Full Board Modification Review Checklist



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University of Virginia IRB for Health Sciences Research

Full Board Modification Review Checklist



IRB-HSR Study #:       Reviewer:      

Principal Investigator:       Sponsor:      


Date of Meeting:      
______________________________________________________________________
IT IS VERY IMPORTANT THAT ALL SECTIONS OF THIS DOCUMENT ARE FILLED OUT IN ORDER TO COMPLY WITH FEDERAL REGULATIONS.
_________________________________________________________________________
Reviewer's Oral Presentation
The reviewer should state the following during their oral presentation to the IRB. Planned responses need to also be written below.


  1. Background

What does the modification involve in 2-3 sentences?

.

     


Does the modification change the target group  YES  NO

If yes, state if this is an appropriate group for this study.      

Points to Consider:

Is selection of subjects equitable in relation to the purposes of the research and the setting in which the research will be conducted?

Are inclusion/exclusion criteria appropriate?


If yes, add your thoughts here about the potential usefulness of the protocol to present and future patients in the newly targeted group.      


  1. Vulnerable Populations

    • Does the modification add any subjects likely to be vulnerable to coercion or undue influence?  YES  NO




      • If Yes, Which ones?      


 YES  NO Children

 YES  NO Pregnant Women, Fetuses, Neonates

 YES  NO Prisoners

 YES  NO Cognitively Impaired


  • What additional safeguards are in place to protect vulnerable populations from undue influence?

COMPLETE the applicable checklist from the list below to determine additional safeguards needed.


      • Children

      • Pregnant Women, Fetuses, Neonates

      • Prisoners

      • Cognitively Impaired




  • Are the additional safeguards adequate?  YES  NO

      • If no, what additional safeguards should be added?      

You may either type the additional safeguards or refer to items checked on vulnerable populations checklist.


  1. Regulatory Issues

Children

Does this modification add a request for inclusion of children?  YES  NO



      • If yes, answer the following :

Children: Part A: Parental Permission (Check one)

See vulnerable population checklist for Children for additional information

 One parent signature require

 Two parents signature required

Children: Part B: Assent of Child (Check one)

See vulnerable population checklist for Children for additional information

 Assent not required

 Assent required (If checked, check below the type of assent documentation to be used)

 Verbal Assent

 Written Assent
Surrogate Consent (One adult giving consent for another adult)


  • Does this modification add a request for surrogate consent?  YES  NO

      • If yes, answer the following :

Things to consider:


  • Is it clear that individuals cannot give informed consent for themselves?

  • where appropriate, have animal and other pre-clinical studies been conducted which suggest a potential for therapeutic benefit?

  • Has standard wording been added to consent?

(Check one)

 Surrogate consent approved

 Surrogate consent not approved
Drugs/IND

Does this modification now involve research on a drug, biologic, supplement or food additive?  YES  NO

If yes, do the following criteria from 21CFR312.2 apply?


 YES  NO

The investigation is intended to be reported to FDA as a well-controlled study in support of a new indication for use or intended to be used to support any other significant change in the labeling for the drug;

 YES  NO

If the drug that is undergoing investigation is lawfully marketed as a prescription drug product, the investigation is intended to support a significant change in the advertising for the product;


 YES  NO

The investigation does involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product.

IRB Guidance

If any of the criteria listed above are answered Yes, an IND # from the FDA is required.

Withhold approval to enroll subjects until IND # is received.




Devices /IDE

Does this modification add research on a device?  YES  NO



      • If yes, answer the following :

 Exempt from IDE regulations

According to 21CFR812.2 (b)(3) a diagnostic device is considered to be exempt if it:

  1. Is non-invasive

  2. Does not require an invasive sampling procedure that presents significant risk

  3. Does not by design or intention introduce energy into a subject, and

  4. Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure.

Additional exempt criteria may be found in 21CFR812.2(c )
 NOT Exempt from IDE regulations: check one below:

 Significant Risk: if SR- requires IDE from FDA.

 Non-significant Risk

According to 21CFR812.3(m) a Significant Risk (SR) device study is one that presents a potential for serious risk to the health, safety, or welfare of a subject and


  • is intended as an implant; or

  • is used in supporting or sustaining human life; or

  • is for use of substantial importance in diagnosing, curing, mitigating or treating disease, or otherwise prevents impairment of human health; or

  • otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

Note: If the participant must undergo a procedure as part of the investigational study, e.g., a surgical procedure to implant the device, the IRB-HSR must consider the potential harm that could be caused by the procedure in addition to the potential harm caused by the device.
Specimen Banking?

  • Does this modification add specimen banking?  YES  NO

Genetic Research?



  • Does this modification add genetic research?  YES  NO


  1. With the incorporation of this modification, does the protocol continue to meet the approval criteria?




  1. Does the study meet the criteria for IRB Approval per Federal Regulations? (45CFR46.116/21CFR56.111)

Use “Points to Consider” starting on next page to assist in addressing the criteria below.

THESE POINTS MUST BE DISCUSSED DURING THE ORAL PRESENTATION AT THE IRB MEETING.

YES

NO

NA

  1. Risks to participants are minimized by using procedures which are consistent with sound research design and do not unnecessarily expose participants to risk AND

whenever appropriate, that are already being performed for diagnostic or treatment procedures.







  1. Risks to participants are reasonable in relation to anticipated benefits to participants directly or society in knowledge that may be expected to result.

Check One:

☐Potential benefit to subjects ☐No potential benefit to subjects ☐societal benefit










  1. Selection of subjects is equitable, taking into account the purposes of the research, the setting in which the research will be conducted, the special problems of research involving vulnerable populations, the selection criteria and the recruitment process.









  1. Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by the regulations and the applicable elements of the consent form are included.








  1. Informed consent will be appropriately documented per 45CFR46.117.










  1. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of participants.








  1. When appropriate, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data AND when some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards are included in the study to protect the rights and welfare of these participants.







Comments:      











If any of the questions above are answered NO, the protocol cannot be approved.



  1. State your Motion:


 Approve modification

 Approved modification pending minor modifications and review by IRB-HSR Staff and Chair or designee

PI will need to submit one copy revised protocol and two copies of revised consent, final approval will be given by IRB-HSR Chair after modifications have been made. Examples of items which are considered minor: grammatical, spelling errors, template issues, providing investigator specific wording to insert
 Approved modification pending minor modifications and review by scientific reviewer, IRB-HSR Staff and Chair or designee.

Examples of items which are considered minor include grammatical or spelling errors, template issues, asking for a section of the consent to be rewritten at a lower reading level. .
 Withhold approval pending major modifications

PI will need to re-submit the protocol and consent at future IRB-HSR Meeting.

PI may be asked to attend future meeting to answer questions.

Examples of items which are considered major:

  • the investigator has not answered all the questions in the protocol

  • investigator has not provided adequate background information including previous animal/ human data,

  • procedures to be done are unclear- making it impossible to determine risk level.


 Rejected.

The investigator may attend a future IRB-HSR meeting to defend the modification if he/she wishes to pursue the study.
 Tabled-

Review of the modification delayed to a future meeting until additional information may be obtained. Protocol and consent forms do not need to be revised until after the next review. Principal Investigator may be asked to attend future meeting or provide additional information.



Please list any required modifications requested:

     

Please list any suggestions: Suggestions are items that do not affect the risk/ benefit analysis and are not required- but may make the protocol/ consent better.

     

_____________________________________________ ____________



Signed (Scientific Reviewer) Date


Version Date11/04/16 Page of



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