ACTIVITIES/DETERMINATIONS FOUND IN VHA POLICY(Handbook 1200.5) AND HUMAN
SUBJECT PROTECTION REGULATIONS \[38 CFR 16, 45 CFR 46, 21 CFR 50 & 56\]

+----------+-------------------+--------------------------------+-----+
| Re       | Activity/decis    | Document/record what           | D   |
| gulation | ion/determination |                                | one |
|          |                   |                                | by  |
+==========+===================+================================+=====+
| 38 CFR   | Review requests   | Determination that research    | IRB |
| 16.101,  | for exemptions    | only involves humans in one or |     |
|          | submitted by      | more exempt categories of      |     |
| VHA      | investigators     | research & is exempt from IRB  |     |
| Handbook |                   | review                         |     |
| 1200.5   | **[VHA additional |                                |     |
| #8.b     | activiti          | **[VHA additional              |     |
|          | es]{.underline}** | documentation]{.underline}**   |     |
|          |                   |                                |     |
|          | -exempt           | -IRB Chair, or IRB member      |     |
|          | determination     | designated by Chair, review    |     |
|          | made by IRB Chair | all requests                   |     |
|          | (or designated    |                                |     |
|          | IRB member)       | -timely determination          |     |
|          |                   |                                |     |
|          | -determination    | -record the decision           |     |
|          | made/communicated |                                |     |
|          | as required by    | -decision communicated in      |     |
|          | VHA policy        | writing to investigator and    |     |
|          |                   | IRB                            |     |
|          | -R&D Committee    |                                |     |
|          | reviews research  | -must include the specific     |     |
|          | determined to be  | categories justifying          |     |
|          | exempt from IRB   | exemption                      |     |
|          | review            |                                |     |
|          |                   | -projects exempt from IRB      |     |
|          |                   | review must be reviewed by R&D |     |
|          |                   | Committee before initiation    |     |
|          |                   |                                |     |
|          |                   | -included in annual R&D        |     |
|          |                   | Committee review of research   |     |
|          |                   | projects                       |     |
+----------+-------------------+--------------------------------+-----+
| 38 CFR   | Identify any IRB  | No IRB member with conflicting | IRB |
| 1        | member(s) who     | interest participated in       |     |
| 6.107(e) | might have        | initial/continuing review of   |     |
| \[45 CFR | conflicting       | project (except to provide     |     |
| 46       | interest(s) in a  | information requested by IRB). |     |
| .107(e), | research project  |                                |     |
| 21 CFR   | being reviewed    |                                |     |
| 56       |                   |                                |     |
| .107(e), | **[VHA additional |                                |     |
| 21 CFR   | activiti          |                                |     |
| 54\],    | es]{.underline}** |                                |     |
|          |                   |                                |     |
| VHA      | IRB ensures steps |                                |     |
| Handbook | taken to manage,  |                                |     |
| 1200.5,  | reduce, eliminate |                                |     |
| #7.a(9)  | potential/real    |                                |     |
|          | conflicts of      |                                |     |
|          | interest          |                                |     |
+----------+-------------------+--------------------------------+-----+
| 38 CFR   | Review research   | Presence of quorum (majority   | IRB |
| 1        | at convened       | of members) for each vote      |     |
| 6.108(e) | meeting **[VHA    | including                      |     |
| \[45 CFR | additional        |                                |     |
| 46       | activiti          | -one member with primary       |     |
| .108(e), | es]{.underline}** | concern in non-scientific area |     |
| 21 CFR   |                   |                                |     |
| 56.1     | additional IRB    | -approval by majority of those |     |
| 08(e)\], | requirements for  | present                        |     |
|          | research          |                                |     |
| VHA      |                   | **[VHA additional              |     |
| Handbook | -quorum with      | documentation]{.underline}**   |     |
| 1200.5,  | FDA-regulated     |                                |     |
| #7.b(2)  | test articles     | **-**if research on FDA test   |     |
|          |                   | article, licensed physician    |     |
|          | -special IRB      | part of quorum                 |     |
|          | membership for    |                                |     |
|          | research using    | -if research includes mentally |     |
|          | mentally          | disabled/impaired decision     |     |
|          | disabled/impaired | making capacity subjects,      |     |
|          | decision making   | membership includes at least   |     |
|          | capacity          | one expert in that area of     |     |
|          |                   | research (may use *ad hoc*     |     |
|          |                   | member(s) as necessary)        |     |
+----------+-------------------+--------------------------------+-----+
| 38 CFR   | IRB decides on    | Notification of approval or    | IRB |
| 1        | research project  | disapproval of proposed        |     |
| 6.109(d) |                   | research activity              | (V  |
| \[45 CFR | -sent to PI       |                                | HA) |
| 46       |                   | -state modifications required  | R&D |
| .109(d), | **[VHA additional | to secure IRB approval         |     |
| 21 CFR   | activiti          |                                |     |
| 56.1     | es]{.underline}** | -disapproval includes reasons  |     |
| 09(e)\], |                   | for decision                   |     |
|          | -sent to R&D      |                                |     |
| VHA      | Committee         | **[VHA additional              |     |
| Handbook |                   | documentation]{.underline}**   |     |
| 1200.5,  |                   |                                |     |
| #7.c     |                   | -investigator given            |     |
|          |                   | opportunity to respond (in     |     |
|          |                   | person or writing)             |     |
|          |                   |                                |     |
|          |                   | -R&D Committee (and higher     |     |
|          |                   | authority) may strengthen      |     |
|          |                   | requirements and/or            |     |
|          |                   | conditions, or add other       |     |
|          |                   | modifications required to      |     |
|          |                   | secure approval.               |     |
|          |                   |                                |     |
|          |                   | -such changes/modifications    |     |
|          |                   | re-approved by IRB before      |     |
|          |                   | initiation                     |     |
+----------+-------------------+--------------------------------+-----+
| \*\*VHA  | IRB approved      | IRB approved consent form has  | IRB |
| Handbook | consent form sent | stamped approval/date of       |     |
| 1200.5,  | to PI             | approval on each sheet         |     |
| #7.a(4)  |                   |                                |     |
+----------+-------------------+--------------------------------+-----+
| \*\*VHA  | R&D decides on    | Approval or disapproval of     | R&D |
| Handbook | research project  | proposed research activity     |     |
| 1200.5,  |                   |                                |     |
| #7.b     |                   | -may need modifications before |     |
|          |                   | R&D approval                   |     |
+----------+-------------------+--------------------------------+-----+
| \*\*VHA  | Initiate research | -has IRB approval (date of     | inv |
| Handbook | project           | continuing review)             | est |
| 1200.5,  |                   |                                | iga |
| #7.b &   |                   | -has R&D approval              | tor |
| 14.c     |                   |                                |     |
|          |                   | -VA Form 10-1223 submitted to  |     |
|          |                   | Pharmacy service               |     |
|          |                   |                                |     |
