Reviewer Checklist for eIRB

Pre-review Content Checklist


Review Process

1.0 General Information

* Please Enter the full title of your study Does this protocol title match the project title on the USU Form 3208?
* Please enter the protocol number you would like to reference the protocol Identifier for the protocol to the team primarily (no review)
Does this protocol involve the use of animals? yes or no review

2. 0 Add sites

2.1 List sites associated with this study:

Are all sites listed here?  

Is the primary site correct? 

If USU is the primary site then we should be the primary review.


3.0  Assign project personnel access to the project

3.1  Please add a Principal Investigator for the study:
Has the PI been added here?
3.2  If applicable, please select the Research Staff personnel:

Are all study team members with EIRB accounts listed here and are they listed with their proper role? A) Investigators

B) Research Support

3.3  Please add a Protocol Contact:
PI should be listed here.  Other contacts do not need training and credentials and they will not have access to the protocol.
3.4  If applicable, please select the Designated Site Approval
Essentially this has been superceded by the Site Approver on the USU Form 3208

4.0  Project Information

4.1  Is this a research study?
Yes or no must be checked.  This is PI's interpretation.
4.2  What type of research is this?
PI's interpretation could effect what CITI training is uploaded
4.4  Is this human subject research…
PI's interpretation of what the project is.  
4.5 Do you believe this human subjects research is exempt from IRB review?
PI's interpretation whether project is exempt or not may help with reviewers determination if the points for exempt research determination are there.
4.6  Identify the category(ies) into which you believe your study falls:
Helps give an indication as to why PI feels the study is exempt.  Reviewer can look at PI's choice and use that as a basis for reviewing the protocol looking for these specific traits during the review.

5.0  Personnel Details

5.1  Will you have a Research Monitor for this study?
PI's determination as to if a Research Monitor (RM) is required.  If the PI feels that a RM is required they may put in a suggested candidate and what role they will serve.  Reviewer may use this to determine if candidate is appropriate for the study.

6.0  Data/Specimen

6.1  Does the study involve the use of existing data or specimens only (no interaction with human subjects)?

If answer is yes to this question, then question 6.2 will need an answer.

Also, do specimens disqualify from an exempt review?  (e.g. are they de-identified, already existing, when were they collected?)

6.2  Sample Characteristics
This should provide answers to questions in 6.1.
6.3 Eligibility Criteria
May help reviewer with determination
6.4  Will the team have access to identifiable information?
Will help reviewer with determination and deciding what additional documentation is required (HIPAA, ICD, other data sharing agreements)

7.0 Funding and Disclosures

7.1  Source of Funding
May assist reviewer with determination as well as reviewing site and what documentation is needed for the study [Grant, COI information, DSA]
7.2 Do you or any other Investigator have a disclosure of a personal interest or financial interest…
This Conflict of Interest (COI) statement should be covered in the COI for each investigator or team member but this may prompt a closer look at the COI's

8.0 Study Locations

8.1 List any Research Team members without EIRB access that are no previously entered in the protocol:
This is a key area where study team members who do not have an EIRB account will be entered along with their role in the protocol.   Reviewer will cross-reference here to make sure all team members have all required training and credentials uploaded into the submission
8.2 Has another IRB reviewed this study?
If answer is yes, it should key the reviewer to look at who reviewed this study.  If it was done at another DoD location then a duplicate review should not be conducted and that reviewing IRB should be the IRB of record unless otherwise agreed upon between the institutions.  This will also tell the reviewer that this is most likely an administrative review and what documentation they should look for.
8.3 Is this a collaborative or multi-site study?
Combined with the above answer will tell the reviewer what type of review should be conducted and what documentation they should look for from the collaborating institutions (IAIR's, letters of support, CRADA, MTA, DSA, and/or other documents)
8.4 Study Facilities and Locations
This will reinforce the above and allow for communications between the institutions if the reviewer has questions they need to address.  
8.5  Are there international sites?
This should key reviewer to look for documentation that is required for international studies including any agreements, IRB approvals, local laws and customs of the international site, etc)
8.6  Is this an OCONUS study?
Similar to 8.5 above however this could include Hawaii and other US posessions as well that would be covered by US statutes.  For international sites in particular permission to conduct that study will need to be attained prior to IRB approval.

