Research at Carolina Offices

• Animal Care & Use
• Clinical Trials
• Economic & Business Development
• Federal Affairs
• GrantSource Library
• Human Research Ethics
• Information & Communications
• Lab Animal Medicine
• Odum Institute for Research in Social Science
• Postdoctoral Affairs
• Research Compliance
• Research Development
• Sponsored Research
• Technology Development
• Vice Chancellor, Research & Economic Development

Forms (from all Research at Carolina offices)

• Animal Care and Use
• Carolina Postdoc Program for Faculty Diversity
• Clinical Trials
• Grant Applications
• Human Embryonic Stem Cell Research/ESCRO Application Form
• Human Subjects/IRB-Related
• Sponsored Research

Some forms are available in more than one format. Some of the PDF files below may be filled out electronically and saved using Adobe Acrobat Reader. (Note: Applications from external agencies are not necessarily fillable online, regardless of file type.)

Animal Care and Use

Application Forms

Amendment Forms

Go to ACAP to start an amendment. The system will direct you to the appropriate location.

Hazard Forms

Title/Description	Format(s)	Notes	Questions?	Admin. Office
Use of Radioactive Materials in Laboratory Animals		n/a	iacuc@med.unc.edu	IACUC
Use of Biohazardous Materials in Laboratory Animals		n/a	iacuc@med.unc.edu	IACUC
Use of Chemical Hazards in Laboratory Animals		n/a	iacuc@med.unc.edu	IACUC

Miscellaneous Forms

Title/Description	Format(s)	Notes	Questions?	Admin. Office
Annual Review Form	ACAP	Annual review now done via ACAP.	iacuc@med.unc.edu	IACUC
Exception Form	ACAP	Exceptions now done via ACAP.	iacuc@med.unc.edu	IACUC
Title/Funding Change Form	ACAP	Title/funding change done via ACAP.	iacuc@med.unc.edu	IACUC
Personnel added to application	ACAP	Personnel added now done via ACAP as amendment.	iacuc@med.unc.edu	IACUC
Principal Investigator Transfer Form	ACAP	PI transfer now done via ACAP as amendment.	iacuc@med.unc.edu	IACUC
Satellite Animal Housing Form	ACAP	Satellite Animal Housing now done via ACAP.	iacuc@med.unc.edu	IACUC
Husbandry Duties Performed by Investigator		n/a	iacuc@med.unc.edu	IACUC
Check Sheet for Investigator Health Monitoring		n/a	iacuc@med.unc.edu	IACUC

Training Forms: paper forms no longer in use

Go to Event Registration to certify personnel online. Contact Training & Compliance at 6-5569 if any questions.

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Carolina Postdoctoral Program for Faculty Diversity

Title/Description	Format(s)	Notes	Questions?	Admin. Office
Carolina Postdoc Program for Faculty Diversity	or	Guidelines	Rhonda Craig-Schwarz	VCRED

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Clinical Trials Forms

Title/Description	Format(s)	Notes	Questions?	Admin. Office
Request for Investigational Drug Services (IDS)		IDS Policy	OCT	IDS
CTA Review Request Form		(for new clinical trial contracts only)	Sabrena Mervin-Blake	OCT
CDA Review Request Form		(for confidentiality agreements only)	Sabrena Mervin-Blake	OCT
Amendment Review Request Form		(for contract amendments only)	Sabrena Mervin-Blake	OCT
Review Request Form		Guidelines	Sabrena Mervin-Blake	OCT
Status Request Form	HTML	n/a	Sabrena Mervin-Blake	OCT

Clinical Research Coordinators Forms (password-protected)

Title/Description	Format(s)	Notes	Questions?	Admin. Office
Internal Budget Template		Instructions	Sabrena Mervin-Blake	OCT
Lab Costs		n/a	Sabrena Mervin-Blake	OCT
Source Document Templates	HTML	n/a	Sabrena Mervin-Blake	OCT
Study Startup Checklist	(form undergoing revisions)	n/a	Sabrena Mervin-Blake	OCT