|          |                   | -VA Form 10-9012 as applicable |     |
+----------+-------------------+--------------------------------+-----+
| \*\*VHA  | Other             | Initial and continuing IRB     | Inv |
| Handbook | investigator      | review and approval            | est |
| 1200.5,  | activities        |                                | iga |
| #10.h    |                   | -knows date of continuing      | tor |
|          |                   | review                         |     |
|          |                   |                                |     |
|          |                   | -aware that project            |     |
|          |                   | automatically suspended when   |     |
|          |                   | continuing review does not     |     |
|          |                   | occur on schedule              |     |
|          |                   |                                |     |
|          |                   | Requests for modifications to  |     |
|          |                   | protocol to IRB                |     |
+----------+-------------------+--------------------------------+-----+
| \*38 CFR | Determines        | Interval for conducting        | Not |
| 1        | interval when     | continuing review (appropriate | spe |
| 6.109(e) | continuing review | to degree of risk, but not     | cif |
| \[45 CFR | of research       | less than once a year)         | ied |
| 46       | project must be   |                                |     |
| .109(e), | done              |                                |     |
| 21 CFR   |                   |                                |     |
| 56.      |                   |                                |     |
| 109(f)\] |                   |                                |     |
+----------+-------------------+--------------------------------+-----+
| \*\*VHA  | Monitor ongoing   | Report includes;               | IRB |
| Handbook | projects -        |                                |     |
| 1200.5.  | investigator      | \(a\) Brief summary of the     |     |
| #7.g     | progress report   | research methodology and       |     |
|          |                   | procedures;                    |     |
|          |                   |                                |     |
|          |                   | \(b\) Number of subjects       |     |
|          |                   | entered and withdrawn          |     |
|          |                   | (including the reason for      |     |
|          |                   | withdrawal)                    |     |
|          |                   |                                |     |
|          |                   | -for the review period         |     |
|          |                   |                                |     |
|          |                   | -since the inception of        |     |
|          |                   | research project;              |     |
|          |                   |                                |     |
|          |                   | \(c\) gender and minority      |     |
|          |                   | status of those entered into   |     |
|          |                   | the protocol;                  |     |
|          |                   |                                |     |
|          |                   | \(d\) Number of subjects       |     |
|          |                   | considered as members of       |     |
|          |                   | specific vulnerable            |     |
|          |                   | populations;                   |     |
|          |                   |                                |     |
|          |                   | \(e\) A copy of the proposal   |     |
|          |                   | and all approved amendments;   |     |
|          |                   |                                |     |
|          |                   | \(f\) A copy of the current    |     |
|          |                   | consent document for the IRB   |     |
|          |                   | to review;                     |     |
|          |                   |                                |     |
|          |                   | \(g\) A copy of current HIPAA  |     |
|          |                   | Authorization document, if     |     |
|          |                   | separate from informed         |     |
|          |                   | consent;                       |     |
|          |                   |                                |     |
|          |                   | \(h\) Information that may     |     |
|          |                   | impact on risk benefit ratio   |     |
|          |                   | such as AEs, unanticipated     |     |
|          |                   | problems, and complaints       |     |
|          |                   | regarding the research;        |     |
|          |                   |                                |     |
|          |                   | \(i\) Research findings to     |     |
|          |                   | date, if available;            |     |
|          |                   |                                |     |
|          |                   | \(j\) Summary of the DSMB or   |     |
|          |                   | DMC meetings (if applicable)   |     |
|          |                   | --or- findings based on        |     |
|          |                   | information collected by the   |     |
|          |                   | data and safety monitoring     |     |
|          |                   | plan submitted in the initial  |     |
|          |                   | proposal;                      |     |
|          |                   |                                |     |
|          |                   | \(k\) An assurance that all    |     |
|          |                   | SAEs and UAEs have been        |     |
|          |                   | reported as required; and      |     |
|          |                   |                                |     |
|          |                   | \(l\) New scientific findings  |     |
|          |                   | in the literature, or other    |     |
|          |                   | relevant findings, that may    |     |
|          |                   | impact on the research.        |     |
+----------+-------------------+--------------------------------+-----+
| \*38 CFR | Advise IRB        | Approval of research using an  | met |
| 1        | members of        | expedited review procedure     | hod |
| 6.110(c) | research          |                                | a   |
| \[45 CFR | proposal(s)       |                                | dop |
| 46       | approved using    |                                | ted |
| .110(c), | expedited review  |                                | by  |
| 21 CFR   | procedure(s)      |                                | IRB |
| 56.      |                   |                                |     |
| 110(c)\] |                   |                                |     |
+----------+-------------------+--------------------------------+-----+
| \*38 CFR | Determine if      | Research uses procedures that  | IRB |
| 1        | research meets    |                                |     |
| 6.111(a) | criteria for      | -are consistent with sound     |     |
| \[45 CFR | approval: (1)     | research design                |     |
| 46       | risks to subjects |                                |     |
| .111(a), | are minimized     | -do not unnecessarily expose   |     |
| 21 CFR   |                   | subjects to risk               |     |
| 56.      |                   |                                |     |
| 111(a)\] |                   | -whenever appropriate, are     |     |
|          |                   | already being performed on     |     |
|          |                   | subjects for diagnostic or     |     |
|          |                   | treatment purposes             |     |
+----------+-------------------+--------------------------------+-----+
| \*38 CFR | Determine if      | Risks reasonable in relation   | IRB |
| 1        | research meets    | to:                            |     |
| 6.111(a) | criteria for      |                                |     |
| \[45 CFR | approval: (2)     | -anticipated benefits, if any  |     |
| 46       | risks are         |                                |     |
| .111(a), | reasonable        | -importance of knowledge that  |     |
| 21 CFR   |                   | may reasonably be expected to  |     |
| 56.      |                   | result.                        |     |
| 111(a)\] |                   |                                |     |
+----------+-------------------+--------------------------------+-----+
| \*38 CFR | Determine if      | Take into account              | IRB |
| 1        | research meets    |                                |     |
| 6.111(a) | criteria for      | -purposes of the research      |     |
| \[45 CFR | approval: (3)     |                                |     |
| 46       | Selection of      | -setting in which research     |     |
| .111(a), | subjects is       | will be conducted              |     |
| 21 CFR   | equitable:        |                                |     |
| 56.      |                   | -special problems if research  |     |
| 111(a)\] |                   | involves vulnerable            |     |
