerous
keynotes; found my way to AoIR, PRIM&R, OHRP Community Forums,
universities—everyone wanted to talk about IRBs and online research!
• 2007: NSF grant surveying IRBs
• 2008: Joined PRIM&R Faculty and Planning Committee
• 2010: Began discussions with SACHRP
• 2012: Co-authored SACHRP recommendations and AoIR guidelines
• Trained in RCR
• Along the way, learned quite a bit about the various roles,
responsibilities, processes, of various IRBs
– Note: I do not have a CIP, but am working on it!
Getting In the (Research) Mood
• Do more people think of IRBs as:
– Grumpy, inflexible regulators?
– The International Rugby League?
– Thoughtful, reasoned, and knowledgeable
partners in research?
What’s Common?
• We all start from the same place, 45CFR46:
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
• We all have institutional policies and SOPs: We all have some model
consisting of IRB administration, IRB Chair/Vice-Chair, and IRB
members:
– In 1979, Robert Levine stated: “…each IRB is an agent of its own
institution. It is not a branch office of OHRP. It is not a branch office of
any other funding or regulatory agency.”
• We all interpret the regulations and make assertions and decisions
in the absence of regulations
• We’re all striving to streamline the process while protecting human
subjects
• We all admit there are grey areas (No! Don’t start talking about
Shades of Grey!!!)
Basic Ethical Principles
• Respect for Persons: The freedom and capacity of subjects must be
protected
• Each subject is an autonomous agent
• Special measures must be taken to protect the rights and welfare of
persons with diminished autonomy
• Informed consent is central to protecting the autonomy of human subjects
• Beneficence: Researchers have the obligation to secure
the well-being of subjects
• Possible benefits must be maximized and possible harms must be
minimized
• Justice: Researchers question who receives the benefits of research and
who bears its burdens
• There must be fairness in the distribution of the risks and benefits of the
research
• Each person must equally share in the distribution of risks/benefits
according to individual need, individual effort, societal contribution, and
merit
• Distinction between research and practice
Who Needs Education/Training?
•
•
•
•
•
IRB Members, Chairs, Staff, IO
Researchers and Research Staff
Others: Institutional
Administrators, Medical Records,
General Public, Legislatures
IRB Scope,
Or, It Depends
What the IRB is NOT
•
•
•
•
Risk Management
Confidentiality Committee
Data Safety Monitoring Board
Editorial Service
IRB Scope
• “…faculty, students, and staff who are involved in research involving
human subjects are required to comply with federal, state and
university policies for the protection of human research subjects.”
• (a) Except as provided in paragraph (b) of this section, this policy
applies to all research involving human subjects conducted,
supported or otherwise subject to regulation by any federal
department or agency which takes appropriate administrative action
to make the policy applicable to such research. This includes research
conducted by federal civilian employees or military personnel, except
that each department or agency head may adopt such procedural
modifications as may be appropriate from an administrative
standpoint. It also includes research conducted, supported, or
otherwise subject to regulation by the federal government outside
the United States.
IS it our Scope?
• Scientific merit:
“Generally, it is not the charge of the IRB to
comment upon the scientific merit of proposals
submitted for review except where the scientific
merit of the research, or lack thereof, increases
either the risks to the subject (directly or indirectly)
or the research burden to be borne by the subject.
In such cases, the investigator may be referred to
his/her advisor (in the case of a student) or to
institutional experts for further guidance.”
Is it Research?
• Is it research?
– A systematic investigation (i.e., the gathering and analysis
of information) designed to develop or contribute to
generalizable knowledge.
– the term "research" designates an activity designed to test
an hypothesis, permit conclusions to be drawn, and
thereby to develop or contribute to generalizable
knowledge [the Belmont Report].”
• IRBs have different policies on classroom research, SOTL,
Internet research, genetic research, international research,
etc
Is it Human Subjects Research?
