September 28, 2015 Brian Herman, Ph.D. Vice President for Research 419 Johnston Hall 101 Pleasant St SE Minneapolis, MN 55455 Brooks Jackson, M.D. Vice President for the Academic Health Center 410 Childrens Rehab Ctr 426 Church Street SE Minneapolis, MN 55455 Dear Drs. Herman and Jackson: The IRB Membership section of the Implementation Team’s Work Plan includes recommendations that establish a solid foundation to build an enhanced Institutional Review Board (IRB) that can more effectively carry out the ethical and regulatory mandates to protect human research participants. We are grateful for your support and commitment to ensure that the Human Research Protection Program (HRPP) is provided increased membership of qualified scientists to broaden the expertise of the IRB and ultimately enhance the protection of human research participants. We are eager to gain new, qualified IRB members who will join us as we move forward and believe the first step in successful implementation is the identification of qualified candidates. These candidates must, among other things, be interested in IRB membership and research ethics, experienced in the critical evaluation of research, and committed to the success of the HRPP program. In an effort to facilitate your work identifying qualified candidates, we have attached qualification standards and IRB membership expectations to ensure that eligible candidates will have more complete information regarding the important commitment they will be making and the responsibility they will share. The success of enhancing the mission of the IRB is dependent on the IRB members’ commitment to the University and the broader community. As stated in the external review team report, its importance as the independent body charged with ensuring that any research it approves is both ethically and scientifically sound cannot be underestimated. The following documents are enclosed: 1) Updated Work Proposal 2) Role, definition and responsibility documents for:  Department Leadership  IRB Chairs  IRB Scientific Members

 IRB Non-scientific Members  Expert Consultants to the IRB 3) 2014 submission metrics and membership requests (i.e. refer to anticipated number section) 4) IRB Membership Compensation Plan As you will note in the description of the department head role, it is our intent that Department Heads/Chairs be engaged in this process and provide a list of potential members (Clinicians and Scientists) from Departments identified in the attached document. Communication to Department Heads/Chairs regarding this critical effort is included with the IRB Membership submission materials. Please keep in mind that the IRB must be sufficiently qualified through the experience and expertise of its members and should reflect diversity in membership, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes. While submission metrics provide critical information and permit us to project anticipated needs regarding IRB member expertise, we must also be prepared to include scientific expertise in fields less frequently observed. This ensures the IRB may depend upon these experts to assist in the review of issues which require expertise beyond or in addition to what is available on the IRB. Therefore, we also request that you provide a list of qualified clinician/scientists who may act as expert consultants available for scientific reviews and when needed to facilitate IRB review. This is a time of tremendous opportunity. To meet the commitments made by President Dr. Eric Kaler, we turn to you for support. Engagement of University Leaders to promote the importance and value of IRB membership is a first step in promoting a culture of research ethics that is beyond reproach. It is our goal to initiate changes in IRB membership and revision to existing rosters no later than January 2016. There is much work to be done. In order to continue this important progress we ask that you confirm this commitment by providing names of potential qualified IRB members prior to this date. Respectfully Submitted,

Joanne Billings, MD MPH University of Minnesota IRB Chair Assistant Professor of Medicine Pulmonary, Allergy, Critical Care and Sleep Medicine University of Minnesota

Michelle Biros, MD, MS, FACEP University of Minnesota IRB Vice-Chair Interim Department Head and Research Director Department of Emergency Medicine University of Minnesota

UNIVERSITY OF MINNESOTA

ADVANCING HUMAN RESEARCH PROTECTION

IMPLEMENTATION: WORK PROPOSAL Instructions and Guidance for completing the Proposal: Who Completes? Work Plan Section Leads Review Process: Proposals should be submitted to the Vice President for Research for review and approval. If necessary, the VPR will ask the Research Compliance Advisory Committee for their review as well. This review process should occur within the first two weeks of the work being started.

Issue section: This section should fully incorporate the implementation team’s understanding of the current state. To accomplish this step, review implementation team’s action plans and final report. Include enough detail that demonstrates both an understanding of the issue and the context back to the external review panel’s recommendations.

Action section: Actions need not be limited to resources that are available right now. However, when crafting your proposal focus on practical and feasible solutions, providing as much logistical detail as possible. A well-thought out proposal that addresses critical aspects of the issue and offers reasonable actions that can be taken is much more likely to succeed. Consider the potential resources available across the University, what aspects might be used to measure the progress and success of your proposed action, and what a possible timeline for full implementation of your proposal might look like. If your proposed action is larger in scale, could it be broken down into multiple phases for easier implementation? Anticipate challenges/barriers that might be encountered during implementation and incorporate strategies into your proposal for addressing these, should they arise.

July 2015

Proposal Form

Page 1 of 4

UNIVERSITY OF MINNESOTA

ADVANCING HUMAN RESEARCH PROTECTION

Work Plan Section: IRB membership Lead(s): Joanne Billings, Michelle Biros Felicia Mroczkowski, Debbie Dykhuis

Date: 8/16/2015, Revised 9/28/2015

Proposal Issue What is the issue/problem? (Define this based on the external review panel’s observations and the implementation team’s translation of the problem) 1. There are insufficient numbers of medical committee members present at meetings to manage the volume of reviews. 2. There are insufficient numbers of medical committee members on the roster to meet the needs of meeting attendance, expertise and volumes of review. 3. There are insufficient numbers of medical board meetings to manage the volume of full committee reviews. 4. The rolling roster was criticized for lack of continuity, consistency or sustained attention to systemic issues. 5. The general expertise of the IRB membership did not correlate with the topics and volume of research protocols submissions. 6. There should be consideration of compensation and alternate incentives (release from teaching time, reduction of other responsibilities, consideration during promotion) to foster and support qualified member participation. Who plays a role in the current process? (This is can be taken directly out of the implementation team actions plans.) IRB members, IRB leadership and staff, research leadership, department/division chairs, faculty Who is impacted by this issue/problem? (This is can be taken directly out of the implementation team actions plans.) Divisions, departments, investigators, IRB staff and leadership, research subjects, research community

Proposed Work Scope Describe the proposed work necessary to address the issue outlined above.