Clinical Trials Tool Kits

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Grant Application Forms

Internal (UNC) Grant Application Forms

Name/Title	Format(s)	Notes	Questions?	Admin. Office
Request for Cost-Sharing in External Funding		n/a	Jo Ann Gustafson	VCRED
Travel to Visit an Extramural Sponsor		n/a		VCRED
University Research Council: Research Grant	or	n/a	Jennifer Pruitt	VCRED
University Research Council: Publication Grant	or	n/a	Jennifer Pruitt	VCRED

Commonly Used Grant Application Forms from External Agencies

Note: Some of these forms are print-only versions and will have to be downloaded as such and then converted for word processing software before they can be customized for UNC-Chapel Hill. If you need assistance converting a form to another software program, please consult your department's technical support staff or the ITS help desk.

Hard copies of application forms are available by contacting the individual funding agencies.

Agency/Form Name	Format(s)	Notes
Grants.gov	varies	Download application packets from participating federal agencies.
American Cancer Society (ACS)	HTML	Many ACS proposals may be submitted via Proposal Central; other awards use forms available from the ACS website.
American Heart Association (AHA)	HTML	Mandatory electronic submission. [Not Firefox compatible]
American Lung Association (ALA)	HTML	Submission through Proposal Central.
Centers for Disease Control (CDC)	HTML	n/a
Department of Education (DOED)	HTML	n/a
Department of Energy, Office of Science	HTML	Mandatory electronic submission.
National Endowment for the Arts (NEA)	HTML	n/a
National Endowment for the Humanities (NEH)	HTML	Mandatory electronic submission.
National Institutes of Health (NIH) ERA Commons Registration Form	HTML	n/a
NIH Research Training and Career Development Award Application	HTML	n/a
NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Applications	HTML	n/a
NIH SBIR Phase I and II Contract Solicitation (PHS 2005-1)	HTML	n/a
NIH Forms and Applications	HTML	n/a
National Science Foundation (NSF) Grant Proposal Guide	HTML
NSF forms	HTML	Proposals must be submitted using NSF Fastlane, the online submission system.
Public Health Service (PHS) General Forms	HTML	Under the Division of Health and Human Services, abbreviated DHHS or HHS.
PHS 424 (for NIH) formerly PHS 398	HTML	Public Health Service (PHS) application guidelines and forms.
PHS 424 (for NIH) formerly PHS 416	HTML	National Research Service Award (NRSA), PHS application guidelines and application forms.
PHS 310 (for NIH)	RTF	Human Subjects assurance form.
PHS 2590 (for NIH)	HTML	PHS Grant Continuation, sometimes called a renewal or a non-competing continuation. Also for Research Career Awards and Institutional National Research Service Awards.
PHS 5161-1	or	PHS Grant Application Information and Instructions for completion of Standard Form 424. Cover package for the SF424 forms kit. (Most federal government agencies accept these applications, except NIH and NSF, which have developed their own packages).

Other sources of electronic application forms

Note: Forms on these pages may have been developed for use by researchers at other institutions and may contain information specific to that institution. Check all forms carefully.

• Texas Engineering (TEES) at Texas A&M
• Vanderbilt University

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Human Embryonic Stem Cell Research/ESCRO Application Form

Title/Description	Format(s)	Notes	Questions?	Admin. Office
Application to use Human Embryonic Stem Cells in Research		Guidelines/Policies	Robert Lowman or Terry Magnuson	Office of the Associate Vice Chancellor for Research

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IRB-Related Forms

There are a variety of forms available, and their use depends on the nature of the study and where it is in its life cycle. People new to the IRB process might benefit from the Guide to the IRB Process.

See Submission Instructions for number of copies and where to send the application. See also meeting deadlines and schedules, important for studies that must be reviewed by the convened IRB ("full board" studies).

Forms may change without notice, and old forms will not be accepted after some period of time. You are strongly advised to go to this web page and download a current form each time you need to submit to the IRB.

Most forms are in Microsoft Word; some are Adobe Acrobat PDF.

