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					eResearch PEERRS error
eResearch amendment, application not updated error
eResearch update to new template for SCR
Legacy section 5 error

Legacy section 1.17 error

Signature Card
Consent 5.2 and 8.1
Stacking consent documents
HIPAA authorization waiver section 25-1.3.2
Instructions for creating an amendment
Missing signature line 1.2 Legacy submission
How to move to new consent template in eResearch
Radiation consent
Unique identifiers
data collection forms
Terminated, ORIO or adverse event
Terminated ORIO Legacy
Incorrect section 5 information
Unanticipated Problem UAP
Unrelated non-serious adverse event
related non-serious adverse event
Serious adverse event
Death adverse event
Face to Face recruitment
Assent update at SCR
adding new co-investigator co-i
external adverse event reporting
Case studies operations manual
Data use agreements
Identifiers and retrospective reviews
11-1.2
6.3 retrospective review
Grants office and IRB review cost billing
JARA change
Miscellaneous header for recruitment documents
replace consent header
PEERRS training for non key team members
On agenda, but expedited by primary reviewer
Adverse Event definitions
SCR lapse in approval
Stack revised consent
Please require ????????? to complete the PEERRS human subjects research training module.
Approval of this study submission is contingent upon successful completion of the PEERRS human
subjects training module.

http://my.research.umich.edu/peerrs/

If PEERRS is not offering you a human subjects training module, then it is because when you
established your PEERRS profile you did not select human subjects research. You may need to edit
your profile in order to access the human subjects training module.

Thank you in advance.
The amendment coversheet looks great, but you have to make the changes in the application. At
the very bottom of the amendment coversheet it says, "Click here to make changes in the
application." Click that line and then go to the appropriate section to make your changes. You will
have to check the appropriate check boxes in section 1.4 of the amendment coversheet to indicate
where you have made changes. Do not make any changes that you do not describe in the
amendment coversheet because eResearch creates an audit trail that our reviewers use to identify
where changes were made and if you make a change that is not described in the coversheet, then
we will send the coversheet back to you for corrections before we review the amendment. It is
probably best if you review the entire application page by page to verify that your amendment
does not require edits in other sections of the application or protocol which you may not have
considered. (Commonly missed sections are the uploaded protocol, methodology section,
recruitment section, informed consent section and the informed consent document).

Thank you and please call the IRBMED office 763-4768 and ask for James Washington if you have
questions.

James Washington
Junior Associate Regulatory Analyst
IRBMED
ph: (734) 763-4768 fax: (734) 763-1234

Mailing Address:
IRBMED
Argus 1
517 W. William St.
Ann Arbor, MI 48103-4943

www.med.umich.edu/irbmed/
We are preparing to review your request for a scheduled continuing review, but we need you to
submit an amendment and put the informed consent document on the newly approved IRB
template version 9-15-2007. The new template contains additional language which helps us to
remain compliant with new regulations. You can access the new informed consent template at
http://www.med.umich.edu/irbmed/ict.htm

We will not be able to approve your SCR until we receive your amendment to update all of the
informed consent documents to the new template. We are requiring this of all studies when they
are due for SCR in 2008.

Thank you,
James Washington
Junior Associate Regulatory Analyst
IRBMED
ph: (734) 763-4768 fax: (734) 763-1234

Mailing Address:
IRBMED
Argus 1
517 W. William St.
Ann Arbor, MI 48103-4943

I am reviewing your SCR submission and there is a discrepancy in the reporting information
provided in section 5. The information in section 5 provided with this SCR does not agree with the
information provided in the previous SCR. I have attached the previous SCR information. Please
email me a corrected section 5. Email to jbwash@umich.edu The number reported in section 5.2
must equal the sum of section 5.4 plus the number reported in section 5.2 of your previous
continuing review application.

