| New
Protocol Submission Forms |
| For
studies involving oncology / cancer research and/or
DFCI principal investigators, co-investigators or
any other DFCI resource, see the oncology
guidance before completing any of the following
forms. |
|
Submission
Instructions and Checklist
6/08
|
Instructions
and checklist for the submission of a new research
protocol for PHRC review. |
| Human
Subject Intervention / Interaction Forms |
Application
Form
8/08
|
For
research involving an intervention or interaction
with human subjects. In some cases an Expedited
Application Form may be used, or for research
limited to Health/Medical Records and Human Material/Tissue,
see limited research application
forms below.
|
Expedited
Application Form
7/08 |
For
research limited to blood collection; prospective
collection of data/samples by noninvasive means;
collection of data through noninvasive procedures
routinely employed in clinical practice; collection
of data through audiovisual recordings made for
research purposes; research employing surveys, interviews,
focus groups, evaluation or QA methodologies.
NOTE: A full
application may be required at the discretion
of the PHRC chair reviewing the protocol.
|
| Sponsor/Funding
Information
4/02
|
To
be included with a PHRC submission
when a research study has more than one sponsor. |
Investigator
Financial Disclosure
2/08 |
Principal
investigators and co-investigators must complete
this form and submit to the IRB in conjunction with
the Application
form when the research involves ANY of the following:
(1) for-profit sponsor or funding source; (2) a
marketed drug, device, or other technology, or a
drug, device, or other technology in development;
or (3) a new technology, software or therapeutic
approach.
|
Site Responsible Investigator
8/08 |
To
be included with a PHRC submission
when a research study involves multiple Partners
performance sites, e.g., BWH
and MGH, complete the site-responsible
investigator form for all sites except the overall
PI's site.
|
|
Co-Investigator/ Study Staff Certification
8/07 |
To
be included with a PHRC submission for each
Co-Investigator and study staff member. Only one
individual in addition to the PI should be designated
as the contact person.
If non-BWH/non-MGH
employees will perform institutionally
designated research activities or exercise institutionally
delegated authority or responsibility for research,
please see the policy "Non-BWH/MGH
Employees As Co-Investigators/Study Staff."
|
HSPH
Site Responsible Investigator
6/06 |
To
be included with a PHRC submission when a research
study involves
Harvard School of Public Health (HSPH) as a performance
site.
|
Protocol
Summary
6/05 |
To
be included with a PHRC submission
unless noted otherwise in submission
instructions. Summary
document describes protocol and investigator's plan
for recruitment and enrollment of subjects. Includes
important regulatory information needed for IRB
review. Refer to documents Prescreening
and Recruitment Guidelines
for acceptable methods of recruitment. Sample
recruitment letters are available.
|
| Schema
Instructions
3/98
|
To
be included with a PHRC submission when the research
involves multiple groups, treatment arms, or randomization.
|
Detailed
Protocol Instructions
3/02
|
Instructions
for investigators who are writing their own protocol
for use when there is no sponsor initiated protocol
or cooperative group protocol.
|
Ancillary
Committee/Specialized Review Forms:
These forms must be submitted with the application
form when applicable. |
Children
8/08
|
For
research enrolling children as research subjects. |
|
Individuals
with Impaired Decision-making
6/05
|
For
research involving adult subjects
with impaired decision-making capacity who cannot
give informed consent and for whom consent to participate
in research will be obtained from a legally authorized
representative as determined by state or local law. |
Neonates
in Research
11/05
|
For
research involving neonates of uncertain viability
and/or nonviable neonates. |
Pregnant
Women/Fetuses
6/05 |
For
research involving pregnant women and human fetuses. |
Wards
of the State
8/08
|
For
research enrolling children as research subjects who
are wards of the State. |
Medical
Devices
6/07
Non-Hospital
Inventory FDA-Approved Devices
8/08
|
For
research involving a medical device that is being
investigated or used as a comparator, or for non-FDA
approved medical devices that are being used to
study human physiology, complete the Medical
Device form. A separate form should be completed
for each medical device being investigated or used.
For
research involving a non-hospital inventory FDA-approved
medical devices provided by the sponsor or others
that is used for research-related ancillary tests,
procedures, or monitoring in accordance with the
device’s FDA-approved labeling, complete the Non-Hospital
Inventory FDA-Approved Devices form. A separate
form should be completed for each non-hospital inventory
FDA-approved medical device being provided.
|
Drugs/Biologics
8/05 |
For
research evaluating or using FDA-approved or investigational
drugs or biologics. A separate form should be completed
for each drug or biologic being evaluated or used.
Do not complete this form for supportive care drugs.
|
Nursing
(Inpatient Studies)
3/98 |
For
research involving inpatients.
|
Radiation
Exposure
3/98
|
For
research involving research related exposure to x-rays
or radiation. |
Nonionizing
Radiation
11/01 |
For
research involving research related exposure to
nonionizing radiation: ultrasound, MRI, lasers,
or ultra-violet radiation.
|
| Waiver
of Informed Consent and
Authorization for Research
2/03
|
Form
used to request waiver of informed consent and authorization
from subjects. See PHRC Policy on Waivers
of Informed Consent and Authorization. |
| Research
Limited to Health/Medical Records and Human Material/Tissue
Application Forms |
Excess
Human Material
12/06 |
For
research limited to the use of human material/tissue
collected as part of the patient's clinical care.
|
| Health/Medical
Records
12/06
|
For
research limited to the use of health/medical records
only. Replaces the Medical Records form. |
Research
Data Repository
11/03 |
For
establishment of a data repository of identifiable
health information derived from patient medical
records, other hospital records, or practice-based
patient health information to conduct research and/or
quality improvement activities. Replaces
the Research-Related Patient Database form.
|
Secondary
Use of Research Samples/Data
4/03
|
For
research limited to the secondary use of human samples
or data. Secondary use is the use of previously
collected samples and/or data for a new research
project.
|
Tissue
or Sample Repository
12/05 |
For
research projects which bank or store human material/tissue
for future research uses. TISSUE
is defined as any specimen/sample obtained
from patients (or human research subjects), for example,
fixed, frozen or fresh pathology or autopsy specimens,
any blood, urine, saliva, semen, breast milk or other
biological material, any purified DNA, RNA, proteins,
cell lines or clones. See Policies
& Guidance on Tissue Uses and Tissue Banking.
|