Initial Application

Forms
Application for IRB Approval of Human Subjects Research (updated 25-June-2009)
Addendum for Multi-Site Studies Where UNC-CH is the Lead Coordinating Center
Determination Whether Research or Similar Activities Require IRB Approval (see instructions on form for when to use this) (updated 22-May-2009)

Consent

Templates for Standard Consent Documents (English documents revised 2-Oct-2007; Spanish, 7-Sep-2005, unless otherwise indicated)	Biomedical	Social Behavioral
Consent to Participate in a Research Study Adult Subjects	English: (updated 22-May-2009) Spanish:	English: (updated 22-May-2009) Spanish:
Parental Permission for a Minor Child to Participate in a Research Study	English: (updated 22-May-2009) Spanish:	English: (updated 22-May-2009) Spanish:
Assent to Participate in a Research Study Adolescent Subjects (15-17 yrs)	English: (updated 22-May-2009) Spanish:	English: (updated 22-May-2009) Spanish:
Assent to Participate in a Research Study Minor Subjects (7-14 yrs--use for Biomed and Soc/Beh)	English: Spanish:
Consent for Stored Specimens, Identified Consent for Stored Specimens, Unidentified (instructions for applications that include use of specimens)	English: English: (updated 24-Jun-2009)
Addendum to provide additional information to subject after original consent	English: (8-Sep-2008)
SSN Collection Forms 1. Use with subject to obtain permission to collect Social Security Number for payment 2. Use with subject to obtain permission to collect Social Security Number to use as an identifier (see SSN guidance for details)	English: (updated 28-Sep-2007) Spanish: (updated 16-Jun-2008) English: (updated 28-Sep-2007)
HIPAA Addendum to Consent Form
HIPAA Authorization Template	English: (updated 18-Mar-2009) Spanish: (updated 16-Sep-2005)
Alternatives to Full Consent Forms; Examples
Short Consent Form (for a single subject who may be illiterate, blind, or otherwise unable to read the consent form — used when full consent form has to be read or translated for subject; updated 22-May-2009)	English: Spanish: French:
Telephone Consent Script (example)
Postal or Email Letter for Anonymous Questionnaire (example)
Information or Fact Sheet (example)
Focus Group (example)

Submissions After Initial Approval: Renewal, Termination, Modification, Adverse Events

Important note for studies that were approved before March 15, 2005: If you used one of the initial application forms current before the formation of OHRE, these are usually grandfathered for renewals and modifications. However, if the IRB finds that the information on the old initial application form is inadequate, you may be requested to update to the new initial application form. Use the new (and brief) submission sheets below for modifications or renewals, but you may attach the existing approved description of the study (IRB application) and consent forms. Application and consent forms may be reformatted if the investigator prefers to use the new templates, but this is not required for previously approved studies. See the IRB Changes FAQ for additional information.

Form
Request for Renewal of IRB Approval or Study Closure (updated 26-Aug-2009)
Modification of Approved Human Subjects Research (updated 22-May-2009)
Effective June 1, 2009, Unanticipated Problems and Adverse Events must be reported online. Click here for instructions, training, and access to the web portal.

Other Forms

HIPAA-Related Forms for Access to Records at UNC-CH (not OHRE forms)
UNC HCS Form HD974: Request for Access to PHI or Aggregate Data for Research Purposes (UNC Hospitals medical records) (updated 7-Feb-2006)
UNC School of Dentistry Request for Access to Protected Health Information (PHI) for Research Purposes
UNC School of Dentistry Guidelines for Release of Protected Health Information (PHI) for Research Purposes
Miscellaneous
Responsibilities of Staff in Human Subjects Research
Statement of Compliance
Report of Emergency Use of a Test Article to the IRB (updated 01-Apr-2009)

Other Approvals that Might Be Required

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Sponsored Research

• Internal Processing Form (IPF) and Related Proposal Forms
• Budget Revision Forms
• Waiver and Exemption Forms
• Post Award Forms
• Service Center Operations