Thank you,

James Washington
In your previous submissions ????????????? have been included as co-investigators. If these people
are still part of the study then please revise the submission application by adding their names to
section 1.17. If they are no longer members of the study team, then please add their names to
section 7.3. Please email the revised submission form to jbwash@umich.edu

Thank you for your assistance,

James Washington
Junior Associate Regulatory Analyst
IRBMED
ph: (734) 763-4768 fax: (734) 763-1234

Mailing Address:
IRBMED
Argus 1
517 W. William St.
Ann Arbor, MI 48103-4943

www.med.umich.edu/irbmed/




James Washington
Junior Associate Regulatory Analyst
IRBMED
ph: (734) 763-4768 fax: (734) 763-1234

Mailing Address:
IRBMED
Argus 1
517 W. William St.
Ann Arbor, MI 48103-4943

www.med.umich.edu/irbmed/
1) In section 5.2 of the consent document these or similar words must not be included in the text,
"The cost of emergency care will be billed to your insurance. If not covered, the University of
Michigan will pay for emergency care if it is determined to be related to the study."

You cannot, in any place in the informed consent document, make a promise of payment for
treatment/medical care by the University of Michigan.

2) Make certain section 8.1 of the consent document includes the sentence,"By signing this form,
you do not give up your right to seek payment if you are harmed as a result of being in this study."
We need you to stack the consent documents in section 10-1. You will want to download all of the
documents to your desktop. Check to make sure that they are saved there. Rename them
indicating the version number. Then upload the oldest version. Click edit and upload the next
version. Click edit and upload each version until you have uploaded the newest version. Click
"save" at the very top of the eResearch window. Then close out of eResearch, relog into the study.
Check to make sure that all of the documents are properly stacked. Then go to the unstacked
documents and delete them from the study so that all that is left is the stacked consent documents.
Double check to make sure that the stacked documents are all there.
In section 25-1.3.2 deselect, "Deidentified data sets" and instead select "Request for full or partial
waiver of HIPAA authorization." In section 25-2.1 select, "Entire Project." Then complete the rest
of section 25-2.
http://www.umich.edu/~eresinfo/docs/16a_amendment.pdf
We have received your submission for study# ??????????, but we need to have the principal
investigator sign the submission on line 1.2. The form we have has an electronic signature, but we
are required to receive a hand-written signature. Please mail the signed first page of the
submission to Attention: James Washington

IRBMED
Argus 1
517 W. William St.
Ann Arbor, MI 48103-4943
1) Go to http://www.med.umich.edu/irbmed/ict.htm and download the new consent template.
2) Go to your old consent version (n) and section-by-section copy and paste the non-template
language from the old consent into the appropriate sections of the new consent template. Do not
move the old header and footer and do not alter the header and footer that is on the new template.
3) There are a couple sections that are new to the new template and you will need to find these
new sections and provide the detail information because these sections were not in the old
template, one example is section 4.3 which was previously built into section 4.2 of the old consent.
4) This is the most important part so make sure you do these two things a) and b).

a) In section 5.2 of the consent document these or similar words must not be included in the text,
"The cost of emergency care will be billed to your insurance. If not covered, the University of
Michigan will pay for emergency care if it is determined to be related to the study."

You cannot, in any place in the informed consent document, make a promise of payment for
treatment/medical care by the University of Michigan.

b) Make certain section 8.1 of the consent document includes the sentence,"By signing this form,
you do not give up your right to seek payment if you are harmed as a result of being in this study."

5) This is the last part. In eResearch go to your study and click "new amendment." Then you will
answer questions in order to complete the amendment cover page. At the very bottom of the
amendment cover page it says "Click here to make changes in the application." Click that line.
Then go to your consent in section 10-1 of your study application. Click the "edit" button. Upload
your new consent version (n+1) and label it version (n+1). Do not delete the previous consent
version. Do not click the "add" button. Just use the "edit" button. In this way, your new consent,
version (n+1), will be stacked below your previous consent, version (n); and we will have a running
record of all of the consents that have been used.

If you do not stack the consents by using the edit button, then someone from the office will contact
you and have to walk you through the process step by step.