9.0 Study Details

9.1 Abstract/ Summary
This section should include a summary of the study which the reviewer will use to help determine what type of determination should be done (Exempt, Expedited, Full board).  Depending on what the initial determination is and what is included in this summary this will determine how the rest of the protocol is reviewed.
9.2 Key words
Often not used by reviewer depending on what key words are here
9.3  Background and Significance
May help reviewer determine if the study should be conducted and what type of literature to look for.
9.4 Objectives/Specific Aims/Research Questions
This should be clear and concise and describe what the study is trying to accomplish.  Are the objectives in line with what is included in the other sections of the protocol?  If needed the reviewer should look back at the Scientific Review for this study to check for congruity.
9.5 Study Design
Reviewer should check to see if the plan is well laid out.  Overhead view of what study  is all about and is it a Pilot, Phase 1, FDA?  Depending on these answers additional documentation may be needed (ie an IND or an IDE for a FDA drug or device study)
9.6 Target Population
Check to see if this is who the study is geared to ultimately benefit not necessarilly who is in the study.
9.7 Benefit to the DoD
Is there a Benefit to the DoD?  Does this directly or indirectly effect the DoD?

10.0 Study Procedures and Data Management

10.1 Study Procedures
Reviewer should look for a step by step process of how the study will be done including the amount of time for each step in the process.   Is each step well laid out?  Is each step necessary for the study?
10.2 Data Collection
What data is being collected?  Is this data de-identified?  Is there a DSA or other agreement to use the data?   This information will help with the determination as well as what type of documentation is needed.
10.3 At any point in the study, will you request, use, or access PII from the MHS?
This will help with what types of agreements are needed and what type of determination will be given to this submission.
10.4 Have you consulted with an MHS data expert to determine the data elements to be extracted or the information systems to access?
Primarily a key that investigator should work with an MHS expert.
10.5 Indicate whether you plan to receive a data extract from the MHS or plan to access an information system directly to create a data set
This provides a key to what type of agreements are needed for the study.  Is it a de-identified data set which may be exempt or if it is access are all of the agreements in place DSA/DUA to have access to the data?
10.6  Do you intend to use only de-identified data from the MHS in your research study?
May provide help in determination of submission.  Possibly Exempt.
10.7  If you research study requires access to an MHS information system, please indicate the system to obtain data
Helps determine what type of an agreement reviewer should look for (DSA approval from DHA possibly)
10.8 Do you intend to merge or otherwise associate the requested data with data from any sources outside of the MHS, including other DoD systems that are not part of the MHS?
10.9 Indicate the categories of data that you will request from MHS systems or MHS health care providers about research participants or relatives, employers, or household members of the research participants
This section indicates to the reviewer if the study team is looking at or collecting PHI for the study.
10.10 Is it possible that the data will become identifiable because of triangulation, a small cell size, or any unique data element
Helps determine if data is truly de-identified and what are the consequences one way or the other.
10.11 HIPAA Privacy Rule and Use of Protected Health Information in Research
Helps reviewer to determine if PHI is being used what level of PHI is being used and if there is a need for waiver or other authorization.
10.12  Managing Data and/or Human Biological Specimens for this Study
The plan for acquiring, keeping, and destroying data and/or  specimens needs to be laid out here very specifically.  How will it be acquired including encryption techniques, where it will be kept both electronically and physically down to the room and locked filing cabinet and when and how it will be destroyed after the completion of the study.  Any agreements should also have this information and an SOP for repository may be needed.
10.13 Managing Data and/or Human Biological Specimens for Future Research
Simiiar to above 10.12 however this section just needs to include how it will be stored, used and destroyed in future studies.

11.0 Statistical/Data Analysis Plan

11.1 Statistical Considerations
11.2 Sample Size Estimation
11.3 Data Analysis Plan

12.0 Participation Information

12.1 Subject Population
12.2 Age Range
Helps determine if Assent is needed or other special considerations based on age
12.3 Gender
May trigger looking for special considerations such as pregnancy
12.4  Special Categories
Depending on the category special permissions, forms, or other stipulations may be required
12.5 Inclusion Criteria
should be addressed in most protocols 
12.6 Exclusion Criteria
should be addressed in most protocols 

13.0 Recruitment and Consent

13.1 Identification and Selection of Subjects
How are subjects being identified? Does HIPAA come into play? Is a HIPAA waiver needed?  Will and informed consent be used?
13.2 Recruitment Process
How are subjects being contacted?  Proactive?  If so are waivers in place for this?  Will flyers be used?  They will need to be IRB approved.  Scripts?  Need IRB approval.  Other media?  Need IRB approval.
13.3 Compensation for Participation
Will there be compensation for participation?  Is compensation coercive?  Are DoD compensation rules being followed for on-duty vs. off duty?
13.4  Eligibility Assessment Process
13.5 Consent Process
Is a waiver or alteration being requested?  What is the process?  Is Consent included in the submission?  In reviewing consent is HIPAA included?  Are all of the elements of consent included in the consent form?
13.6 DoDI 3216.02 requires an Ombudsman to be present during recruitment briefings…
If answer is Propose Ombudsman check for proper Citi training, CV.  Does Ombudsman provide an unbiased source for answers to the protocol questions.
13.7 Withdrawal from Study Participation
Withdrawal process should be discussed here and steps laid out on who to contact for withdrawal.

