This guide is divided into 3 parts:

Part 1: What is KC? Understanding the program itself, its structure and content

Part 2: Reviewing a protocol

Part 3: Preparing for a board meeting
Part 1: What is KC? .................................................................................................................................................................. 2
Logging In ............................................................................................................................................................................ 2
Upper Tabs - User Roles ...................................................................................................................................................... 3
Representation of a Protocol in KC ..................................................................................................................................... 3
Part 2: Reviewing a Protocol ................................................................................................................................................... 5
How do I find the correct electronic protocol to review? .................................................................................................. 5
How do I Review this Electronic Protocol Application? ...................................................................................................... 6
Overview of the Process ................................................................................................................................................. 6
Overview of Review Method 1........................................................................................................................................ 6
Overview of Review Method 2........................................................................................................................................ 6
Details of the Reading Process - Both Review Methods ................................................................................................ 7
Completing the Review in KC ............................................................................................................................................ 14
Review Method 1 Details: ............................................................................................................................................. 14
Review Method 2 Details: ............................................................................................................................................. 16
Part 3: Preparing for a Board Meeting .................................................................................................................................. 18
Search for the protocol by number................................................................................................................................... 18
APPENDIX A – Exempt and Expedited Categories Full Text .................................................................................................. 20
APPENDIX B – Reviewer Form Checklists .............................................................................................................................. 22
APPENDIX C – Paper Applications Translated ....................................................................................................................... 23
Appendix C.1 Biomedical Applications.............................................................................................................................. 23
Appendix C.2 Social, Behavioral and Educational Applications ........................................................................................ 25
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Symbol Guide
When you see a lightning bolt icon, this indicates a passage where terminology is explained.
When you see a star, this indicates a place to pay close attention, or a step not to be missed.
When you see a “no” sign, this means that you will be completing a final step or action and will not be able to return and modify anything after that step.
Kuali Coeus is the new research administration software that will unify and bring consistency to a new, all-inclusive research administration data resource. This common platform will enable transparency and consistency between the various units within the University’s research enterprise. KC is divided into units called modules. Almost all aspects of research will require some involvement in one or more modules in the KC system, from proposal development and award management to animal research. For the IRB and human research, KC will handle the entire IRB submission, approval and maintenance process. Additional aspects of KC that will be of interest to the IRB will be Conflict of Interest management and Contract Negotiation tracking. These modules will be implemented at a later time.
We have chosen to brand this product ORCA for brevity and ease of recall. ORCA stands for Online Research
Comprehensive Application.
KC uses your UTAD username and password. Simply navigate to https://myorca.utoledo.edu/kc/ and you will see a login screen. Enter your username and password and click the “Login” button.
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Across the top of the screen there are a set of “tabs” labeled “Researcher,”“Unit,” “Central Admin,” “Maintenance” and
“System Admin.” These describe the “types” or “roles” of people logging and will be referred to as Role Tabs. As reviewers, the functions you will need to perform are all located on the “Researcher” tab, which is the default start page when you log into KC.
Some Terminology in KC
KC refers to the entire collection of submitted information as the “Protocol,” not simply the narrative which describes the work and procedures. When the term “protocol” is used in this guide, it refers to the entire project.
Continuing Reviews are called “renewals”.
To navigate around a protocol you will need to understand the structural elements in addition to the data. A protocol is broken up into tabs, similar to the role tabs in the application. Depending on the resolution of your monitor, these tabs will adjust into a single or multiple lines. These are the parts of the protocol in KC.
Each tab will have different folders inside it. For example, the questionnaire tab contains many of the pieces of the old application and currently looks like this for one example protocol:
3

And finally, each folder has sections which are distinguished by a grey bar. As an example, each person listed on the protocol is a folder and inside are sections which vary depending on their role on the project. Here is an example of sections for a specific person folder on the personnel tab. The sections of this folder are “Person
Details,” “Contact Information,” “Attachments” and “Unit Detail”
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In order to find which protocols you have been assigned to review you have two options.
Option 1. Click on “Action List” in the upper left corner of the page. You can use the sort or the filter to organize or limit the list to just the items of type “KC Protocol Review.” These items are the protocols you need to review. Click on the ID link to open the protocol in a new window.
