{"id":1862,"date":"2022-07-15T12:24:57","date_gmt":"2022-07-15T17:24:57","guid":{"rendered":"https:\/\/uwm.edu\/irb\/?page_id=1862"},"modified":"2025-04-01T14:00:42","modified_gmt":"2025-04-01T19:00:42","slug":"standard-operating-procedures","status":"publish","type":"page","link":"https:\/\/uwm.edu\/irb\/guidance-documents\/standard-operating-procedures\/","title":{"rendered":"Standard Operating Procedures"},"content":{"rendered":"

<\/p>\n

IRB Role and Structure<\/span><\/h2>\n

001: The Role of the Institutional Review Board (12\/05\/2018)<\/strong><\/span>

<\/span><\/p>\nTerms and Abbreviations<\/span>
\n

FDA:<\/strong> Food and Drug Administration.<\/p>\n

FWA:<\/strong> Federal-wide Assurance.<\/p>\n

HRPP:<\/strong> Human Research Protection Program.<\/p>\n

IO:<\/strong> Institutional Official.\u00a0Individual who is legally authorized to act for the institution and ensures the effective functioning of the IRB.<\/p>\n

IRB:<\/strong> Institutional Review Board.<\/p>\n

IRB office staff:<\/strong> the IRB Manager, IRB Administrator, and any other IRB office staff, either collectively or individually.<\/p>\n

UWM:<\/strong> University of Wisconsin \u2013 Milwaukee.<\/p>\n<\/div>
\n<\/span><\/p>\n

Overview<\/span>

<\/span><\/p>\n

Role<\/strong> <\/span><\/p>\n

The role of the UWM IRB is to protect the rights and welfare of human subjects in research conducted by UWM faculty, staff, and students. This is accomplished by reviewing and overseeing research studies involving human subjects to ensure compliance with ethical principles and federal regulations. The IRB\u2019s decisions are based on the ethical principles in the Belmont Report and the Declaration of Helsinki. IRB operates under the rules of conduct established by the Code of Federal Regulations, Wisconsin state laws, and UWM policies. The IRB is also responsible for ensuring that the standards of the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) are met when protected health information is used or disclosed for research purposes. The IRB exercises autonomy in decision-making. <\/span><\/p>\n

Authority<\/strong> <\/span><\/p>\n

The IRB has the authority to: <\/span><\/p>\n

\u2022 Approve research, require modifications to protocols in order to approve research, or disapprove research; <\/span><\/p>\n

\u2022 Require progress reports or other information from investigators regarding the conduct of the research and the informed consent process; <\/span><\/p>\n

\u2022 Place restrictions on, suspend, or terminate the approval of research that: o is not being conducted in accordance with IRB requirements, or o has been associated with unanticipated problems that involve serious risks to subjects or others. <\/span><\/p>\n

Jurisdiction<\/strong> <\/span><\/p>\n

The IRB has jurisdiction over research involving the use of human subjects, which includes identifiable data and bio-specimens from human subjects, when UWM is considered \u201cengaged\u201d in research. <\/span><\/p>\n

<\/div><\/span><\/p>\n

Details and Procedures<\/span>

<\/span><\/p>\n

Independent Review<\/strong> \u00a0<\/span><\/p>\n

The HRPP in the Department of University Safety and Assurances is the administrative home of the IRB and supports the IRB\u2019s independence from external influences. The IRB Chair fosters an environment that encourages the free and full participation of all IRB members in its deliberations. As an integral component of the HRPP, the IRB maintains an open line of communication with the IRB Manager, Administrator, and\/or the HRPP staff (individually and collectively, the \u201cIRB office staff\u201d). The IRB office staff is the primary liaison between the IRB and campus researchers, staff, and any others who require assistance or desire interaction with the IRB. The IRB also has a direct relationship with the Associate Vice Chancellor of Facilities Planning & Management, who serves as the Institutional Official (IO). The IO is the University officer, designated by the UWM Chancellor, who is ultimately accountable for the IRB and the HRPP. The IRB reports directly to the IO and is supported by the IRB office staff and the University Safety and Assurances Department. The IRB is constituted by the IO and is registered with Department of Health and Human Services, Office for Human Research Protections (OHRP) under the UWM\u2019s Federal-wide Assurance FWA #00006171 and IRB Registration # IRB00000263. <\/span><\/p>\n

Functions<\/strong> <\/span><\/p>\n

The IRB ensures human subject protections by conducting the initial and continuing review of research protocols, and determining which research protocols require review more frequently than once per year. The IRB requires that proposed changes in research are promptly reported and that changes in approved research are not initiated without prior IRB review and approval, except when necessary to eliminate apparent immediate hazards to subjects. The IRB may require verification from sources other than the investigator that no material changes have occurred since the most recent IRB review and approval. The IRB reports its determinations and decisions in writing to investigators and the institution. <\/span><\/p>\n

The IRB requires the following for ongoing research:<\/strong><\/span><\/p>\n

\u2022 Unanticipated problems involving risks to subjects or others (UPIRSOs) must be promptly reported to the IRB Chair by the IRB office staff. <\/span><\/p>\n

\u2022 Any serious or continuing noncompliance with UWM HRPP Policies and\/or federal regulations, or the requirements or determinations of the IRB, must be promptly reported to the IRB, the IRB office staff and the IO. <\/span><\/p>\n

\u2022 Any suspension or termination of IRB approval must be promptly reported to the IO and the IRB office staff. When appropriate, the IO will also report these to pertinent federal agencies and\/or internal University Administrators. <\/span><\/p>\n

Definition of Human Subjects Research<\/strong> <\/span><\/p>\n

UWM follows the definition for human subjects research outlined in the federal regulations (45 CFR \u00a7 46). Research to satisfy a requirement imposed by UWM for the award of a degree (such as theses and dissertations) requires IRB review, if it also meets the definition of human subjects research. Class projects done solely to fulfill an individual course requirement do not typically require IRB review. <\/span><\/p>\n

Definition of \u201cEngaged\u201d<\/strong> <\/span><\/p>\n

UWM is \u201cengaged\u201d in research when the research is conducted by: <\/span><\/p>\n

\u2022 UWM faculty (any appointment, including adjunct, emeritus and non-salary);<\/span><\/p>\n

\u2022 UWM staff; or <\/span><\/p>\n

\u2022 UWM students AND when the research results are:<\/span><\/p>\n

\u2022 Used to fulfill a UWM degree requirement; or<\/span><\/p>\n

\u2022 Published, presented, or otherwise disseminated using UWM credentials. <\/span><\/p>\n

<\/div><\/span><\/p>\n

References<\/span>

<\/span><\/p>\n

45 CFR \u00a7 46 (Common Rule) <\/span><\/p>\n

21 CFR \u00a7 50 (FDA) <\/span><\/p>\n

21 CFR \u00a7 56 (FDA) <\/span><\/p>\n

45 CFR Parts 160 and 164 (HIPAA) <\/span><\/p>\n

The Belmont Report Declaration of Helsinki <\/span><\/p>\n

<\/div><\/span><\/p>\n

Link to PDF Version<\/span>

<\/span><\/p>\n

UWM IRB SOP 001: The Role of the Institutional Review Board (PDF)<\/a> <\/span><\/p>\n