When you are finished click the submit button so we can review your consent amendment.
During the course of this study, as a result of procedures to be carried out for research reasons,
you will be exposed to radiation in the form of ???????? rays. The biological effect of radiation is
measured in terms of Roentgen equivalents in man, or “rem”, which is a unit of uniform whole body
exposure. Radiation you will be exposed to in this study will amount to less than ???????? rems.
The effects on your body of this radiation exposure will be added to your overall life-time radiation
risk. Your life-time radiation risk includes the background radiation you are exposed to naturally
like everyone else living on this planet, which is on the average 0.3 rem per year; the radiation you
will be exposed to in this study is about ???????? times the yearly background radiation. The
Federal Government requires that the amount of radiation exposure of radiation workers does not
exceed 5 rems per year; the radiation you will be exposed to in this study is about ????????% of that
amount. Your life-time radiation risk also includes any radiation you may have received in the past
for diagnosis or treatment, and any such radiation you may be exposed to in the future. Please tell
us if you have had any major radiation exposure in the past, particularly in the past two years, such
as treatment with x-rays or radioactivity, or diagnostic x-rays, CT-scans or nuclear medicine scans.
"We will assign a unique identifier to each subject and this unique identifier will be recorded on the
data collection form. A separate document linking the unique identifer to the patient name and
UMHS registration number will be securely maintained by the PI."
In section 44.1 please upload a data collection form which lists all of the variables that you will be
collecting from the medical records. The data collection form will have your unique subject
identifier on it, but it will not include the patient name, registration number, birthdate or any other
identifiable information. It can contain their age, but not their birthdate.
In eResearch you can submit an ORIO or an adverse event even after the study has been
terminated. Click on the button that says, "New Adverse Event/ORIO." In section 15.1 of the ORIO
make sure you state the name of the material that you are asking us to approve. I think there is
also a location for you to upload the document, you may need to scan the document if you do not
have an electronic copy of it.
If you are required to distribute a handout to the study subjects, eventhough the study has been
terminated the handout needs to be reviewed by the IRB. This review can be initiated by you when
you submit an ORIO (other reportable information and occurrences) form either in Legacy. ORIOs
are submitted in Legacy by completing sections 1,2,3, and 10 of the Legacy submission form.
The recruitment numbers that you have reported in your current continuing review application do
not agree with the numbers that you reported in section 5 of your previous continuing review
submission.

I have attached your previous continuing review submission as a reference for you. Please correct
the numbers in section 5 of your new continuing review submission and email it to me at
jbwash@umich.edu


If you have any questions, then call me by dialing 763-4768 and ask for James Washington.

If you incorrectly reported recruitment numbers on your previous continuing review submission,
then complete an ORIO report by adding section 10 to your continuing review submission.

We will not be able to review your continuing review submission until I receive your corrected
document.

Sincerely,
James Washington, IRBMED, 763-4768
An unanticipated problem is unexpected and related to the research
Reported with scheduled continuing review
Reported within 14 days of event or notification of event, but if it is an expected AE then it can be
reported at the time of scheduled continuing review
Serious adverse events are reported within 7 days of learning about the event if they are related or
at the time of scheduled continuing review if they are not related to the research.
A death adverse event must be reported within 7 days of notification regardless of the relatedness
You or your study coordinator are probably going to have to recruit face to face with potential
subjects if you want to beef up recruitment for the study. You'll need to amend the project to
request consent waivers (in section 10 and complete section 10-3) and HIPAA authorization
waivers (specified in 25-1 and completing 25-2) to view the clinic schedules so you know who to
approach.
Dear primary reviewer:

Robin Sedman has asked that I remind primary reviewers that the IRB office has a new assent
document template at the following URL:

http://www.med.umich.edu/irbmed/ict/Assent%20Template.doc

During your review of continuing reviews which contain assent documents please determine if you
would like to recommend that the study team update their assent document. Updating the assent
document is not required unless the primary reviewer asks that it be done as a contingency for
approval.

Sincerely,
James Washington, IRBMED, 763-4768
To add co-investigators to your eResearch studies you must do the following for each study that
you want to add a co-investigator to:

1) Open the parent study in eResearch.
2) Click the tab on the left side of the screen that says, "create new amendment."
3) Complete the amendment coversheet specifying that you are making administrative changes
and adding co-investigators.
4) At the bottom of the third page of the amendment coversheet it says "Click here to make
changes in the application." Click that line. Then go to section 1 of your study application and add
each new co-investigator.
5) If the study uses a consent document, then go also go to section 10-1 and upload a revised
version of the consent document with the new investigators listed in section 1.3 of the consent.