Option 2. You can also use the “All My Reviews” shortcut. The shortcut is found on the “Researcher” page. At the top of the middle column is a section pertaining to IRB Protocols which looks like the following:
The “All My Reviews” link is second from the bottom. Click this link and you will be taken to the Protocol Review Lookup page.
You do not have to change any of the criteria, simply click the “Search” button and all reviews assigned to you will be returned in a list.
Click the “edit” link in the Actions column to be taken to that protocol.
Note that even if you have not started work on the review, the status will still be “SAVED.”
5

O verview of the Process
To ease transition to the new system, DHRP administration has decided to allow two different review methods while we transition to an entirely electronic system. The first, and preferred, review method will involve no additional reviewer form and will be done entirely within the KC system. The second method will closely mimic the current paper review process and will involve only one additional step on the part of the reviewer.
Overview of Review Method 1
All review comments can be made directly into KC without the need for the old form. In this case there are only two steps:
1.
Read through the protocol application using one of the two paths described on pages 11-18.
2.
Complete the Determination Recommendation field found on the “Online Review” tab,
3.
Type your comments into the reviewer comment section
4.
Upload any annotated files,
5.
Click “Approve Review”. By clicking “Approve Review”you are “signing” your review form.
Overview of Review Method 2
In order to keep the transition to the new system as smooth and painless as possible, IRB administration has decided that reviewers can continue using the current review forms. This means that the review process involves only one additional step overall. The steps to complete your review will be as follows:
1.
Read through the protocol application using one of the two paths described on pages 11-18.
2.
Download and open the appropriate reviewer form from the Z: drive as usual.
3.
Complete the form as you normally would by typing in your comments, marking off checkboxes etc, and save it to the local hard drive or a location on the network.
4.
INSTEAD OF PRINTING THE FORM AND SIGNING IT, complete the Determination Recommendation field found on the “Online Review” tab
5.
Upload the reviewer form and any annotated files.
6.
Click “Approve Review”. By clicking “Approve Review”you are “signing” your review form.
You will not have to print out the review form in hard copy or do a wet signature. Please notify the IRB office that you have completed your review.
6

Details of the Reading Process - Both Review Methods
Reading an electronic protocol application is similar to reading a hard copy; however, the pieces of the application are now in the tabs, folders and sections as structured by KC. To assist you with finding the appropriate locations for the parts of the former application package, the headings for each section of the old applications are listed in the Appendix, along with where the items in those sections can be found in KC, represented by example pictures of the pertinent tab, folder and section. Because one goal of this new software is to unify the applications, some questions may be worded or grouped differently to reflect the best possible union of applications.
Once you have opened the Protocol for review, you will be on the “Online Review” tab of the protocol.
You are now ready to begin reviewing the Protocol pieces.
There are at two different paths to approach reading a protocol application in KC.
Path 1: You can read the protocol application as a researcher would have entered it by examining each of the protocol’s tabs.
Path 2: You can read all the information on those tabs solely from the Protocol Actions tab.
Each path is outlined below. Once you are comfortable, you can mix and match the reading paths to best suite your personal tastes.
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Path 1: View the protocol as researcher would have entered it.
Path 1, Step 1: Determine what kind of application you are reviewing
1.
Click on the “Protocol Actions” tab. There is a folder here named Summary & History.
2.
Click the “Show” button to expand the folder. There is only one section: Summary & History, with three subsections: Summary, Submission Details, and History.
3.
Click the “Show” button next to Submission Details. You are presented with 6 more subsections: Submission
Details, Reviewers, Vote Summary, Amendment Details, Check List Items, Review Comments, and Review
Attachments.
4.
Click the “Show” button next to Submission Details. You will see the following information. Note, highlighting is for user guide only, this will not appear in KC. Scheduled Date will tell you what meeting at which this protocol was originally scheduled to be discussed or acknowledged. Submission type will tell you if this is a new application, an amendment, a resubmission response after corrections, or a yearly renewal. And finally, review type will tell you what the whether the researcher is submitting as an Exempt, Expedited or Full Board review.