July 2015

Proposal Form

Page 2 of 4

UNIVERSITY OF MINNESOTA

ADVANCING HUMAN RESEARCH PROTECTION

Be detailed in your description and focus on practical actions, particularly those that could feasibly by undertaken by a responsible University Unit. 1. Restructure the current medical IRB a. Please see the attached Proposed Medical Committee Revised Structure b. retire the rolling roster c. create 4 medical panels of at least 13 members (quorum of 7) d. a minimum 8 members must be present at meetings to account for a member leaving the meeting for COI or other e. each panel will meet weekly with a limited agenda with the expectation of a 2 hour meeting a. define medical panels by their expertise in order distribute submissions appropriately 2. Increase medical membership to accommodate the above proposed changes from the current membership of 37 to at least 52 members a. identify a balance between scientists, non-scientists, affiliated, nonaffiliated and community members for each panel b. consider broadening the base of experts from the School of Nursing, School of Pharmacy, School of Dentistry and research coordinators 3. Target membership from Departments/Division that more accurately reflect the topic of protocol submissions a. Please see the attached documents: i. 2014 Medical and Social Behavioral Submission Data ii. 2014 Medical Committee Submission Data and Membership iii. Expectations of Departmental Leadership b. expand membership to more accurately reflect the nature of the protocols/applications according to medical IRB submission metrics c. review current membership and define areas of need related to these metrics d. review medical submission metrics twice yearly to assure that the membership accurately reflects need e. develop a communication to Department Heads to facilitate identification of new members f. define expectations of Department leadership to maintain membership numbers g. maintain a list of internal and external consultants that are available for scientific review and to assist in committee reviews 4. Design a compensation plan for affiliated and non affiliated members a. Please see the attached IRB Member Compensation Plan b. facilitate efforts by IRB members to pursue scholarship in the area of human subjects research protection c. recognize that effective service to the IRB contributes to promotion and tenure 5. Clearly define expectations of members a. Please see the attached documents for Review and Meeting Conduct Expectations of Members: i. IRB Committee Co-Chair: Review and Meeting Conduct Expectation ii. IRB Non-Scientist1 Committee Member: Review and Meeting Conduct Expectations iii. IRB Scientist 1 Committee Member: Review and Meeting Conduct Expectations iv. IRB Expert Consultants: Engagement and Review Expectations

July 2015

Proposal Form

Page 3 of 4

UNIVERSITY OF MINNESOTA

ADVANCING HUMAN RESEARCH PROTECTION

What other personnel or other resources are needed to make the plan work? (include expertise) Support from AHC leadership Define the estimate time line by major deliverable: Review the post-report activities work plan section for the proposed timeline and based on that list the major expected outcomes. Increase in membership should occur over the next 6 months. Members will require training and preparation for changes in their effort distribution (clinical schedules). Change to meeting structure over the next 6 to 12 months. Does this plan require the identification of additional resources? Resources could include money, equipment, space and personnel. Yes. No I don’t know If yes, describe: Funds to support compensation. IRB staff to restructure the medical meeting plans Does this plan require permissions or expertise from outside the University to fully implement it? Yes. No I don’t know If yes, describe: Would appreciate input from Dr. Strauss on the process. What challenges or barriers do you anticipate may be encountered during implementation? (These aren’t deal breakers, but instead help us estimate time and energy needed) Increasing membership will take time, educational commitment and Department/Division commitment. For clinical faculty, it may require a change in their clinical duties. Most clinical faculty are on a academic calendar, so these changes may not be able to occur until July. Management of the compensation plan and the increase responsibilities of medical meeting management will require IRB staff. Much of these of these efforts have concentrated on the medical IRB. Consideration should be given to further process improvement for the social behavioral IRB.

July 2015

Proposal Form

Page 4 of 4

Work Proposal Section 1 Attachment

1) Proposed Medical Committee Revised Structure

Medical Committees Member Type

physician scientist physician scientist physician scientist physician scientist physician scientist physician scientist scientist scientist non‐scientist non‐scientist non‐scientist non‐affiliated (Scientist,  physician scientist, or non‐ scientist) non‐affiliated (Scientist,  physician scientist, or non‐ scientist)

Medical 1: Vulnerable  Medical 2: Pediatrics‐  Subjects (Appendix I) Hematology, Oncology,  BMT, Department of  Medicine

Medical 3: Adults‐ Hematology, Oncology,  BMT, Cardiology, CMRR

Bioethicist

Bioethicist

Anticipated Composition Medical 4: Pharmacy,  Genetics, Surgery, Public  Health, Broad Medical  Sciences

Quorum Composition  Requirements: 7 Members  (8 members required to be  present) Chair (Scientist, Physician  Scientist or Non‐Scientist) Physician Scientist Physician Scientist Scientist Scientist Non‐Scientist Non‐Scientist Physician Scientist or Non‐ Scientist)

Work Proposal Section 3 Attachments

1) 2014 Medical & Social Submission Data 2) 2014 Medical Committee Submission Data and Membership 3) Expectations of Department Leadership

FULL COMMITTEE - MEDICAL SUBMISSIONS BY COLLEGE 1/1/2014 to 12/31/2014 Study Type

Medical

Count of Study Number College Medical School Other Public Health, School of

Full Committee Submissions

Total 1788 215 32

Education/Human Dev, Col of

31

AHC Shared Units

31

Science & Engineering, Col of

30

Dentistry, School of

29

Liberal Arts, College of

21

Nursing, School of

17

217 33 175

Expedited Review Submissions

Medical Social Student Social

491 96 359

Exempt Submissions

Undifferentiated

373

Full Committee Active Studies

Medical/Emergency Social Student Social

366 85 393

Expedited Review Active Studies

Medical Social Student Social

505 100 596

Exempt Active Studies

Undifferentiated

4

VP for Research, Office of

4

Health Sciences Administration

2

Design, College of

1

UM Duluth

1

Carlson School of Management

1

Public Affairs, HHH School of

1

Grand Total

#

43

Pharmacy, College of

Food, Ag & Nat Res Sci, Col of

"Other" Breakdown Medical/Emergency  Social Student Social

2251

4170

EXPEDITED - MEDICAL SUBMISSIONS BY COLLEGE 1/1/2014 to 12/31/2014 Study Type

Medical

Count of Submission ID College Total Medical School Other Public Health, School of Pharmacy, College of Dentistry, School of Education/Human Dev, Col of AHC Shared Units Liberal Arts, College of Science & Engineering, Col of Nursing, School of Food, Ag & Nat Res Sci, Col of Veterinary Medicine, Col of Biological Sciences, Col of UM Duluth VP for Research, Office of University Health & Safety Public Affairs, HHH School of Continuing Education, Col of Student Affairs, Vice Provost Design, College of MN Extension Grand Total

2235 491 143 72 72 52 45 37 36 32 19 11 10 6 3 2 2 2 1 1 1 3273

FULL COMMITTEE - SOCIAL SUBMISSIONS BY COLLEGE 1/1/2014 to 12/31/2014 Study Type Count of Submission ID College Education/Human Dev, Col of Liberal Arts, College of Medical School Other Public Health, School of Nursing, School of UM Duluth Carlson School of Management UM Morris Pharmacy, College of Design, College of Food, Ag & Nat Res Sci, Col of Science & Engineering, Col of MN Extension AHC Shared Units Student Affairs, Vice Provost Equity & Diversity University Finance Public Affairs, HHH School of Dentistry, School of UM Rochester Law School Biological Sciences, Col of Grand Total

Social

Total 69 64 64 33 28 19 16 12 7 7 5 5 4 4 3 3 2 2 2 2 1 1 1 354

EXPEDITED - SOCIAL SUBMISSIONS BY COLLEGE 1/1/2014 to 12/31/2014 Study Type

Social

Count of Submission ID College Total Education/Human Dev, Col of Liberal Arts, College of Medical School Public Health, School of Other Nursing, School of UM Duluth Food, Ag & Nat Res Sci, Col of UM Morris Science & Engineering, Col of Carlson School of Management MN Extension Design, College of UM Rochester Pharmacy, College of AHC Shared Units Public Affairs, HHH School of University Finance Dentistry, School of Student Affairs, Vice Provost Veterinary Medicine, Col of Acad Affairs&Provost, Sr VP Global Programs & Strategy Biological Sciences, Col of Law School VP for Research, Office of UM Crookston Equity & Diversity Undergrad Ed, V Provost & Dean Grand Total