<\/div><\/span><\/p>\n<\/div>\n

<\/p>\n

101: IRB Membership (12\/05\/2018)<\/strong><\/span>

<\/span><\/p>\n

Terms and Abbreviations<\/span>

<\/span><\/p>\n

IO:<\/strong> Institutional Official. <\/span>Individual who is legally authorized to act for the institution and ensures the effective functioning of the IRB. <\/span><\/p>\n

IRB:<\/strong> Institutional Review Board. <\/span><\/p>\n

IRB office staff:<\/strong> The IRB Manager, IRB Administrator, and any other IRB office staff, either collectively or individually. <\/span><\/p>\n

UWM:<\/strong> University of Wisconsin \u2013 Milwaukee. <\/span><\/p>\n

<\/div><\/span><\/p>\n

Overview<\/span>

<\/span><\/p>\n

The IRB includes a minimum of 5 members. As required by applicable federal regulations, these individuals are diverse in terms of race, gender, expertise, and cultural background. <\/span><\/p>\n

Through the combined experience and expertise of its members, the IRB is qualified to review studies in a range of health and behavioral sciences and to judge the acceptability of the research in terms of institutional commitments and regulations, applicable laws, and standards of professional conduct and practice. The IRB has the professional competence necessary to review the various kinds of human subject research conducted at UWM. <\/span><\/p>\n

Members include: <\/span><\/p>\n

\u2022 At least one non-scientist <\/span><\/p>\n

\u2022 At least one unaffiliated member<\/span><\/p>\n

\u2022 At least one scientist <\/span><\/p>\n

\u2022 A Chair and one or more Vice Chairs. <\/span><\/p>\n

In addition to these basic criteria, the members are carefully selected to ensure the IRB includes: <\/span><\/p>\n

\u2022 Expertise in a range of health and behavioral sciences. <\/span><\/p>\n

\u2022 Familiarity with relevant standards of professional conduct and practice. <\/span><\/p>\n

\u2022 Expertise in the problems and issues facing vulnerable populations, such as children, students, prisoners, individuals with impaired decision-making capacity, and economically or educationally disadvantaged persons. <\/span><\/p>\n

\u2022 Knowledge of various community perspectives in the Milwaukee area. A single member may fulfill multiple roles. As a representative of the institution and the IRB, each member must exhibit high standards of moral integrity and ethical conduct. The protection of human subjects is the highest priority as members review research, above any personal or institutional interests. <\/span><\/p>\n

Additional resources are available to the IRB:<\/span><\/p>\n

\u2022 Non-voting ad hoc consultants <\/span><\/p>\n

\u2022 IRB office staff for interpretation of federal regulations governing human subjects research<\/span><\/p>\n

\u2022 UWM\u2019s Office of Legal Affairs for interpretation of applicable federal, state, and local laws <\/span><\/p>\n

Member Liability Protection <\/strong>The actions of IRB members with respect to their official duties as IRB members are covered by the State of Wisconsin Self-Funded Property and Liability Program (insurance). <\/span><\/p>\n

<\/div><\/span><\/p>\n

Details and Procedure<\/span>

<\/span><\/p>\n

Selection of Members<\/strong><\/span><\/p>\n

\u2022 Scientist members are active or retired members of UWM faculty or academic staff, or current graduate students. They have experience in research with human subjects and are chosen for their expertise in the types of research most commonly conducted at UWM.<\/span><\/p>\n

\u2022 An unaffiliated member is an individual who is not affiliated with UWM and does not have any immediate family members affiliated with UWM. o Unaffiliated members are chosen for their ability to represent community perspectives. Whenever possible, they are respected leaders in their communities, with close ties to, and understanding of, the issues facing the various cultural and ethnic groups in the Milwaukee area. They also provide a perspective from outside the university community. <\/span><\/p>\n

A person is unaffiliated if they and their immediate family have NOT held any of the following positions at UWM within the past 10 years:<\/span><\/p>\n

\u25aa Faculty<\/span><\/p>\n

\u25aa Staff<\/span><\/p>\n

\u25aa Degree-seeking student <\/span><\/p>\n

Ideally, the unaffiliated member is someone who has never attended or worked at UWM, and whose immediate family members have never attended or worked at UWM. <\/span><\/p>\n

\u2022 Non-scientist members have expertise in an area that is relevant to human subjects protections, such as community attitudes, ethics, legal concerns, etc. <\/span><\/p>\n

\u2022 The IRB will contain a minimum of 5 members. Beyond this minimum, the number of full voting members and alternates may be expanded or reduced as deemed appropriate by the IO. <\/span><\/p>\n

Appointment Process<\/strong> <\/span><\/p>\n

1. When there is a vacancy on the IRB, the IRB office staff solicits member nominations through direct contact and via referrals from colleagues and IRB members. <\/span><\/p>\n

2. The IRB office staff sends the CV(s) of nominee(s) to the members for input and feedback. <\/span><\/p>\n

3. If member responses are favorable, nominee(s) are presented to the IO, the Vice Provost for Research, and the Vice Chancellor of Finance Administrative Affairs. <\/span><\/p>\n

4. Once approved by the IO and Vice Chancellors, the IRB office staff forwards the nomination to the Chancellor, who issues the appointment letter. <\/span><\/p>\n

5. Upon acceptance of the Chancellor\u2019s Letter of Appointment, the nominee officially becomes either a Primary Voting Member or an Alternate Member of the IRB. <\/span><\/p>\n

Responsibilities of Members<\/strong> <\/span><\/p>\n

\u2022 Attend the required initial education program. <\/span><\/p>\n

\u2022 Maintain confidentiality of all IRB-related activities and refrain from discussing them outside the context of these duties. <\/span><\/p>\n

\u2022 Conduct reviews of research protocols in a timely manner.<\/span><\/p>\n

\u2022 Attend and contribute to the IRB review and discussion of protocols during full board meetings.<\/span><\/p>\n

\u2022 Attend any required continuing education for IRB members. <\/span><\/p>\n

Resignation and Removal<\/strong> <\/span><\/p>\n

Members who wish to resign from the IRB should do so in writing to the IRB office staff. Members attend all meetings and conduct all protocol reviews assigned up until the date their resignation takes effect. The IO may remove an IRB member at any time after consulting with the Vice-Chancellors for Research and Finance and Administrative Affairs, the IRB Chair, and the IRB office staff. <\/span><\/p>\n

Alternate Voting Members<\/strong> <\/span><\/p>\n

The IRB may recruit alternate members to substitute for primary voting members of the IRB. Alternate members may attend, count towards quorum, and vote in place of any absent primary voting member. The maximum number of votes that can be counted equals the number of full voting members. If the total number of primary and alternate members attending a given meeting exceeds the number of primary voting members, one or more alternates would not vote. The role of the individuals attending will determine who votes; an alternate who fulfills the same role as a full member in attendance would not vote. <\/span><\/p>\n

Example: Suppose the IRB has 16 full voting members and 10 alternates. At a given meeting, 18 members attend, 3 of whom are alternates. The full member and alternate from Psychology are present, and the full member and alternate from Kinesiology are present. The alternate student member is present, but the full member is not. In this case, the alternates from Psychology and Kinesiology may contribute to the discussion, but they would not vote. The student alternate member would vote. The procedures for appointment, the expectations for membership, and the procedure for removal of an alternate member are the same as that of a primary voting member. <\/span><\/p>\n

