The IRBs maintain documentation of their activities.  IRB records include IRB protocol files, minutes for convened IRB meetings, and other documentation.

8.1      IRB Protocol Files

Section revised: 3/13/13  

The IRB maintains a complete set of materials relevant to the review of the research protocol or plan for a period of time sufficient to comply with legal and regulatory requirements, Sponsor requirements, and organizational policies and procedures. (AAHRPP Element II.5.A)

The RCO employs an electronic protocol application system, eProtocol.  Copies of some documents are also maintained in hard copy files. 

Electronic Protocol System (eProtocol)

The eProtocol system maintains electronic records of all documents submitted through the system for every protocol event.  The eProtocol system contains a search function for locating and retrieving protocols by protocol number, protocol title, name of Protocol Director (PD), names of co-investigators, review type, meeting date, internal funding number, sponsor, IRB number, reviewer or any combination of the above categories.  Electronic copies of all materials submitted to the IRB can be accessed through eProtocol on an event by event basis through the eProtocol Event History function, thus all documents supporting each protocol event are accessible to reconstruct the entire history of a protocol.  

A protocol file contains, as applicable to the research: 

     1.         Protocol Application(s).  The protocol file includes one or more of the following application types:

      Protocol Application for medical or nonmedical research (Regular, Expedited and Exempt review) submitted for all new research projects;

      Modification Form, submitted for modifications to approved research;

      Continuing Review Form, submitted for continuing review of research;

      Reports submitted for reportable events and information per guidance Events and Information that Require Prompt Reporting to the IRB.

      Final Report Form, submitted for closing Regular review protocols.

IRB comments and investigator responses that occurred during IRB review are included with each application.  Comments and responses exchanged via fax or email are also included as attachments, or are stored in the hard copy file. 

     2.         The IRB-approved informed consent document(s).  The protocol file includes all approved consent forms, including the currently approved consent form.  When a sample DHHS consent form is provided, it is included in the protocol file.  

     3.         The IRB-approved Assent form(s).  If a study involves children from whom the investigators will obtain assent, copies of approved assent forms will be included in the protocol file. 

     4.         Scientific evaluations of the proposed research.  Documentation of scientific review is included in the protocol file.  See Chapter 1.7 for information on scientific and scholarly review.

     5.         Sponsor Materials.  For investigational drug studies, the Investigators Brochure and Sponsors Protocol, including current amended editions of these documents and all previous versions are included in the protocol file. 

For investigational devices, a report of prior investigations and the Sponsors Protocol are filed.

     6.         Application for federal grant support. For research supported by federal funds, a copy of the grant proposal is included in the protocol file.  If the federal funding is subcontracted through another institution, the sub-contract with that institution is noted in the protocol file.

     7.         Advertisements, phone screening scripts and non-medical oral scripts, flyers, website or other subject recruitment materials.

     8.         Questionnaires, surveys, interview scripts, diaries or other documents used in the course of the study.

     9.         Participant informational sheets, brochures and sponsor newsletters.

  10.         Reports submitted for reportable events and information per guidance Events and Information that Require Prompt Reporting to the IRB.

  11.         Final reports submitted for regular protocols.

  12.         Data and Safety Monitoring Board (DSMB) reports, Annual Progress reports.

  13.         Conflict of Interest (COI) documents, when COI or ICOI is applicable.

  14.         Correspondence and communication between IRB members, IRB staff and investigators.

  15.         Other IRB correspondence related to the research.

  16.         Documentation of all actions including approvals, disapprovals, waivers or alterations of consents and HIPAA authorizations (as documented in the protocol application forms).

  17.         Approval letter (or Notice of Exempt Review for research subject to exempt review.)

  18.         Documentation of protocol closeout if any, including Final Report forms for regular protocols.

  19.         Expiration notice sent-date.

  20.         IRB approvals from collaborating institutions are requested and included in the research file.  IRB approval notices are requested from collaborating institutions when STANFORD is the coordinating center for a multi-site study, or when data is being received at STANFORD.  If the study is a multi-site study, with STANFORD as one of several participants, no other IRB approval is gathered or included from other participating sites.

  21.         Various IRB checklists including Protocol, Reviewer, Informed Consent, Exemption Eligibility, Expedited Eligibility, Expedited Modification Checklist, and Continuing Review checklists.

 

Each protocol file is organized to allow a reconstruction of a complete history of all IRB events related to the review and approval of the protocol.

 

Other Documentation Maintained

Information Specific to Certain Types of Research or Special Situations

Emergency Use of a Test Article

Research involving the emergency use of a test article under FDA regulations 21 CFR 56.104(c) is described in Chapter 5.  Documentation of the emergency use of a test article is submitted to the IRB within five days of the use of the test article and includes the following documents:

      Emergency Use of a Test Article Notification Form

      Consent form, if applicable

The IRB Chair of a medical IRB or a designated physician IRB member reviews the materials submitted to verify conditions of 21 CFR 56.103(c) have been met, including requirements for informed consent unless the conditions of 21 CFR 50.23(a)-(b) have been met.  IRB review is documented by the Exemption from IRB Review for Emergency use of a Test Article.

