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SOP 300 Functions and Operations (FO)

301 Research Submission Requirements


1. OBJECTIVE
IRB members rely on the documentation submitted by Investigators for initial and continuing review. Therefore, this material must provide IRB members with enough information about a study to assess if it adequately meets the IRB's criteria for approval.

A submitted protocol will be scheduled for IRB review when it has been determined that the information and materials submitted present an adequate description of the proposed research.

Specific Procedures
1.1 Submission Requirements for Initial Review
1.1.1 Required: Investigators applying for initial approval of a proposed research protocol must submit:

  • Complete IRB Application
  • Questionnaires & assessment instruments
  • Proposed informed consent document
  • Proposed subject instructions
  • Any other supporting material, such as examples of recruitment advertising, etc.

1.2 Submission Requirements During Approval Periods
1.2.1 During the approval period, Investigators must submit documentation to inform the IRB about changes in the status of the study including, but not necessarily limited to:

  • Any protocol changes not previously approved by the IRB
  • Deviations from the protocol (protocol violations)
  • Reports of serious or unexpected adverse events
  • Changes to the status of Principal or Sub-investigators

1.2.2 Progress Report and/or Request to Renew IRB Approval Within sixty days prior to IRB approval expiration date, Investigators requesting renewal of an approved research project must submit:

  • Annual Review of Approved Research form.
  • All the required materials that are indicated on the form are also required prior to review.

1.3 Action Taken If Documentation is Not Adequate or Additional Information is Required
If the IRB or IRB staff determines that the submitted documents are not adequate, Investigators will be required to submit additional information. No incomplete submission will be reviewed by the IRB.

2. SCOPE
These policies and procedures apply to all research submitted to the IRB.

3. APPLICABLE REGULATIONS AND GUIDELINES
45 CFR 46.108, 46.111, 46.115
21 CFR 56.108 (a)(4), 312, 812

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

302 Research Exemptions


1. OBJECTIVE
Research activities in which the only involvement of human subjects will be in one or more specific categories, which are listed in section 1.1 of these Procedures, may be exempt from Federal review. Exempt status proposals are reviewed by the IRB Administrator. Determination of exemption must be based on regulatory and institutional criteria.

Specific Procedures
Human subjects research activities must be reviewed to determine whether the research meets one or more of the exemption categories described below and whether the research complies with applicable ethical standards. Federally-funded research determined to be exempt is not subject to 45 CFR 46 unless otherwise specified.

Investigators do not have the authority to make an independent determination that research involving human subjects is exempt and must submit an application to the BYU IRB office for final determination of exemption.

Research qualifies as exempt only if it falls into one or more of the exempt categories described below and meets these additional requirements:

  • The research must present no more than minimal risk to subjects.
  • The research is consistent with the ethical principles reflected in the Belmont Report, which include:
    • Respect for Persons (Autonomy). Individuals should be treated as autonomous agents, and persons with diminished autonomy are entitled to protection.
    • Beneficence. Individuals should not be harmed and the research should maximize possible benefits and minimize possible harms.
    • Justice. Selection of participants should be equitable and the benefits and risks of research should be distributed fairly.
  • As appropriate, there are adequate provisions to maintain the privacy interests of participants and the confidentiality of data.

1.1 Exempt Research Activities
Research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from IRB review:
A. Category 1
45 CFR 46.101 (b)(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
B. Category 2
45 CFR 46.101 (b)(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
(ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
C. Category 3
45 CFR 46.101 (b)(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under Category 2, if:
(i) the human subjects are elected or appointed public officials or candidates for public office; or
(ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
D. Category 4
45 CFR 46.101 (b)(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects
E. Category 5
45 CFR 46.101 (b)(5) Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:
(i) Public benefit or service programs;
(ii) procedures for obtaining benefits or services under those programs;
(iii) possible changes in or alternatives to those programs or procedures; or
(iv) possible changes in methods or levels of payment for benefits or services under those programs.
F. Category 6
45 CFR 46.101 (b)(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Research involving prisoners
The exemption categories listed above do not apply to research involving prisoners.
Research involving children
Exemption Category 2, 45 CFR 46.101(b)(2), does not apply to research with children, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.
Research subject to FDA regulations
The IRB will not consider any research exempt that involves a test article regulated by the FDA, unless the research meets the criteria for exemption described in 45 CFR 46.101(b)(6) and 21 CFR 56.104(d).
Research subject to HIPAA regulations
A determination that a study is exempt does not remove relevant HIPAA considerations. If HIPAA applies to an exempt study, authorization or a waiver of authorization must be obtained.
Continuing Review
Studies confirmed as meeting the criteria for exemption are not subject to continuing review. BYU, nonetheless, remains responsible for exercising proper oversight for research conducted under its auspices. To exercise this oversight, the IRB office will annually send a notice to all PIs to confirm:

  • That the research is on-going. If it is not, the PI will be asked to close out the study.
  • That the PI is aware of her/his responsibilities under the BYU IRB exemption determination.

