- How
and when do you receive the materials to review?
The
agenda and materials related to the human-subjects
research and clinical investigations scheduled
for review at the PHRC meeting are delivered by
courier to members at least five (5) days in advance
of the meeting to allow them sufficient time for
review. For more information, see PHRC
Governance and Operating Procedures.
-
What regulatory and ethical issues do you consider
when reviewing a protocol?
The
PHRC office has created a “Points to Consider”
guidance document for PHRC members, which outlines
the Criteria
for IRB Approval of Research. This document
is included in each PHRC meeting packet and is
available on the PHRC website.
-
How do you evaluate risk and benefit when reviewing
a protocol?
The
PHRC office has created a “Points to Consider”
guidance document for PHRC members, which outlines
the Criteria
for IRB Approval of Research. This document
is included in each PHRC meeting packet and is
available on the PHRC website. Additionally, a
one-page document on Analyzing
Risks and Benefits was created to serve as
a mini refresher for PHRC members.
-
Do you use a checklist to remind you of the issues
while you review a protocol?
The
PHRC office has created a Reviewer
Worksheet, which outlines the criteria for
IRB approval of research and provides members
and reviewers with the framework for review. Additionally
the “Points to Consider” guidance Criteria
for IRB Approval of Research and Requirements
for Informed Consent are included in each
PHRC meeting packet and are available on the PHRC
website.
-
If you think that additional expertise beyond
that available on the committee is needed for the
protocol review, whom do you tell?
Contact
the Chairperson or Administrative Chairperson
and let him/her know that you think that additional
expertise beyond that available on the Committee
is needed. Additionally, when the protocol is
discussed at the meeting, the Committee may vote
to defer action and require review by an expert
in the scientific area or discipline. When additional
expertise is needed, the Chairperson is responsible
for identifying a consultant and for requesting
such consultation. The Chairperson may solicit
recommendations from PHRC members and from others
in the medical community. Consultants may attend
the meeting or provide written comments; however
consultants in attendance are not considered voting
members and may not vote with the Committee. For
more information, see PHRC
Governance and Operating Procedures, Use of Consultants.
-
How do you evaluate investigator financial conflicts
of interest?
The
PHRC has a new policy that requires investigators
to complete an investigator financial disclosure
form if 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. The PHRC office reviews these forms
and refers disclosures of financial conflicts
of interest to Libby
Hohmann, the Director and Chair, who will
bring any potential financial conflict of interest
to the attention of the Committee for consideration.
The Financial
Conflicts of Interest policy and Investigator
Financial Disclosure form are available on
the PHRC website.
-
How do you review the consent form? What
elements do you check? Do you use a checklist to
remind you of these elements?
The
PHRC office provides members and reviewers with
the guidance document Requirements
for Informed Consent in each PHRC meeting
packet. Additionally, the PHRC office has developed
an Informed
Consent Document Checklist and Instructions
for Preparing Research Consent Forms, both
of which are available on the PHRC website.
-
What do you consider when you review privacy protections?
The
PHRC office has created a “Points to Consider”
guidance document for PHRC members, which outlines
the Criteria
for IRB Approval of Research. This guidance
document has a section on privacy protections.
This document is included in each PHRC meeting
packet and is available on the PHRC website. Additionally,
a one-page document on Confidentiality
Versus Privacy and How it Relates to Human Subjects
Protections was created to serve as a mini
refresher for PHRC members.
-
What do you consider when you review confidentiality
protections?
The
PHRC office has created a “Points to Consider”
guidance document for PHRC members, which outlines
the Criteria
for IRB Approval of Research. This guidance
document has a section on confidentiality protections.
This document is included in each PHRC meeting
packet and is available on the PHRC website. Additionally,
a one-page document on Confidentiality
Versus Privacy and How it Relates to Human Subjects
Protections was created to serve as a mini
refresher for PHRC members.
-
How are confidentiality protections different from
privacy protections?
Confidentiality
refers to the researcher’s agreement with the
participant about how the participant’s identifiable
private information will be handled, managed and
disseminated. The evaluation of confidentiality
should include storage, handling and sharing of
data. Privacy refers to a person’s desire to control
the access of others to themselves. The evaluation
of privacy should include how the investigator
will access information from or about participants.
Additionally, a one-page document on Confidentiality
Versus Privacy and How it Relates to Human Subjects
Protections was created to serve as a mini
refresher for PHRC members.
-
How is the duration of approval decided? When do
you consider approving studies for less than one
year?
The
duration of approval may not exceed one year from
the date at which the protocol was approved (or
approved with modifications) at a convened meeting
of the PHRC. When determining the duration of
approval, the PHRC considers the degree of risk
to subjects. Examples of protocols that may be
considered for review more frequently than annually
include:
-
Phase I studies of a challenging or novel new
drug or biologic;
-
Studies involving Category A significant risk
devices;
-
Studies in which healthy volunteers may undergo
anesthesia or medical procedures involving sedation
with no direct health benefits;
-
Studies for which there is little external oversight
or data safety monitoring;
-
Studies involving gene transfer or xenotransplantation;
or
-
Studies involving infectious agents.