If a protocol is submitted as Exempt or Expedited, the researcher must also have chosen a category. If this is a full board convened review, then you can skip instruction 5.
5.
Click the “Show” button next to Check List Items. You will see the category or categories chosen.
Only the first few words of the category are shown. If you wish to review the entire description, you can click the small green arrow button at the end of the truncated description to open a pop-up window with the full description.
6.
Finally, use the “Hide” button on Check List Items and Submission Details.
Path 1, Step 2: View the Protocol Tab by Tab
If you are a researcher yourself, you might be more comfortable viewing the information in the same manner that the researcher entered it. In this case, you will be navigating between the tabs of the protocol. After determining the type of protocol application you are looking at, it is suggested that you view the tabs of the protocol in the following order:
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1.
Protocol: The Protocol tab contains the main information about the Protocol, the title, PI and status will be found on the tab. There are folders for performances sites (called ”Organizations” in KC) and for funding sources. This tab also contains a folder for Participant Types, which contains the vulnerable populations. Click the “Show” button next to any of the folders you would like to see more information about. For example, to see the vulnerable populations, click the “Show” button on the Participant Types folder.
2.
Personnel: Each person listed on the protocol has their own folder here which contains contact information and also defines the role of each person on the protocol. During pre-review the IRB administrator has verified appropriate training and conflict of interest forms for all study personnel, so there is no additional information to be found here unless you need the contact information for any of the study personnel.
3.
Questionnaire: This tab is where most of the application is found, the lettered sections of the old application are listed as separate folders here, labeled with the kind of submission to which they apply. Each folder can be expanded using the “Show” button and after review can be minimized by using the “Hide” button. Read through the answers just as you would read the answers on a regular application. Some answers may have been too long for the space in KC, in that case, there will be a “Questionnaire Overflow” attachment under the Notes & Attachments tab.
See #6 for instructions on the Notes & Attachments tab.
4.
Custom Data: This tab contains administrative maintenance data. It will be unlikely that you would visit this tab for an initial application; however, this tab contains enrollment data that may be important when reviewing an amendment that is asking for an enrollment increase or during a renewal, where enrollment details such as the number of deaths or subject withdrawals is recorded. Each folder can be expanded using the “Show” button and after review can be minimized by using the “Hide” button.
5.
You can skip both the Special Review and Permissions tabs. They are administrative tabs and are not part of the application.
6.
Notes & Attachments: All additional documents that would normally be included in the submission--such as consent/assent forms, advertisements, data collection tools and the protocol narrative--will be found in this tab under the Protocol Attachments folder. Additionally, any answers that would not fit in the Questionnaire section can be found here. A good example might be a literature search or the expanded risk chart for studies with multiple risks. Expand the folder using the show button to reveal a list of the attached documents. For each document in the list that you wish to examine, click the show button on the left side. This will expand the details for that document.
At the bottom of the details there is a view button. Click the view button to download a copy of the attached document to your machine.
If you wish to make suggestions on a document, save the document to your local machine in a logical location with a logical file name and make the suggested changes in the document itself. This will NOT change the document as loaded by the researcher. During the completion of your review you will upload these changed documents to your review. If you do not need to or want to make suggestions, you can simply close the document after reviewing it.
You have now seen the complete application; proceed to Completing the Review in KC.
9

Path 2: Use only the Protocol Actions tab.
Path 2, Step 1: Determine what kind of application you are reviewing
1.
Click on the Protocol Actions tab. There is a folder here named Summary & History.
2.
Click the “Show” button to expand the folder. There is only one section: Summary & History, with three subsections: Summary, Submission Details, and History.
3.
Click the “Show” button next to Submission Details. You are presented with 6 more subsections: Submission
Details, Reviewers, Vote Summary, Amendment Details, Check List Items, Review Comments, and Review
Attachments.
4.
Click the “Show” button next to Submission Details. You will see the following information. Note, highlighting is for user guide only, this will not appear in KC. Scheduled Date will tell you what meeting at which this protocol was originally scheduled to be discussed or acknowledged. Submission type will tell you if this is a new application, an amendment, a resubmission response after corrections, or a yearly renewal. And finally, review type will tell you what the whether the researcher is submitting as an Exempt, Expedited or Full Board review.