Ad Hoc Consultant Reviewers<\/strong> <\/span><\/p>\n

The IRB may invite individuals with special expertise to assist in the review of research protocols. They may be from within UWM or outside the UWM community. <\/span><\/p>\n

Ad hoc reviewers may: <\/span><\/p>\n

\u2022 Have access to all documents submitted to the IRB relevant to the specific research protocol under review. <\/span><\/p>\n

\u2022 Participate in the IRB meeting during discussion. <\/span><\/p>\n

\u2022 Make recommendations on the research protocol.<\/span><\/p>\n

\u2022 Provide written comments in addition to, or in place of, attending the IRB meeting. <\/span><\/p>\n

Ad hoc reviewers do not vote. All ad hoc reviewers sign a statement of confidentiality prior to performing any review. By signing, they agree to maintain strict confidence relating to all activities performed during their course of consultancy and to refrain from discussing the activities outside of the context of these duties. <\/span><\/p>\n

<\/div><\/span><\/p>\n

References<\/span>

<\/span><\/p>\n

45 CFR \u00a7 46.107 (IRB Membership) <\/span><\/p>\n

45 CFR \u00a7 46.304 (Prisoner Representative) <\/span><\/p>\n

SOP 102: IRB Chair and Vice \/ Co-Chair <\/span><\/p>\n

<\/div><\/span><\/p>\n

Link to PDF Version<\/span>

<\/span><\/p>\n

UWM IRB SOP 101: IRB Membership (PDF) <\/span><\/a><\/p>\n

<\/div><\/span><\/p>\n<\/div>\nAppendix<\/strong> 101.1: Member\/ Ad Hoc Reviewer Confidentiality Agreement Template<\/strong><\/span>

<\/span><\/p>\n

Institutional Review Board Committee Member or Invitee Non-Disclosure Agreement<\/a><\/p>\n<\/div>\n

<\/p>\n

102 IRB Chair and Vice Chair (12\/05\/2018)<\/strong><\/span>

<\/span><\/p>\n

Terms and Abbreviations<\/span>

<\/span><\/p>\n

IO:<\/strong> Institutional Official; individual who is legally authorized to act for the institution and ensures the effective functioning of the IRB. <\/span><\/p>\n

IRB:<\/strong> Institutional Review Board. <\/span><\/p>\n

IRB office staff:<\/strong> the IRB Manager, IRB Administrator, and any other IRB office staff, either collectively or individually. <\/span><\/p>\n

UWM:<\/strong> University of Wisconsin \u2013 Milwaukee. <\/span><\/p>\n

<\/div><\/span><\/p>\n

Overview<\/span>

<\/span><\/p>\n

The IRB has a Chair and one or more Vice Chairs. The Chair is a respected, active member of the faculty or staff of UWM, who is concerned about human rights and ethical issues. The Chair is knowledgeable about the application of regulations and ethical principles in human subject research. The Chair also leads the IRB meetings and facilitates communication between investigators and the IRB office staff. As a representative of the institution and the IRB, the Chair exhibits high standards of moral integrity and ethical conduct and sets an example for IRB members. The IRB Chair fosters an environment that encourages the free and full participation of all IRB members in its deliberations. The Vice Chair is considered a Chair-in-Training. As a representative of the institution and the IRB, the Vice Chair must exhibit high standards of moral integrity and ethical conduct. The Vice Chair leads IRB meetings in the Chair\u2019s absence. <\/span><\/p>\n

<\/div><\/span><\/p>\n

Details and Procedures<\/span>

<\/span><\/p>\n

IRB Chair<\/strong> <\/span><\/p>\n

1. Appointment process <\/span><\/p>\n

a. The IO solicits recommendations for the Chair from the IRB and IRB office staff. The IO consults with the IRB and the Vice Provost for Research and the Vice Chancellor of Finance and Administrative Affairs regarding the candidate(s) for Chair. <\/span><\/p>\n

b. Once approved by the IO and Vice Chancellors, the IRB office staff forwards the nomination to the Chancellor, who issues the appointment letter. <\/span><\/p>\n

c. The Chair formally accepts this role by signing and returning the Chancellor\u2019s Letter of Appointment. <\/span><\/p>\n

2. A Chair serves continuously without limit at the discretion of the IO. <\/span><\/p>\n

3. The IO may remove an IRB Chair at any time, after consulting with the Vice Provost for Research, the Vice Chancellor of Finance and Administrative Affairs, the IRB office staff, and\/or IRB members, as appropriate. <\/span><\/p>\n

Vice Chair<\/strong> <\/span><\/p>\n

1. Appointment Process <\/span><\/p>\n

a. The IO solicits recommendations from the IRB Chair and IRB office staff for a Vice Chair. The IO consults with the Vice Provost for Research and the Vice Chancellor of Finance and Administrative Affairs regarding the nominee(s) for Vice Chair. <\/span><\/p>\n

b. The IO determines the term length (one to three years). <\/span><\/p>\n

c. Once approved by the IO and Vice Chancellors, the IRB office staff forwards the nomination to the Chancellor, who issues the appointment letter. <\/span><\/p>\n

d. The Vice Chair formally accepts this role by signing and returning the Chancellor\u2019s Letter of Appointment. <\/span><\/p>\n

2. The Vice Chair\u2019s term may be renewed at the discretion of the IO. There is no limit to the number of terms. <\/span><\/p>\n

3. Whenever the Chair is not available, the Vice Chair assumes the responsibilities of the Chair during the period of absence or other unavailability. <\/span><\/p>\n

4. The IO may remove an IRB Vice Chair at any time, after consulting with the IRB office staff and the IRB Chair. <\/span><\/p>\n

Temporary Chair<\/strong> <\/span><\/p>\n

If both the Chair and Vice Chair are unavailable, the IO may designate a temporary Chair. When feasible, the IO discusses the appointment of a temporary Chair with the IRB. <\/span><\/p>\n

<\/div><\/span><\/p>\n

References<\/span>

<\/span><\/p>\n

\u00a0101: IRB Membership<\/span><\/p>\n

<\/div><\/span><\/p>\n

Link to PDF Version<\/span>

<\/span><\/p>\n

UWM IRB SOP 102: IRB Chair and Vice Chair (PDF)<\/a> <\/span><\/p>\n

<\/div><\/span><\/p>\n<\/div>\n

<\/p>\n

Education<\/span><\/h2>\n

201: IRB Member Education (12\/5\/2018)<\/strong><\/span>

<\/span><\/p>\n

Terms and Abbreviations<\/span>

<\/span><\/p>\n

CITI:<\/strong> Collaborative Institutional Training Initiative (CITI Program); an organization that provides web-based educational courses in research ethics, regulatory oversight, responsible conduct of research, research administration, etc. <\/span><\/p>\n

HIPAA:<\/strong> Health Insurance Portability and Accountability Act of 1996; federal legislation relating to the privacy and security of medical records. <\/span><\/p>\n

IRB:<\/strong> Institutional Review Board.<\/span><\/p>\n

IRB office staff:<\/strong> the IRB Manager, IRB Administrator, and any other IRB office staff, either collectively or individually. <\/span><\/p>\n