2. SCOPE
These policies and procedures apply to Investigator claims for exemption from Federal review.

3. APPLICABLE REGULATIONS AND GUIDELINES
45 CFR 46.101
21 CFR 56. 104, 105

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

303 IRB Meeting Administration


1. OBJECTIVE
All studies that do not meet the criteria for exemption or expedited review will be reviewed by the IRB at convened meetings at which a quorum is present. Each IRB will meet monthly, or at some other frequency determined by the IRB Chairperson and the IRB Administrator.

Specific Procedures
1.1 Quorum
1.1.1 A quorum is defined as one half of the number of regular members plus one.
1.1.2 A quorum consists of regular and/or their alternate members and includes: at least one member whose primary concerns are in scientific areas, and one member whose primary concerns are in nonscientific areas.
1.1.3 An alternate member may attend in the place of an absent regular member in order to meet the quorum requirements outlined above.
1.1.4 A special consultant(s) will not be used to establish a quorum.
1.2 Meeting Materials Sent Prior to IRB Meetings
All IRB members will be sent study documentation required for review sufficiently in advance of the meeting to allow time for adequate review. These include:
1.2.1 Agenda: a meeting agenda will be prepared by the IRB Secretary and distributed to IRB members prior to each meeting. The meeting agenda will remind members to declare any potential COI they may have with research that is about to be reviewed at the outset of each meeting. The IRB minutes should also specifically reflect such recusals as they occur during meetings.
1.2.2 Reviewer materials
A. All IRB members

  • Full Investigator’s protocol
  • Proposed informed consent document(s) and/or script as appropriate
  • Copies of surveys, questionnaires, or electronic media.
  • Copies of letters of assurance or cooperation with research sites
  • Advertising intended to be seen or heard by potential subjects, including email solicitations.
  • Grant Application: The IRB Administrator or a designated reviewer will review the grant application, if any, to ensure that the research described in the IRB proposal is consistent with the grant application. The grant application does not need to be reviewed by every IRB member. A copy of the grant application or proposal should be retained in the IRB/ ORCA Office and made available to any IRB member who may wish to review it. The IRB may require the Investigator(s) to: (i) summarize, and cross-reference to the application, specific information contained in the grant application; (ii) identify any IRB-approved protocols that describe the proposed research; and (iii) either certify that the application or proposal is consistent with any corresponding IRB protocol(s) or submit protocol amendments to reconcile any discrepancies.

1.3 Minutes
The Federal regulations for the protection of human subjects [45 CFR 46.115(a)(2)] require that "Minutes of IRB meetings… shall be in sufficient detail to show attendance at the meeting; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution."
1.3.1 Recording: The IRB Secretary or designee will take minutes of each meeting. Minutes will be written in sufficient detail to show the following:

  • Meeting attendance; including status of each attendee (regular member, consultant, etc.), and conflicts of interest, if any;
  • Actions taken by the IRB on each agenda item requiring full IRB action, including, the basis for requiring changes in or disapproving the research and protocol specific determinations.
  • Summary of the discussion of controverted issues and resolution;
  • Voting results, including number for, against and members who recused themselves.

1.3.2 Approval: Draft minutes will be distributed to members at the next IRB meeting for review and approval.

  • Corrections requested by the IRB will be made by the IRB Secretary or designee and the minutes in printed form are made available upon request. The IRB Administrator will maintain copies of the minutes.

A majority of members must vote in favor of an action for that category of action to be accepted by the IRB. Only regular and alternate members acting in place of absent regular members may vote. The vote will be recorded in the minutes. Members with a conflict of interest will recuse themselves from the discussion and voting and such will be noted in the minutes. 1.4 Telephone Use
1.4.1 Convened meeting using speaker phone:
Should a member not be able to be physically present during a convened meeting, but is available by telephone, the meeting can be convened using a electronic communication. The member who is not physically present will be connected to the rest of the members via speakerphone. In this manner, all members will be able to discuss the protocol even though one member is not physically present. Members participating by such speakerphone call may vote, provided they have had an opportunity to review all the material the other members have reviewed.
1.4.2 Meetings Conducted Via Conference Calls:
On occasion, meetings may be convened via a conference call. A quorum (as defined above) must participate for the conference call meeting to be convened. To allow for appropriate discussion to take place, all members must be connected simultaneously for a conference call to take place -- "polling" (where members are contacted individually) will not be accepted as a conference call.

Members not present at the convened meeting, nor participating in the conference call may not vote on an issue discussed during a convened meeting (no voting by proxy).
1.5 Voting
Members of the IRB vote upon the recommendations made by the reviewers according to the criteria for approval, protocol specific determinations and frequency of review for each protocol.

2. SCOPE
These policies and procedures apply to all research submitted to the IRB.

3. APPLICABLE REGULATIONS AND GUIDELINES
45 CFR 46.103, 46.108, 46.109, 46.115
21 CFR 56.108, 56.109

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

304 Administrative Review and Distribution of Materials


1. OBJECTIVE
The efficiency and effectiveness of the IRB is supported by administrative procedures that ensure that IRB members not only have adequate time for thorough assessment of each proposed study, but that the documentation they receive is complete and clear enough to allow for an adequate assessment of study design, procedures, and conditions.