325 265 194 152 96 94 61 42 30 26 26 25 17 13 11 10 10 8 7 7 5 5 4 4 3 2 2 1 1 1446

FULL COMMITTEE - SUBMISSIONS BY DEPARTMENT--1/1/2014 to 12/31/2014 College Count of Submission ID Dept Name MED Hema, Onc, Transplant Adm MED Hema, Onc, Transplant Adm Total PSYCH Psychiatry Dept Admin PSYCH Psychiatry Dept Admin Total PEDS Hematology PEDS Hematology Total Surgery Administration Surgery Administration Total MED Cardiology Division MED Cardiology Division Total PEDS Endocrine & Diabetes Div PEDS Endocrine & Diabetes Div Total NEUR Neurology Dept Admin NEUR Neurology Dept Admin Total PEDS Blood/Marrow Transplant PEDS Blood/Marrow Transplant Total MED Pulmonary, Allergy, Crit MED Pulmonary, Allergy, Crit Total MED Endocrine & Diabetes Div

(Multiple Items)

Study Type Emergency Medical Medical Social Medical Emergency Medical Medical Social Medical Medical Medical Medical Medical

<-- Select the college from the filter to view the department detail

approximate Total % of total 2 301 303 16 142 18 160 8 147 147 8 1 111 112 6 101 1 102 5 88 88 5 84 84 4 72 72 4 71 71 4 57

anticipated number

actual number

5

0

3

1

3

1

2

0

2

0

2

0

1

0

1

2

1

1

Count of Submission ID Dept Name MED Endocrine & Diabetes Div Total Magnetic Resonance Res, Ctr Fr Magnetic Resonance Res, Ctr Fr Total FamMed Family Medicine Admin FamMed Family Medicine Admin Total MED Inf Disease & Internationl

MED Inf Disease & Internationl Total MED Gastro, Hepa, Nutrion Div MED Gastro, Hepa, Nutrion Div Total OBGYN Gynecologic Oncology OBGYN Gynecologic Oncology Total NEUR Pediatric Neurology NEUR Pediatric Neurology Total ORSU Orthopaedic Admin ORSU Orthopaedic Admin Total Physical Therapy Physical Therapy Total DERM Dermatology Dept Admin DERM Dermatology Dept Admin Total OPH Ophthalmology Admin OPH Ophthalmology Admin Total PEDS Genetics & Metabolism Div PEDS Genetics & Metabolism Div Total

Study Type Medical Medical Social Emergency Medical Social Medical Medical Medical Medical Medical Social Medical Medical Medical

Total 57 48 48 27 16 43 3 34 2 39 38 38 37 37 36 36 34 34 26 1 27 26 26 23 23 20 20

approximate % of total 3

anticipated number 1

actual number 1

3

1

1

2

1

1

2

2

2 2 2 2

1

1

Count of Submission ID Dept Name PEDS Neonatology PEDS Neonatology Total NSU Neurosurgery Dept Admin NSU Neurosurgery Dept Admin Total PEDS Pediatric Epidemiology PEDS Pediatric Epidemiology Total LMP Administration LMP Administration Total PEDS Pediatrics Cardiology Div PEDS Pediatrics Cardiology Div Total Urology Administration Urology Administration Total PEDS Adolescent Health and Med PEDS Adolescent Health and Med Total MED Rheumatic & Autoimmune MED Rheumatic & Autoimmune Total ANES  Admin ANES  Admin Total PEDS  Nephrology PEDS  Nephrology Total PEDS Gastro, Hepa, Nutrit Div PEDS Gastro, Hepa, Nutrit Div Total PEDS Pulmonary, Allergy Admin PEDS Pulmonary, Allergy Admin Total PEDS Infectious Disease Div

Study Type Medical Emergency Medical Medical Medical Medical Medical Social Student Social Medical Medical Medical Medical Medical Emergency

Total 19 19 1 18 19 19 19 18 18 17 17 15 15 14 1 15 15 15 14 14 12 12 12 12 11 11 2

approximate % of total

anticipated number

actual number

1

Count of Submission ID Dept Name PEDS Infectious Disease Div PEDS Infectious Disease Div Total MED Veteran's Adm Medical Ctr MED Veteran's Adm Medical Ctr Total Radiology Administration Radiology Administration Total MED General Internal Medicine

Study Type Medical Medical Medical Medical Social

MED General Internal Medicine Total OTOL Otolaryngology Dept Admin Medical OTOL Otolaryngology Dept Admin Total DMED Biobehav Hlth/Population Medical Social DMED Biobehav Hlth/Population Total PEDS Global Pediatrics Medical PEDS Global Pediatrics Total Radiation Oncology Administrat Medical Radiation Oncology Administrat Total NSCI Neuroscience Admin Medical NSCI Neuroscience Admin Total MICRO Microbiology Admin Medical MICRO Microbiology Admin Total MED Medicine Education Medical MED Medicine Education Total Surgery Vascular Medical Surgery Vascular Total PEDS  Rheumatology Div Medical

Total 9 11 10 10 10 10 3 5 8 7 7 2 4 6 6 6 5 5 5 5 4 4 3 3 3 3 3

approximate % of total

anticipated number

actual number

1

Count of Submission ID Dept Name PEDS  Rheumatology Div Total ORSU Orthopaedic Clin Ops/Adm ORSU Orthopaedic Clin Ops/Adm Total PEDS Pediatric Critical Care PEDS Pediatric Critical Care Total PEDS Emergency Medicine PEDS Emergency Medicine Total PEDS  Neuropsychology PEDS  Neuropsychology Total Surgical Education Office Surgical Education Office Total NSU Neurosurgery Education NSU Neurosurgery Education Total OBGYN Maternal Fetal Medicine OBGYN Maternal Fetal Medicine Total MED Renal & Hypertension Div MED Renal & Hypertension Div Total PMR Education PMR Education Total PEDS International Adoption PEDS International Adoption Total PEDS General Pediatrics Div PEDS General Pediatrics Div Total GCD MS Department Admin GCD MS Department Admin Total

Study Type Medical Emergency Medical Medical Medical Social Medical Medical Medical Medical Medical Social Medical Medical

Total 3 3 3 1 2 3 3 3 1 1 2 2 2 2 2 2 2 2 2 2 2 1 1 1 1 1 1

approximate % of total

anticipated number

actual number

Count of Submission ID Dept Name IBP Physiology Administration IBP Physiology Administration Total ORSU Orthopaedic Education ORSU Orthopaedic Education Total OBGYN Reprodctve Endo & Infert OBGYN Reprodctve Endo & Infert Total DMED Biomedical Sciences DMED Biomedical Sciences Total DERM Dermatology Education DERM Dermatology Education Total Grand Total

Study Type Medical Medical Medical Social Medical

Total 1 1 1 1 1 1 1 1 1 1 1863

approximate % of total

anticipated number

actual number

Expectations of Departmental Leadership in support of the University of Minnesota IRB and Human Subjects Protection Program