<\/div><\/span><\/p>\n

Overview<\/span>

<\/span><\/p>\n

IRB members participate in both initial and continuing education.<\/strong> <\/span><\/p>\n

These programs focus on: <\/span><\/p>\n

\u2022The ethical principles and regulatory requirements underpinning human subject protections.<\/span><\/p>\n

\u2022Applying those principles and requirements to the review of research. <\/span><\/p>\n

<\/div><\/span><\/p>\n

Details and Procedures<\/span>

<\/span><\/p>\n

Initial Education Program<\/strong> <\/span><\/p>\n

The initial education program consists of in-person training provided by the IRB office staff and online training provided by CITI. All IRB Chairs, Vice Chairs, members, and alternates must complete the training in the following areas before actively participating in the IRB: <\/span><\/p>\n

1.<\/strong> Ethical Principles and the Belmont Report <\/span><\/p>\n

2.<\/strong> Regulatory Requirements <\/span><\/p>\n

3.<\/strong> UWM Federal Wide Assurance (FWA) <\/span><\/p>\n

4.<\/strong> UWM Institutional Policies and Procedures <\/span><\/p>\n

5.<\/strong> IRB\u2019s Role and Responsibilities <\/span><\/p>\n

6.<\/strong> Application of the Principles and Regulations to the Initial and Continuing Review of Research and Modifications <\/span><\/p>\n

7.<\/strong> Research Protocol Review Criteria and Review Process <\/span><\/p>\n

8.<\/strong> Informed Consent Process and Document <\/span><\/p>\n

9.<\/strong> Vulnerable Populations: Pregnant Women, Fetuses, Prisoners, Children and Others <\/span><\/p>\n

10.<\/strong> Investigator Responsibilities <\/span><\/p>\n

11.<\/strong> HIPAA Policies and Procedures In addition, new members are assigned to review at least one protocol along with an experienced member before reviewing protocols on their own. <\/span><\/p>\n

Continuing Education Program<\/strong> <\/span><\/p>\n

IRB members complete a CITI training course every 3 years, and the IRB office staff provides continuing education specifically for IRB members at least once annually. IRB members are also encouraged to take advantage of the following continuing education opportunities: <\/span><\/p>\n

\u2022 Scheduled short current topics (case studies and current events)<\/span><\/p>\n

\u2022 Just-in-Time training, in response to specific issues raised during the review of research protocols<\/span><\/p>\n

\u2022 Regional and national educational conferences<\/span><\/p>\n

\u2022 Training sessions for researchers offered by the IRB office staff <\/span><\/p>\n

<\/div><\/span><\/p>\n

References<\/span>

<\/span><\/p>\n

45 CFR \u00a7 160 (HIPAA) <\/span><\/p>\n

45 CFR \u00a7 164 (HIPAA) <\/span><\/p>\n

<\/div><\/span><\/p>\n

Link to PDF Version<\/span>

<\/span><\/p>\n

UWM IRB SOP 201: IRB Member Education (PDF) <\/a> <\/span><\/p>\n

<\/div><\/span><\/p>\n<\/div>\n

202: Research Education (02\/13\/2020)<\/strong><\/span>

<\/span><\/p>\n

Terms and Abbreviations<\/span>

<\/span><\/p>\n

CITI:<\/strong> Collaborative Institutional Training Initiative (CITI Program); an organization that provides web-based educational courses in research ethics, regulatory oversight, responsible conduct of research, research administration, etc. <\/span><\/p>\n

GCP:<\/strong> Good Clinical Practice. <\/span><\/p>\n

HIPAA:<\/strong> Health Insurance Portability and Accountability Act of 1996; federal legislation relating to the privacy and security of medical records. <\/span><\/p>\n

IRB:<\/strong> Institutional Review Board. <\/span><\/p>\n

IRB office staff:<\/strong> the IRB Manager, IRB Administrator, and any other IRB office staff, either collectively or individually. <\/span><\/p>\n

NIH: <\/strong>National Institutes of Health. <\/span><\/p>\n

PI:<\/strong> Principal Investigator. <\/span><\/p>\n

SPI:<\/strong> Student Principal Investigator. <\/span><\/p>\n

UWM:<\/strong> University of Wisconsin – Milwaukee.<\/span><\/p>\n

<\/div><\/span><\/p>\n

Overview<\/span>

<\/span><\/p>\n

To ensure that individuals conducting research with human subjects are sufficiently qualified to protect the safety and wellbeing of those subjects, researchers must complete training in human subjects protections on a regular basis. In addition to the required training, the IRB office staff offers a range of optional in-person or online training.<\/span><\/p>\n

<\/div><\/span><\/p>\n

Details and Procedures<\/span>

<\/span><\/p>\n

Scope<\/strong> The Required Training outlined below applies only to PIs and SPIs or other primary contacts on a study. For other research personnel, the PI determines what training is necessary for the individual\u2019s specific role and ensures that it is completed. <\/span><\/p>\n

The PI\u2019s discretion regarding training is superseded when:<\/strong> <\/span><\/p>\n

\u2022 Specific training is required by external funding agencies (e.g. GCP training for all key personnel on NIH-funded clinical trials); or <\/span><\/p>\n

\u2022 The IRB determines that specific additional training is necessary to ensure the protection of human subjects and\/or the scientific validity of the data. PIs are required to keep training records of all personnel working on their research studies and may be asked to provide these training records to the IRB. <\/span><\/p>\n

Required Training<\/strong> <\/span><\/p>\n

At the time of initial study submission, the IRB office staff verifies that the PI and SPI \/ primary contact have completed IRB CITI training within the last 3 years. Any one of the following UWM-specific CITI courses fulfills this requirement:<\/span><\/p>\n

\u2022 IRB-Biomedical Researchers <\/span><\/p>\n

\u2022 IRB-Biomedical and Social & Behavioral Combined Researchers<\/span><\/p>\n

\u2022 IRB-Social & Behavioral Researchers <\/span><\/p>\n

\u2022 IRB Members <\/span><\/p>\n

\u2022 Refresher courses for any of the above. <\/span><\/p>\n

CITI training completed through another institution may be accepted in lieu of the courses listed above, if the completed course is similar to the UWM required modules. IRB office staff make this determination. If the researcher has not completed CITI training within the last 3 years, the IRB office staff notifies the researcher that this needs to be completed. <\/span><\/p>\n

\u2022 For exempt studies, approval may be issued in rare cases with CITI training incomplete at the discretion of the IRB office staff. Example: A student project where the SPI has completed CITI training and the faculty PI agrees to complete the training within the next month. <\/span><\/p>\n

\u2022 For expedited and full board studies, IRB approval of the study is not issued until CITI training is complete and current. <\/span><\/p>\n

GCP<\/strong> <\/span><\/p>\n

GCP training is required for all key personnel on NIH-funded clinical trials, and strongly recommended for all key personnel on all other federally-funded clinical trials. Any one of the following CITI courses fulfills this requirement: <\/span><\/p>\n

\u2022 GCP \u2013 Social and Behavioral Research Best Practices for Clinical Research <\/span><\/p>\n

\u2022 GCP for Clinical Investigations of Devices <\/span><\/p>\n

\u2022 GCP for Clinical Trials with Investigational Drugs and Medical Devices (US FDA Focus)<\/span><\/p>\n