|          |                   | populations                    |     |
+----------+-------------------+--------------------------------+-----+
| \*38 CFR | Determine if      | Consent will be obtained in    | IRB |
| 1        | research meets    | accordance with, and to the    |     |
| 6.111(a) | criteria for      | extent required by the         |     |
| \[45 CFR | approval: (4)     | regulations                    |     |
| 46       | Informed consent  |                                |     |
| .111(a), | sought from each  |                                |     |
| 21 CFR   | prospective       |                                |     |
| 56.      | subject (or       |                                |     |
| 111(a)\] | legally           |                                |     |
|          | authorized        |                                |     |
|          | representative)   |                                |     |
+----------+-------------------+--------------------------------+-----+
| \*38 CFR | Determine if      | Consent will be documented in  | IRB |
| 1        | research meets    | accordance with, and to the    |     |
| 6.111(a) | criteria for      | extent required by the         |     |
| \[45 CFR | approval: (5)     | regulations (see 38 CFR 16.116 |     |
| 46       | Informed consent  | and 117)                       |     |
| .111(a), | will be           |                                |     |
| 21 CFR   | appropriately     |                                |     |
| 56.      | documented        |                                |     |
| 111(a)\] |                   |                                |     |
+----------+-------------------+--------------------------------+-----+
| 38 CFR   | Determine if      | Adequate monitoring of subject | IRB |
| 1        | research meets    | safety in research             |     |
| 6.111(a) | criteria for      |                                |     |
| \[45 CFR | approval: (6)     | **[VHA additional              |     |
| 46       | research plan     | documentation]{.underline}**   |     |
| .111(a), | makes adequate    |                                |     |
| 21 CFR   | provision to      | -review data/safety monitoring |     |
| 56.1     | monitor data to   | plan in investigator-developed |     |
| 11(a)\], | ensure subject    | protocol                       |     |
|          | safety of (if     |                                |     |
| VHA      | applicable)       | -for studies without DSMB/DMC, |     |
| Handbook |                   | review data/safety monitoring  |     |
| 1200.5,  | **[VHA additional | plan (including AE reporting)  |     |
| #10.b &  | activiti          | for studies that are blinded,  |     |
| 7.a(5)   | es]{.underline}** | have multiple sites, involve   |     |
|          |                   | vulnerable populations, or     |     |
|          | focused review of | employ high-risk interventions |     |
|          | data/safety       |                                |     |
|          | monitoring plan   |                                |     |
+----------+-------------------+--------------------------------+-----+
| 38 CFR   | Determine if      | If appropriate, the research   | IRB |
| 1        | research meets    | contains adequate provisions   |     |
| 6.111(a) | criteria for      | for privacy and                |     |
| \[45 CFR | approval: (7)     | confidentiality                |     |
| 46       | there are         |                                |     |
| .111(a), | adequate          | -why such provisions are       |     |
| 21 CFR   | provisions to     | necessary                      |     |
| 56.1     | protect subject   |                                |     |
| 11(a)\], | privacy and       | -research plan has such        |     |
|          | maintain data     | provisions                     |     |
| VHA      | confidentiality   |                                |     |
| Handbook | (if appropriate)  | -provisions are adequate       |     |
| 1200.5,  |                   |                                |     |
| #7.a(7)  | **[VHA additional | **[VHA additional              |     |
|          | activiti          | documentation]{.underline}**   |     |
|          | es]{.underline}** |                                |     |
|          |                   | consideration of HIPAA, 45 CFR |     |
|          | additional        | Parts 160 and 164, and other   |     |
|          | considerations    | laws regarding protection/use  |     |
|          | related to HIPAA, | of veterans' information,      |     |
|          | and special laws  | including Privacy Act of 1974, |     |
|          | related to        | 5 U.S.C. 552a; VA Claims       |     |
|          | protection/use of | Confidentiality Statute, 38    |     |
|          | veterans'         | U.S.C. 5701; Confidentiality   |     |
|          | information       | of Drug Abuse, Alcoholism and  |     |
|          |                   | Alcohol Abuse, Infection with  |     |
|          |                   | Human Immunodeficiency Virus   |     |
|          |                   | (HIV), Sickle Cell Anemia      |     |
|          |                   | Medical Records, 38 USC 7332;  |     |
|          |                   | and Confidentiality of         |     |
|          |                   | Healthcare Quality Assurance   |     |
|          |                   | Review Records, 38 USC 5705    |     |
+----------+-------------------+--------------------------------+-----+
| 38 CFR   | Determines        | Additional safeguards included | IRB |
| 1        | research involves | in the study to protect rights |     |
| 6.111(b) | subjects likely   | and welfare of vulnerable      |     |
| \[45 CFR | to be vulnerable  | subjects                       |     |
| 46       | to coercion or    |                                |     |
| .111(b), | undue influence   | **[VHA additional              |     |
| 21 CFR   |                   | documentation]{.underline}**   |     |
| 56.1     | **[VHA additional |                                |     |
| 11(b)\], | activiti          | -when including pregnant       |     |
|          | es]{.underline}** | women, show all determinations |     |
| VHA      |                   | found in 1200.5, Appendix D,   |     |
| Handbook | -ensuring         | #4 are met                     |     |
| 1200.5,  | research          |                                |     |
| Appendix | involving         | -when involving mentally       |     |
| D        | participation of  | disabled/impaired decision     |     |
|          | pregnant women as | making capacity, make sure the |     |
|          | subjects meets    | following requirements from    |     |
|          | specific          | 1200.5, Appendix D, #6 are met |     |
|          | requirements      |                                |     |
|          |                   | \- IRB membership includes at  |     |
|          | -ensuring         | least one expert in the area   |     |
|          | research          | of research (may use *ad hoc*  |     |
|          | involving         | member(s) as necessary)        |     |
|          | mentally          |                                |     |
|          | disabled/impaired | \- specific determinations     |     |
|          | decision making   | must be assessed, met and      |     |
|          | capacity meets    | documented in writing (see     |     |
|          | specific          | 1200.5, Appendix D #6)         |     |
|          | requirements      |                                |     |
+----------+-------------------+--------------------------------+-----+
| \*\*VHA  | Determine PI (all | Show PI (and other             | IRB |
| Handbook | other             | investigators)                 |     |
| 1200.5,  | investigators in  |                                |     |
| #7.a(10) | proposed          | -meet all current educational  |     |
|          | research) have    | requirements for the           |     |
|          | met education and | protection of human research   |     |
|          | other             | subjects as mandated by        |     |
|          | requirements      | facility's Assurance, VA ORD,  |     |
|          |                   | funding institutions, and      |     |
|          |                   | applicable OHRP requirements   |     |
|          |                   |                                |     |
|          |                   | -are qualified through         |     |
|          |                   | education, training, and       |     |
|          |                   | experience to do the research  |     |
+----------+-------------------+--------------------------------+-----+
| \*\*VHA  | IRB               | Notification to investigator   | IRB |
| Handbook | conducts/receives | of findings that require       |     |
| 1200.5,  | report on         | changes                        |     |
| #7.c(4)  | internal audit of |                                |     |
|          | investigator's    |                                |     |
|          | research files    |                                |     |
+----------+-------------------+--------------------------------+-----+
| \*38 CFR | Suspend or        | Reason(s) to suspend or        | IRB |
| 16.113   | terminate         | terminate approval of research |     |