PURPOSE: To describe the institutional expectations of Department leadership in supporting the role, activities, and membership of the University of Minnesota IRB in its review of Human Subjects Research. Key to an effective IRB and scientific review is appropriate composition of the IRB so that the specific scientific, medical, and ethical issues that arise during research review can be adequately addressed. This requires specific clinician and scientific expertise among IRB membership from among the most research experienced and knowledgeable departments. EXPECTATIONS: It is an institutional expectation that department leadership will identify among its faculty individuals who have the required expertise to adequately review submitted IRB applications of relevant clinical, basic, or social science research. The qualifications of IRB membership are described in attached documents to the Implementation Team Work Plan. Selected individuals will receive salary compensation to offset the time required to perform IRB duties. This compensation is described in IRB Membership Compensation Plan. It is further expected that the identified faculty will be supported with a reduction in other responsibilities so that adequate time is available to successfully perform IRB duties. The importance of membership in the IRB as a representative of the department must be emphasized to all faculty. This is a serious commitment; these individuals will play a role in protecting human subjects, will provide the expertise to avoid incomplete, superficial or biased review of protocols that impact potential patients, and will represent their peers and their departments during discussions of research related issues. Department leadership will need to provide justification to other faculty (beyond the salary offset) why identified individuals will be given release time to perform this essential service. Leadership will also need to assure selected faculty that their IRB service is valuable beyond the salary compensation, in order to advance the research mission of the department. If the member is not meeting the expectations outlined, it will be brought to the attention of the Department Head for corrective action or replacement. It is understood that this expectation may impose a burden to already busy departments that daily deal with many competing demands for time, effort and productivity. However, the Institution is committed to best practices for protection of human subjects. In order to 1 September 2015

achieve this goal, changes in previous practices are required. Among these is to close the gap that has often existed between scientific expertise among existing IRB members and the review of complex research protocols. Supplementing existing membership with a cadre of specialists from the most research experienced and knowledgeable departments will improve the level of performance of the Human Research Protection Program, and ultimately advance the overall research mission of the departments and the institution.

2 September 2015

Work Proposal Section 4 Attachment

1) IRB Member Compensation Plan

IRB MEMBER COMPENSATION PLAN This document outlines both member compensation and the associated, required meeting attendance and review commitments. University of Minnesota Employee Compensation for IRB Committee Chairs: Medical 44 meetings (34 medical meetings + 10 IRB Exec meetings) for 25% or 520 hours (XREV, scientific assessment, and attendance as a non-chair member included) Faculty Social

18 meetings (8 Faculty Social meetings + 10 IRB Exec meetings) for 10% or 208 hours (XREV, scientific assessment, and attendance as a non-chair member included)

Student Social 18 meetings (8 Student Social meetings + 10 IRB Exec meetings) same as Faculty Social Compensation for Non-University Employee IRB Committee Chairs: Medical $500/meeting chaired ($50/XREV completed $150/meeting attended as a nonchair) Social

not applicable

Student Social not applicable University of Minnesota Employee Compensation for Non-chair IRB Committee Members (excluding IRB staff): University Clinical Faculty Medical 34 meetings for 10% or 208 hours (XREV and scientific assessment included) University Clinical Faculty Social 8 meetings for 2.5% or 52 hours (XREV and scientific assessment included) University Clinical Faculty Student Social 8 meetings for 2.5% or 52 hours (XREV and scientific assessment included) University Non-clinical Faculty Medical $150/meeting attended; $50/XREV review up to a maximum of $7,500/year University Non-clinical Faculty Social $150/meeting attended; $50/XREV review to a maximum of $7,500/year University Non-Clinical Faculty Student Social $150/meeting attended; $50/XREV review to a maximum of $7,500/year Compensation for Non-University Employee Non-Chair IRB Committee Members Medical $150/meeting attended; $50/XREV review up to a maximum of $5,500/year Social $150/meeting attended; $50/XREV review up to a maximum of $5,500/year Student Social $150/meeting attended; $50/XREV review up to a maximum of $5,500/year

Page 1 of 3

2016.02.13

Clinical faculty IRB members are compensated by the UMN through the provision of salary support to their department or division to allow protected time from other responsibilities to serve on the IRB. The NIH salary cap will serve as the upper boundary for calculating compensation for service. Compensation for University faculty will be calculated based on actual salary or the NIH cap, whichever is less. (2016 NIH salary cap is $185,100). Member Type Clinical faculty are defined as those faculty members whose responsibilities include providing patient care services. Meeting Attendance & Review Commitment FDA and OHRP suggested during review of the UMN IRB practices that member attendance at each convened IRB meeting be at least one over quorum. Increasing the meeting attendance expectation from 60%, as proposed in the work plan, to 65% ensures that the IRB will meet that expectation: Medical IRB Member Attendance Requirements and Review Volume Projections (period 9/1/2014 to 9/1/2015): • Attend 65% of IRB Meetings (34 meetings/year). Approximately 1350 items were assigned to a medical meeting agenda in 2015. If there are 208 medical meetings each year, an average meeting agenda would include 7 items. • If designated as a Scientist, participate in scientific review procedures as part of HRPP Scientific Review. Based on current volume, it is estimated that 32-40 scientist members would be asked to review 1-5 protocols/year. Submission volume will increase when department review ends but the extent of the increase is currently unknown. • If a designated Expedited Reviewer, complete review of studies qualifying for Expedited Review (XREV). 447 new studies received in 2015 distributed across 52 IRB members would result in approximately 9 new studies per member/year. Average Medical Member attending the minimum number of meetings will be responsible for reviewing approximately 238 total meeting items per year (7 items per agenda multiplied by 34 meetings). 247 total IRB reviews including XREV. This total will be increased by 5 for Scientist members who are also asked to contribute to the scientific review for a total of 252 total reviews per year. Medical IRB Chair/Co-Chair Attendance Requirements: • Attend 65% of designated IRB meetings (34 meetings/year) • Attend no less than 80% of IRB Executive meetings (10 meetings/year) • If designated as a Scientist, participate in scientific review procedures as part of HRPP Scientific Review • If designated as a Physician Scientist, participate in the review of emergency use research • Complete Expedited Reviews

Page 2 of 3

2016.02.13

Faculty Social IRB Member Requirements and Review Volume Projections: • Attend 65% of designated IRB meetings (8 meetings/year). Approximately 195 items were assigned to a meeting agenda in 2015. If there are 12 meetings per year, an average meeting agenda would include 16 items. • If designated as a Scientist, participate in scientific review procedures as part of HRPP Scientific Review • If a designated as Expedited Reviewer, complete review of studies qualifying for Expedited Review (XREV) 256 new studies received in 2015 distributed across 11 Members would result in approximately 23 new studies per member/year. Average faculty social member attending the minimum number of meetings will be responsible for reviewing 128 total meeting items per year. 151 total IRB reviews including XREV. Student Social IRB Member Requirements and Review Volume Projections: • Attend 65% of designated IRB meetings (8 meetings/ year). Approximately 99 items were assigned to a meeting agenda in 2015. If there are 12 meetings, an average meeting agenda would include 8 items. • If designated as a Scientist, participate in scientific review procedures as part of HRPP Scientific Review • If designated as Expedited Reviewer, complete review of studies qualifying for Expedited Review (XREV). 229 new studies received in 2015 distributed across 11 members would result in approximately 21 new studies per member/year. Average student social member attending the minimum number of meetings will be responsible for reviewing 64 total meeting items per year. 85 total IRB reviews including XREV. Faculty Social and Student Social IRB Chair/Co-Chair Attendance Requirements: • Attend 65% of designated IRB meetings (8 meetings/year) • Attend no less than 80% of IRB Executive meetings (10 meetings/year) • If designated as a Scientist, participate in scientific review procedures as part of HRPP Scientific Review • Complete Expedited Reviews