• Human subject means a living individual about
whom an investigator (whether professional
or student) conducting research obtains
• (1) Data through intervention or interaction
with the individual, or
(2) Identifiable private information.
Should the IRB be Involved?
• Like most universities, we have chosen to
extend the Common Rule to all research done
by faculty, staff, or students (not just that
which is federally funded). An individual said,
“But I’m doing this research on my own time,
using my own computer, paying my own
postage, etc. Who are you to tell me what to
do during my free time?”
Engagement
• Revised OHRP policy on engagement at:
http://www.hhs.gov/ohrp/policy/engage08.html
• Is an individual engaged in research? Is he/she acting
as an agent of your institution? Your institutional policy
define parameters of employment.
– “For purposes of this document, an institution’s employees
or agents refers to individuals who: (1) act on behalf of the
institution; (2) exercise institutional authority or
responsibility; or (3) perform institutionally designated
activities. “Employees and agents” can include staff,
students, contractors, and volunteers, among others,
regardless of whether the individual is receiving
compensation.”
Membership
•
•
The requirements for IRB membership are addressed in the HHS regulations at 45 CFR
46.107 [Note: 45 CFR 46.304 requires a specialized IRB composition when research
involving prisoners is being reviewed, including the presence of a prisoner
representative].
An IRB must:
– have at least five members with varying backgrounds to promote complete and
adequate review of the research activities commonly conducted by the institution;
– make every nondiscriminatory effort to ensure that the membership is not
composed of entirely men or entirely women;
– include at least one member whose primary concerns are in scientific areas and at
least one member whose primary concerns are in nonscientific areas;
– include at least one member who is not otherwise affiliated with the institution and
who is not part of the immediate family of a person who is affiliated with the
institution; and
– not allow any member to participate in the initial or continuing review of any project
in which the member has a conflicting interest, except to provide information
requested by the IRB. Please see the regulations at 45 CFR 46.107 for complete
information on all of the required qualifications to properly compose an IRB.
Membership
• Signatory Officials or IOs should not serve on
IRBs—they represent the institution
• Members of IRB must be diverse: Discipline,
gender, age
• If you review both SBER and med/biomed, you
need representation of expertise from those
fields
• You can supplement an IRB if you have a unique
project for which you do not have expertise
Special Considerations
• Children
• Prisoners
– Wardens are not appropriate; instead, look for prison chaplain,
social worker, former prisoner—someone that can represent the
prisoner and understand his/her condition
• Scientists and non-scientists: Consider training,
background, occupation
• Non-scientist must be present for quorum (meetings can
not continue without non-scientist member)
• Non-affiliated member: Must have at least one; only role is
as IRB member; no family relations to other IRB members
• One person can serve in multiple roles, eg non-scientist and
non-affiliated
Procedures
• Quorum is critical!!
– Appointment of alternates
– Alternates can serve for all or part of a meeting
• Conflicts of interest—financial or otherwise; cannot be
an investigator, research team member
• Recusal versus abstentions:
– Recusal is used with a conflict of interest; member who is
recused does not count towards quorum
– Abstentions are used for many other reasons; members
who abstain do not have a COI; a member who is
abstaining from a vote can still count towards quorum
The Chair
• No regulatory requirements or qualifications
• Ensures IRBs Carry Out Their Regulatory Responsibility
– Each Approved Protocol Meets All Requirements of 45 CFR 46 & if
Applicable 21 CFR 50 & 56, 38 CFR Part 16, or Any Other Applicable
Agency Requirements
•
Conducts Exempt/Expedited Review or Delegates
• Maintains Communication with Investigators, IRB Staff, & Signatory Official
• Should have:
– Experience on an IRB
– Willing to spend time without much in the way of compensation
– Institutional decision
• For example, at Stout, we employ a chair/vice chair model to ensure consistency
IRB Member Responsibilities
1. Conduct Protocol Review
2. Apply Disciplinary & Regulatory Knowledge
3. Attend Convened Meetings
4. Disclose Conflicts of Interest
5. Propose & Develop IRB Policy
6. Complete Mandatory Education Requirements
7. Handle Allegations of Noncompliance
8. Maintain Confidentiality
9. Make Determination Which Impacts Whether
Federal Reports are Required
IRB Admin Responsibilities
1. Advising
2. Managing Protocol Review
3. Education
4. Recordkeeping
5. Reporting
6. Developing HRPP/IRB Policies & Procedures
7. Handling Allegations, Complaints, & Noncompliance
8. Off-Site/Cooperative Research
9. Quality Improvement/Metrics for IRBs and Principal Investigators
10. Management of Staffing and Infrastructure
11. Serving Liaison Function
12. Overseeing Special Initiatives (e.g., Obtaining & Maintaining
Accreditation)
What Governs the IRB’s Decision-making?