Call me if you have any questions or if you would like additional help.

Sincerely,
James Washington, IRBMED, 763-4768
All external UaPs need to be reported. If a sponsor reports an AE for a study drug that occurred on
a protocol that is not being used at UofM, then it does not get reported at UofM unless the sponsor
and UofM PI have an agreement that it must be reported at UofM.
Please refer the principal investigator to the operations manual. Access the following URL:

http://www.research.umich.edu/hrpp/om/FullOM.pdf

Use the search feature to find, "case studies" without the quotes. There are descriptions of 3 types
of case studies. Identify which description pertains to the PI's study and the "yes" or "no" means,
"yes" an eResearch application is necessary, or "No" IRBMED approval is not necessary.

After reviewing the Operations Manual you and or the PI is welcome to call back and talk with us.
We are instructed to ask PIs to review the OM first, this helps to create awareness that the OM
exists.

Sincerely,
James Washington, IRBMED, 763-4768
Internal data use agreements are faxed from the study team to the IRBMED office and maintained
at the IRMED office. External data use agreements are handled by the privacy office. A Co-I
reviewing potential PHI that goes beyond the scope of a Limited Data Set (LDS). The HRPP-OM
defines a LDS and so does UM Policy 01-04-342. Because of this issue the study team will need to
contact Nancy Helmick at 936-6786 or nehlmick@umich.edu to discuss the drafting of the
appropriate document to cover the information that the Co-I will see. A business authorization
agreement might be used. All external data use agreements are handled by the privacy office. If
the study is funded then external data use agreements must also go to DRDA.

I hope this helps!
The required approach for extraction of medical data for use in research is to not have direct
identifiers on the data collection form; no names, no CPI numbers, no dates of birth. You can use
age, but not date of birth.

The study team should assign a unique identifier to each subject and only the unique identifier
should be on the data collection from. A master sheet linking the unique identifer to the identity of
the patient should be securely maintained by the PI in a location that is separate from the research
data.

In this way the identity of the subject will never be found on research sheets which contain medical
information.
In section 11-1.2 you should also state, "The PI will securely maintain the master data sheet which
links the subject names to the indirect identifiers which are used on the research record. The link
will be stored separately from the medical information."
In section 6.3 please list, "A rare, but serious risk of loss of confidentiality" which will be minimized
by limiting access to subject data to only the study team members and also by using only indirect
identifiers on the data records.
Heather (Offhaus) in the grants office takes care of billing for IRBMED reviews. The telephone
number is 34272.
I have forwarded your message to Carol Hutsko because Carol is now serving your department and
I am no longer serving your department. The IRBMED office allowed Carol and I to swap our
departments of service so that we would have an opportunity to interact with a larger number of
investigators within the research community.

Carol has worked in the IRBMED longer than I have and her and Robin Sedman are serving your
department.

I did enjoy working with you and many of the research teams that I served with Robin, but I am
happy to accept this opportunity to learn about the research that is taking place in the other
departments who are not served by Robin's team.

Carol will be happy to help you and if my name comes up in conversation please help pass the word
that I am no longer working with your department, but I am serving Urology, Psych, Derm,
Dentistry, Hep and public health.

Thank you, and I will still be around and I may even be working with you again in the future. For
now, Carol needs to learn more about you and your department.


Sincerely,
James Washington
In section 8-2.7 add the IRBMED miscellaneous document header to the top of the flyer as a header.
Do not alter the header in any way, just copy and paste the header onto the flyer.

You can access the header at the following URL:

http://www.med.umich.edu/irbmed/ict/eResearch-IC-Other-Header.doc
Replace the header on the informed consent document. Copy the header from the consent
template at the following URL:

http://www.med.umich.edu/irbmed/ict/Standard_ICT.doc

Do not alter the header in any way, just delete the header on your consent document and paste the
unaltered header on to it. The eResearch application will fill in the header for you after the IRB
review is complete.
University policies require EVERYONE involved in human subjects research to have PEERRS
training BUT the IRB's job is limited to assuring 'key personnel' have done it. In other words, we
are not supposed to hold up an application if non-keys don't have it done. If you notice someone
involved in research doesn't have PEERRS it would be a 'nice favor' to remind the PI of the
university requirement but we are not empowered to make sure it happens.