Specific Procedures
1.1 Exemptions
The IRB Administrator will oversee claims for exemption submitted by Investigators in consultation with the IRB Chairperson trained to review exempt protocols. Such claims of exemption will be logged and filed.
1.2 Incomplete Submissions
Incomplete applications will not be accepted for review until the Investigator has provided all necessary materials as determined by the IRB Administrator or designee. The IRB Administrator will notify the submitting Investigator to obtain any outstanding documentation or additional information before the application is scheduled for review.
1.3 Scheduling for Review
Complete applications that appear to meet qualifications for expedited review will be submitted to the Chairperson or his/her designee. If a submission meets expedited review requirements, the review will be performed as described in SOP RR 401 (Expedited Review). All other applications will be placed on the agenda for the earliest meeting possible for review by the full IRB as described in SOP FO 303 (IRB Meeting Administration).
1.4 Distribution to Members Prior to IRB Meetings
Copies of application materials will be distributed to all IRB members, generally ten (10) days prior to the meeting. Each regular member of the IRB, and any alternate members attending the meeting in place of a regular member, will receive a copy of the material. Consultants will only receive copies of material that pertain to their requested input. The originals of submission materials will be retained in the IRB Office and available for the IRB meeting.
1.5 Confidentiality
All material received by the IRB will be considered confidential and will be distributed only to meeting participants (regular members, alternate members and special consultants) for the purpose of review. All application materials will be stored in an IRB study file with access limited to the IRB members and staff and other authorized officials.

2. SCOPE
These policies and procedures apply to all research submitted to the IRB.

3. APPLICABLE REGULATIONS AND GUIDELINES
45 CFR 46.109
21 CFR 56.109

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

305 Documentation and Document Management


1. OBJECTIVE
The IRB’s files must be maintained in a manner that contains a complete history of all IRB actions related to review and approval of a protocol, including continuing reviews, amendments and adverse event reports. All records regarding a submitted study (regardless of whether it is approved) must be retained in an appropriate manner as required by regulatory requirements and/or institutional policy.

Records must be accessible for inspection and copying by authorized representatives of the Sponsor, funding department or agency, regulatory agencies and institutional auditors at reasonable times and in a reasonable manner.

Required documents must be submitted to the appropriate funding entity as required.

Specific Procedures
1.1 Document Retention
The IRB Office must retain all records regarding an application (regardless of whether it is approved) for at least three (3) years. For all applications that are approved and the research initiated, the IRB Office must retain all records regarding that research for at least three (3) years after completion of the research.
1.1.1 Study-related documents:
Adequate documentation of each IRB's activities will be prepared, maintained and retained in a secure location. Retained documents include:

  • Copies of all original research protocols reviewed, approved consent documents, and reports of adverse events occurring to subjects and reported deviations from the protocol.
  • Agendas and minutes of all IRB meetings.
  • Copies of all continuing review activities.
  • Copies of all correspondence between the IRB and the Investigators.
  • Statements of significant new findings provided to subjects.
  • Reports of any complaints received from subjects.

1.2 IRB Administration Documents
The IRB Office must maintain and retain all records regarding IRB administrative activities that affect review activities for least three (3) years.

The IRB Office must retain all records regarding protocols that are approved and the research initiated for at least three (3) years after completion of the research.
1.2.1 Rosters of regular and alternate IRB members identified by name, earned degrees, representative capacity, and indications of experience sufficient to describe each regular and alternate member's chief anticipated contribution to the IRB’s deliberations; and any employment or other relationship between each member and the IRB and/or the Brigham Young University (e.g., full-time employee, part-time employee, paid or unpaid consultant).

Alternate members shall be included on the roster. In addition to the above information, the roster shall indicate the regular member for whom the alternate may substitute.

Current and obsolete membership rosters will remain in the IRB Office and then archived according to Brigham Young University policy.

The roster of IRB members must be submitted to OHRP. Any changes in IRB membership must be reported to OHRP.
1.2.2 Maintain current and obsolete copies of the Standard Operating Policies and Procedures.
1.2.3 Delegation of specific functions, authorities, or responsibilities by the IRB Chairperson must be documented in writing and filed in the IRB Office.
1.3 Destruction of Copies
All material received by the IRB, which is considered confidential and in excess of the required original documentation and appropriate controlled forms, will be collected at the end of the meeting and destroyed by a method deemed appropriate by the Institutional Official.
1.4 Archiving and Destruction
After 3 years, all documents and materials germane to IRB determinations will be archived according to institutional policy. Archiving policies of the Brigham Young University will determine when such archived records may be destroyed.

2. SCOPE
The policies and procedures apply to all controlled documents used in the submission, initial review, and continuing review of research submitted to the IRB.

3. APPLICABLE REGULATIONS AND GUIDELINES
45 CFR 46.103, 46.115
21 CFR 56.115

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