Page 3 of 3

2016.02.13

# of Convened Mtgs

# of Executive Mtgs

Emergency Use Research

U of M Clinical Faculty Chair

34

10

Yes

Non-U of M Employee Chair

34

10

No

U of M Clinical Faculty Member

34

No

No

U of M Non-Clinical Faculty Member

34

No

No

Non-U of M Employee Member

34

No

No

U of M Faculty Chair

8

10

NA

U of M Faculty Vice-Chair

8

10

NA

U of M Clinical Faculty Member

8

NA

NA

U of M Non-Clinical Faculty Member

8

NA

NA

Non-U of M Employee Member

8

NA

NA

U of M Faculty Chair

8

10

NA

U of M Faculty Vice-Chair

8

10

NA

U of M Clinical Faculty Member

8

NA

NA

U of M Non-Clinical Faculty Member

8

NA

NA

Non-U of M Employee Member

8

NA

NA

Medical

Faculty Social

Student Social

Expedited Reviews

Scientific Assessments

Compensation

Yes1

Yes

Yes

1

No

25% of actual up to 25% of NIH cap $500/mtg chaired; $150/mtg attended; $50/XREV

Yes

1

Yes

10% of actual up to 10% of NIH cap

Yes

1

Yes

$150/mtg; $50/XREV up to $7500/yr

Yes1

No

$150/mtg; $50/XREV up to $5500/yr

Yes1

Yes2

10% of actual up to 10% of NIH cap

Yes

1

Yes

2

10% of actual up to 10% of NIH cap

Yes

1

Yes

2

2.5% of actual up to 2.5% of NIH cap

Yes

1

Yes

2

$150/mtg; $50/XREV up to $7500/yr

Yes

1

No

$150/mtg; $50/XREV up to $5500/yr

Yes1

Yes2

10% of actual up to 10% of NIH cap

1

2

10% of actual up to 10% of NIH cap

Yes

1

Yes

Yes1

Yes2

2.5% of actual up to 2.5% of NIH cap

Yes1

Yes2

$150/mtg; $50/XREV up to $7500/yr

Yes1

No

$150/mtg; $50/XREV up to $5500/yr

If a Designated Expedited Reviewer

2

If designated as a Scientist member

Work Proposal Section 5 Attachments

1) IRB Member Co-Chair Review and Expectations 2) IRB Non-Scientist Committee Member: Review and Meeting Conduct Expectations 3) IRB Scientist Committee Member: Review and Meeting Conduct Expectations 4) IRB Expert Consultants: Engagement and Review Expectations

IRB Committee Co-Chair: Review and Meeting Conduct Expectation ____________________________________________ PURPOSE: To describe the role, expectations, qualifications, and responsibility of IRB Chairs, and the procedures for conducting IRB meetings. QUALIFICATIONS: Must hold terminal degree (M.D., D.O. , Ph.D) or be qualified by 10 or more years of professional experience to ensure competence necessary to lead the discussion of specific research activities presented for UMN IRB review. Candidates should be recognized in their field. Must have two or more years experience as an IRB member and expert knowledge of federal regulations pertaining to the protection of human research participants. Demonstrated commitment to ethical conduct and an interest in research ethics are required. Strong leadership abilities to promote a culture consistent with the objectives of the UMN HRPP, including assuring that the respect for and protection of research participants are never eclipsed by research interests. STATUS: Maintain awareness of representative member capacity as Scientist1 or Non-Scientist member requirements. When necessary, serve as an alternate for any comparably qualified member (e.g. Scientist Member can alternate for a Scientist member) on any other UMN IRB panel. AFFILIATION: Non-affiliated3 members are expected to provide input regarding their individual knowledge about the local community and be willing to discuss issues and research from that perspective. A non-affiliated member is also a scientist2 or nonscientist3 member and would be expected to provide input on areas germane to his/her knowledge, expertise and experience, professional and otherwise.

Version Date: September 2015 1)

2)

3)

Scientist IRB Member: Members whose training, background, and occupation would include them to view scientific activities from the standpoint of someone within a behavioral or biomedical research discipline. Scientist IRB members are professionally conversant with the scientific method (either by virtue of advanced training or by current occupation in scientific fields) and who might thus be included to view a research protocol primarily from the viewpoint of a scientist. 45CFR46.107(c), 21CFR56.107(c), & SACHRP January 24, 2011 letter) Non-Scientist IRB Member: Members whose training, background, and occupation would incline them to view scientific activities from the standpoint of someone outside of any behavioral or biomedical research discipline. Non-Scientific members typically are those members who have little or no scientific or medical training or experience. Examples of non-scientific or non-medical occupations may include, but not limited to, lawyers, clergy, ethicists, teachers, engineers, accountants, musicians, or business majors. (45CFR46.107(c), 21CFR56.107(c), & SACHRP January 24, 2011 letter) Non-Affiliated: Members who are not otherwise affiliated with the UMN, Fairview, or Gillette and who are not part of the immediate family of a person who is affiliated with the aforementioned institutions.(45CFR46.107(c), 21CFR56.107(c)

CONFLICTS OF INTEREST: All IRB members are to know the definition of Conflict of Interest (COI). No IRB member may participate in any review (including discussion or voting) in which he or she has a COI, except to provide information requested by the IRB. When reviewing an item, each IRB member is to consider whether he or she has a COI, and if so, to self-identify that COI. ATTENDANCE & TERM: Attend 65% of all scheduled meetings of the assigned committee. Prompt notification to HRPP staff of a pending absence from assigned committee is expected. IRB membership is set at three (3) year, renewable terms. TRAINING: Complete all required training in a timely manner and report completion to HRPP staff. CONFIDENTIALITY: All IRB members are to treat all oral and written information obtained as part of the review process as confidential. IRB members must not disclose or use confidential information without prior authorization. COMPENSATION: The UMN IRB adheres to Federal Guidance when recognizing the critical work performed by IRB members. In order to avoid real or perceived conflicts of interest, no IRB member may be paid more than reasonable compensation or receive more than reasonable benefits for IRB-related activities; and no IRB member may receive compensation or benefits under arrangements that could impede or discourage objective decision-making on behalf of human participants.