Internal Processing Form (IPF) and Related Proposal Forms

Title/Description	Format(s)	Notes	Policy/Questions	Admin. Office
Internal Proposal Processing Form (IPF)	Electronic Form	See Instructions and/or Frequently Asked Questions below.	Web form technical questions: Andrew Reynolds | Policy questions: Margaret Vigiolto	OSR
IPF Help page	HTML	IPF Instructions	n/a	OSR
IPF FAQ	HTML	Frequently Asked Questions	n/a	OSR
IPF Question List		Provides a hard copy of all the questions asked on the IPF.	n/a	OSR
Modular (Mod) Budget Justification		Modular Budgets only	Margaret Vigiolto	OSR
On-Campus Mod Budget Template		Modular Budget template, On-Campus only	Margaret Vigiolto	OSR
Off-Campus Mod Budget Template A		Modular Budget template, Off-Campus only	Margaret Vigiolto	OSR
Off-Campus Mod Budget Template B		Modular Budget template, Off-Campus within 10 miles only	Margaret Vigiolto	OSR
OSR Upload tool	ONYEN/SOMID required	Allows users to upload completed Grants.gov application package(s) to OSR or SPO for review.	Important: Please notify the appropriate OSR/SPO contract specialist after your application has been uploaded.	OSR
Sample Proposal Cover Page		Example if no prescribed form exists.	Margaret Vigiolto	OSR
Sample Subcontractor Commitment Letter (outgoing)		Example of the information required for incoming subcontract	Margaret Vigiolto	OSR
Sample Subcontractor Commitment Letter (incoming)		Example of the information required for outgoing subcontract	Margaret Vigiolto
Human Subjects Certification Data Sheet	or	Required with IPF when appropriate.	n/a	OSR
Project Financial Guarantee Form		Request made through RAMSeS to request account number prior to institutional acceptance of an award.	Contact ORIS HelpDesk 843-2594	OSR

Budget Revision Forms

Title/Description	Format(s)	Notes	Policy/Questions	Admin. Office
Cover Sheet Prime/Sub Budget Revision	or	n/a	n/a	OSR
Budget Revision	or	n/a	n/a	OSR
Prime/Sub Account Budget Revision	or	n/a	n/a	OSR

Waiver and Exemption Forms

Title/Description	Format(s)	Notes	Policy/Questions	Admin. Office
Cost Accounting Standards (CAS) Exemption Request	HTML	Used to charge costs normally treated as F&A, as Direct	Post Award Services	OSR
F&A Rate Reduction Request: Form 1		Used when sponsor is a for-profit company.  (see F&A Policy)	Margaret Vigiolto	OSR
F&A Rate Reduction Request: Form 2		Used for all other sponsors (see F&A Policy)	Margaret Vigiolto	OSR

Post Award Forms

Title/Description	Format(s)	Notes	Policy/Questions	Admin. Office
Application for Advancement of C&G Funds		Used to request an advance of Contracts & Grants Funds for cash advances	OSR Policy 500.14 OSR Procedure 500.14.1 / Post Award Services	OSR
Application for Purchase of Computers		Used to request approval for computer purchase	DDD memo on Direct vs. F&A charges to Sponsored Agreements	OSR
Equipment Assignment		Off site equipment assignment	Post Award Services	OSR
Final Invention and Certification Form			Post Award Services	OSR
Notice of Termination (NOTR)			Financial Reporting	OSR
Account Adjustment Request (AJ1)		Instructions included with the form.	Post Award Services	OSR
Letter of Justification: Changing Investigator's Percent Effort		Instructions included with the form.	n/a	OSR
Institutional Prior Approval System (IPAS)	or	Instructions included with the form.	n/a	OSR
Documentation of Non Personnel Cost Sharing		Used to document expenditures towards the fulfillment of cost sharing commitments.		OSR
PHS 3734		Official Statement Relinquishing Interests and Rights in a Public Health Service Research Grant	Kelly Musty	OSR
Travel Coordinator Certification Program	or	n/a	n/a	OSR

Service Center Operations

Title/Description	Format(s)	Notes	Policy/Questions?	Admin. Office
Service Center Oversight (Flowchart)		Flowchart to determine fee oversight authority.	Kevin Maynor	OSR
Research Service Center Policy	HTML	n/a
Research Service Center Procedure	HTML	n/a
Operating Guidelines for Institutional Research Service Centers
Research Service Center Operating Plan		n/a
Rate Development Worksheet		n/a

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Updated Monday, October 20, 2008.
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