| \[45 CFR | approval of       |                                |     |
| 46.113,  | research project  | -not being conducted in        |     |
| 21 CFR   |                   | accordance with IRB\'s         |     |
| 56.113\] |                   | requirements                   |     |
|          |                   |                                |     |
|          |                   | -associated with unexpected    |     |
|          |                   | serious harm to subjects       |     |
+----------+-------------------+--------------------------------+-----+
| 38 CFR   | Documentation of  | Research records               | In  |
| 1        | IRB activities    |                                | sti |
| 6.115(a) | (records)         | -copies of all research        | tut |
| \[45 CFR |                   | proposals reviewed             | ion |
| 46       | \(1\) Information |                                | or  |
| .115(a), | related to        | -scientific evaluations, if    | IRB |
| 21 CFR   | research proposal | any, accompanying proposals    |     |
| 56.1     |                   |                                |     |
| 15(a)\], | **[VHA additional | -approved sample consent       |     |
|          | activiti          | documents                      |     |
| VHA      | es]{.underline}** |                                |     |
| Handbook |                   | -progress reports submitted by |     |
| 1200.5,  | additional        | investigators                  |     |
| #7.i     | documentation     |                                |     |
|          | requirements      | -reports of injuries to        |     |
|          |                   | subjects                       |     |
|          | -copies of all    |                                |     |
|          | items reviewed    | **[VHA additional              |     |
|          |                   | documentation]{.underline}**   |     |
|          | -continuing       |                                |     |
|          | review activities | required records including     |     |
|          |                   | [but not limited               |     |
|          |                   | to]{.underline}                |     |
|          |                   |                                |     |
|          |                   | -Investigator Brochures        |     |
|          |                   |                                |     |
|          |                   | -recruitment materials         |     |
|          |                   |                                |     |
|          |                   | \- approved HIPAA              |     |
|          |                   | Authorization document (if     |     |
|          |                   | separate from informed         |     |
|          |                   | consent)                       |     |
|          |                   |                                |     |
|          |                   | -any proposed amendments and   |     |
|          |                   | IRB action on each             |     |
|          |                   |                                |     |
|          |                   | -serious and unexpected        |     |
|          |                   | adverse events                 |     |
|          |                   |                                |     |
|          |                   | -documentation of protocol     |     |
|          |                   | violations                     |     |
|          |                   |                                |     |
|          |                   | -documentation of              |     |
|          |                   | non-compliance with applicable |     |
|          |                   | regulations                    |     |
|          |                   |                                |     |
|          |                   | -documentation related to      |     |
|          |                   | continuing review(s)           |     |
+----------+-------------------+--------------------------------+-----+
| 38 CFR   | Documentation of  | C+ontents of minutes           | In  |
| 1        | IRB activities    |                                | sti |
| 6.115(a) | (records)         | -attendance at meetings        | tut |
| \[45 CFR |                   |                                | ion |
| 46       | \(2\) Minutes of  | -actions taken by IRB          | or  |
| .115(a), | IRB meetings      |                                | IRB |
| 21 CFR   |                   | -vote on IRB actions (number   |     |
| 56.1     | **[VHA additional | voting for, against,           |     |
| 15(a)\], | activiti          | abstaining)                    |     |
|          | es]{.underline}** |                                |     |
| VHA      |                   | -basis for requiring changes   |     |
| Handbook | make sure minutes | in or disapproving research    |     |
| 1200.5,  | contain           |                                |     |
| #7.i     | additional items  | -summary of discussion of      |     |
|          |                   | controverted issues and their  |     |
|          |                   | resolution                     |     |
|          |                   |                                |     |
|          |                   | **[VHA additional              |     |
|          |                   | documentation]{.underline}**   |     |
|          |                   |                                |     |
|          |                   | -documentation of resolution   |     |
|          |                   | of controverted issues when it |     |
|          |                   | occurs                         |     |
|          |                   |                                |     |
|          |                   | -instances where alternate     |     |
|          |                   | member replaces primary and    |     |
|          |                   | for whom they are substituting |     |
|          |                   |                                |     |
|          |                   | -actions and justification for |     |
|          |                   | waiver of or alteration of     |     |
|          |                   | from/content of HIPAA          |     |
|          |                   | authorization, as required by  |     |
|          |                   | 45 CFR 164(i)(2)               |     |
|          |                   |                                |     |
|          |                   | -if including pregnant women   |     |
|          |                   | as subjects, show all          |     |
|          |                   | determinations listed in       |     |
|          |                   | 1200.5, Appendix D, #4 are met |     |
|          |                   |                                |     |
|          |                   | -when convened IRB approves    |     |
|          |                   | research contingent on         |     |
|          |                   | specific minor conditions,     |     |
|          |                   | approval by Chair, or          |     |
|          |                   | designee, documented in the    |     |
|          |                   | minutes of first IRB meeting   |     |
|          |                   | taking place after date of the |     |
|          |                   | approval                       |     |
|          |                   |                                |     |
|          |                   | -presence of quorum throughout |     |
|          |                   | meeting (including presence of |     |
|          |                   | member with primary concern in |     |
|          |                   | non-scientific area)           |     |
|          |                   |                                |     |
|          |                   | -attendance including those    |     |
|          |                   | members (or alternates)        |     |
|          |                   | participating through video or |     |
|          |                   | teleconference with            |     |
|          |                   | documentation that they        |     |
|          |                   |                                |     |
|          |                   | -received all pertinent        |     |
|          |                   | material before meeting        |     |
|          |                   |                                |     |
|          |                   | -were able to actively and     |     |
|          |                   | equally participate in all     |     |
|          |                   | discussions                    |     |
|          |                   |                                |     |
|          |                   | -documentation of the 4        |     |
|          |                   | required findings for          |     |
|          |                   | approving a consent procedure  |     |
|          |                   | that does not include or       |     |
|          |                   | alters some or all of the      |     |
|          |                   | required elements of informed  |     |
|          |                   | consent \[38 CFR 16.116(d)\]   |     |
|          |                   |                                |     |
