Huntington
PURPOSE: To establish guidelines for documentation of the activities of the IRB to assure compliance with 38 CFR 16, Food and Drug Administration (FDA) regulations, and other federal regulations.
POLICY: It is the policy to maintain a system of
records that accurately records the activities of the Institutional Review
Board.
Access to and Record
Retention. The IRB
records are retained for at least 3 years after the completion of the
research, and all other records are retained for at least 3 years.
PROCEDURES:
IRB Records:
(1) Written operating procedures
(2) IRB membership rosters
(3) Educational training records
(4) All IRB correspondence
(5) IRB research application (protocol) files
(6) Research (protocol) tracking system
(7) Documentation of exemptions and exceptions reviews
(8) Documentation of expedited reviews
(9) Documentation of convened IRB meetings –(i.e., IRB minutes)
(10) Documentation of
review by outside consultants when
appropriate.
(11) Federal Wide Assurances (FWA)
(12) Any existing Single Project Assurances (SPA)
(13) Serious Adverse Event (SAE) reports
(14) Project tracking documents from automated system
(15) Documentation of cooperative review agreements, e.g., Memorandum of Agreements (MOAs)
(16) DHHS-approved sample consent documents
(17) Progress reports submitted by investigators
(18) Reports of injuries to participants
(19) Records of continuing review activities
(20) Statements of significant new findings provided to participants
(21) Reports of consultants invited to provide additional expertise to the IRB
(22) Correspondence between the IRB and the Research and Development Committee
(23) Protocol violations submitted to the IRB
(24) A resume for each IRB member
IRB records will document determinations required by the regulations and protocol-specific findings supporting those determinations. IRB records for each study's initial and continuing review will note the frequency for the next continuing review.
IRB Membership Rosters. The Director, ORI ensures that current IRB membership rosters are maintained and that any changes in IRB membership are reported promptly by the IRB Coordinator to OHRP. The membership rosters include the following information:
(1) Names of IRB members.
(2) Names
of alternate members (if any) and the corresponding regular member(s) for who
each alternate may serve.
(3) Earned degrees of each member and alternate, where applicable.
(4) Specific scientific qualifications (such as board certifications and licenses) or other relevant experience. sufficient to describe each member’s chief anticipated contribution to IRB deliberations.
(5) The representative capacity of each member or alternate.
(6) Any employment or other relationship with Marshall University or with the collaborating institutions (e.g., full or part time employee, stockholder, member of governing board, paid or unpaid consultant).
(7) Scientific/nonscientific status.
(8) Affiliation status (whether the member or an immediate family member of the member is affiliated with the organization).
(9) Whether the member has been appointed by the VA Medical Center Director in the past three years to be the VA representative.
Education and Training Records.
All IRB members, research investigators, and other staff must complete the required orientation and training as outlined in the Standard Operating Procedure entitled “Education and Training.” Documentation of completion of the mandated education is tracked and maintained through an Excel spreadsheet or other software tracking programs, as appropriate.
IRB
Correspondence. All research investigators and staff involved
with human subject research must provide the IRB with copies of any
reports or correspondence concerning research in which they are involved to or
from any regulatory or compliance enforcement Federal agency, such as OHRP, or the FDA that exercises
oversight over the protection of human subjects in research. Copies of any reports or correspondence to or
from various government agencies concerning the facility’s research
is provided to the IRB which
determines whether any additional notifications are necessary. The IRB Coordinator ensures that accurate records are
maintained of all such correspondence.
IRB
Research (Protocol) Application Files. The IRB maintains a separate file for each research application
(protocol) that it receives for review.
Protocols are numbered sequentially by calendar year, in the order in
which they are initially received. Each IRB
research application (protocol) file contains the following materials (if applicable):
(1) The IRB Research (Protocol) Application Form.
(2)
The IRB-approved informed consent document, with the
approval date and dates of each change on the affected page. (Note: Any change to the consent form will require a new consent submission in its
entirety. All previously approved
consent forms will be
retained.)