\u2022 Refresher courses for any of the above. <\/span><\/p>\n

HIPAA<\/strong> <\/span><\/p>\n

HIPAA training, available through UWM\u2019s legal department, is strongly recommended for any PI or SPI using medical records in research. <\/span><\/p>\n

Optional Education<\/strong> <\/span><\/p>\n

1. The IRB office staff offers multiple in-person training sessions each year on a variety of topics. Researchers are encouraged to attend these sessions to learn more about a specific area of human subjects research, refresh current knowledge, and to ask questions. <\/span><\/p>\n

2. Self-paced online training on select topics is available for researchers through the UWM IRB website. <\/span><\/p>\n

<\/div><\/span><\/p>\n

References<\/span>

<\/span><\/p>\n

45 CFR \u00a7 160 (HIPAA) <\/span><\/p>\n

45 CFR \u00a7 164 (HIPAA)<\/span><\/p>\n

<\/div><\/span><\/p>\n

Link to PDF Version<\/span>

<\/span><\/p>\n

UWM IRB SOP 202: Researcher Education (PDF)<\/a> <\/span><\/p>\n

<\/div><\/span><\/p>\n<\/div>\n

<\/p>\n

Operations<\/strong><\/h2>\n

301: Operations (02\/13\/2020)<\/strong><\/span>

<\/span><\/p>\n

Terms and Abbreviations<\/span>

<\/span><\/p>\n

HSR:<\/strong> Human Subjects Research, as defined in 45 CFR 46. <\/span><\/p>\n

IO:<\/strong> Institutional Official.\u00a0<\/span>Individual who is legally authorized to act for the institution and ensures the effective functioning of the IRB. <\/span><\/p>\n

IRB:<\/strong> Institutional Review Board. <\/span><\/p>\n

IRB office staff:<\/strong> the IRB Manager, IRB Administrator, and any other IRB office staff, either collectively or individually. <\/span><\/p>\n

<\/div><\/span><\/p>\n

Overview<\/span>

<\/span><\/p>\n

The IRB office staff supports the IRB in the following ways:<\/strong> <\/span><\/p>\n

\u2022 Protocol reviews <\/span><\/p>\n

\u2022 Providing expertise in regulations and laws related to human subjects research <\/span><\/p>\n

\u2022 Post-approval reviews <\/span><\/p>\n

\u2022 Facilitating IRB meetings <\/span><\/p>\n

\u2022 Administrative Functions The IRB office staff may be voting members of the IRB<\/span><\/p>\n

<\/div><\/span><\/p>\n

Details and Procedures<\/span>

<\/span><\/p>\n

Protocol Reviews<\/strong> <\/span><\/p>\n

The IRB office staff receives and processes all submissions to the IRB and performs the initial review. This includes new studies, amendments, continuing reviews, reportable events, and requests for HSR determination. Where a primary reviewer is required, the IRB office staff assigns a reviewer from among the IRB members, in consultation with the Chair when necessary. For studies requiring review by the convened IRB, the IRB office staff places the submission on the next available meeting agenda. IRB office staff serve as non-compliance subcommittee members when reports of noncompliance are received. They may be tasked with investigating details of instances of non-compliance so that the subcommittee and\/or the IRB may make an informed decision.<\/span><\/p>\n

Regulatory Expertise<\/strong> <\/span><\/p>\n

The IRB office staff regularly participates in continuing education, ensuring that UWM IRB remains aware of current thought and changes in regulations related to human subjects research. The IRB office staff shares this knowledge and expertise with IRB members and researchers through formal in-person training sessions, guidance documents, communications with the research community about new events or changes, and individual consultation on questions or concerns researchers and members may have. <\/span><\/p>\n

Post-Approval Reviews<\/strong> <\/span><\/p>\n

The IRB office staff schedules and conducts post-approval reviews to ensure compliance with the appropriate regulations and the approved protocol.<\/span><\/p>\n

Facilitating IRB Meetings<\/strong> <\/span><\/p>\n

The IRB office staff schedules IRB meetings, records member attendance, monitors to ensure quorum is maintained, documents the IRB\u2019s decisions and discussion, and creates the meeting agenda and minutes. The IRB office staff notifies investigators of the IRB\u2019s decisions and any conditions or stipulations of approval. The IRB may designate the IRB office staff to review requested revisions and determine that all conditions of approval are met. <\/span><\/p>\n

Administrative Functions<\/strong> <\/span><\/p>\n

The IRB office staff maintains all required records for individual studies until at least 3 years past the end date of the study, or longer if required by regulations. The IRB office staff also maintains all records of IRB meetings in accordance with Wisconsin open records laws and federal regulations. The IRB office staff maintains and updates the IRB website as needed, creates and updates SOPs, and publishes and disseminates important communications to IRB members and the research community. The IRB office staff arranges reliance agreements with other institutions, in cooperation with the IO.<\/span><\/p>\n

<\/div><\/span><\/p>\n

References<\/span>

<\/span><\/p>\n

45 CFR 46.102 Wis. Stats. <\/span><\/p>\n

\u00a7\u00a7 19.21-19.39 (Wisconsin open records law) <\/span><\/p>\n

SOP 201 \u2013 IRB Member Education SOP 202 \u2013 Researcher Education <\/span><\/p>\n

SOP 302 \u2013 Record Retention <\/span><\/p>\n

SOP 303 \u2013 IRB Meetings <\/span><\/p>\n

SOP 401 \u2013 Review of Research <\/span><\/p>\n

SOP 309 \u2013 Compliance and Post-Approval Reviews <\/span><\/p>\n

<\/div><\/span><\/p>\n

Link to PDF Version<\/span>

<\/span><\/p>\n

UWM IRB SOP 301: Role of the IRB Staff (PDF)<\/a> <\/span><\/p>\n

<\/div><\/span><\/p>\n<\/div>\n

<\/p>\n

302: Record Retention (02\/13\/2020)<\/strong><\/span>

<\/span><\/p>\n

Terms and Abbreviations<\/span>

<\/span><\/p>\n

FDA:<\/strong> Food and Drug Administration; the division of HHS that oversees drugs, medical devices, and food. <\/span><\/p>\n

HHS:<\/strong> Health and Human Services; a department of the US government whose responsibility is the protection of the health of Americans <\/span><\/p>\n

IRB:<\/strong> Institutional Review Board <\/span><\/p>\n

IRB office staff:<\/strong> the IRB Manager, IRB Administrator, and any other IRB office staff, either collectively or individually <\/span><\/p>\n

OHRP:<\/strong> Office of Human Research Protections; a division of HHS that oversees human subjects research <\/span><\/p>\n

PI:<\/strong> Principal Investigator <\/span><\/p>\n

SPI:<\/strong> Student Principal Investigator <\/span><\/p>\n

UWM:<\/strong> University of Wisconsin \u2013 Milwaukee <\/span><\/p>\n

<\/div><\/span><\/p>\n

Overview<\/span>

<\/span><\/p>\n

The Principal Investigator and IRB must maintain and retain the appropriate records for each research study, consistent with federal regulations, Wisconsin open meeting laws, and UWM\u2019s records retention policies. Records must be maintained in a confidential and secure manner. IRB records are generally subject to open records requests. <\/span><\/p>\n