IRB Chair Expectations Responsibilities:   





 

Review and confirm that agenda items are assigned to primary reviewers sufficiently qualified to present the item. Request and communicate the need for expert consultants when required. Preside over meetings of the fully convened IRB and ensure that the IRB carries out its duly authorized responsibilities as required by federal regulations, ethical principles, state laws and University policy. Ensure, at each meeting chaired, that the members present are sufficiently qualified through experience and expertise to review all research activities on the agenda, and that expert consultants have contributed, if applicable. Review and approve protocol submissions that qualify for expedited review pursuant to federal regulations, ethical principles, state laws and University policies, or delegate such authority to a qualified and experienced IRB member to conduct such review and approval. Review and approve the minutes of each meeting chaired. Ensure that membership of the IRB is recruited, appointed and oriented such that the IRB is duly qualified to fulfill its obligations to review, require modifications to, approve (or 2

  



  

disapprove) research protocols that represent the breadth of research submitted to the IRB by UMN or affiliate researchers. Act on requests for emergency use of investigational drug, biologic, or device (physician scientist only) Serve on the Executive Committee and apprise individual panels of relevant issues discussed during Executive Committee meetings Serve as a liaison between the HRPP and the University research community to promote communication and understanding of the concerns of the IRB, the research community and other HRPP partners. Ensure that reports related to safety, noncompliance, unanticipated problems in research and adverse events are reviewed, attended to and reported pursuant to federal regulations, state laws and University policy. Respond to local and federal investigations relating to protocols and actions, as required. Work with IRB members, institutional officials, and investigators to ensure that the rights and welfare of research participants is adequately protected. In conjunction with HRPP leadership, develop and revise HRPP and IRB policies, procedures and guidelines to stay current with societal thinking, regulatory changes and national best practice standards.

Committee Management Procedures: The chair implements the following procedures when leading IRB meetings:    



 

Calls the meeting to order Ensures that the members present are sufficiently qualified through experience and expertise to review all research activities on the agenda. Ensures that all members are asked to contribute to the discussion of every item. Ensures that individuals with COI are not present during the vote or discussion of items for which they are conflicted and ensures that these individuals rejoin the meeting, when appropriate. Makes a motion to “Approve”, “Approve with Stipulations”, “Defer”, “Disapprove”, “Suspend”, Terminate”, or “Lift Suspension”, as applicable for the submission. For all motions except “Approve”, the chair summarizes the IRB’s reasons for the decision, and provides additional information as needed. Calls for a vote of IRB members “For,” “Against,” or “Abstaining” for the motion made on the submission. If more than half the IRB members present vote “For,” the motion is approved. Ensures that the HRPP staff member taking minutes have recorded the IRB’s actions, such as: required modifications, reasons, recommendations, determinations, and findings as applicable Adjourns the meeting when, for example, there is no further business or when notified by an HRPP staff member that quorum for all remaining agenda items cannot be met.

Committee Review Procedures

3

All IRB members are to review regulatory requirements and, when acting as primary reviewer, complete applicable checklists for each submission. The IRB must determine that federal criteria for IRB approval are met prior to approving each research protocol/plan. The guiding ethical principles outlined in the Belmont Report of respect for persons (autonomy), beneficence, and justice must be considered when conducting each review IRB members are responsible for reviewing every agenda item assigned to their allotted meeting and for notifying HRPP staff to request additional information (e.g. entire study file) if needed. Primary Reviewer Responsibility: The primary reviewer for each submission leads the discussion for the studies on which he or she is assigned. They are expected to fill out applicable checklists with preliminary judgments as to whether each criterion for approval is met and provide preliminary study-specific findings justifying determinations. The primary reviewer also reviews all submitted materials for consistency with the materials reviewed by all IRB members, including the following when they exist:       

The complete application including any previously approved protocol modifications Investigator brochure Current protocol HHS grant application, HHS approved protocol & HHS-approved template consent document interventions Consent materials, including recruitment materials HIPAA Authorization and/or request for HIPAA Waiver Any additional materials relevant to IRB review

During the presentation of the submission, the primary reviewer:   

  

Confirms an individual(s) with scientific/scholarly expertise performed a scientific/scholarly review, when applicable Reviews relevant findings of regulatory review and regulatory review contingencies. For a review related to an Unanticipated Problem Involving Risks to Participants or Others, Serious Noncompliance, Continuing Noncompliance, Suspension of IRB Approval, or Termination of IRB Approval, leads the IRB members through a discussion of the Report Form Review Sheet. Leads the IRB through a discussion of the criteria in applicable worksheets. When a checklist is applicable, discusses the checklist determinations and study-specific findings supporting those determinations. Summarize the IRB’s consensus 4

Initial Review: In advance of the meeting, all IRB members are to review the following materials to a depth sufficient to determine whether the criteria in applicable worksheets and checklists are met:    

Initial application form(s) Sections of the protocol relevant to the criteria. Consent document(s) and script(s), when they exist Recruitment materials, when they exist

Modifications to Protocols: In advance of the meeting, all IRB members are to review the modification, determine which criteria in applicable worksheets and checklists are affected, and review the following materials as necessary to a depth sufficient to determine whether affected criteria are met:    

Protocol Previously approved modifications not reflected in the current protocol, or a summary thereof Consent document(s) and script(s), when they exist Recruitment materials, when they exist

Continuing Review: In advance of the meeting, all IRB members review continuing review progress report and attachments, determine which criteria in applicable worksheets and checklists are affected, and review the following materials as necessary to a depth sufficient to determine whether affected criteria are met:     

Protocol Previously approved modifications not reflected in the current protocol, or a summary thereof Consent document(s) and script(s), when they exist New consent document(s) and script(s), when they exist Recruitment materials, when they exist

New Information: In advance of the meeting, all IRB members review the new information and attachments, determine which criteria in applicable worksheets and checklists are affected, and review the relevant sections of the following materials to a depth sufficient to determine as necessary whether affected criteria are met:    

Protocol Previously submitted modifications or a summary thereof Consent document(s) and script(s), when they exist Written reports of consultants, when they exist 5

Special Considerations: 





If the research involves prisoners as participants, the prisoner representative reviews the submitted information to determine whether criteria in IRB Policy 501C (Requirements for Research Involving Prisoners) are met, be present when the research is reviewed, and provide a review either orally or in writing. As required by federal regulations and/or UMN Policy, apply additional safeguards when reviewing research involving: pregnant women, human fetuses, or neonates; prisoners; children, and individuals with impaired consent capacity. All IRB members review written reports of consultants, if any.