14.0 Risks and Benefits

14.1 Risks of Harm
Reviewer should make sure all risks (physical, mental, breach of confidentiality, etc) are addressed here.
14.2 Measures to Minimize Risks of Harm
Reviewer should make sure study team is doing everything possible to minimize the above mentioned risks
14.3 Confidentiality Protections
Researcher should make sure that confidentiality of records is addressed here.  This is different from Privacy but is often confuse with privacy.
14.4 Potential Benefits
Any direct benefits should be addressed here.  If there are no potential benefits that should also be listed here.
14.5 Privacy for Subjects
Researcher should make sure privacy issues are addressed here.  Privacy would involve how the subject is being handled directly both the recruitment and setting for the study.  Having an ombudsman would be one way to help protect the privacy of an individual.  
14.6 Incidental or Unexpected Findings
Researcher should address specifically how incidental or unexpected findings directly related to the study will be handled.  Will they inform the participant?  Will they inform the participants family or physician?

15.0  Study Monitoring

15.1 Data Monitoring Plan
This section should outline who data collection and dissemination will be monitored and how often it will be monitored to comply with what is specified in the study procedures.
15.2  Safety Monitoring Plan
How will the data be secured and monitored to assure that it is kept safe for the participant.
15.3  Does your study require independent data and safety monitoring?
If this question is answered yes there will be an additional dialog for the researcher to explain who and how the data and safety will be monitored.  In many cases if yes is the answer here a Data Safety Monitoring Board or similar committee will often be the principal group for making sure the data and the safety of the participants is periodically reviewed and if necessary actions are taken.  This section should also note what activities are being monitored and how often.

16.0 Reportable Events

16.1  Reportable Events
This section outlines what types of adverse events should and do not need to be reported.  If there are expected adverse events they should be noted here along with their frequency, severity, implications, and management of such events.  This section should also detail how unexpected adverse events will be reviewed and reported including what time frame, to whom, and a scale of severity.

17.0  Equipment/non-FDA Regulated Devices

17.1  Does the study involve the use of any unique non-medical devices/equipment
If the study is using any unique devices here they should check yes and then describe what the device is and how it will be used in the study.

18.0  FDA-Regulated Products

18.1 Will any drugs, dietary supplements, biologics, or devices be utilized in this study?
If one of these is chosen by check box additional fields will be opened up (18.2 for drugs, dietary supplements, and biologics)(18.3 for devices).  Additionally 18.4 will be opened up as well.
18.2  Drug Details
1 Checkbox asking if the drug is being used in accordance with approved labeling or another checkbox if it is being used other than it's approved labeling.   If a drug is being used the drug will show up in the table along with the name, whether it is FDA approved, or a new drug or a new use for an already approved drug and the IND number if applicable.  If the drug is not able to found in a searchable table by the researcher only 1 of the checkboxes will be checked with no other details about the drug.
18.3 Device Details
One (1) Checkbox asking if the device is being used in accordance with approved labeling or another checkbox if it is being used other than it's approved labeling.   If a device is being used the device will show up in the table along with the name, whether it is FDA approved, or a new device or a new use for an already approved device and the IDE number if applicable.  If the device is not able to be found in a searchable table by the researcher only 1 of the checkboxes will be checked and there will be no other details about the device.
18.4  Reporting Requirements for FDA-Regulated Research under IND and IDE:
The researcher should describe here the requirements for complying with the FDA for adverse event reporting of either the drug or device in the study.
18.5  Sponsor (organization/institution/company)
If there is a sponsor for the drug or device that information will be included here.  If there is no sponsor N/A will be checked.

19.0  Research Registration Requirements

19.1  Clinical Registration:
1 of the 3 checkboxes should be checked here whether the registration of the protocol is FDA pending, complete, or not required.  In general all FDA drug or device studies should be required to be listed on
19.2  Defense Technical Information Center (DTIC) Registration (Optional):
This is an optional site that the PI may choose to register their protocol.

20.0  References and Glossary

20.1  References:
The PI should list all articles and publications that have been referenced in developing this protocol.  These may or may not have been footnoted in other sections of the protocol application.
20.2  Abbreviations and Acronyms:
All abbreviations and Acronyms that have been used in this protocol submission should be defined here even if they were defined in other sections of the protocol.