Exceptions:<\/strong><\/span><\/p>\n

\u2022 Minutes of closed session IRB meetings<\/span><\/p>\n

\u2022 Student research projects<\/span><\/p>\n

\u2022 Any other documents created by or related to a student <\/span><\/p>\n

<\/div><\/span><\/p>\n

Details and Procedures<\/span>

<\/span><\/p>\n

Principal Investigator Record Retention<\/strong> <\/span><\/p>\n

Each Principal Investigator must retain records of all correspondence relating to the use of human subjects in research, as required by UWM procedures and federal regulations. <\/span><\/p>\n

This includes:<\/strong> <\/span><\/p>\n

\u2022 All IRB application materials (initial, amendment, continuing review, etc.) <\/span><\/p>\n

\u2022 All approval letters and important correspondence (initial, continuing review, and amendment approval letters; reportable event memos, etc.) <\/span><\/p>\n

\u2022 All versions of approved informed consent forms<\/span><\/p>\n

\u2022 Training records for research team members <\/span><\/p>\n

\u2022 Research data, which must be stored according to the IRB approved protocol Records of human subject research may be inspected by federal authorities, the IRB, and\/or accreditation agencies. Research records must be kept for a minimum of three years after completion of the study. For studies that involve drugs or devices seeking FDA approval, records must be kept for three years after the FDA has taken final action on the marketing application. Other requirements for record retention may also apply. Funding agency, department, professional field, or other UWM requirements may be different. Records should be maintained in a manner compliant with the most stringent of all applicable requirements. <\/span><\/p>\n

Researchers Leaving UWM<\/strong><\/span><\/p>\n

If a researcher leaves UWM, appropriate arrangements should be made for the care and retention of the records. This may include transfer of oversight of the data to another UWM faculty or staff member, de-identification or destruction of data, or transfer of the data to a new institution. All actions related to transfer of data to another institution must be discussed with appropriate parties within both UWM and the receiving institution, including the IRBs of both institutions.<\/span><\/p>\n

IRB Record Retention<\/strong> <\/span><\/p>\n

The IRB maintains records of all protocols and correspondence submitted to the IRB and minutes from all full board meetings for a minimum of three years after completion of the study. All records are accessible for inspection and copying by authorized representatives of OHRP, HHS, FDA, Sponsors, university officials, and internal auditors at reasonable times and in a reasonable manner. <\/span><\/p>\n

<\/div><\/span><\/p>\n

References<\/span>

<\/span><\/p>\n

45 CFR 46.115 21 CFR 56.115 Wis. Stats. <\/span><\/p>\n

\u00a7\u00a7 19.21-19.39 (Wisconsin open records law) Wis. <\/span><\/p>\n

Stats. \u00a7\u00a7 19.81-19.98 (Wisconsin open meetings law) <\/span><\/p>\n

<\/div><\/span><\/p>\n

Link to PDF Version<\/span>

<\/span><\/p>\n

UWM IRB SOP 302: Record Retention(PDF)<\/a> <\/span><\/p>\n

<\/div><\/span><\/p>\n<\/div>\n

303: IRB Meetings (02\/19\/2020)<\/strong><\/span>

<\/span><\/p>\n

Terms and Abbreviations<\/span>

<\/span><\/p>\n

IRB:<\/strong> Institutional Review Board <\/span><\/p>\n

IRB office staff:<\/strong> the IRB Manager, IRB Administrator, and any other IRB office staff, either collectively or individually <\/span><\/p>\n

<\/div><\/span><\/p>\n

Overview<\/span>

<\/span><\/p>\n

IRB members convene regularly to review protocols involving human subjects. The IRB reviews all research protocols at convened meetings where a quorum has been established, except where an application is eligible for exempt or expedited review. The IRB office staff prepares minutes of each meeting to document the IRB\u2019s review of research protocols, policy discussions, and continuing education. <\/span><\/p>\n

Investigators and Guests<\/strong> <\/span><\/p>\n

The IRB may invite investigators and\/or research team members to attend the IRB meeting. This allows IRB members to ask questions and clarify information. The IRB complies with the State of Wisconsin open meeting regulations. If a member requests that the IRB go into closed session, investigators and other guests will be asked to leave the room unless invited by the Chair to remain. The Chair will call for a motion to go into closed session.<\/span><\/p>\n

Confidentiality<\/strong> <\/span><\/p>\n

IRB members, staff, and guests are reminded a teach meeting to maintain confidentiality of the IRB\u2019s discussions and decisions. <\/span><\/p>\n

<\/div><\/span><\/p>\n

Details and Procedures<\/span>

<\/span><\/p>\n

Meeting scheduling<\/strong> <\/span><\/p>\n

The IRB generally meets monthly, but may meet more or less often as needed. IRB office staff set the dates for meetings and contact members to ensure there will be quorum at the meeting. IRB office staff conduct a pre-review of all submissions and determine the level of review required, consulting with IRB members or the Chair when necessary. All protocols deemed either to involve more than minimal risk or that require full board review for regulatory compliance (e.g. device studies where a \u201cnon-significant risk\u201d determination is required), are placed on the next available meeting agenda. <\/span><\/p>\n

Materials<\/strong> <\/span><\/p>\n

Members receive the meeting agenda and all submitted materials for each full board review. The agenda includes: <\/span><\/p>\n

\u2022Research protocols for full board review <\/span><\/p>\n

\u2022Research that has been approved through exempt or expedited review procedures (including new submissions, amendments, continuing reviews, and reportable events) <\/span><\/p>\n

\u2022Research deferred to other institutions <\/span><\/p>\n

\u2022Post-approval reviews conducted Submitted materials for full board reviews include: \u2022Study protocol <\/span><\/p>\n

\u2022Informed consent and assent documents <\/span><\/p>\n

\u2022Recruitment materials<\/span><\/p>\n

\u2022Data collection tools<\/span><\/p>\n

\u2022Any other documents deemed necessary or helpful for the review. <\/span><\/p>\n

IRB office staff distribute the meeting materials at least 4 days before the meeting. This allows members sufficient time to review the materials and to contact investigators with questions if they choose. <\/span><\/p>\n

Quorum, Meeting Procedures, and Voting<\/strong> <\/span><\/p>\n

A quorum is defined as greater than 50% of the voting membership, including at least one member whose primary concerns are in nonscientific areas. Voting members may attend meetings by teleconference or videoconference if: <\/span><\/p>\n

1.They have received all items for review in advance of the meeting; AND <\/span><\/p>\n

2.The equipment permits meaningful participation in discussion and voting.<\/span><\/p>\n

A scientist and non-scientist must be present at each meeting. In order to in initiate a vote, a motion must be made by a voting member of the IRB and seconded. When a motion is not seconded, it does not go forward to a vote. Any motion that is seconded must go forward for a vote unless the person who made the motion withdraws it. If a motion does not pass, then the Chair will ask for another motion, and so on, until a motion passes or is withdrawn. <\/span><\/p>\n

The approval of IRB actions requires the vote of a simple majority (greater than 50%) of the voting members present at the meeting. Only IRB members who attend the meeting may vote. Members who are unable to attend may submit written comments or questions prior to the meeting, but do not vote. <\/span><\/p>\n