If a protocol is submitted as Exempt or Expedited, the researcher must also have chosen a category. If this is a full board convened review, then you can skip instruction 5.
5.
Click the “Show” button next to Check List Items. You will see the category or categories chosen.
Only the first few words of the category are shown. If you wish to review the entire description, you can click the small green arrow button at the end of the truncated description to open a pop-up window with the full description.
6.
Finally, use the “Hide” button on Check List Items and Submission Details.
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Path 2, Step 2: Open the Summary of the Protocol
1.
You should currently be on the Protocol Actions tab, in the folder named Summary & History and the section named Summary & History should be expanded to look like this: Summary, Submission Details, and History.
2.
Click the “Show” button next to Summary to see an overview of the protocol. This contains the basic information about the protocol including personnel listed, funding sources, performance sites, etc. From a review perspective, the most important pieces will be the attachments and the participant types, which are the vulnerable populations. Please note: the graphic below depicts an already approved protocol, status and approval dates will not appear in a new protocol application, amendment or renewal. Also note: Highlighting is for illustration in this user guide and does not appear in KC.
3.
You may want to leave this summary expanded, as it gives you quick access to the attached documents.
Step 3: Print the Questionnaires to view the questions of the application.
1.
Expand the Print folder by clicking the “show” button.
2.
In the Print section, click the checkbox next to the questionnaires you wish to include in the report. a.
If the protocol was submitted as a request for exemption, then you will will want :
01.
Exempt ONLY – Screening Questions
02.
Exempt ONLY – Application Questions
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04.
All Protocols – Educational Research
05.
All Protocols – Study Funding
06.
All Protocols – Data Collection Methods
07.
All Protocols – Conflict of Interest a.
If the protocol is Expedited or Convened then you will want all but the Exempt Screening and Exempt
Application.
03.
Expedited and Full – Methods and Procedures
04.
All Protocols – Educational Research
05.
All Protocols – Study Funding
06.
All Protocols – Data Collection Methods
07.
All Protocols – Conflict of Interest
08.
Expedited and Full – Risk/Benefit Assessment
09.
Expedited and Full – Human Research Subjects
10.
Expedited and Full – Recruitment Procedures
11.
Expedited and Full – Consent Process or Waiver
12.
Expedited and Full – Confidentiality
13.
Full Board Biomed ONLY – Intervention Info
08.
After selecting the appropriate questionnaires, click the “Print Selected” button. This will create a PDF file of the questions and answers for the checked questionnaires.
09.
Read through the answers just as you would read the answers on a regular application. Some answers may have been too long for the space in KC, in that case, there will be a “Questionnaire Overflow” attachment in the attachments area of the summary as described above.
10.
Click the “Hide” button to minimize the Print folder again.
Step 4: Examine the attached documents
1.
Return folder named Summary & History and the section named Summary & History. If you have used the Hide button, you will need to use the Show button to expand the section again until it looks like this: Summary,
Submission Details, and History.
2.
Click the “Show” button next to Summry to see an overview of the protocol. Please note: the graphic below depicts an already approved protocol, status and approval dates will not appear in a new protocol application, amendment or renewal. Also Note: Highlighting is for illustration and does not appear in KC.
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3.
You will see the documents in a group under the heading “Attachments.”
4.
At the far right of each list item, there is a View button. Click the “View” button to download a copy of the attached document to your machine.
If you wish to make suggestions on a document, save the document to your machine in a logical location with a logical file name and make the suggested changes in the document itself. This will NOT change the document as loaded by the researcher. During the completion of your review you will upload these changed documents to your review. If you do not need to or want to make suggestions, you can simply close the document after reviewing it.
You have now seen the complete application; proceed to Completing the Review in KC.
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Once you have finished reviewing the protocol via your preferred path, you are ready to finish your review with KC.
As stated in on page 9 in the Overview section, there are 2 review methods.
Review Method 1: for those who wish to make their comments directly into KC.
Review Method 2: for those most comfortable using the old reviewer form.
