IRB: Scene 1February 2015

Elizabeth Buchanan, Ph.D.Endowed Chair in Ethics

Director, Center for Applied EthicsIRB 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 Review2. Apply Disciplinary & Regulatory Knowledge3. Attend Convened Meetings4. Disclose Conflicts of Interest5. Propose & Develop IRB Policy6. Complete Mandatory Education Requirements7. Handle Allegations of Noncompliance8. Maintain Confidentiality9. Make Determination Which Impacts Whether Federal Reports are Required

IRB Admin Responsibilities1. Advising2. Managing Protocol Review3. Education4. Recordkeeping5. Reporting6. Developing HRPP/IRB Policies & Procedures7. Handling Allegations, Complaints, & Noncompliance8. Off-Site/Cooperative Research9. Quality Improvement/Metrics for IRBs and Principal Investigators10. Management of Staffing and Infrastructure11. Serving Liaison Function12. Overseeing Special Initiatives (e.g., Obtaining & Maintaining Accreditation)

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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.)

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