Minutes<\/strong> <\/span><\/p>\n

The minutes are recorded in sufficient detail to document the following: <\/span><\/p>\n

\u2022IRB Member attendance and the presence of any invited investigators or guests.<\/span><\/p>\n

\u2022Motions to go into closed session, the reasons for doing so, the applicable statutory exemptions for closed sessions, and the board\u2019s vote on such motions. <\/span><\/p>\n

\u2022IRB committee acknowledgement of expedited and exempt reviews. <\/span><\/p>\n

\u2022Summary of the discussion and controverted issues for each research protocol reviewed. <\/span><\/p>\n

\u2022Decisions reached and any required modifications. <\/span><\/p>\n

\u2022Votes on the decisions, including a tally of votes for, against, and abstaining for each vote, and recusal of members due to conflicting interests. <\/span><\/p>\n

\u2022Reasons for requiring modifications to secure approval of a research protocol, for disapproving a research protocol, or suspending or terminating a research protocol.<\/span><\/p>\n

\u2022Documentation that a waiver or alteration of informed consent or a waiver of documentation of informed consent, if granted, is appropriate. <\/span><\/p>\n

\u2022The level of risk involved in the research. <\/span><\/p>\n

\u2022The review frequency for the next continuing review, if less than one year. <\/span><\/p>\n

\u2022For studies determined to be minimal risk, whether or not continuing review will be required.<\/span><\/p>\n

\u2022Policy discussions <\/span><\/p>\n

\u2022Any continuing education provided during a meeting Members receive a copy of the minutes for review prior to the next meeting. Suggested modifications to the minutes are discussed at a full board meeting and agreed to by consensus, and the IRB staff modifies the minutes according to the IRB\u2019s recommendations. <\/span><\/p>\n

<\/div><\/span><\/p>\n

References<\/span>

<\/span><\/p>\n

Wis. Stats. \u00a7\u00a7 19.81-19.9845 <\/span><\/p>\n

CFR \u00a7\u00a746.108, 46.11521 <\/span><\/p>\n

CFR \u00a7\u00a756.108, 56.115 <\/span><\/p>\n

102: IRB Chair and Vice Chair <\/span><\/p>\n

<\/div><\/span><\/p>\n

Link to PDF Version<\/span>

<\/span><\/p>\n

UWM IRB SOP 303: IRB Meetings(PDF)<\/a> <\/span><\/p>\n

<\/div><\/span><\/p>\n<\/div>\n

304: Conflict of Interest (07\/02\/2020)<\/strong><\/span>

<\/span><\/p>\n

Terms and Abbreviations<\/span>

<\/span><\/p>\n

COI: <\/strong>Conflict of Interest<\/span><\/p>\n

IRB:<\/strong> Institutional Review Board <\/span><\/p>\n

PI:<\/strong> Principal Investigator <\/span><\/p>\n

SPI:<\/strong> Student Principal Investigator <\/span><\/p>\n

UWM:<\/strong> University of Wisconsin-Milwaukee<\/span><\/p>\n

<\/div><\/span><\/p>\n

Overview<\/span>

<\/span><\/p>\n

Researchers inherently have a conflict of interest in their research proposals, as the research frequently has a direct impact on the researcher\u2019s professional or academic career. Additionally, successful completion of research proposals is vital to tenure, promotion, publication, and completion of degrees. In some cases, researchers may also have a financial conflict of interest in the outcome of the research. IRB members may have a conflict of interest due to their involvement as a researcher in a protocol under review, due to personal or professional relationships with the researcher(s), or due to a financial interest in the proposed research. UWM may have an institutional conflict of interest when the institution is better or worse off depending on the outcome of the research. The IRB has the responsibility to ensure that these potential conflicts of interest do not negatively impact the rights or welfare of participants, or the fair and unbiased review of research proposals.<\/span><\/p>\n

<\/div><\/span><\/p>\n

Details and Procedures<\/span>

<\/span><\/p>\n

A Conflict of Interest occurs whenever an individual has incentive to act in a way to put their own personal or professional interests ahead of ethical considerations. COI also occurs when there is any appearance that an individual\u2019s actions may be biased. A COI may be personal, professional, or financial. Identification of a potential COI does not confer any judgment about the moral character of the person identified to have a COI, but rather recognizes that the opportunity for biased conduct or wrongdoing exists. Measures taken to manage these COIs vary with the degree and type of COI. <\/span><\/p>\n

Researcher COI<\/strong> <\/span><\/p>\n

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research asserted that \u201cinvestigators are always in positions of potential conflict by virtue of their concern with the pursuit of knowledge as well as the welfare of the human subjects of their research.\u201d (1978). This inherent COI exists in all studies, and may or may not require any special management to ensure the protection of participants\u2019 rights and welfare. Examples of other COIs may occur in studies where the researcher: <\/span><\/p>\n

\u2022 Stands to accrue a significant financial benefit from the research (e.g. devices that may be patented and\/or sold for a profit if successful) <\/span><\/p>\n

\u2022 Has a relationship with the potential participants (e.g. instructors recruiting their own students) In each protocol review, the IRB notes any potential COI that could impact the rights or welfare of participants, and may require additional safeguards to minimize this impact. For research involving entities for which the PI has a financial COI disclosed to the university, the PI must have a COI management plan reviewed and approved by the UWM COI committee and a copy should be shared with the UWM IRB for relevant studies. Examples of potential actions the IRB may take to manage COIs:<\/span><\/p>\n

\u2022 Require that the researcher disclose the COI to participants (typically in the informed consent document) <\/span><\/p>\n

\u2022 Require that the researcher with the COI not participate in participant recruitment or consent activities <\/span><\/p>\n

\u2022 Require the inclusion of an unbiased co-investigator on the study team <\/span><\/p>\n

\u2022 Observe or monitor the consent process Investigators may choose to manage their own COI. Examples of self-management may include: <\/span><\/p>\n

\u2022 Having someone else conduct the research <\/span><\/p>\n

\u2022 Divesting financial interests<\/span><\/p>\n

IRB Member COI <\/strong><\/span><\/p>\n

COIs may exist in studies where the IRB member: <\/span><\/p>\n

\u2022 Is the PI or a co-investigator<\/span><\/p>\n

\u2022 Is the faculty member overseeing a SPI\u2019s project<\/span><\/p>\n

\u2022 Has a personal relationship (either positive or negative) with any member of the study team, such that the member feels it may be difficult to provide an unbiased review <\/span><\/p>\n

\u2022 A power differential exists (e.g. the researcher is Chair of the IRB member\u2019s department)<\/span><\/p>\n

\u2022 May benefit financially from the study in some way <\/span><\/p>\n

\u2022 Believes for any other reason that they are unable to perform an objective review, or that others may perceive the review as biased. Managing COI in Studies Undergoing Full Board Review <\/span><\/p>\n

\u2022 IRB members must disclose any known potential COI to the Chair at the start of the IRB meeting. <\/span><\/p>\n

\u2022 IRB members do not vote on research protocols in which they may have conflicting interests.<\/span><\/p>\n

\u2022 The member may be asked to recuse (leave the room) for the duration of the discussion and vote on that research protocol if the member\u2019s presence could create a bias. Managing COI in Studies Undergoing Expedited Review<\/span><\/p>\n