6

IRB Non-Scientist1 Committee Member: Review and Meeting Conduct Expectations

PURPOSE: To describe the expectations, role and qualifications of IRB Non-scientist members serving the University of Minnesota IRB review of Human Research. QUALIFICATIONS: High moral code and interest in research ethics. Should have effective knowledge of subject populations and other factors that can foreseeably contribute to a determination of a risk-benefit ratio. Practical and timely when given tasks. Must be comfortable with the electronic environment and able to navigate in email and the internet. STATUS: Maintain awareness of representative member capacity as Non-Scientist. When necessary, serve as an alternate for any comparably qualified member (e.g. Non-Scientist Member can alternate for a Non-Scientist member) on any other UMN IRB panel. AFFILIATION: Non-affiliated2 members are expected to provide input regarding their individual knowledge about the local community and be willing to discuss issues and research from that perspective. A non-affiliated member is also a scientist2 or nonscientist3 member and would be expected to provide input on areas germane to his/her knowledge, expertise and experience, professional and otherwise. CONFLICTS OF INTEREST: All IRB members are to know the definition of Conflict of Interest (COI). No IRB member may participate in any review (including discussion or voting) in which he or she has a COI, except to provide information requested by the IRB. When reviewing an item, each IRB member is to consider whether he or she has a COI, and if so, to self-identify that COI. ATTENDANCE & TERM: Attend 65% of all scheduled meetings of the assigned committee. Prompt notification to HRPP staff of a pending absence from assigned committee is expected. IRB membership is set at three (3) year, renewable commitments. Version Date: September 2015 1

2

Non-Scientist IRB Member: Members whose training, background, and occupation would incline them to view scientific activities from the standpoint of someone outside of any behavioral or biomedical research discipline. NonScientific members typically are those members who have little or no scientific or medical training or experience. Examples of non-scientific or non-medical occupations may include, but not limited to, lawyers, clergy, ethicists, teachers, engineers, accountants, musicians, or business majors. (45CFR46.107(c), 21CFR56.107(c), & SACHRP January 24, 2011 letter) Non-Affiliated: Members who are not otherwise affiliated with the UMN, Fairview, or Gillette and who are not part of the immediate family of a person who is affiliated with the aforementioned institutions. (45CFR46.107(c), 21CFR56.107(c),)

1

TRAINING: Complete all required training in a timely manner and report completion to HRPP staff. CONFIDENTIALITY: All IRB members are to treat all oral and written information obtained as part of the review process as confidential. IRB members must not disclose or use confidential information without prior authorization. COMPENSATION: The UMN IRB adheres to Federal Guidance when recognizing the critical work performed by IRB members. In order to avoid real or perceived conflicts of interest, no IRB member may be paid more than reasonable compensation or receive more than reasonable benefits for IRB-related activities; and no IRB member may receive compensation or benefits under arrangements that could impede or discourage objective decision-making on behalf of human participants.

Committee Review Procedures All IRB members are to review regulatory requirements and, when acting as primary reviewer, complete applicable checklists for each submission. The IRB must determine that federal criteria for IRB approval are met prior to approving each research protocol/plan. The guiding ethical principles outlined in the Belmont Report of respect for persons (autonomy), beneficence, and justice must be considered when conducting each review IRB members are responsible for reviewing every agenda item assigned to their allotted meeting and for notifying HRPP staff to request additional information (e.g. entire study file) if needed. Primary Reviewer Responsibility: The primary reviewer for each submission leads the discussion for the studies on which he or she is assigned. They are expected to fill out applicable checklists with preliminary judgments as to whether each criterion for approval is met and provide preliminary study-specific findings justifying determinations. The primary reviewer also reviews all submitted materials for consistency with the materials reviewed by all IRB members, including the following when they exist:     

The complete application including any previously approved protocol modifications Investigator brochure Current protocol HHS grant application, HHS approved protocol & HHS-approved template consent document interventions Consent materials, including recruitment materials 2

 

HIPAA Authorization and/or request for HIPAA Waiver Any additional materials relevant to IRB review

During the presentation of the submission, the primary reviewer:   

  

Confirms an individual(s) with scientific/scholarly expertise performed a scientific/scholarly review, when applicable Reviews relevant findings of regulatory review and regulatory review contingencies. For a review related to an Unanticipated Problem Involving Risks to Participants or Others, Serious Noncompliance, Continuing Noncompliance, Suspension of IRB Approval, or Termination of IRB Approval, leads the IRB members through a discussion of the Report Form Review Sheet. Leads the IRB through a discussion of the criteria in applicable worksheets. When a checklist is applicable, discusses the checklist determinations and study-specific findings supporting those determinations. Summarize the IRB’s consensus

Initial Review: In advance of the meeting, all IRB members are to review the following materials to a depth sufficient to determine whether the criteria in applicable worksheets and checklists are met:    

Initial application form(s) Sections of the protocol relevant to the criteria. Consent document(s) and script(s), when they exist Recruitment materials, when they exist

Modifications to Protocols: In advance of the meeting, all IRB members are to review the modification, determine which criteria in applicable worksheets and checklists are affected, and review the following materials as necessary to a depth sufficient to determine whether affected criteria are met:    

Protocol Previously approved modifications not reflected in the current protocol, or a summary thereof Consent document(s) and script(s), when they exist Recruitment materials, when they exist

Continuing Review: In advance of the meeting, all IRB members review continuing review progress report and attachments, determine which criteria in applicable worksheets and checklists are affected, and review the following materials as necessary to a depth sufficient to determine whether affected criteria are met: 

Protocol 3

   

Previously approved modifications not reflected in the current protocol, or a summary thereof Consent document(s) and script(s), when they exist New consent document(s) and script(s), when they exist Recruitment materials, when they exist

New Information: In advance of the meeting, all IRB members review the new information and attachments, determine which criteria in applicable worksheets and checklists are affected, and review the relevant sections of the following materials to a depth sufficient to determine as necessary whether affected criteria are met:    

Protocol Previously submitted modifications or a summary thereof Consent document(s) and script(s), when they exist Written reports of consultants, when they exist

Special Considerations: 





If the research involves prisoners as participants, the prisoner representative reviews the submitted information to determine whether criteria in IRB Policy 501C (Requirements for Research Involving Prisoners) are met, be present when the research is reviewed, and provide a review either orally or in writing. As required by federal regulations and/or UMN Policy, apply additional safeguards when reviewing research involving: pregnant women, human fetuses, or neonates; prisoners; children, and individuals with impaired consent capacity. All IRB members review written reports of consultants, if any.

4

IRB Scientist 1 Committee Member: Review and Meeting Conduct Expectations

PURPOSE: To describe the expectations, role and qualifications of IRB Scientist members serving the University of Minnesota IRB review of Human Research. Wide ranging scientific or scholarly expertise among IRB members allows the IRB to review the broad variety of research in which UMN investigators are engaged. QUALIFICATIONS: Will have the professional scientific experience and competence necessary to review the specific research activities presented for IRB review (e.g. Physician, nurses, etc). Experience in research and/or the critical assessment of research (e.g. peer reviewed journals). Training, background, and occupation would incline them to view scientific activities from the standpoint of someone within a behavioral or biomedical research discipline. High moral code and interest in research ethics. Should have effective knowledge of subject populations and other factors that can foreseeably contribute to a determination of a risk-benefit ratio. Practical and timely when given tasks. STATUS: Maintain awareness of representative member capacity as Scientist1. When necessary, serve as an alternate for any comparably qualified member (e.g. Scientist Member can alternate for a Scientist member) on any other UMN IRB panel. Scientist members are expected to review assigned studies, as well as contribute to the evaluation of a research project on its scientific merits and standards of practice. Scientist members will be required to complete scientific reviews when assigned by the HRPP staff. These members are able to advise the IRB when additional expertise in a scientific area is required to assess whether a research project plan will adequately protect the rights and welfare of subjects. AFFILIATION: Non-affiliated2 members are expected to provide input regarding their individual knowledge about the local community and be willing to discuss issues and research Version Date: September 2015 1.) Scientist IRB Member: Members whose training, background, and occupation would include them to view scientific activities from the standpoint of someone within a behavioral or biomedical research discipline. Scientist IRB members are professionally conversant with the scientific method (either by virtue of advanced training or by current occupation in scientific fields) and who might thus be included to view a research protocol primarily from the viewpoint of a scientist. (45CFR46.107(c), 21CFR56.107(c), & SACHRP January 24, 2011 letter) 2.) Non-Affiliated: Members who are not otherwise affiliated with the UMN, Fairview, or Gillette and who are not part of the immediate family of a person who is affiliated with the aforementioned institutions.(45CFR46.107(c), 21CFR56.107(c)

