Standard Operating Procedures - Chapter 8
IRB RECORD KEEPING AND REQUIRED DOCUMENTATION
8.1 Access to IRB Records
All IRB records are stored in locked filing cabinets and secure computer systems in the HRPO. Record access is limited to:
• Institutional officials
• IRB members
• HRPO staff
• Officials of federal regulatory agencies conducting reviews such as the OHRP and FDA
• Research investigators (reasonable access to files related to their research)
All other access to IRB records is limited to those who have legitimate need for them, to the extent permitted by state and federal laws.
8.2 List of IRB Members and Qualifications
The HRPO maintains the IRB membership rosters. A list outlining IRB members for each IRB is filed with the Department of Health & Human Services (DHHS). DHHS is promptly notified of any changes in IRB membership. All IRB membership rosters include the following information, as required by the OHRP:
• Names of IRB members
• Names of alternate members and the corresponding full member(s) for whom each alternate may serve
• Earned degree of each member and alternate, where applicable
• Department and area of expertise, where applicable
• Representative capacity of each member or alternate, e.g., scientist or non-scientist, affiliated or non-affiliated ,vulnerable populations
• Affiliation with UMASS
Up-to-date resumes or curriculum vitae of all IRB members are kept on file in the HRPO. This information includes earned degree(s); indication of experience, such as board certification, licensures, or other relevant experience sufficient to describe each member’s chief anticipated contribution to IRB deliberations;and employment or other relationship between each member and UMASS.
8.3 Education and Training Records
All individuals involved in human participant research under the auspices of UMASS must complete an educational program(s) on the protection of human research participants before final approval is granted. Copies of all training certificates are kept in the HRPO.
8.4 Documentation of Full IRB Meetings
Detailed minutes of each IRB meeting shall be kept by the HRPO. The format and subject matter comply with the federal regulations and include the following:
• Attendance at IRB meetings, including a list of members (i.e., full and alternate) and guests, and documentation of when individuals join and leave the meeting
• Documentation of the quorum and votes for each IRB action and determination by recording votes to denote the total number voting, number voting for, number voting against, number abstaining, and names of those excluded or abstaining due to conflicts of interest
• Review of the minutes from the previous meeting
• A list of research approved since the last meeting via expedited review procedures and the specific citation for the category of expedited review of the individual study
• Actions taken by the IRB on the initial or continuing review of research and any votes underlying those actions.
• The basis for requiring changes in or disapproving research
• A written summary of the discussion of controversial issues and their resolution
• Memos to investigators indicating the actions and decisions of the IRB
• Actions taken by the IRB regarding complaints, adverse events or non-compliance
Detailed minutes of each IRB meeting are kept on file. Minutes are distributed in advance and brought before the board members for approval at the next scheduled meeting. Alternate members may receive a copy of the minutes only for the meeting attended.
8.5 IRB Study Files
The IRB maintains a separate file for each research application (study) it receives for review. Studies are assigned a tracking number at the time of submission by a computer database system. Each file will contain the following, when and where applicable:
- Approval Letter(s)
- Correspondence
- Correspondence to and from the PI
- Letters of Agreement
- Certificate of Confidentiality
- IRB Authorization Agreement
- Sponsor, OHRP & FDA
- Extraordinary Events
- Significant Adverse Event
- Adverse Event Trend
- Other Adverse Event
- Conflict of Interest
- Non-compliance
- Protocol Deviation
- Informed Consent Forms
- Adult Form
- Parental Permission Form
- Assent Form
- Addendum
- Debriefing Statement
- Instruments
- Surveys/Questionnaires
- Interview/Focus group Scripts
- Data Collection forms
- Monitoring
- Auditing Reports – internal and external
- Data Safety & Monitoring Board (DSMB) reports
- Protocol Documents
- Full Protocol
- Selected Protocol Pages
- Amendment
- Investigator Brochure
- Recruitment
- Recruitment Materials
- Eligibility Screening
- Review Documents
- Reviewer Sheet
- Additional Information Request
- PI response
- Submission Forms
- Initial Application
- Modification Requests
- Continuing Progress Report (CPR) forms
- Abstract
- Project Closeout form
- Grant Application
8.6 Protocol Management System
The IRB maintains an electronic protocol management system to assist in the administration of the review and approval process. Each research study includes at a minimum:
- Title of the research study
- Names of principal investigator and co-investigators including completed training
- Funding source
- Date of initial approval
- Date of most recent continuing approval
- End of current approval period
- Level of review (expedited, full review or exempt)
- Department responsible for the study
Information is generated from the system to send continuing review notices to investigators.
8.7 Retention of Records
All IRB records related to research are maintained intact for at least six years following the study’s completion date in accord with state regulations and are maintained in a designated storage area. Investigators are required to maintain their research records and the original signed informed consent forms for at least six years after the research terminates. Records are accessible for inspection by the IRB and authorized representatives of federal or accreditation agencies or departments.
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