(3) Scientific evaluations of the proposed research, if any. For drugs, the Investigator’s Brochure; for devices, a report of prior investigations.
(4) Applications for Federal support, if any.
(5) A complete copy of the protocol, or research plan, or investigational plan (projects which receive no direct funding, sponsor or cooperative group protocols).
(6) Advertising or recruiting materials, if any.
(7) Protocol amendments or modifications.
(8) Continuing review progress reports and related information.
(9) Reports of unanticipated problems involving risks to subjects or others.
(10) Reports of adverse events occurring within the Institution (or involving employees or agents of the Institution) and reported to any regulatory agency.
(11) Reports of external adverse events received from sponsors or cooperative groups.
(12) Data and Safety Monitoring Board (DSMB) reports, if any.
(13) Results of any internal quality control and monitoring activities.
(14) Results of any external monitoring activities, including reviews provided to the investigator by sponsors, cooperative groups, or Federal agencies.
(15) All IRB correspondence to or from research investigators.
(16) All other IRB correspondence related to the research.
(17) Documentation of all IRB review and approval actions, including initial and continuing convened (full) IRB review.
(18) Documentation of project closeout.
Research (Protocol) Tracking System. The ProIRB computerized tracking system is utilized to maintain and track all protocols presented to the IRB. Funding for protocols is tracked through the Marshall University Research Corporation (MURC).
(1) Title of the Research (Protocol)
(2) Names of principal investigator and co-investigators where appropriate
(3)
Funding source
(4) Date of initial approval
(5) Date of most recent continuing approval
(6) End of current approval period
(7) Type of review (expedited, convened review, or exempt)
(8) Current status (under review, approved, suspended, closed)
Documentation of Convened IRB Meetings in the Minutes. The IRB Coordinator compiles the minutes of IRB meetings. The minutes of the IRB proceedings must be written and available for review within 3 weeks of the meeting date. The following specific information is recorded in the meeting minutes:
- Attendance at IRB Meetings.
The IRB minutes list attendance as follows:
(1) Names of members present
(2) Names of absent members
(3) Names of alternates (if applicable) attending in lieu of specified (named) absent members. Alternates may substitute for specific absent members only as designated on the official IRB membership roster
(4) Names of consultants present
(5) Names of investigators present
(6) Names of guests present
Each vote will reflect the number of "Members Present" at the meeting. Each vote will also list the members that are listed in the "Members
Present", but not present for that vote.
- Quorum Requirements and Voting at IRB
Meetings.
The IRB Coordinator is responsible to monitor the members present at convened meetings and determine that meetings are appropriately convened and remain so.
Quorum Requirements:
- A majority of the IRB members (or their
designated alternates), including at least one member whose primary
concerns are in nonscientific areas AND at least one member who is a
community representative, must be present to conduct a convened
meeting. In order for research to
be approved, it must receive the approval of a majority of those members
present at the meeting.
- Members may be present in person or
audio (telephone) or audio-visual teleconference. Members present via teleconference are
noted as such in the meeting minutes, which also indicates that the
members received all pertinent information prior to the meeting and were
able to actively and equally participate in all discussions.
- IRB minutes include documentation of
quorum and votes for each IRB action and determination by recording votes
as follows: Total Number Voting ( ); Number voting for ( ); Number voting
against ( ); Number abstaining ( )
- Members recusing themselves due to conflicts
of interest may not be counted toward quorum requirements (i.e., may not
be counted among those voting or abstaining) or be counted as among the
majority of members necessary to constitute a quorum.
- An individual who is not listed on the
official IRB membership roster may not vote with the IRB. Proxy votes are not allowed.
- Any ex-officio member of the IRB may not
vote with the IRB.
- Ad hoc consultants may not vote with the
IRB.
- A non-scientist member AND a member
who is not otherwise affiliated with
the institution and who is not part of the immediate family of a person who is
affiliated with the institution must
always be present for a vote to be taken.
- If research involving a FDA regulated article is involved, a licensed physician must be included in the quorum. If a quorum is not maintained, the proposal must be tabled or the meeting must be terminated.