Review Method 1 Details:
Step 1. Return to the Online Review tab for the protocol.
Step 2. Enter your determination in the Determination Recommendation Drop down Box.
It is located on the Online Review: Your Name folder which will have your name on it in the Online Review section.
All determination choices are available for all protocol types and submission types including amendments and renewals, however not all are appropriate all the time. Below is a list of the determinations and what they mean.
What should my determination be?
Approval – used for convened protocols, amendments or renewals which require no additional changes for approval by the Board.
Expedited Approval – used for expedited protocols, amendments or renewals that can be approved as is and need no additional changes.
Grant Exemption – used for exempt protocols that can be approved as is and need no additional changes.
Specific Minor Revisions – used for any Protocol, Amendment or Renewal that requires minor modifications before approval can go into effect. This is the equivalent of “Approve with Minor Modifications”.
Substantive Revisions Required – used for when a Protocol, Amendment or Renewal is recommended for either deferral (convened) or resubmission (expedited and/or exempt).
Disapprove – used when a protocol is problematic or not considered good science and should not be approved.
Close Administratively and Terminate – not used currently.
Step 3. Enter your comments in the Review Comments section
Move down to the Review Comments section pictured here.
Add your comments as you would normally type them or write them on the form. It is best to separate them by topic so that they can be organized by the IRB administration.
Click the “Add” button to the right of the Comment. DO NOT FORGET THIS STEP! This will record your comment and the time you entered it. You can modify these comments at any time until you finish your review so add them as soon as they are mostly complete.
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Step 4. If you made corrections to any files during the review process.
Move down to the Review Attachments section pictured here.
Add a short description of the file.
Use the “Browse” button to find the files you modified or made suggestions about.
Click the “Add” button to the right of the File Name. DO NOT FORGET THIS STEP! This will add the file to the database. Failure to click the add button will result in the file not being attached to the review when the review is saved or submitted.
You can attach multiple files if you have made suggestions or corrections to other attached documents (such as marking up the consent form) or have had correspondence with the PI regarding a clarification. Previously, these items were requested to be attached to the reviewer form and now should be attached here instead.
There is also a Save button which will save your determination recommendation, comments and the attachments but will not submit it to the IRB. This is in case you wish to work on this review again later. However, if you make changes to the reviewer form, or any attached file, you will have to remember to delete the attached version and upload the new version before clicking the “Approve Review” button, just like an email attachment.
Step 5. Click the “Approve Review” button.
This will submit your review to the IRB. You will no longer be able to make changes, or attach more files.
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Review Method 2 Details:
Step 1 (outside of KC). Download the appropriate Reviewer Form from the Z: drive
Step 2 (outside of KC). Save the Reviewer Form file on your desktop or in a location you can easily remember. Rename the file to something appropriate to the protocol you are reviewing so you can identify it later.
Step 3 (outside of KC). Complete the Reviewer Form by typing in the information requested, checking the appropriate boxes, and putting in your comments from your review.
Step 4 (outside of KC). Save the completed reviewer form file. Close the file.
Step 5 (in KC). Return to the Online Review tab for the protocol.
Step 6 (in KC). Enter your determination in the Determination Recommendation Drop down Box.
It is located on the Online Review: Your Name folder which will have your name on it in the Online Review section.
All determination choices are available for all protocol types and submission types including amendments and renewals, however not all are appropriate all the time. Below is a list of the determinations and what they mean.
What should my determination be?
Approval – used for convened protocols, amendments or renewals which require no additional changes for approval by the Board.
Expedited Approval – used for expedited protocols, amendments or renewals that can be approved as is and need no additional changes.
Grant Exemption – used for exempt protocols that can be approved as is and need no additional changes.
Specific Minor Revisions – used for any Protocol, Amendment or Renewal that requires minor modifications before approval can go into effect. This is the equivalent of “Approve with Minor Modifications”.
Substantive Revisions Required – used for when a Protocol, Amendment or Renewal is recommended for either deferral (convened) or resubmission (expedited and/or exempt).
Disapprove – used when a protocol is problematic or not considered good science and should not be approved.
Close Administratively and Terminate – not used currently.
