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SOP 100 General Administration (GA)

101 Procedures Maintenance


1. OBJECTIVE
Following regulations and guidance of OHRP and supported by Institutional policies, ensures that the rights and welfare of human subjects of such research will be overseen and protected in a uniform manner, regardless of changes in personnel. Written procedures must be in place to ensure the highest quality and integrity of the review and oversight of research involving human subjects.

Standard operating policies and procedures (SOPs) provide the framework for the ethical and scientifically sound conduct of human research.

Specific Procedures
1.1 Review, Revision, Approval of Policies & Procedures
1.1.1 Changes to regulations, federal guidelines, or research practice as well as the policies and procedures of BRIGHAM YOUNG UNIVERSITY may require a new SOP or a revision to a previously issued SOP.
1.1.2 Approval of new or revised SOPs is required by the Institutional Official.
1.2 SOP Dissemination and Training
1.2.1 When new or revised SOPs are approved, they will be disseminated to the appropriate individuals and they will be encouraged to read them.

2. SCOPE
These policies and procedures apply to all IRB members and staff.

3. APPLICABLE REGULATIONS AND GUIDELINES
45 CFR 46.106
21 CFR 56.108, 56.109, 56.113

4. REFERENCES TO OTHER APPLICABLE SOPS
This SOP affects all other SOPs.

102 IRB Staff & Members Education


1. OBJECTIVE
Education of IRB staff and members is critical if the IRB is to fulfill its mandate to protect the rights and welfare of research subjects in a consistent manner throughout the Brigham Young University research community.

IRB members, staff and others charged with the responsibility for reviewing, approving, and overseeing human subject research should receive education in the regulations, guidelines, ethics and policies applicable to human subjects research.

Specific Procedures
1.1 Education
1.1.1 Management level staff and members of any IRB who are overseeing research on human subjects, that is managed, funded, or taking place in an entity under the jurisdiction of the Trustees of Brigham Young University will receive initial and ongoing education/training regarding the responsible review and oversight of research and these policies and accompanying procedures.
1.1.2 The IRB Administrator establishes the educational requirements for IRB members and staff who review research involving human subjects at this institution and who perform related administrative duties. Initial and ongoing education is provided by this institution through the OFFICE OF RESEARCH AND CREATIVE ACTIVITIES (ORCA).
1.1.3 Members of the IRB will participate in initial and continuing education in areas germane to their responsibilities.
1.1.4 Chairpersons will receive additional education in areas germane to their additional responsibilities.
1.1.5 IRB staff will receive initial and continuing education/training in the areas germane to their responsibilities, including all Standard Operating Policies and Procedures (SOP).
1.1.6 IRB members and staff will be encouraged to attend workshops and other educational opportunities focused on IRB functions. Brigham Young University will support such activities to the extent possible and as appropriate to the responsibilities of members and staff.
1.2 Documentation
Education/training shall be documented and added to the records of the IRB as described in these policies and procedures.

2. SCOPE
These policies and procedures apply to all IRB members and staff.

3. APPLICABLE REGULATIONS AND GUIDELINES
45 CFR 46.107
OHRP IRB Guidebook
21 CFR 56.107

4. REFERENCES TO OTHER APPLICABLE SOPS
This SOP affects all other SOPs.

103 Management of IRB Personnel


1. OBJECTIVE
IRB staff provides consistency, expertise, and administrative support to the IRB, and serves as a daily link between the IRB and the research community. Thus, the IRB staff is one of the vital components in the effective operation of BRIGHAM YOUNG UNIVERSITY's human subjects' protection program. Therefore, the highest level of professionalism and integrity on the part of IRB staff is expected.

Specific Procedures
1.1. Job Descriptions and Performance Evaluations
Members of the IRB staff should have a description of the responsibilities expected of their positions. The performance of IRB staff will be reviewed according to current Brigham Young University policy.
1.2 Staff Positions
Staffing levels and function allocation will be determined according to Brigham Young University policy, management assessment of support requirements and budget constraints.
1.3 Hiring and Terminating IRB Staff
The human resources policies of BRIGHAM YOUNG UNIVERSITY determine the policies for recruiting and hiring staff.
1.4 Delegation of Authority or Responsibility
Delegation of specific functions, authorities, or responsibilities by the Chairperson to a staff member must be documented in writing.
1.5 Documentation
The policies of BRIGHAM YOUNG UNIVERSITY's Department of Human Resources determine the means of identifying, documenting and retaining formal staff interactions (such as performance reviews, termination procedures).

2. SCOPE
These policies and procedures apply to all IRB staff.

3. APPLICABLE REGULATIONS AND GUIDELINES
None

4. REFERENCES TO OTHER APPLICABLE SOPS
This SOP affects all other SOPs.

104 Conflict of Interest: IRB Member & Investigator


1. OBJECTIVE
In the environment of research, openness and honesty are indicators of integrity and responsibility, characteristics that promote quality research and can only strengthen the research process. Therefore, conflicts of interest (COI) should be eliminated when possible and effectively managed and disclosed when they cannot be eliminated.