- For research involving prisoners, a majority of the IRB (exclusive of prisoner members) must have no association with the prison involved. At least one member of the board present at the meeting will be a prisoner representative.
Should the quorum fail during the meeting
(e.g., loss of a majority through recusal of members with conflicting interests
or early departures, or absence of a nonscientist member), the IRB may not take further
actions or votes unless the quorum can be restored.
- Actions Taken by the Convened IRB.
The IRB minutes include all actions taken by the convened IRB and the votes underlying those actions. These actions are also provided in writing to investigators after formal approval from the R&D Committee is received. The IRB actions for initial or continuing review of research include the following:
(1) Approved with no changes (or no additional changes). The research may proceed.
(2) Approvable with minor changes to be reviewed by a designated IRB member the IRB Chairman or his designee. Such minor changes must be clearly delineated by the IRB so the investigator may simply concur with the IRB’s stipulations. The research may proceed after the required changes are verified and the protocol approved by the designated reviewer.
(3) Approvable with substantive changes must be re-reviewed at a convened IRB meeting. The research may proceed only after the convened IRB has reviewed and approved the required changes to the research.
(4) Deferred pending receipt of additional substantive information. The IRB determines that it lacks sufficient information about the research to proceed with its review. The research may not proceed until the convened IRB has approved a revised application incorporating all necessary information.
(5)
Disapproved.
The IRB has determined that the research cannot be conducted at the
facility or by employees or agents of the facility.
- Votes.
The voting on any actions at the IRB meetings are categorized by “for, against, and abstain or recused due to a conflicting interest”.
- Changes in research
activity.
The minutes of IRB meetings include the basis for requiring changes in or disapproving research.
F. Controverted issues.
The minutes include a written summary of IRB findings, determinations, and discussion of all controverted issues and their resolution.
G. IRB Findings and Determinations.
The IRB findings and
determinations are provided in writing to the investigator, who is given an
opportunity to respond in person or in writing. Certain findings may be documented in other formats, such
as reviewer checklists that are filed in the protocol files. The following findings and
determinations will be documented in the IRB minutes or on approved checklists:
(1) The level of risk of the research.
(2) The approval period for the research, including
identification of research that warrants review more often than
annually.
(3) Identification of any research for which there is need for
verification from sources other than the investigator that no material changes
are made in the research,
if the IRB deems it necessary. (e.g.,
Cooperative Studies, or other collaborative
research).
(4) Justification for waiver of the requirement for written
documentation of consent in accordance with the criteria at 38 CFR
16.117(c).
(5) For DHHS-supported research, justification for approval of research involving pregnant women, human fetuses, and neonates involved in research, addressing each of the criteria specified under 45 CFR 46 Subpart B of the DHHS human subject regulations. (See Standard Operating Procedure entitled “Vulnerable Subjects")
(6) For DHHS-supported research, justification for approval of
research involving prisoners, addressing each of the categories and criteria
specified under 45 CFR 46 Subpart C of the DHHS human subject regulations. The IRB Coordinator is responsible for
providing certification of the IRB’s findings to OHRP.
(7) For DHHS and FDA regulated research, justification for
approval of research involving children, addressing each of the categories and
criteria specified under 45 CFR 46 Subpart D of the DHHS and FDA human subject
regulations. The IRB Coordinator is
responsible for providing notification to OHRP of the IRB’s findings concerning
research requiring review by a panel of experts convened in accordance with
Subpart D. For FDA regulated
research, documentation of the IRB findings is required and notification goes to
the Commissioner of the FDA.
(8) Special protections warranted in specific research projects for groups of subjects who are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, regardless of source of support for the research.
(9) Justification of any deletion or substantive modification of information concerning risks or alternative procedures contained in the DHHS-approved sample informed consent document.
(10) The rationale for significant risk/non-significant risk device determinations.
(11) Information provided by consultants who attend IRB meetings to provide additional expertise to the IRB.
(12) When an alternate member replaces a primary member.