\u2022 IRB members will not be assigned as expedited reviewers for any study where there is an obvious COI. <\/span><\/p>\n

\u2022 If an IRB member is assigned to review a study for which they have a COI, the member must notify IRB office staff and request that the study be assigned to a different reviewer. The member may simply state that they are unable to review the protocol, and do not need to disclose the nature of the COI to the IRB office staff. <\/span><\/p>\n

Institutional COI<\/strong> <\/span><\/p>\n

To manage institutional conflicts of interest, the IRB functions independently from the university as an independent board whose determinations are not dictated or influenced by anyone outside the IRB. Upper-level administrators may not be voting members of the IRB, and do not attend meetings where there may be an institutional COI. The potential for hierarchical COI for the IRB office staff is also present. This COI is managed by having an organizational structure where the IRB office is not under any department or division charged with promoting or bringing additional research to campus, but is instead a part of University Safety and Assurances, under the Division of Finance and Administrative Affairs. If these structural measures are not sufficient to manage an institutional conflict of interest for a specific protocol, other measures may be implemented, such as hiring an external IRB to review and oversee the conduct of the study, or hiring an external individual or organization to conduct the research.<\/span><\/p>\n

<\/div><\/span><\/p>\n

References<\/span>

<\/span><\/p>\n

45 CFR 46.107 <\/span><\/p>\n

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Report and recommendations: Institutional review boards (DHEW[OS]78-00008). Washington, DC: Department of Health, Education, and Welfare; 1978. <\/span><\/p>\n

<\/div><\/span><\/p>\n

Link to PDF Version<\/span>

<\/span><\/p>\n

UWM IRB SOP 304: Conflicts of Interest(PDF)<\/a> <\/span><\/p>\n

<\/div><\/span><\/p>\n<\/div>\n

Review of Research <\/strong><\/h2>\n

401: Initial Review of Research (02\/19\/2020)<\/strong><\/span>

<\/span><\/p>\n

Terms and Abbreviations<\/span>

<\/span><\/p>\n

CFR:<\/strong> Code of Federal Regulations <\/span><\/p>\n

FDA:<\/strong> Food and Drug Administration <\/span><\/p>\n

FERPA:<\/strong> Family Educational Rights and Privacy Act <\/span><\/p>\n

Full board:<\/strong> A convened meeting of the IRB at which a quorum of members is present <\/span><\/p>\n

HIPAA:<\/strong> Health Insurance Portability and Accountability Act <\/span><\/p>\n

IO:<\/strong> Institutional Official. Individual who is legally authorized to act for the institution and ensures the effective functioning of the IRB.<\/span><\/p>\n

IRB:<\/strong> Institutional Review Board<\/span><\/p>\n

Minimal risk:<\/strong> The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.<\/span><\/p>\n

PI:<\/strong> Principal Investigator <\/span><\/p>\n

UWM:<\/strong> University of Wisconsin \u2013 Milwaukee <\/span><\/p>\n

<\/div><\/span><\/p>\n

Overview<\/span>

<\/span><\/p>\n

For all review of research, the IRB bases its determinations on upholding the Belmont principles of Respect for Persons, Justice, and Beneficence, as well as complying with all applicable federal and state laws and university policies.<\/span><\/p>\n

Regulations<\/strong><\/span><\/p>\n

In order to approve a new research protocol involving human subjects, the IRB must determine that all of the criteria from 45 CFR \u00a7 46.111 are satisfactorily met: <\/span><\/p>\n

1. Risks to subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. <\/span><\/p>\n

2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result from the research. <\/span><\/p>\n

3. Selection of subjects is equitable. In making this assessment the IRB takes into account the purposes of the research and the setting in which the research will be conducted. The IRB is particularly cognizant of the special problems of research that involves subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons. <\/span><\/p>\n

4. Informed consent will be sought from each prospective subject or their legally authorized representative, as required by \u00a746.116 <\/span><\/p>\n

5. Informed consent will be appropriately documented or appropriately waived in accordance with \u00a746.117.<\/span><\/p>\n

6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. <\/span><\/p>\n

7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. For research that falls under the purview of the FDA, the IRB determines that the criteria from 21 CFR \u00a7 56.111 are met. For research that is not federally funded or subject to FDA oversight, the IRB may use flexible policies in granting exceptions to the requirements of 45 CFR 46 when deemed appropriate. <\/span><\/p>\n

Risk Level<\/strong> <\/span><\/p>\n

Research involving more than minimal risk must be reviewed by the IRB at a convened meeting (\u201cfull board\u201d review). Research involving minimal risk that fits into one or more expedited or exempt review categories may be reviewed by a designated IRB reviewer rather than by the full IRB. <\/span><\/p>\n

Compliance<\/strong> <\/span><\/p>\n

Principal Investigators must not start any aspect of research involving human subjects (e.g., recruitment, screening, etc.) until they have received written notification of IRB approval. The PI is responsible for compliance with other laws and institutional rules (such as compliance with HIPAA, FERPA, biosafety regulations, etc.) and must provide the documentation of any other reviews to the IRB upon request. <\/span><\/p>\n

Communication<\/strong> <\/span><\/p>\n

The IRB communicates all its findings and actions to the PI and notifies the Institutional Official in writing. When projects are federally funded, the PI is responsible for sending a copy of the approval letter to the Grants and Contracts Office and\/or the funding agency, as needed. <\/span><\/p>\n

<\/div><\/span><\/p>\n

Details and Procedures<\/span>

<\/span><\/p>\n

Review Process for New Research Protocols<\/strong> <\/span><\/p>\n

Principal Investigators who intend to conduct research involving human subjects must submit a research protocol and any other supporting documentation to the IRB for review and approval using the designated electronic system. Upon receipt of a new protocol submission, the IRB office staff conducts an initial review. The office staff determines the review level required (Exempt, Expedited, Full Board, or Not Human Subjects Research). Depending on the review level and completeness of the submission, IRB office staff may either request revisions or process the submission to the next stage of review <\/span><\/p>\n

Exempt Review<\/strong> <\/span><\/p>\n

Certain types of research protocols may be eligible for review under exempt review procedures. The research must involve no more than minimal risk and fit one or more of the categories for exempt research as outlined in 45 CFR \u00a746.104(d). IRB office staff review the protocol and may assign an IRB member as an additional reviewer if needed. IRB office staff work with the PI until the study satisfactorily meets the same requirements for approval as expedited and full board studies. The IRB office staff then notify the PI of this approval in writing. Exempt studies are generally required to follow 45 CFR 46, but flexibility in compliance with these regulations is left to the discretion of IRB office staff and\/or reviewing IRB member, who may waive one or more requirements when such a waiver does not negatively impact the rights or welfare of human subjects.<\/span><\/p>\n

Limited IRB Review<\/strong> <\/span><\/p>\n

Certain exempt studies may qualify for exemption only with a \u201climited IRB review\u201d. For this type of review, the IRB will make the following determination(s): <\/span><\/p>\n

\u2022 For Exempt categories 2, 3, or 8, where the information is recorded by the investigator in such a manner that the identity of the human subject can readily be ascertained, directly or through identifiers linked to the subjects; or for secondary research for which broad consent is required, the IRB will make the following determination as required by \u00a7 46.111(7): <\/span><\/p>\n

1. There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. <\/span><\/p>\n