1

from that perspective. A non-affiliated member is also a scientist2 or nonscientist3 member and would be expected to provide input on areas germane to his/her knowledge, expertise and experience, professional and otherwise. CONFLICTS OF INTEREST: All IRB members are to know the definition of Conflict of Interest (COI). No IRB member may participate in any review (including discussion or voting) in which he or she has a COI, except to provide information requested by the IRB. When reviewing an item, each IRB member is to consider whether he or she has a COI, and if so, to self-identify that COI. ATTENDANCE & TERM: Attend 65% of all scheduled meetings of the assigned committee. Prompt notification to HRPP staff of a pending absence from assigned committee is expected. IRB membership is set at three (3) year, renewable terms. TRAINING: Complete all required training in a timely manner and report completion to HRPP staff. CONFIDENTIALITY: All IRB members are to treat all oral and written information obtained as part of the review process as confidential. IRB members must not disclose or use confidential information without prior authorization. COMPENSATION: The UMN IRB adheres to Federal Guidance when recognizing the critical work performed by IRB members. In order to avoid real or perceived conflicts of interest, no IRB member may be paid more than reasonable compensation or receive more than reasonable benefits for IRB-related activities; and no IRB member may receive compensation or benefits under arrangements that could impede or discourage objective decision-making on behalf of human participants.

Committee Review Procedures All IRB members are to review regulatory requirements and, when acting as primary reviewer, complete applicable checklists for each submission. The IRB must determine that federal criteria for IRB approval are met prior to approving each research protocol/plan. The guiding ethical principles outlined in the Belmont Report of respect for persons (autonomy), beneficence, and justice must be considered when conducting each review IRB members are responsible for reviewing every agenda item assigned to their allotted meeting and for notifying HRPP staff to request additional information (e.g. entire study file) if needed. Primary Reviewer Responsibility:

2

The primary reviewer for each submission leads the discussion for the studies on which he or she is assigned. They are expected to fill out applicable checklists with preliminary judgments as to whether each criterion for approval is met and provide preliminary study-specific findings justifying determinations. The primary reviewer also reviews all submitted materials for consistency with the materials reviewed by all IRB members, including the following when they exist:       

The complete application including any previously approved protocol modifications Investigator brochure Current protocol HHS grant application, HHS approved protocol & HHS-approved template consent document interventions Consent materials, including recruitment materials HIPAA Authorization and/or request for HIPAA Waiver Any additional materials relevant to IRB review

During the presentation of the submission, the primary reviewer:   

  

Confirms an individual(s) with scientific/scholarly expertise performed a scientific/scholarly review, when applicable Reviews relevant findings of regulatory review and regulatory review contingencies. For a review related to an Unanticipated Problem Involving Risks to Participants or Others, Serious Noncompliance, Continuing Noncompliance, Suspension of IRB Approval, or Termination of IRB Approval, leads the IRB members through a discussion of the Report Form Review Sheet. Leads the IRB through a discussion of the criteria in applicable worksheets. When a checklist is applicable, discusses the checklist determinations and study-specific findings supporting those determinations. Summarize the IRB’s consensus

Initial Review: In advance of the meeting, all IRB members are to review the following materials to a depth sufficient to determine whether the criteria in applicable worksheets and checklists are met:    

Initial application form(s) Sections of the protocol relevant to the criteria. Consent document(s) and script(s), when they exist Recruitment materials, when they exist

Modifications to Protocols: In advance of the meeting, all IRB members are to review the modification, determine which criteria in applicable worksheets and checklists are affected, and 3

review the following materials as necessary to a depth sufficient to determine whether affected criteria are met:    

Protocol Previously approved modifications not reflected in the current protocol, or a summary thereof Consent document(s) and script(s), when they exist Recruitment materials, when they exist

Continuing Review: In advance of the meeting, all IRB members review continuing review progress report and attachments, determine which criteria in applicable worksheets and checklists are affected, and review the following materials as necessary to a depth sufficient to determine whether affected criteria are met:     

Protocol Previously approved modifications not reflected in the current protocol, or a summary thereof Consent document(s) and script(s), when they exist New consent document(s) and script(s), when they exist Recruitment materials, when they exist

New Information: In advance of the meeting, all IRB members review the new information and attachments, determine which criteria in applicable worksheets and checklists are affected, and review the relevant sections of the following materials to a depth sufficient to determine as necessary whether affected criteria are met:    

Protocol Previously submitted modifications or a summary thereof Consent document(s) and script(s), when they exist Written reports of consultants, when they exist

Special Considerations: 





If the research involves prisoners as participants, the prisoner representative reviews the submitted information to determine whether criteria in IRB Policy 501C (Requirements for Research Involving Prisoners) are met, be present when the research is reviewed, and provide a review either orally or in writing. As required by federal regulations and/or UMN Policy, apply additional safeguards when reviewing research involving: pregnant women, human fetuses, or neonates; prisoners; children, and individuals with impaired consent capacity. All IRB members review written reports of consultants, if any.

4

IRB Expert Consultants: Engagement and Review Expectations

PURPOSE: As set forth in 45 CFR 46.107(f) and 21 CFR 56.107(f), the IRB may, at its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. The purpose of this document is to describe the expectations and role of expert consultants who may be called upon to assist the IRB during review of human participants research. QUALIFICATIONS: Professional scientific experience and competence necessary to review the specific research activities presented. Experience in research and/or the critical assessment of research (e.g. reviewer for peer review journals). High moral code and interest in research ethics. IRB Scientist Member Review Expectations: Role: Provide expert review of research to facilitate the IRB’s evaluation of the Criteria for IRB Approval. Confidentiality: Expert consultants are to treat all oral and written information obtained as part of the review process as confidential. Consultants must not disclose or use confidential information without prior written authorization. Conflicts of Interest: Consultants are subject to the IRB Conflict of Interest Policy pertaining to IRB members. Availability: Potential expert consultants are an available resource to the IRB and will be called upon on an as needed or when IRB members lack the expertise needed in the scientific area of concern. Review Expectations: If the consultant agrees to review the protocol and the consultant has no conflicting interest, s/he is provided with all relevant information available to the IRB in order to perform an in-depth review of the research. The consultant will understand the background, aims and methods of the research. Consultants are asked to attend the IRB meeting to present their findings relative to the scientific merits of the study and risks and benefits to participants, and to answer questions. However, if the consultant is unavailable to attend the meeting, s/he may provide written comments for distribution to the IRB members in attendance. Consultants are not voting members of the IRB. Version Date: September 2015

1