A copy of the minutes will be provided to the following:
-
MU Institutional Official
-
Director, ORI
-
HRPP representative of each affiliated institution
-
VA Research and Development Committee
Research contingent on specific minor conditions by the chair or designee will be documented in the minutes of the first IRB meeting that takes place after the date of the approval. The minutes will be written and available for review within three weeks of the meeting date. Once approved by the members at a subsequent IRB meeting, the minutes may not be altered by anyone including a higher authority.
H. Members that
recused themselves.
Members who recuse themselves by name and with the name of the protocol will appear in the
IRB minutes.
OTHER
DOCUMENTATION REQUIREMENT
Documentation of Expedited
Reviews.
Expedited IRB review procedures are employed only for (1) minor changes in previously approved research during the specified approval period, or (2) initial or continuing review of research falling within specific categories. Expedited reviews are conducted by the IRB Chairperson or a qualified IRB member designated by the Chairperson. Documentation for expedited review and approval consists of the reviewer’s concurrence with the Expedited Checklist found in the IRB research application file that the research activity described in the investigator’s Application for Expedited Review satisfies the conditions (1) for a minor change, or (2) involves minimal risk. Investigators must report to the IRB any proposed changes in previously approved IRB research, including proposed changes in informed consent documents. No changes may be initiated without prior approval of the IRB, except where necessary to eliminate apparent immediate hazards to subjects. The investigator will be notified in writing of the final decision.
IRB records for initial and continuing review by the expedited procedure will include:
-
The specific permissible category
-
Description of action taken by the reviewer
-
Any findings required under the regulations
Procedure for
Documentation of
Exemptions.
The investigator completes the IRB
Initial
Protocol Application, which includes a checkbox to
request exempt status. The IRB
Chairman or his designee reviews the protocol for exempt status based on the exempt categories. The investigator indicates on the Exempt
Checklist under which category he/she believes is appropriate and the Chairman
or his/her designee will determine if the protocol meets that exempt status. If the protocol meets exempt status, the
Chairman reports to the IRB.
The investigator is notified in writing of the final
decision. Documentation of verified
exemptions consists of the Exempt Checklist signed and dated by the
Chairman and filed in the protocol file in the Research Office.
Categories of exempt research
are listed in the Standard Operating Procedure entitled “Types of Research and Types
of Reviews.”
The IRB records for exempt determinations will include the specific category of
exemption determined by the reviewer.
Documentation of Exemptions from IRB Review Requirements for Emergency Use of a Test Article.
Emergency use of a test article without IRB review is
permitted. Emergency use is defined
as use of a test article on a human subject in a life-threatening situation in
which no standard acceptable treatment is available, and in which there is not
sufficient time to obtain IRB approval. Written documentation of the emergency use must be
submitted to the IRB within 5 working days. Any subsequent use of the test article
requires IRB review. The IRB
Coordinator is responsible for maintaining this
documentation in the IRB records.
Documentation of Exceptions from Informed
Consent Requirements for Emergency Use of a Test Article.
It is permitted to use a test article without the informed consent of the subject (or the subject’s legally authorized representative) where the clinical investigator and a physician not otherwise involved in the research certify in writing that:
(1) the subject is confronted with an immediately life threatening emergency;
(2) informed consent cannot be obtained because of an inability to communicate;
(3) time is not sufficient to obtain consent from the subject’s legally authorized representative; and
(4) there is no alternative approved or generally recognized therapy that provides equal or greater likelihood of saving the subject. If time is not sufficient to obtain an independent physician’s determination that the four conditions above apply, the clinical investigator should make the determination and within 5 working days after the use of the article, have the determination reviewed and evaluated in writing by an independent physician.
This information can be documented on the “Waiver of Informed Consent” form.
This written certification must be submitted to the IRB within 5 working days of the use of the test article. The IRB Coordinator is responsible for maintaining this documentation in the IRB records. The IRB Chairman and the Director, ORI must verify that conditions for the use have been met.
Follow Up
Responsibility: Director, Office of Research
Integrity
References: 45 CFR
46.
21 CFR 50; 21 CFR 56
38 CFR 16; 38 CFR 115