|          |                   | -note indicating if IRB member |     |
|          |                   | has real/potential conflict of |     |
|          |                   | interest related to project    |     |
|          |                   | under review including         |     |
|          |                   | information related to         |     |
|          |                   |                                |     |
|          |                   | -IRB member not present during |     |
|          |                   | deliberations or voting        |     |
|          |                   |                                |     |
|          |                   | -quorum was maintained         |     |
|          |                   |                                |     |
|          |                   | --IF not documented elsewhere  |     |
|          |                   | in IRB records                 |     |
|          |                   |                                |     |
|          |                   | -review of additional          |     |
|          |                   | safeguards to protect          |     |
|          |                   | vulnerable populations if      |     |
|          |                   | entered as study subjects      |     |
|          |                   |                                |     |
|          |                   | -determination of the level of |     |
|          |                   | risk                           |     |
|          |                   |                                |     |
|          |                   | -IRB determination of          |     |
|          |                   | frequency of continuing review |     |
|          |                   | of each proposal               |     |
+----------+-------------------+--------------------------------+-----+
| \*\*VHA  | Procedures for    | -must be written/available for | IRB |
| Handbook | producing and     | review within 3 weeks of       |     |
| 1200.5,  | approving IRB     | meeting date                   |     |
| #7.i(2)  | minutes           |                                |     |
|          |                   | -once approved by members at a |     |
|          |                   | subsequent IRB meeting,        |     |
|          |                   | minutes must not be altered by |     |
|          |                   | anyone including a higher      |     |
|          |                   | authority                      |     |
+----------+-------------------+--------------------------------+-----+
| \*\*VHA  | Activities of R&D | R&D Committee must review and  | VHA |
| Handbook | Committee related | act upon                       | R&D |
| 1200.5,  | to IRB minutes    |                                | Com |
| #7.j(3)  | (for both VA and  | -all complete (non-redacted)   | mit |
|          | affiliate IRBs)   | IRB minutes submitted to them  | tee |
|          |                   |                                |     |
|          |                   | -copies maintained in facility |     |
|          |                   | research office                |     |
+----------+-------------------+--------------------------------+-----+
| 38 CFR   | Documentation of  | All written IRB-Investigator   | In  |
| 1        | IRB activities    | interaction                    | sti |
| 6.115(a) | (records)         |                                | tut |
| \[45 CFR |                   | **[VHA additional              | ion |
| 46       | \(4\) Copies of   | documentation]{.underline}**   | or  |
| .115(a), | all               |                                | IRB |
| 21 CFR   | IR                | all IRB-R&D interactions       |     |
| 56.      | B-investigator(s) |                                |     |
| 115(a)\] | correspondence    |                                |     |
|          |                   |                                |     |
| VHA      | **[VHA additional |                                |     |
| Handbook | activiti          |                                |     |
| 1200.5,  | es]{.underline}** |                                |     |
| #7.i(4)  |                   |                                |     |
|          | IRB and R&D       |                                |     |
|          | Committee         |                                |     |
|          | interactions      |                                |     |
+----------+-------------------+--------------------------------+-----+
| 38 CFR   | Documentation of  | -name                          | In  |
| 1        | IRB activities    |                                | sti |
| 6.115(a) | (records)         | -earned degrees                | tut |
| \[45 CFR |                   |                                | ion |
| 46       | \(5\) List of IRB | -representative capacity       | or  |
| .115(a), | members           |                                | IRB |
| 21 CFR   |                   | -experience (board             |     |
| 56.1     | **[VHA additional | certifications, licenses,      |     |
| 15(a)\], | activiti          | etc.)                          |     |
|          | es]{.underline}** |                                |     |
| VHA      |                   | -relationship between each     |     |
| Handbook | additional        | member and the institution     |     |
| 1200.5,  | information       |                                |     |
| #7.i(5)  | related to IRB    | **[VHA additional              |     |
|          | membership        | documentation)]{.underline}**  |     |
|          |                   |                                |     |
|          |                   | -IRB roster must identify      |     |
|          |                   | primary member(s) for whom     |     |
|          |                   | alternates substitute          |     |
|          |                   |                                |     |
|          |                   | -status as scientist           |     |
|          |                   |                                |     |
|          |                   | -voting status                 |     |
|          |                   |                                |     |
|          |                   | status as chairperson          |     |
|          |                   |                                |     |
|          |                   | -resume for each member needs  |     |
|          |                   | to be maintained               |     |
+----------+-------------------+--------------------------------+-----+
| \*38 CFR | documentation of  | Procedures for                 | In  |
| 1        | IRB activities    |                                | sti |
| 6.115(a) | (records)         | -conducting initial and        | tut |
| \[45 CFR |                   | continuing review of research  | ion |
| 46       | \(6\) Written     |                                | or  |
| .115(a), | procedures for    | -reporting IRB findings and    | IRB |
| 21 CFR   | IRB to follow for | actions to investigator and    |     |
| 56.      |                   | institution                    |     |
| 115(a)\] |                   |                                |     |
|          |                   | -determining which projects    |     |
|          |                   | require review more often than |     |
|          |                   | annually                       |     |
|          |                   |                                |     |
|          |                   | -determining projects verified |     |
|          |                   | from sources other than        |     |
|          |                   | investigators that no material |     |
|          |                   | changes occurred since         |     |
|          |                   | previous IRB review            |     |
|          |                   |                                |     |
|          |                   | -ensuring prompt reporting to  |     |
|          |                   | IRB of proposed changes in     |     |
|          |                   | research                       |     |
|          |                   |                                |     |
|          |                   | -ensuring that changes in      |     |
|          |                   | approved research not be       |     |
|          |                   | initiated without IRB review   |     |
|          |                   | /approval except when          |     |
|          |                   | necessary to eliminate         |     |
|          |                   | apparent immediate hazards to  |     |
|          |                   | subject                        |     |
|          |                   |                                |     |
|          |                   | -ensuring prompt reporting to  |     |
|          |                   | IRB, appropriate institutional |     |
|          |                   | officials, and                 |     |
|          |                   | Department/Agency head of      |     |
|          |                   |                                |     |
|          |                   | -any unanticipated problems    |     |
|          |                   | involving risks to subjects or |     |
|          |                   | others                         |     |
