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Guidebook
SECTION
B: FORMS CHECKLIST
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See also:
Downloading
Forms Bureau Approval Forms
Who
Signs What FAQ:
Forms
| APPLICATIONS FOR FUNDING |
Forms/Documents Required: |
Found in Section |
IF This is
an application for external funding (grant, contract, cooperative agreement,
gift or donation)
Section D-I
is required for all applications for external funding, including non-research
projects, research projects that are exempted from IRB review, and animal
research projects.
|
Administrative Approval
Form
Copy of grant application
Copy of project budget |
D-I |
|
| IF This project
will use the resources of the following for more than routine care:
Pharmacy Services
Laboratories |
Pharmacy Commitment Form
Laboratory Commitment
Form |
D-II.a
D-II.b |
|
| IF
Biohazardous materials will be brought to the facility specifically for
this project;
OR |
Research
Biosafety Form
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|
| Radioactive materials
will be used for research purposes apart from normal clinical care;
OR |
| This project will employ
recombinant DNA |
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NEW RESEARCH PROJECTS |
| Human
Research |
Forms/Documents Required: |
Section |
| IF
This project will require either a full or expedited IRB review (See
Section C.11)
OR |
Administrative
Approval Form
Scientific Committee (IRB)
Approval Form
Complete Protocol
Consent Forms to be used,
reproduced on letterhead |
D-I
D-III
D-V |
| IF
This project qualifies for an exemption from IRB review (See
Section C.16) |
Request
for Exemption from Review |
D-III.f |
Animal Research |
| IF
This is a research or training project using vertebrate animal subjects |
Animal
Committee Forms
Research Protocol |
|
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| All Research
IF
You have a significant financial interest in this research project (See
Section C.4)
|
Financial Interest Statement |
D-II.d
|
CONSENT FORMS
You may rewrite, reformat
or edit these samples as long as the document includes all required elements
of informed consent (See
Section C.24). Consent forms must be reproduced on institutional letterhead |
|
| Sample Form to Consult |
Section |
| IF Your
study will employ participants over age eighteen |
Basic Consent to Research |
D-V.a |
| IF Your study
will employ participants under the age of 18 (See
Section C.29) |
Permission & Assent
for a Minor to Participate in Research |
D-V.b |
| IF Your study
will employ persons lacking decision making capacity (See Sections
C.30 & C.32) |
Permission for a
Person Lacking Decision Making Capacity to
Participate in Research |
D-V.c |
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| CONTINUING
PROJECTS |
| For Human Research Projects: |
Forms/ Documents Required |
Section |
IF
Your protocol is due to be renewed
(See
Section C.53) |
Progress Report Form |
D-
IV.a |
| IF You must
report an adverse event (See
Section C.55 ) |
Adverse Event Report
Form
A letter with this information
is acceptable in lieu of the form |
D-
IV.b |
| IF
You wish to request approval for a revision to your protocol or consent
form |
A letter describing the
changes and a copy of the new consent form or protocol, if any |
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For Animal Research Projects: |
| IF
You wish to request approval for a revision to your protocol |
A letter describing the
changes |
|
| IF
Your protocol is due to be renewed |
Animal Committee Annual
Report Form |
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Send comments to ord@cchil.org
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