OBJECTIVE:

To describe the full board initial review process and related procedures.

DESCRIPTION:

Full Board review of research is exercised when the research does not meet the criteria for exemption review or expedited review or otherwise is determined to necessitate review at the convened full board meeting of the IRB membership.

Please refer to the following WPPs and internal citations, especially concerning vulnerable populations, for additional guidance relative to the protocol specifications:

II-5:      State Law Applicability for Research Conducted In- and Outside of Virginia

XI-3:     Legally Authorized Representative

XIII-1:  Pregnant Women, Human Fetuses, and Neonates

XV-1:   Permissible Categories:  Children

XV-2:   Assent/Considerations for Parental Permission

XV-3:   Children in Court-Appointed or State Custody and Emancipated Minors.

XVII-6: Involving Non-VCU Institutions in Human Subjects Research

XI-1:     Consent Process, Elements, Waiver of Element(s), and Modification

XI-2:     Informed Consent Documentation, Waiver of Documentation, and Required Signatures

A.     Panel Composition:

In order to conduct research via Full Board review, the panel must meet the requirements described in VCU IRB WPP VII-5.

B.     Reviewer Expertise:

The designated reviewer (primary and secondary reviewers) must, together, have the appropriate scientific knowledge and experience, as well as experience and understanding of issues affecting any vulnerable populations included in the research (in accordance with VCU IRB WPP IV-5).  Primary and secondary reviewer assignments are initially made by the VCU ORSP staff, based upon a list of reviewers designated by the IRB chairperson (including the chairperson and vice chairperson) and by area of experience as documented to the staff.  Assignments are subject to the approval of the Chairperson or designee.  If staff detect that a reviewer may not be available or have the expertise required, they contact the chairperson to obtain a consultation recommendation.  Please see also VCU IRB WPPs#: VII-5 and IV-2 regarding the use of consultants.  

C.     Continuing Review of Research (Consideration at Initial Review):

The VCU IRB will plan for continuing review of research at intervals appropriate to the degree of risk, but not less than once per year, and will exercise the authority to observe or have a third party observe the consent process and the research, as appropriate (given the level or risk, experience of the investigator, vulnerability of subjects, or other concerns) [45 CFR 46.109(e)].  The IRB may require review more often than annually for ANY research activities, including:

1.       Research that involves withdrawal of therapy when there may be significant morbidity or mortality.

2.       Research that involves an invasive surgical procedure (that would not otherwise be done).

3.       Research in which there are serious risks to participants and non potential benefits, or

4.       More than minimal risk research involving a vulnerable population with no prospect of direct benefit to the individual participants.

Note:  Expedited Category 9 permits that a previously full board study be reviewed as expedited for continuing review if it was not conducted under an investigational new drug application or investigational device exemption where Expedited categories two (2) through eight (8) did not apply.  Expedited review for continuing review using this category cannot occur until the protocol is first brought to the full panel where initially reviewed and documented to involve no greater than minimal risk and no additional risks have been identified.

D.     Document Distribution and Full Board Meeting Preparation:

The primary and secondary reviewers and other panel members and alternates receive review materials at least five (5) business days in advance of the meeting in accordance with VCU IRB WPP VII-2.

1.       Each protocol will be assigned to a primary reviewer who will be responsible for a full review of all materials, and will lead the discussion of the protocol, the complete grant application (as applicable) and the risk/benefit ratio.

2.       Each protocol will be assigned to a secondary reviewer, whose major responsibility is to review the consent document and provide input for panel discussion.

3.       If the reviewers’ disagree with the necessity for full board review for a given protocol, the reviewers may recommend expedited review or exempt review by notifying the IRB Coordinator of their recommendation.

4.       If there is any protocol-related information requiring clarification, the primary and/or secondary reviewers may contact the principal investigator directly (or appropriate designee).

5.       Reviewer's comments should be prepared prior to the IRB meeting and presented by the primary and secondary reviewers.   Comments should be documented in writing and made available to the IRB Coordinator.  This documentation must address and/or prepare for comprehensive discussion of the following, as appropriate:

a)      Comments on review of consent process and document (unless waiver of consent was requested).

i)           If a waiver of consent (45 CFR 46.116(c-d)) or waiver of documentation of informed consent (45 CFR 46.117(c)(1-2)) is requested/approved, the required determinations must be included along with protocol specific findings justifying each of those determinations.  [The VCU IRB requires that the protocol include the precise information that justifies the need for waiver of consent or documentation and that this information be part of the IRB application].

b)      If children are involved as research participants (in Virginia, individuals under the age of 18 years unless emancipated), the following information must be documented:

i)           The category or children's research (under 45 CFR 46 Part D).  Note that children who are in court-appointed or state custody may not be included unless specifically requested by the PI.  For information regarding wards of the state, see VCU IRB WPP#: XV-3:  Children in Court-Appointed or State Custody and Emancipated Minors.

ii)         The unique determinations required by the regulations (for the children's category or categories of research) must be documented.  This documentation must include protocol specific findings justifying each of those determinations.  [The VCU IRB requires that the protocol include the precise information that justifies the findings of the IRB and that this information be part of the IRB application. PIs must complete the Children’s Supplement Form for research involving Children.  The Form is available at the IRB Forms website].

iii)        The requirements for ASSENT and documentation of assent  [See WPP XV-2 Assent and Parental/Guardian Permission Considerations for more information about assent and parental permission].

iv)       The determination of whether permission of both parents is required (unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child), or whether the permission of one parent is sufficient.  Note that Children’s category 405 allows permission from only 1 parent or guardian, however, the IRB must document that 1 parent/guardian will be permitted for the specific protocol.

c)      If pregnant women and/or fetuses are, or could be, involved as research participants, confirmation of determinations required under 45 CFR 46 Part B along with protocol specific findings justifying each of those determinations must be included.  [The VCU IRB requires that the protocol include the precise information that justifies the involvement (even if inadvertent) of pregnant women and fetuses and that this information be part of the IRB application].   See WPP XIII-1 Pregnant Women, Human Fetuses, and Neonates for more information regarding these special populations.

d)      If prisoners are involved as research participants, confirmation of determinations required under 45 CFR 46 Part C along with protocol specific findings justifying each of those determinations must be included.  Note:  The VCU IRB requires that the principal investigator submit a written justification that serves as the foundation for this documentation.  The final IRB-approved protocol must include a comprehensive final justification (e.g, may be in the form of an updates prisoner submission form and/or written comments by the primary reviewer).

e)      Approval period dates (if less than annual continuing review is recommended) or detailed limitations to approval periods (such as limitations to enrollment numbers prior to reporting back for continuing review). 

6.       The Chairperson will be prepared to encourage and foster a full and complete discussion regarding ethical concerns and issues impacting research subjects prior to requesting a motion of the IRB, requesting a second motion, and then calling for a final vote.

7.       The actions of the panel will be recorded by the IRB Coordinator and transferred to documents to be signed by the IRB Chairperson.

RESPONSIBILITY:

The principal investigator is responsible for submission of all necessary materials to the VCU IRB at time of submission.  It is the responsibility of the panel chairperson and/or panel members to conduct all processes described above in accordance with 45 CFR 46.

REFERENCES:

HHS 45 CFR 46.108(b)

HHS 45 CFR 46.109(e)

VCU IRB WPP#: IV-5

VCU IRB WPP#: VII-2

VCU IRB WPP#: VII-5

VCU IRB WPP#: XIV-1