|
AGREEMENTS
AND ASSURANCES |
| Clinical
Trial Agreement |
Agreements
between corporate-sponsors and Partners
CSCR
designates by department and specialty |
Doug Reichgott
|
Data
Use Agreement |
Agreement
between covered entity and researcher that limits
use/disclosure of PHI |
HIPAA
Privacy Officers Listed by Site |
IRB
Authorization Agreement |
Agreement
between institutions that allows an institution
to accept another institution's IRB approval |
Deb
Barnard |
| Materials
Transfer Agreement |
Agreement
covering the transfer of human materials to for-profit
entities |
Ed
Cormier |
|
CLINICAL TRIALS REGISTRATION |
| Principal
investigators are now being asked to register their
clinical trials in a publicly accessible registry.
In some cases this is a condition of consideration
for publication in a journal that has adopted the
registration requirements of the International Committee
of Medical Journal Editors (ICMJE). For more information
about clinical trials registration, click
here |
Deb
Barnard
Vicki Mirabello |
| CONTROLLED
SUBSTANCES IN RESEARCH |
| The
Massachusetts
Controlled Substances Registration (MCSR) to
use Controlled Substances and Investigational New
Drugs (IND) in Research, provides accountability
for the manufacture, distribution, dispensing, possession,
prescribing and administering of controlled substances
that, in Massachusetts, includes all prescription
drugs. See also Massachusetts DPH
researcher registration. |
Deb
Barnard
Vicki Mirabello |
| EDUCATION
REQUIREMENTS (CITI) AND EDUCATIONAL PROGRAMS |
| PHRC
Human Subject Protection Education Requirements
(CITI) |
Investigators
and study staff must complete a human subject protection
education program to participate in the conduct
of research. |
Vicki
Mirabello |
|
BWH Center for Clinical Investigation
(CCI) |
Educational
programs offered by the BWH CCI. |
Marianne
Moore |
MGH
Clinical Research Program
(CRP) |
Educational
programs offered by the MGH CRP. |
Lee Leahy |
| Harvard Medical Community Events Calendar |
Educational
programs offered by the Harvard Medical Community. |
Calendar Administrator |
| HIPAA
AND RESEARCH |
| Privacy
Rule |
The
Privacy Rule defines how institutions that provide
health care are required to protect the privacy
of identifiable health care information, including
information used or released for research. |
Judy
Scheer |
|
Security
Rule
|
The
Security Rule defines standards for protecting electronic
protected health information (PHI) with detailed
attention to how PHI is stored, accessed, transmitted,
and audited. |
Judy
Scheer |
| INSIGHT
(eIRB) |
Insight
Version 1.0
Protocol Tracking |
Web-based
application that allows investigators/study
staff to track documents submitted for review
to the PHRC. |
Daniel
Connor |
PHRC
Document Submission Tool |
Web
page that allows anyone to submit any type of document
to the PHRC for review. |
Daniel
Connor |
| MASSACHUSETTS
DEPT OF PUBLIC HEALTH RESEARCHER REGISTRATION |
| For
information about institutional compliance with
the Massachusetts DPH researcher registration requirements,
click
here. See also Controlled
Substances in Research. |
Deb
Barnard
Vicki Mirabello |
| PHRC
MEMBERSHIP |
| For
information about IRB membership |
Maria
Sundquist |
| PHRC
NEWSLETTER |
| For
information about the IRB newsletter content, distribution,
or suggestions |
Deb
Barnard |
| PHRC
REVIEW / POLICIES AND PROCEDURES / REGULATIONS |
| Tracking
Protocols/Submitted Documents |
See
Insight (eIRB) |
Daniel
Connor |
| For
questions about forms, instructions, or specific
requirements |
Maria
Sundquist |
| New
Submission |
For
information about requirements for submission of
new protocols, including research proposals limited
to the use of medical records and/or samples/specimens.
|
Maria
Sundquist |
| Continuing
Review |
For
information about requirements for continuing review
submissions as well as expiration of IRB approval
of a protocol.
|
Jo
O'Driscoll-Davis |
| Amendments,
Adverse Events, Other Events |
For
information about requirements for submission of
proposed
changes to ongoing IRB-approved protocols, as well
as prompt reporting of unanticipated problems involving
risks to subjects or others (SAEs and other events).
|
Maria
Sundquist |
| Consent
Forms |
For
information about preparation of consent forms |
Ann
Ogletree |
| Noncompliance |
For
information about requirements for reporting possible
or actual noncompliance with the regulations or
requirements of the IRB.
|
Rosalyn
Gray |
Subjects
Rights/Complaints |
For
information about subjects' rights and for information
on filing a complaint or reporting complaints by
subjects or others.
|
Rosalyn
Gray |
| Suggestions |
|
Rosalyn
Gray |
| PHRC
STAFF |
| Chairpersons |
Alphabetical
listing of all IRB chairpersons and brief biographical
information |
About
PHRC |
| Dept.
Protocol Administrators |
Departmental
listing of IRB Protocol Administrator assignments |
Contact
Protocol Administrator |
Management
Staff |
Listing
of key PHRC management staff |
Contact
PHRC Management |
| Staff
List |
Alphabetical
listing of all PHRC staff |
Contact
PHRC |
| RESEARCH
RESOURCES |
| Important
Data for NIH Funded Studies |
Information
on gender, race and ethnicity of patients seen at
BWH and MGH. |
Rosalyn
Gray |
|
BWH Center for Clinical Investigation
(CCI) |
The
Center for Clinical Investigation (CCI) provides
a full range of services and resources necessary
to expand and promote clinical research activities
at BWH. |
Yemi
Talabi-Oates |
| MGH
Clinical Research Program
(CRP) |
The
mission of the Clinical Research Program (CRP) is
to help develop a nurturing environment for clinical
research within the institution and a cadre of well-trained
investigators with opportunities to make careers
in clinical research.
|
Lee Leahy |
| Partners
Human Research Quality Improvement Program
(QI Program) |
Partners
Human Research Quality Improvement Program (QI Program)
is committed to providing on-going support and education
to the research community. Our knowledgeable staff
conducts routine on-site reviews, audit preparation,
on-site and online monitoring, and educational QI
In-services to ensure clinical research compliance.
Click
here to see a complete list and description
of the QI Program's services and activities. |
Delia
Wolf, MD |
BWH
- General Clinical Research Center
(GCRC)
|
The
GCRC provides a clinical research infrastructure
for physician investigators who conduct patient-oriented
research. |
BWH
GCRC
|
| MGH
- General Clinical Research Center (GCRC) |
The
GCRC provides a clinical research infrastructure
for physician investigators who conduct patient-oriented
research. |
MGH
- GCRC |
| Partners
Research Patient Data Registry (RPDR) |
The
Research Patient Data Registry (RPDR) is a central
clinical data registry allowing investigators to
focus and expedite their search for data in a manner
that respects patient confidentiality and follows
PHRC policies.
|
Laurie
Bogosian |
| SUGGESTIONS
/ COMMENTS / COMPLAINTS |
| To
make suggestions, provide comments, or make a complaint
about the PHRC/IRB review process. |
Rosalyn
Gray |
| WEBSITE |
| PHRC
Website |
Daniel
Connor
|