•
•
•
•
•
•
Federal regulations
State regulations
Institutional policy
The Belmont Report
Terms of our Federalwide Assurance (FWA)
Other mandates (HIPAA, NIH, etc.)
25
IRB Staff, Space, and Record Keeping
•
It is a regulatory requirement to ensure proper staffing and space (meeting rooms, file
storage) for the IRB! (45 CFR 46 .115(b)(2)
•
Official records must be maintained and available for review and copying upon request;
should be secured in a single location
(maintained for 3 years; 3 years after the completion of a project; minimum
requirement)
– Proposals, protocols, scientific reports, progress reports, grant applications
– Minutes, continuing review; correspondence between IRB/Investigator; SOPs;
unanticipated findings
•
Minutes must reflect what decisions/approvals were made; be sure staff taking minutes
are trained and know what to include
– Attendance, alternates, visitors; document comings and goings of board members;
– Show actions taken: Did IRB approve a study? Require modifications?
– Show numbers of voting members: total, voting for, voting against, abstention,
recusal
– Details why a board is disapproving research; show the basis for requiring
modifications
– Controverted issues: be very specific about the differences, how controversy was
resolved
How Many IRB Staff?
• Ratio of staff to applications
• Number and types of IRBs
• Time allocation and payment to Chair/board
– How many of us pay your board members or
provide another form of incentive?
Your Best Guess:
• As of 2013, how many US IRBs have opted to
“uncheck the box?”
– 50%
– I have no idea what check or box you are
discussing.
– 33%
Federal Wide Assurance
• Through the FWA, an institution commits to HHS that it
will comply with the requirements in the HHS
Protection of Human Subjects regulations at 45 CFR
part 46.
– Statement of commitment to conduct research within the
ethical standards outlined in the Belmont Report
– Applies to all research involving human subjects regardless of
source of funding or support conducted by XX, as well as to
research conducted elsewhere by students, staff, or other
representatives of the in connection with their institutional
responsibilities
• A great overview from HHS:
https://www.youtube.com/watch?v=4PscFoIww44
IRB Registration and Upkeep
• Through OHRP website;
• Revisions to registration necessary when you
have new board members, new IO
“Flexing” Our Flexibilities
• The Flexibility Coalition consists of institutions from across the nation that
have achieved a more flexible approach to increasingly burdensome
federal requirements, by finding simpler ways of reviewing studies. The
freedom to be compliant yet flexible, is permitted for institutions which
have opted to “uncheck the box” on the Federalwide Assurance for the
Protection of Human Subjects.
• Unchecking the box limits HHS oversight to projects funded and regulated
by OHRP. The coalition goals are to identify additional areas of flexibility
that can be implemented without diminishing the protection of human
subjects. It is important for affiliated institutions to have a strong policy
statement providing equivalent protections for all human subjects
participants. Examples of flex policies include establishing additional
exempt categories and extending IRB approval dates and expedited review
categories. All studies eligible for flex must be non-federally funded and
involve no more than minimal-risk research.
Trends in IRBs
• Private IRBs
– One stop shops for ethical review, accreditation,
etc
• Central IRBs
• Accreditation