Specific Procedures for Member Conflict of Interest
1.1 Definition of a COI for IRB Members
A conflict of interest is defined as a close personal or professional association with the submitting Investigator(s); direct participation in the research (e.g., protocol development, Principal or Sub-investigator); or any significant financial interest related to the research in the sponsoring company as defined in the Research Conflict of Interest Policy as (example, $5,000 or 5% ownership).
Questions regarding COIs may be referred to the IRB Administrator or IRB Chair.
1.2 Disclosure and Documentation of Financial Interest and COI
No regular or alternate member of the IRB or consultant may participate in the review of any research project in which the member has a conflict of interest, except to provide information as requested. It is the responsibility of each voting member or alternate member of the IRB to disclose any COI in a study submitted to the IRB and recuse himself or herself from deliberations and voting. The procedures for recusal of IRB members, including the Chairperson, from deliberating/voting on all protocols for which there is a potential or actual financial conflict of interest are detailed in SOP FO 303, IRB Meeting Administration.
1.3 Education and Training in COI
IRB members and staff are required to participate in education and training activities related to conflict of interest issues including those required by their institution.

Specific Procedures for Investigator Conflict of Interest
All PIs and key personnel applying to conduct human subjects research must disclose on each IRB application any potential conflicts of interest involving outside significant financial interest (see Definitions) and

  • any proprietary interest related to the research, including but not limited to a patent, trademark, copyright, or licensing agreement;
  • any arrangement, ownership interest, or compensation that could be affected by the outcome of the research; and

The IRB will evaluate the disclosure for any considerations relating to the protection of human subjects. If there is a significant financial interest that the IRB believes relates to the study, the IRB will require the investigator to disclose the interest(s) to potential subjects by including appropriate language in the informed consent statement. In addition, the IRB may take any of the following actions:
A. Require an independent investigator to obtain consent;
B. Require an independent investigator to conduct the study;
C. Require independent safety monitoring;
D. Require frequent renewal; and/or
E. Any other restrictive action deemed appropriate based on the nature of the conflict.
The IRB has final authority to decide whether the interest and management, if any, allow the research to be approved.

2. SCOPE
These policies and procedures apply to all IRB members, faculty, staff and students of the BRIGHAM YOUNG UNIVERSITY.

3. APPLICABLE REGULATIONS AND GUIDELINES
21 CFR 46.103, 107
21 CFR 56.107
21 CFR 54 (as reference)
42 CFR 50

4. REFERENCES TO OTHER APPLICABLE SOPS
This SOP affects all other SOPs.

105 Signatory Authority


1. OBJECTIVE
The CHAIRPERSON OR IRB ADMINISTRATOR is authorized by the Institutional Official to sign any and all documents in connection with the review and approval of research projects involving the use of humans as subjects, which have been reviewed and approved pursuant to Brigham Young University policies and procedures. In the absence of the IRB Administrator or Chairperson, the ORCA Director may sign a review or approval of research letter. In all cases individuals must sign their own name and no other.

Specific Procedures
1.1 Authorization for Signatory Authority
Authorization to sign documents not described in this procedure may be made in writing from the Institutional Official.
1.2 Correspondence with External Agencies
Any letters, memos or emails sent to agencies of the federal government, funding agencies (whether private or public) or their agents will be signed by the Institutional Official.

2. SCOPE
These policies and procedures apply to all IRB staff.

3. APPLICABLE REGULATIONS AND GUIDELINES
45 CFR 46.103, 46.115

4. REFERENCES TO OTHER APPLICABLE SOPs
This SOP affects all other SOPs.

106 PI Eligiblity


1. OBJECTIVE
It is the policy of BYU that only individuals meeting the eligibility requirements of a principal investigator defined in this policy may be listed as such on applications for human subjects research.

Specific Procedures
Each human subject research submission must have a designated principal investigator (PI).

The PI generally is a tenured or tenure-track faculty member of the University but may be any full-time academic appointee or staff who is personally and professionally qualified to conduct the project as determined by the dean or director of the submitting unit. Approval of the proposal by the submitting unit or dean’s office constitutes the unit’s approval of the employee as PI.

Full-time faculty members (regardless of academic rank) and full-time staff are eligible to serve as PI. Other persons (such as visiting faculty) are eligible to serve as PI upon approval by the dean and IRB Office. In such cases, a Memorandum of Understanding must be signed and on file with the IRB Office.

Due to lines of institutional responsibility and accountability, neither post-doctorates nor students, either graduate or undergraduate, may serve as PI. A faculty mentor must be identified as the PI with the student or post-doctorate identified as Co- Investigator. The faculty member shares PI responsibilities with post-doctorate or student.

2. SCOPE
The policies and procedures apply to all human subjects research involving post-doctorates or students.

3. APPLICABLE REGULATIONS AND GUIDELINES
BYU Policy