 

Human Subject Determination  

Human Subject Determination applications, Notices of Determination and any other materials acquired in the process of review of proposed research that has been found to not meet the definition of Human Subject Research is kept in a separate file in the Research Compliance Office.

 

Other IRB-related Information

Other information is maintained by the Research Compliance Office, such as correspondence between the IRB and outside agencies and institutions, IRB convened meeting documentation - minutes, minutes lists, agenda, and agenda lists, information about each IRB Member including; contact information, background and experience, curriculum vitae, etc.

8.2      Record Retention

Section revised: 3/13/13  

The IRB maintains a complete set of materials relevant to the review of the research protocol or plan for a period of time sufficient to comply with legal and regulatory requirements, Sponsor requirements, and organizational policies and procedures.  (AAHRPP Element II.5.A)

In accordance with the Common Rule and FDA regulations (45 CFR 46.115(b) and 21 CFR 56.115(b)), IRB records are retained for at least three years after the completion of the research, either electronically or as hard copy.  In accordance with federal HIPAA privacy regulations, IRB records containing protected health information (PHI) are retained for at least six years after the completion of the research.  It is STANFORD policy to retain records for the greatest amount of mandated time.  Thus, RCO retains all research records for at least six years.  This policy applies to all research studies, whether or not participants were enrolled.  Sponsored grants and contracts may require additional periods for record retention. 

Records of VAPAHCS research are retained until disposition instructions are approved by the National Archives and Records Administration and are published in VHA's Records Control Schedule (RCS 10-1). 

Other documents, such as meeting agendas and agenda lists and meeting minutes and minutes lists for the current IRB year are maintained in the office of the IRB Manager.  Periodically, these documents are sent to an external vendor for long-term storage. 

General correspondence from investigators and other documents not specific to a particular research protocol are maintained indefinitely in the RCO.

See Research Policy Handbook RPH 1.9 Retention of and Access to Research Data for Stanford University policy on record retention.

Maintenance of and Access to IRB Records

All hard copy IRB records of active protocols are secured in closed filing cabinets in locked buildings with regular security patrols and alarms.  Records of closed protocols are sent to an external vendor for long-term storage.  Access to those materials can be obtained in 48 hours, or less, if necessary.

The eProtocol system resides on a secured server, with password-protected access.

Access to IRB records is routinely provided to the Vice Provost and Dean of Research, IRB Chairs, IRB members, IRB staff, and authorized VAPAHCS representatives (e.g., R&D Committee representatives) to carry out HRPP operations.  Research investigators are provided reasonable access to files related to their own research. 

All other STANFORD access to IRB records is limited to those with a legitimate need for access, such as the Research Management Group, Office of Technological Licensing, Office of Sponsored Research, or Internal Audit.  In addition, the RCO may allow access to IRB records by outside entities (e.g., monitors of sponsors of clinical trials) and agencies (e.g., regulatory agencies).

Research Policy Handbook RPH 18.4 Confidentiality of Administrative Panel Proceedings addresses the confidentiality of IRB meetings, meeting minutes, IRB Chairs annual reports, research protocols and consent forms.  The RCO will consider the IRB confidentiality policy, and use its discretion and the reason for a request, to determine whether to grant access.

 

8.3      IRB Minutes

Section revised: 6/03/2016  

The IRB documents discussions and decisions on research studies and activities in accordance with legal and regulatory requirements, Sponsor requirements (if any), and organizational policies and procedures. (AAHRPP Element II.5.B)

The IRB or EC has and follows written policies and procedures to conduct reviews by the convened IRB: (AAHRPP Element II.2.D)

Element II.2.D.1. – Initial review

Element II.2.D.2. – Continuing review

Element II.2.D.3. – Review of proposed modifications to previously approved research

The IRB documents discussions, decisions, and findings either through the IRB minutes or for protocols subject to expedited review through documentation in the protocol file or other records.

The IRB minutes document:

      Meeting attendees and invitees

      Discussions and actions taken by the IRB and the separate deliberations for each action

      Determinations made by the IRB and the protocol-specific findings that justify those determinations

      Votes for each action recorded as numbers for, against, or abstaining

      Other issues requiring convened IRB review.

 

Attendance at an IRB Convened Meeting

Attendance at an IRB convened meeting is recorded in the minutes by documenting:

      The IRB members (voting, non-voting, and ex-officios) who are in attendance.  Non-voting members include ex-officio members or alternate members attending for informational purposes

      The IRB members who are not in attendance

      When an alternate member replaces a primary member in attendance and voting at the convened meeting

      The continued presence of quorum for all votes, including a member whose primary concern is in a nonscientific area

      Attendance of members and alternate members who participate through videoconference or teleconference, and documentation that those members received all pertinent material before the meeting and had the opportunity to actively and equally participate in all discussions

      The IRB members who leave the meeting because of a conflicting interest

      The IRB members who leave the meeting briefly, are not present during a vote, and are not counted as part of the quorum

      The IRB members who arrive late or depart early from the meeting and their arrival or departure times

      The Research Compliance Office staff present

      Any others present (e.g., invited guests, investigators invited to address the IRB, and consultants)

Discussions and Actions Taken By the IRB

      Discussions and actions taken by the IRB, and the separate deliberations and basis for each action are documented in the minutes, such as:

      Discussion of protocol events – new, continuing review, modifications, reports of unanticipated problems and events and information requiring prompt review

      Approval of research – including the approval period for research, at initial and continuing review, (and if appropriate to the degree of risk determination of an approval period of less than one year)

      Approval of research contingent on specific minor conditions, and the designee (staff or Panel member) appointed to sign off on the condition when met.  If the condition is met after the minutes for that meeting are approved, the approval is documented in the minutes of the first IRB meeting that takes place after the contingency is met.