Step 7 (in KC). Attach your reviewer form.
Move down to the Review Attachment section pictured here.
Add a short description of the file.
Use the “Browse” button to find the reviewer form you saved.
Click the “Add” button to the right of the File Name. DO NOT FORGET THIS STEP!
You can attach multiple files if you have made suggestions or corrections to other attached documents (such as marking up the consent form) or have had correspondence with the PI regarding a clarification. Previously, these items were requested to be attached to the reviewer form and now should be attached here instead.
Please Note: There is also a Save button which will save your determination recommendation and the attachments but will not submit it to the IRB. This is in case you wish to work on it again later. However, if you make changes to the reviewer form, or any attached file, you will have to remember to delete the attached version and upload the new version before clicking the “Approve Review”button, just like an email attachment.
16

Step 8 (in KC). Click the “Approve Review”button.
This will submit your review to the IRB. You will no longer be able to make changes, or attach more files.
17

In order to continue to make the transition to the new system as easy as possible, the Primary Reviewer Agenda will still be provided prior to Biomedical IRB meetings. Convened protocols, amendments and renewals scheduled for discussion at the meeting will all be listed on this agenda by IRB number, PI and title.
Step 1. The link to do a direct search is found on the Researcher page. At the top of the middle column is a section pertaining to IRB Protocols which looks like this:
The “Search Protocols” link is third from the bottom. Click this link and you will be taken to the Protocol Lookup page.
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Step 2. Type the IRB Number from the Primary Reviewer Agenda into the Protocol # field. Remember that the Protocol
Number must be typed EXACTLY as it appears on the Agenda. You can use the * character to represent wildcard characters.
Click the “Search” button.
Step 3. Click the “view” link on the returned record.
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EXEMPT CATEGORIES OF RESEARCH
1.
2.
Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricular or classroom management methods. This category may include children.
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless :
(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
(ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employment or reputation. Research which deals with sensitive aspects of the subject’s own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol, cannot be exempt from review.
This category may not include children except for observation of public behavior when the investigator(s) do to participate in the activities being observed.
3.
4.
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b) (2) of this section if (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statue(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. Research which deals with sensitive aspects of the subject’s own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol, cannot be exempt from review.
Research involving the collection or study of existing data 2 , documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. This category may include children.
5. Research and demonstration projects which are conducted by or subject to the approval of federal department or agency heads and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs. This category may include children.
6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the U.S. Food and Drug Administration or approved by the
Environmental Protection Agency or the Food and Safety and Inspection Service of the U.S. Department of Agriculture. This category may include children.
1 Harm to subjects means that any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or can be damaging to subjects’ financial standing, employability, or reputation.
2 Existing data means the items exist before the research was proposed or was collected prior to the research for a purpose other than the proposed research. (For purposes of a grant, this refers to data collected prior to the time the research was proposed.)
20

EXPEDITED CATEGORIES OF RESEARCH
1.
2.
3.
4.
5.
6.
7.
8.
9.
Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
1a Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
1b Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
2a from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
2b from other adults and children 2 , considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than
2 times per week.
Prospective collection of biological specimens for research purposes by noninvasive means.
Examples: a. hair and nail clippings in a nondisfiguring manner; b. deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; c. permanent teeth if routine patient care indicates a need for extraction; d. excreta and external secretions (including sweat); e. uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; f. placenta removed at delivery; g. amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; h. supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; i. mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; j. sputum collected after saline mist nebulization.
Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)
Examples: a. physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy; b. weighing or testing sensory acuity; c. magnetic resonance imaging; d. electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow, and echocardiography; e. moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects, 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.
Collection of data from voice, video, digital, or image recordings made for research purposes.
Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
Continuing review of research previously approved by the convened IRB as follows:
8a
8b where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or where no subjects have been enrolled and no additional risks have been identified; or
8c where the remaining research activities are limited to data analysis.
Minor changes in previously approved research (convened or expedited) during the period (of one year or less) for which IRB approval is authorized. NOTE: Changes that adversely alter the overall risk-benefit or could potentially affect willingness to participate should be reviewed by the convened IRB.