|          |                   |                                |     |
|          |                   | -any serious or continuing     |     |
|          |                   | noncompliance with this policy |     |
|          |                   | or IRB                         |     |
|          |                   | requirements/determinations    |     |
|          |                   |                                |     |
|          |                   | -any suspension or termination |     |
|          |                   | of IRB approval                |     |
+----------+-------------------+--------------------------------+-----+
| \*38 CFR | Documentation of  | -significant new findings (if  | In  |
| 1        | IRB activities    | any) developed during the      | sti |
| 6.115(a) | (records)         | course of research that may    | tut |
| \[45 CFR |                   | relate to subject willingness  | ion |
| 46       | \(7\) Statements  | to continue participation      | or  |
| .115(a), | of significant    |                                | IRB |
| 21 CFR   | new findings      |                                |     |
| 56.      | provided to       |                                |     |
| 115(a)\] | subjects          |                                |     |
+----------+-------------------+--------------------------------+-----+
| \*\*VHA  | Documentation of  | -written notification of       | In  |
| Handbook | IRB activities    | approval                       | sti |
| 1200.5,  | (records)         |                                | tut |
| #7.c(1)  |                   | -copy of the approved consent  | ion |
|          |                   | form with stamped approval and | or  |
|          |                   | date of the approval on each   | IRB |
|          |                   | sheet                          |     |
+----------+-------------------+--------------------------------+-----+
| \*\*VHA  | Determine if      | Necessary to protect subject's | IRB |
| Handbook | subject's medical | safety by indicating           |     |
| 1200.5,  | record must be    | participation in the study     |     |
| Appendix | flagged           |                                |     |
| C        |                   |                                |     |
+----------+-------------------+--------------------------------+-----+
| \*\*VHA  | Determine if      | -consent document consisting   | IRB |
| Handbook | there is a        | of VHA Form 10-1086, Research  |     |
| 1200.5,  |                   | Consent Form with all required |     |
| Appendix | -VHA Form         | elements completed             |     |
| C        | 10-1086, Research |                                |     |
|          | Consent Form      | -stamp with most recent        |     |
|          |                   | approval date is present on    |     |
|          | -stamp on each    | each page (if consent amended  |     |
|          | page of VHA       | during protocol approval       |     |
|          | 10-1086 showing   | period, the form bears the     |     |
|          | date of most      | amendment approval date)       |     |
|          | recent IRB        |                                |     |
|          | approval          |                                |     |
+----------+-------------------+--------------------------------+-----+
| \*38 CFR | Determine         | The consent document           | Not |
| 16.116   | submitted         |                                | spe |
| \[45 CFR | document meets    | -contains information in       | cif |
| 46.116,  | the general       | language understandable to     | ied |
| 21 CFR   | requirements for  | subject (or representative)    |     |
| 50.20\]  | informed consent  |                                |     |
|          |                   | -whether oral or written, does |     |
|          |                   | not contain any exculpatory    |     |
|          |                   | language through which subject |     |
|          |                   | (or representative)            |     |
|          |                   |                                |     |
|          |                   | -waives or appears to waive    |     |
|          |                   | any legal rights               |     |
|          |                   |                                |     |
|          |                   | -releases or appears to        |     |
|          |                   | release investigator, sponsor, |     |
|          |                   | institution or its agents from |     |
|          |                   | liability for negligence       |     |
+----------+-------------------+--------------------------------+-----+
| 38 CFR   | Determine         | The consent document contains  | Not |
| 1        | submitted         |                                | spe |
| 6.116(a) | document contains | \(1\) statement that           | cif |
| \[45 CFR | information       |                                | ied |
| 46       | required in       | -study involves research       |     |
| .116(a), | seeking informed  |                                |     |
| 21 CFR   | consent           | -explanation of purposes of    |     |
| 50.      |                   | the research                   |     |
| 25(a)\], | \(a\) basic       |                                |     |
|          | elements          | -expected duration of          |     |
| VHA      |                   | subject\'s participation       |     |
| Handbook | **[VHA additional |                                |     |
| 1200.5,  | activiti          | -description of procedures to  |     |
| Appendix | es]{.underline}** | be followed                    |     |
| C        |                   |                                |     |
|          | additional basic  | -identification of any         |     |
|          | elements in       | experimental procedures;       |     |
|          | consent document  |                                |     |
|          |                   | \(2\) description of any       |     |
|          |                   | reasonably foreseeable risks   |     |
|          |                   | or discomforts to subject;(s)  |     |
|          |                   |                                |     |
|          |                   | \(3\) description of any       |     |
|          |                   | benefits to subject or to      |     |
|          |                   | others reasonably be expected  |     |
|          |                   | from the research;             |     |
|          |                   |                                |     |
|          |                   | \(4\) disclosure of            |     |
|          |                   | appropriate alternative        |     |
|          |                   | procedures or courses of       |     |
|          |                   | treatment, if any, that might  |     |
|          |                   | be advantageous to subject;    |     |
|          |                   |                                |     |
|          |                   | \(5\) statement describing     |     |
|          |                   | extent, if any,                |     |
|          |                   | confidentiality of records     |     |
|          |                   | identifying subjects will be   |     |
|          |                   | maintained; \[and notes        |     |
|          |                   | possibility that Food and Drug |     |
|          |                   | Administration may inspect     |     |
|          |                   | records                        |     |
|          |                   |                                |     |
|          |                   | \(6\) for more than minimal    |     |
|          |                   | risk research, explanation if  |     |
|          |                   | any compensation and/or        |     |
|          |                   | medical treatments are         |     |
|          |                   | available if injury occurs     |     |
|          |                   | and, if so, what they consist  |     |
|          |                   | of, or where further           |     |
|          |                   | information may be obtained;   |     |
|          |                   |                                |     |
|          |                   | \(7\) explanation of whom to   |     |
|          |                   | contact for answers to         |     |
|          |                   | pertinent questions about the  |     |
|          |                   | research and research          |     |
|          |                   | subjects\' rights, and whom to |     |
|          |                   | contact if there is a          |     |
|          |                   | research-related injury to     |     |
|          |                   | subject                        |     |
|          |                   |                                |     |
|          |                   | \(8\) statement that           |     |
|          |                   | participation is voluntary,    |     |
|          |                   | refusal to participate will    |     |
|          |                   | involve no penalty or loss of  |     |
|          |                   | benefits to which subject is   |     |