Here is the citation:

It is the responsibility of the PI to enforce the institutional requirement for PEERRS Human Subject
Module certification for personnel in other study team roles:Consultants: A consultant is a
specialist in a specific area of the research project, usually from outside the regular study team.
While a consultant may be paid or unpaid, he/she does not typically commit a measurable amount
of time/effort for the duration of the study (otherwise, consider him/her a Co-Investigator). The
IRBs recognize multiple consultants for a given study.
Staff: This is a broad term used to describe many members of the study team. Staff can include (but
is not limited to) recruiters, medical staff, nursing staff, interviewers, focus group facilitators, or
technical/analysis staff. However, a staff member with overall responsibility for the coordination
and administration of the study should be listed as the Study Coordinator (SC) or Project Manager
(PM). The IRBs recognize multiple staff members for a given study.
Other: If the study team member does not fit into any of the above categories, they are listed as
"other" in eResearch. For example, a research administrator responsible for tracking/monitoring
the status of approved research projects in his/her unit. eResearch will accept multiple “other”
entries for a given study."
This is found at: http://my.research.umich.edu/peerrs/help.php
If a submission is assigned to an agenda, but the primary reviewer expedites it, then we enter,
"Tabled."
32-1.3* Affirm that the adverse events will be reported to the IRB according to the following
generalized AE GRADING SCALE:


 0
•	 - No adverse event
 1
•	 - Mild AE – No treatment needed
 2
•	 - Moderate AE – Resolved with treatment
 3
•	 - Severe AE – Inability to carry on normal activities, required professional medical attention
 4
•	 - Life-threatening or disabling AE
 5
•	 - Fatal AE
32-1.6* Affirm that the EXPECTEDNESS will be assigned for each adverse event according to the
following definitions:


 U
•	nexpected adverse events (i.e., has NOT been addressed or described in one or more of the
following: Informed consent document(s) for this study, IRB application for this study, grant
application or study agreement, protocol or procedures for this study, investigators' brochure or
equivalent (for FDA regulated drugs or devices), DSMB/DSC Reports, published literature, other
documentation)
 E
•	xpected adverse events (i.e., has been addressed or described in one or more of the following:
Informed consent document(s) for this study, IRB application for this study, grant application or
study agreement, protocol or procedures for this study, investigators' brochure or equivalent (for
FDA regulated drugs or devices), DSMB/DSC Reports, published literature, other documentation,
or characteristics of the study population)
IRB Lapses in Approval Part 3 (f) UM IRB Operating Manual (OM)
http://www.research.umich.edu/hrpp/om/Part3.html:

It is the principal investigator’s responsibility to submit a continuing review application before
expiration of IRB approval, and in ample time for IRB review. eResearch provides notification of
impending expiration and directions for submitting a continuing review application. If an
investigator fails to provide a continuing review application to the IRB, or the IRB has not reviewed
and approved the continuing review application by
the expiration date of the current approval (regardless of the reason or circumstances), the study
will be considered lapsed and the research must stop unless the IRB finds it is in the best interest
of individual subjects currently participating in the study to continue the research interventions or
interactions. Enrollment of new subjects during a lapse is prohibited, and the IRB will remind
investigators that resources must not be expended for unallowable activities. DRDA is notified of
lapses through eResearch or otherwise. Please note that when IRB approval lapses, expires, or is
terminated, no identifiable data may be collected or analyzed.
Dial 763-4768 ask for Ellen LaChance or James Washington and request that one of them help you
stack the new informed consent document so that there is only one stack of two documents with
the newest document added to the stack second., , Right now you have two stacks of one document
rather than one stack of two documents. In order to have only a single stack you should click the,
"edit" button which is to the left of the document titled, "Informed consent." Then using the, "edit
button" you can upload the document, "New informed consent with the new CI." Revisions of an
exisiting consent should always be uploaded by using the, "edit" button. Don't use the add button
and do not delete the previous version of the consent document. Using the edit button allow you
to create a history of all of the revisions of a consent document within a single stack. You can use
the, "add" button to create a new stack if you have multiple consent documents for different
subject sets.

				
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