VA research:

The IRB Chair or an experienced IRB voting member designated by the Chair must sign off when conditions are met.

      Suspensions and terminations of previously approved research

      Disapproval of research

      Discussion of controverted issues and their resolution or disposition

      Requests for consultant review or input from an expert in the field (e.g. requests made during a convened meeting)

      Actions resulting from review of reports of unanticipated problems involving risks to participants or others, or other reportable events and information

      Actions resulting from determinations of serious or continuing non-compliance

      If a protocol is using a DHHS-approved sample consent: The justification of any deletion or substantive modification of information concerning risks or alternative procedures contained in the sample consent document

Determinations made by the IRB

Determinations made by the IRB are recorded in the minutes with documentation of the protocol-specific findings justifying those determinations as appropriate, such as:

      Significant risk and non-significant risk device determinations, pursuant to:

-       21 CFR 812.2(b), 21 CFR 812.150(b)(9)

-       and considering FDA Information Sheet Significant and Non-significant Risk Medical Device Studies

      Approval of waiver or alteration of informed consent, pursuant to:

-       45 CFR 46.116(c) and 45 CFR 46.116(d)

      Waiver of informed consent documentation, pursuant to:

-       45 CFR 46.117(c) and 21 CFR 56.109(c)(1)

      Research involving adults with impaired decision-making

      Waiver of HIPAA Authorization, pursuant to 45 CFR 164.512(i)(2)(ii)

      Waiver of HIPAA Authorization for recruitment or screening, pursuant to 45 CFR 164.512(i)(2)(ii)

      Alteration of HIPAA Authorization, pursuant to 45 CFR 164.512(i)(2)(ii)

      Use of short form process for consent:

-       45 CFR 46.117(b)(2) or 21 CFR 50.27(b)(2)

      When research involves children, the following IRB decisions are documented:

-        Appropriate children finding applicable to research:

  45 CFR 46.404, 45 CFR 46.405, 45 CFR 46.406, 45 CFR 46.407, 45 CFR 46.408 (OHRP)

  21 CFR 50.51,  21 CFR 50.52, 21 CFR 50.53, 21 CFR 50.54, 21 CFR 50.55 (FDA)

-       Whether the permission of one parent/guardian is sufficient or if permission from both parents/guardians is required. (See guidance Parental Permission.)

-       How assent is to be solicited or obtained, unless waived.

-       The participation of children who are wards of the state is approved under:

  45 CFR 46.406, 45 CFR 46.407 only if 45 CFR 46.409(a) is satisfied, or

  21 CFR 50.53, 21 CFR 50.54 only if  21 CFR 50.56(a) is satisfied

      Appropriate involvement of pregnant women, fetuses, and neonates pursuant to:

-       45 CFR 46.204, 45 CFR 46.205, 45 CFR 46.206, and 45 CFR 46.207

      Approval of research involving transplantation of fetal tissue:

-       42 USC 498A(b)(1) and (2)

      Approval of research involving prisoners as participants under the following regulations:

-       45 CFR 46.305 and 45 CFR 46.306

      Determination of the level of risk

      Determinations of serious or continuing non-compliance

      Unanticipated Problems and Unanticipated Adverse Device Effect

      For VA research (see VHA Handbook 1200.05) determinations may address:

-       Research involving adults unable to consent in VA research

-       If recruitment of non-Veterans is justified and appropriate

Other Issues

Other issues are documented in the minutes, including but not limited to:

      Other events and information that require prompt reporting to the IRB (per guidance Events and Information that Require Prompt Reporting to the IRB)

      DSMB reports

      Approval of minutes of prior convened IRB meetings

      The approval of research contingent on specific minor conditions by the chair or designee, in the minutes of the first IRB meeting that takes place after the date of the approval

      Presentation of information from an outside consultant or expert as previously requested by the IRB

      Special situations such as use of a test article and humanitarian use devices

      The names of IRB members who abstain for reasons other than conflict of interest

      Other items as applicable

      For VA research: Correspondence between the IRB and the Research & Development Committee

Disposition of the IRB Minutes

The IRB staff writes minutes and makes them available for IRB review one week before the next months meeting. Minutes may not be altered by anyone including a higher authority once approved by the members at a subsequent IRB meeting.

The minutes of convened IRB meetings are considered confidential, and access to them is restricted and secured.

The Vice Provost and Dean of Research is copied on all IRB convened meeting minutes.

The IRB provide those portions of the minutes concerning VA research to the VA Palo Alto Health Care System (VAPAHCS).