|          |                   | otherwise entitled, and        |     |
|          |                   | subject may discontinue        |     |
|          |                   | participation at any time      |     |
|          |                   | without penalty or loss of     |     |
|          |                   | benefits to which subject is   |     |
|          |                   | otherwise entitled.            |     |
|          |                   |                                |     |
|          |                   | **[VHA additional              |     |
|          |                   | documentation]{.underline}**   |     |
|          |                   |                                |     |
|          |                   | -name of study and principal   |     |
|          |                   | investigator (PI)              |     |
|          |                   |                                |     |
|          |                   | -statement that                |     |
|          |                   | veteran-subject will not be    |     |
|          |                   | required to pay for care as    |     |
|          |                   | part of VA research (except    |     |
|          |                   | where co-payment may apply)    |     |
|          |                   |                                |     |
|          |                   | \- when insufficient numbers   |     |
|          |                   | of veterans to complete        |     |
|          |                   | research, such a clause also   |     |
|          |                   | applies to any non-veteran     |     |
|          |                   | subjects enrolled in           |     |
|          |                   | VA-approved research (1200.5   |     |
|          |                   | #16.b)                         |     |
+----------+-------------------+--------------------------------+-----+
| \*38 CFR | Determine         | When appropriate, one or more  | Not |
| 1        | submitted         | of the following elements of   | spe |
| 6.116(b) | document contains | information shall also be      | cif |
| \[45 CFR | information       | provided to each subject:      | ied |
| 46       | required in       |                                |     |
| .116(b), | seeking informed  | \(1\) a statement that the     |     |
| 21 CFR   | consent           | particular treatment or        |     |
| 50       |                   | procedure may involve risks to |     |
| .25(b)\] | \(b\) additional  | the subject (or to the embryo  |     |
|          | elements          | or fetus, if the subject is or |     |
|          |                   | may become pregnant) which are |     |
|          |                   | currently unforeseeable;       |     |
|          |                   |                                |     |
|          |                   | \(2\) anticipated              |     |
|          |                   | circumstances under which the  |     |
|          |                   | subject\'s participation may   |     |
|          |                   | be terminated by the           |     |
|          |                   | investigator without regard to |     |
|          |                   | the subject\'s consent;        |     |
|          |                   |                                |     |
|          |                   | \(3\) any additional costs to  |     |
|          |                   | the subject that may result    |     |
|          |                   | from participation in the      |     |
|          |                   | research;                      |     |
|          |                   |                                |     |
|          |                   | \(4\) the consequences of a    |     |
|          |                   | subject\'s decision to         |     |
|          |                   | withdraw from the research and |     |
|          |                   | procedures for orderly         |     |
|          |                   | termination of participation   |     |
|          |                   | by the subject;                |     |
|          |                   |                                |     |
|          |                   | \(5\) A statement that         |     |
|          |                   | significant new findings       |     |
|          |                   | developed during the course of |     |
|          |                   | the research which may relate  |     |
|          |                   | to the subject\'s willingness  |     |
|          |                   | to continue participation will |     |
|          |                   | be provided to the subject;    |     |
|          |                   | and                            |     |
|          |                   |                                |     |
|          |                   | \(6\) the approximate number   |     |
|          |                   | of subjects involved in the    |     |
|          |                   | study.                         |     |
+----------+-------------------+--------------------------------+-----+
| \*\*VHA  | Required language | Required HIPAA language in     | IRB |
| Handbook | for valid HIPAA   | consent document               |     |
| 1200.5,  | authorization     |                                |     |
| Appendix | included in       |                                |     |
| C        | consent document  |                                |     |
+----------+-------------------+--------------------------------+-----+
| \*\*VHA  | Decide on HIPAA   | Waiver of authorization or     | IRB |
| Handbook | authorization     | alteration of from/contend     |     |
| 1200.5,  |                   | done in compliance with HIPAA  |     |
| Appendix | -waiving          | Privacy Rule (45 CFR 164.508)  |     |
| E        | requirement       |                                |     |
|          |                   |                                |     |
|          | -alter            |                                |     |
|          | form/content of   |                                |     |
|          | HIPAA             |                                |     |
|          | authorization     |                                |     |
+----------+-------------------+--------------------------------+-----+
| 38 CFR   | Document consent  | Place for signature/date of    | IRB |
| 1        | with consent form | subject (legally authorized    |     |
| 6.117(a) | signed & dated by | representative)                |     |
| \[45 CFR |                   |                                |     |
| 46       | -subject (legally | **[VHA additional              |     |
| .117(a), | authorized        | documentation]{.underline}**   |     |
| 21 CFR   | representative)   |                                |     |
| 50.      |                   | place for signature/date of    |     |
| 27(a),   | **[VHA additional |                                |     |
|          | activiti          | -witness to signature          |     |
| VHA      | es]{.underline}** |                                |     |
| Handbook |                   | -person obtaining consent      |     |
| 1200.5,  | -witness          |                                |     |
| Appendix | (witnessed        |                                |     |
| C        | signature) to     |                                |     |
|          | sign/date         |                                |     |
|          |                   |                                |     |
|          | -person obtaining |                                |     |
|          | consent           |                                |     |
+----------+-------------------+--------------------------------+-----+
| \*38 CFR | Short form        | IRB approval of written        | IRB |
| 16.1     | written consent   | summary of what is to be said  |     |
| 17(b)(2) | document will be  | to the subject or the          |     |
| \[45 CFR | used in research  | representative                 |     |
| 46.11    | study             |                                |     |
| 7(b)(2), |                   |                                |     |
| 21 CFR   |                   |                                |     |
| 50       |                   |                                |     |
| .27(b)\] |                   |                                |     |
+----------+-------------------+--------------------------------+-----+
| \*38 CFR | IRB decides on    | Approval only if IRB finds and | IRB |
| 1        | resea             | documents that:                |     |
| 6.116(c) | rch/demonstration |                                |     |
| \[45 CFR | project consent   | \(1\) research/demonstration   |     |
| 46.      | procedure that    | project is conducted by or     |     |
| 116(c)\] |                   | subject to approval of state   |     |
|          | -does not include | or local government officials  |     |
|          | or alters some or | and is designed to study,      |     |
|          | all of informed   | evaluate, or otherwise         |     |
|          | consent elements  | examine:                       |     |
|          |                   |                                |     |
|          | \- waives         | \(i\) public benefit or        |     |