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REQUIREMENTS FOR EXEMPT APPROVAL
The research activities involve minimal or no risk.
The research is within a permissible category justifying exempt review authorized by 45 CFR 46.101 (b).
The specific category(s) is/are:
REQUIREMENTS FOR EXPEDITED APPROVAL
The research activities involve no more than minimal risk.
The research is within a permissible category justifying expedited review authorized by 45 CFR 46.110.
The specific category(s) is/are:
Identification of subjects and/or their responses will not reasonably place them at risk of criminal or civil liability or be damaging to the subjects (e.g. financial standing, insurability, reputation, stigmatizing) unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are not greater than minimal.
The informed consent form is adequate (see checklist below)
INFORMED CONSENT CHECKLIST (Source: United States Office for Human Research Protections)
A statement that the study involves research
An explanation of the purpose(s) of the research
The number of subjects sought for participation in the study
The expected duration of the subject's participation
A description of the procedures to be followed
Identification of any procedures which are experimental
A description of any reasonably foreseeable risks or discomforts to the subject
A description of any benefits to the subject or to others which may reasonably be expected from the research
A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
An explanation of whom to contact for answers to pertinent questions about the research,
An explanation of whom to contact for answers to pertinent questions about research subjects' rights,
An explanation of whom to contact in the event of a research-related injury to the subject.
A statement that participation is voluntary, that the decision to not participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled
Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent (if applicable)
Any additional costs to the subject that may result from participation in the research (if applicable)
The procedure for an orderly termination of participation should the subject decide to withdraw from the research (if applicable)
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C.1.a Convened
A.
Study Information
Title, PI, PI Department
PI Contact Info
Other Contact, Info
Company Protocol
Number and version date
Date and IRB Number
B.
Study Personnel
Personnel Name
Role in Project
Role in Consent Process
C.
Study Funding
D.
Performance Sites
E.
Proposed Research Description
1.
Methods and Procedures
2.
Intervention Information
And depending on the answers, there might be additional information in attachments
3.
Risk/Benefit Assessment
And depending on the answers, there might be additional information in attachments
F.
Human Research Subjects
G.
Recruitment Procedures
H.
Informed Consent
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I.
Confidentiality
J.
Conflict of Interest
Additionally, any documents that would normally have been included in the application packet, such as consent forms, full protocol narrative, data collection tools and the like will be found in the
C.1.b Biomedical Expedited Application – TBD
C.1.c Biomedical Exempt Application – TBD
C.1.d Biomedical Renewal – TBD
C.1.e Biomedical Amendment – TBD
24

C.2.a SBE Convened and Expedited Application
A.
Study Information
Title, PI, PI Department
PI Contact Info
Student or Other Contact,
Info
Sponsor Protocol Number and version date
Date and IRB Number
Intended purpose of
Application
B.
Study Funding
C.
Performance Sites
D.
Study Personnel
Personnel Name
Role in Project
Role in Consent Process
E.
Conflict of Interest
F.
Methods and Procedures
G.
Data Collection Methods
H.
Risk/Benefit Assessment
I.
Human Research Subjects
J.
Recruitment Procedures
K.
The Consent Process
L.
Confidentiality
Additionally, any documents that would normally have been included in the application packet, such as consent forms, full protocol narrative, data collection tools and the like will be found in the
25

C.2.b SBE Exempt Application
Exempt Screening Questions
Exempt Category Claimed
A.
Study Information
Title, PI, PI Department
PI Contact Info
Student or Other Contact Info
Date and IRB Number
B.
Study Funding
C.
Performance Sites
D.
Study Personnel
Personnel Name
Role in Project
E.
Methods and Procedures
F.
Surveys and Questionnaires
G.
Information to be included the Protocol Summary
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C.2.c SBE Renewal
A.
Study Information
Title, PI, PI Department
PI Contact Info
Student or Other Contact Info
Date and IRB Number
B.
Assurances (Signatures)
C.1. Status
C.2. Enrollment
C.3. Participant Activity
C.4. Adverse Events
D.1. Reason for Project Continuance
D.2. Amemdent Requests
C.2.d SBE Amendment – TBD
27