|
AGREEMENTS
AND ASSURANCES |
|
Clinical
Trial Agreement |
Agreements
between corporate-sponsors and Partners.
For more information, refer to the PCRO web site. |
Maureen Lawton
|
|
Data
Use/Materials Transfer Agreements |
The linked spreadsheet defines the type of agreements that are needed when receiving or distributing data or tissue specimens to academic institutions or for-profit companies, and who may sign the agreement. All data or tissue transfers have to be approved by the IRB before the various departments (Research Management, Partners Clinical Research Office, Research Ventures and Licensing) will sign off on them.
NOTE: investigators should not sign any agreements, with the exception of outgoing HIPAA Limited Data Set data use agreements (if the PHS template is used) and outgoing Tissue Transfer Agreement Letters to Academic Collaborators.Refer to Data/Tissue Transfer Information. The link to the spreadsheet is a PHS internal only link. |
|
IRB
Authorization Agreement |
Agreement
between institutions that allows an institution
to accept another institution's IRB approval |
Maria
Sundquist |
| Materials
Transfer Agreement |
Agreement
covering the transfer of human materials to for-profit
entities. For more information, refer to the RVL web site. |
Ed
Cormier |
| Working
with Collaborators |
If
you are collaborating with someone outside of Partners
(non-MGH, BWH and/or Faulkner Investigators), please
review Working
with collaborators guidance document. |
Maria
Sundquist |
|
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 |
Sarah White
Emily Ouellette |
| 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. |
Sarah White
Emily Ouellette |
| 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. Click here to view staff members who have completed the education requirement. |
Partners CITI Administrator |
|
BWH Center for Clinical Investigation
(CCI) |
Educational
programs offered by the BWH CCI. |
Erin Grundman |
MGH
Clinical Research Program
(CRP) |
Educational
programs offered by the MGH CRP. |
Stacey Grabert |
| 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
eIRB |
The eIRB application allows users to electronically prepare, submit, sign and track their submissions to the Partners IRBs. Click here for instructions and reference guides.
|
Nilda Amado |
| PHRC
MEMBERSHIP |
| For
information about IRB membership |
Maria
Sundquist |
| PHRC
NEWSLETTER |
| For
information about the IRB newsletter content, distribution,
or suggestions |
Rosalyn
Gray |
| PHRC
REVIEW / POLICIES AND PROCEDURES / REGULATIONS |
| Tracking
Protocols/Submissions |
See
Insight eIRB. |
Nilda Amado |
| 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.
|
Fareeza Nazir |
| 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. |
Maria
Sundquist |
| 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 (PHS internal link) |
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.
|
Stacey Grabert |
AE/SAE Notification Tool
for Clinical Researchers |
The AE/SAE Notification Tool can be set up to automatically notify you if your research subjects come in to many of the PHS Emergency Departments or are directly admitted to a hospital. The system covers PHS affiliated hospitals and reduces the amount of time to gather information about adverse events and reinforces subject safety. Designated study staff can be notified by email, page or phone 24/7. Click here for more information. |
Keith Jennings |
| 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. |
Sarah White |
| Partners Research Computing |
Providing Partners Investigators with consulting, training, technical computing, cloud services, administrative applications, data and more.... (PHS internal only link) |
Contacts |
| 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. For access, contact rpdrhelp@partners.org with the protocol number of the study that is IRB approved to use RPDR.
|
RPDR Help |
| SUGGESTIONS
/ COMMENTS / COMPLAINTS |
| To
make suggestions, provide comments, or make a complaint
about the PHRC/IRB review process. |
Rosalyn
Gray |
| WEBSITE |
| PHRC
Web site |
|