|          | requirement to    | service programs               |     |
|          | obtain informed   |                                |     |
|          | consent           | \(ii\) procedures for          |     |
|          |                   | obtaining benefits or services |     |
|          |                   | under those programs           |     |
|          |                   |                                |     |
|          |                   | \(iii\) possible changes       |     |
|          |                   | in/alternatives to those       |     |
|          |                   | programs or procedures         |     |
|          |                   |                                |     |
|          |                   | \(iv\) possible changes in     |     |
|          |                   | methods or levels of payment   |     |
|          |                   | for benefits or services under |     |
|          |                   | those programs                 |     |
|          |                   |                                |     |
|          |                   | \(2\) research could not       |     |
|          |                   | practicably be carried out     |     |
|          |                   | without waiver/alteration.     |     |
+----------+-------------------+--------------------------------+-----+
| \*38 CFR | IRB decides on    | Approval only if IRB finds and | IRB |
| 1        | consent procedure | documents that:                |     |
| 6.116(d) | that does not     |                                |     |
| \[45 CFR | include or        | \(1\) research involves no     |     |
| 46.      | alters, some or   | more than minimal risk to      |     |
| 116(d)\] | all of elements   | subjects;                      |     |
|          | of informed       |                                |     |
|          | consent, or       | \(2\) the waiver or alteration |     |
|          | waives            | will not adversely affect the  |     |
|          | requirements to   | rights and welfare of          |     |
|          | obtain informed   | subjects;                      |     |
|          | consent           |                                |     |
|          |                   | \(3\) research could not       |     |
|          |                   | practicably be carried out     |     |
|          |                   | without waiver/alteration      |     |
|          |                   |                                |     |
|          |                   | \(4\) whenever appropriate,    |     |
|          |                   | subjects will be provided with |     |
|          |                   | additional pertinent           |     |
|          |                   | information after              |     |
|          |                   | participation.                 |     |
|          |                   |                                |     |
|          |                   | **[VHA additional              |     |
|          |                   | documentation]{.underline}**   |     |
|          |                   |                                |     |
|          |                   | -documentation of 4 findings   |     |
|          |                   | recorded in meeting minutes    |     |
+----------+-------------------+--------------------------------+-----+
| \*38 CFR | IRB decides to    | IRB finds 1 of 2 possible      | IRB |
| 1        | waive requirement | situations                     |     |
| 6.117(c) | that investigator |                                |     |
| (45 CFR  | obtain signed     | \(1\) the only record linking  |     |
| 46.      | consent form for  | subject and research would be  |     |
| 117(c)\] | some or all       | the consent -principal risk    |     |
|          | subjects          | would be potential harm        |     |
|          |                   | resulting from a breach of     |     |
|          |                   | confidentiality                |     |
|          |                   |                                |     |
|          |                   | -each subject to be asked if   |     |
|          |                   | they want documentation        |     |
|          |                   | linking the them with the      |     |
|          |                   | research - the subject\'s      |     |
|          |                   | wishes govern                  |     |
|          |                   |                                |     |
|          |                   | \(2\) research presents        |     |
|          |                   |                                |     |
|          |                   | -no more than minimal risk of  |     |
|          |                   | harm to subjects               |     |
|          |                   |                                |     |
|          |                   | -involves no procedures for    |     |
|          |                   | which written consent is       |     |
|          |                   | normally required outside of   |     |
|          |                   | research context.              |     |
+----------+-------------------+--------------------------------+-----+
| \*38 CFR | Where             | Where documentation            | IRB |
| 1        | documentation is  | requirement waived, IRB may    |     |
| 6.117(c) | waived, IRB       | require investigator provide   |     |
| (45 CFR  | requires          | subjects with a written        |     |
| 46.      | investigator to   | statement regarding the        |     |
| 117(c)\] | provide written   | research                       |     |
|          | statement about   |                                |     |
|          | research to       |                                |     |
|          | subjects          |                                |     |
+----------+-------------------+--------------------------------+-----+
| \*21 CFR | Use of test       | Both investigator and          | Inv |
| 50.23    | article without   | physician not otherwise        | est |
|          | consent           | participating in clinical      | iga |
|          |                   | investigation certify in       | tor |
|          | \(a\) emergency   | writing all the following:     |     |
|          | use of test       |                                |     |
|          | article without   | \(1\) life-threatening         |     |
|          | informed consent  | situation necessitating use of |     |
|          | but with          | test article                   |     |
|          | certification of  |                                |     |
|          | specific criteria | \(2\) cannot get informed from |     |
|          | before use of     | subject because of an          |     |
|          | test article      | inability to communicate with  |     |
|          |                   | or obtain legally effective    |     |
|          | \(b\) emergency   | consent from them              |     |
|          | use of test       |                                |     |
|          | article without   | \(3\) time not sufficient to   |     |
|          | informed consent  | obtain consent from the        |     |
|          | and certification | subject's legal                |     |
|          | of specific       | representative.                |     |
|          | criteria before   |                                |     |
|          | use of test       | \(4\) no alternative method of |     |
|          | article           | approved or generally          |     |
|          |                   | recognized therapy providing   |     |
|          | \(c\) reporting   | equal or greater likelihood of |     |
|          | emergency use     | saving subject's life.         |     |
|          | without consent   |                                |     |
|          | to IRB            | -If time not sufficient to     |     |
|          |                   | obtain required certifications |     |
|          |                   | in advance, within 5 working   |     |
|          |                   | days after use of test         |     |
|          |                   | article, investigator will     |     |
|          |                   | make required determinations   |     |
|          |                   | which are then reviewed and    |     |
|          |                   | evaluated in writing by        |     |
|          |                   | physician not participating in |     |
|          |                   | clinical investigation.        |     |
|          |                   |                                |     |
|          |                   | -written certification in (a)  |     |
|          |                   | and (b) above submitted to the |     |
|          |                   | IRB within 5 working days      |     |
|          |                   | after use of test article.     |     |
+----------+-------------------+--------------------------------+-----+
| \*21 CFR | Emergency use of  | Emergency use reported to IRB  | Not |
| 5        | a test article    | within 5 working days          | spe |
| 6.104(c) | without prior IRB |                                | cif |
|          | approval          |                                | ied |
+----------+-------------------+--------------------------------+-----+