CAMC/WVU INSTITUTIONAL REVIEW BOARD AND INSTITUTIONAL SCIENTIFIC REVIEW BOARD

Research Policy Handbook Document/Form Title Revised Date Fill In (Microsoft Word) Print Only New Study Application 02/05/08 Emergency Use Packet 8/20/04 Continuing Review Packet 8/20/04 Important Reminders and Changes about Consent Form Format MEMO- dated 10/03 8/20/04   Template for Patient Enrollment in Research Projects other than Clinical Trials or Sponsored Research *Note: If the patient is enrolled in a research study but not a clinical trial or other sponsored research with billing components, the 7412 template is to be used. The 7412 form can be used for patients enrolled as inpatients and a copy of it can be placed on the chart (which investigators like to do). It should not trigger the process outlined below like form 7411 does. 11/01/06 Drug Data Form 07/27/07 Form Preparation 07/27/07 Labratory Data and Pathology Form 07/27/07 New Technologies Form 07/27/07 Nursing Participation Form 07/27/07 Revision Modification Amendment Form   07/27/07 Submission of Information Form 07/27/07 HIPAA forms HIPAA De-Identification Form 08/10/07 HIPAA Authorization (2nd person) 08/10/07 HIPAA Waiver of Authorization   08/10/07         These forms are in pdf format, so they cannot be filled in. Please print them and fill them out as you would a packet from the IRB office. All forms/packets from the IRB office are now available here. NOTE: W e will be updating some of these documents.  However, these are the most up to date.

All other forms located below

Mandatory Training
Once you complete the online tutorial, print the certificate and submit to Research and Grants Administration. Your protocol will not be reviewed otherwise.
CITI Log On Instructions

 download meeting dates and deadlines in pdf document

Investigator Initiated Research Studies:

If your study is investigator-initiated, and full-board or expedited, your application is required to receive institutional scientific review by the Institutional Scientific Review Board (ISRB) prior to review by the IRB.  If your study is a quality improvement project, please call our office at 388-9970 before submitting your application.

Instructions for number of copies of applications to submit to Research Review Office:

Please submit your original and 2 or 17 copies (depending on whether or your study is expedited or full board) of your original application to the Research Review Office in WVU Building, Room 3283, according to the deadlines above for IRB review.

If your study will require ISRB review, please submit your original application and 11 copies of your original application according to the deadlines above. Following ISRB review, the investigator will be notified of necessary revisions. Upon completion of your ISRB review, you will need to submit your revised original and 2 or 17 copies (depending on whether or your study is expedited or full board) to the Research Review Office to begin IRB review.

Contact Information:

IRB/ISRB Links

The Belmont Report
http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm

The Nuremberg Code
http://ohrp.osophs.dhhs.gov/references/nurcode.htm

Declaration of Helsinki
http://www.wma.net/e/policy/17-c_e.html

Federal Wide Assurance Number for IRB
http://ohrp.cit.nih.gov/search/dasurdtl.asp?asuid=FWA00002709&asutyp=X

Provides an excellent sample titled: "How to Write a Human Subjects Application."
http://www.niaid.nih.gov/ncn/grants

1) On all forms you will be on the first field when you open the form
2) Tab between fields
3) Click on the field to go back or to make corrections/changes
4) Click on a box to remove or add an "X" or tab through the boxes
5) Please be certain that the signature at the end of the form appears with the last question on the form- A SIGNATURE SHOULD NOT BE ON A SEPARATE PAGE BY ITSELF. If in the process of completing a form, the signature is the only item on the last page, please enter returns in the second to last question so that the signature is on a page with the final question. A signature should not stand alone on a page
6) If you see something highlighted in yellow, move your cursor over it to receive instructions
7) If you have any technical problems with the forms (not the content),
phone (304)-388-9978

IRB Forms and Policies

Available as fill in forms or in print - Click on Icon for Downloads
Please be advised that these forms and policies may sometimes be updated, but the most current versions should be available on this site.

Please contact 388-9971 or 388-9973 for forms not yet available on line

Document/Form Title	Revised Date	Fill In (Microsoft Word)	Print Only
AE Form - Internal  (SAE-01)	2/22/04
AE Form - External (SAE-02)	2/22/04
AE Instructions	2/22/04
AE Policy	2/22/04
AE Submission Guide	2/22/04
AE Tracking Log- SAMPLE	2/22/04
AE Tracking Log- Template	2/22/04
Continuing Review Packet (Form A & Form B)	2/22/04
Continuing Review Policy	2/22/04
Drug Data Form	07/27/07
Emergency Use Packet	2/22/04
Form Preparation	07/27/07
Labratory Data and Pathology Form	07/27/07
Modification/Amendment form - Form B	02/22/04
New Technologies Form	07/27/07
Nursing Participation Form	07/27/07
Revision Modification Amendment Form	07/27/07
Revision Log- SAMPLE	2/22/04
Revision Log - Template	2/22/04
Sponsored Projects Approal App.	04/30/04
Submission of Information Form	07/27/07
Sponsored Projects Approal App.	04/30/04
HIPAA forms HIPAA De-Identification Form 08/10/07 HIPAA Authorization (2nd person) 08/10/07 HIPAA Waiver of Authorization   08/10/07