For
more information, see Initial
and Continuing Review of Human-Subjects Research
and Proposed Changes in Approved Research at a
Convened PHRC Meeting.
-
Are there special considerations for involvement
of children in research?
Yes.
Researchers are required to complete the PHRC
form Additional
Protections for Children Involved as Subjects
in Research that addresses the regulatory
requirements for approval of research involving
children. The information provided by the researchers
in this form assists the PHRC in making the determinations
required by regulation about research including
children. Additionally, PHRC has a policy on Research
Involving Vulnerable Populations.
-
Are there special considerations for involvement
of pregnant women and fetuses in research?
Yes.
Researchers are required to complete the PHRC
form Additional
Protections for Pregnant Women or Human Fetuses
Involved in Research that addresses the regulatory
requirements for approval of research involving
pregnant women or human fetuses. The information
provided by the researchers in this form assists
the PHRC in making the determinations required
by regulation about research involving pregnant
women or human fetuses. Additionally, PHRC has
a policy on Research
Involving Vulnerable Populations.
-
Are there special considerations for involvement
of prisoners?
Yes,
however because the Partners Human Research Committee
(PHRC) does not meet the special membership requirements
for review of research involving prisoners, Partners
has executed an IRB Authorization Agreement with
the Harvard School of Public Health (HSPH) that
allows the PHRC to utilize the HSPH IRB for review
of research involving prisoners. For more information,
refer to the PHRC guidance on Research
Involving Prisoners.
-
Are there special considerations for involvement
of decisionally-impaired persons?
Yes.
Researchers are required to complete the PHRC
form Additional
Protections for Individuals with Impaired Decision-making
Capacity and provide the rationale for including
subjects who are decisionally impaired in their
research. Additionally, Human Research Affairs
has developed guidance on Surrogate
Consent to Research for Individuals with Impaired
Decision-making Capacity (internal link) for
researchers and PHRC members. The information
provided by the researchers in this form and the
guidance document on surrogate consent assists
the PHRC in making the determinations about the
appropriateness of including individuals with
impaired decision-making in the research.
-
How do you determine whether an IND is needed when
an FDA-approved drug is being studied for another
indication?
The
FDA has specific criteria for determining when
the off-label research use of an approved drug
requires an IND. The PHRC has developed a form
Research
Use of Drugs/Biologics/Dietary Supplements
that requires researchers to provide the PHRC
with information related to the FDA status of
the drug and its use in the study. This form captures
information related to these special criteria
and assists the PHRC in its determinations about
whether or not off-label use of an approved drug
for research requires an IND.
-
How do you determine whether an IDE is needed when
a device is being studied?
The
PHRC is responsible for reviewing clinical investigations
of devices and for determining whether the study
is a significant risk or nonsignificant risk device
study. When the clinical investigation is being
conducted under an IDE, the sponsor and the FDA
have already determined that the device is a significant
risk device. In the absence of an IDE, the PHRC
must make this determination. The PHRC has developed
a form Research
Related Use of Medical Devices that requires
researchers to provide information to assist the
PHRC in making the determination about the risk
status of the device.
-
What do you do if you have a conflict of interest
with a protocol that is on the agenda of the meeting
you plan to attend?
Partners
has a Conflicts
of Interest Policy for IRB Members. PHRC members
are required to disclose any conflicts of interest
and recuse themselves from participating in the
discussion and vote on human-subjects research
with which they have a conflict of interest. When
meeting materials are delivered, members are reminded
by email to review the agenda and notify the Chairperson
or Administrative Chair of any conflicts of interest.
The Chairperson also reminds members at the beginning
of each meeting that they must recuse themselves
and leave the room for the discussion and vote
on any research with which they have a conflict
of interest, except to provide information at
the PHRC’s request prior to the discussion and
vote. Recusals are noted in the minutes of the
meeting and do not count towards the quorum requirement
for the review. For more information about conflicts
of interest, see PHRC
Governance and Operating Procedures, Conflicts
of Interest.
-
What do you do if you think that you are being pressured
into approving a protocol that you might not otherwise
approve?
The
PHRC must exercise its authority to approve human-subjects
research with independence. No one within the
institution may overrule the PHRC’s decision to
disapprove research. In the event that you feel
you are being pressured or unduly influenced by
someone to provide a specific vote or outcome
of a study under review, you should report this
to Libby
Hohmann or Rosalyn
Gray as soon as possible. They will work with
the Director of Partners Human Research Affairs
(HRA) and the Institutional Officials (IOs), as
necessary, to remedy any concern. For more information
about the independence of the IRB and undue influence,
see PHRC
Governance and Operating Procedures, Independence
of the IRB and Undue Influence.
-
When you became an IRB member, did you receive an
orientation?
The
PHRC instituted a formal member orientation program
three years ago. New members are now asked to
complete the CITI Basic Course and meet with the Administrative Chair of their panel.
-
As an IRB member, do you receive any routine training
and/or educational materials?
During
PHRC meetings, individual topics are covered through
“IRB Education Bites,” one-page or short documents
that focus on a specific IRB regulatory or policy
issue. Topics that have been covered in the past
year can be found on the PHRC website under PHRC
Member Handbook, Education. Additionally,
the PHRC obtains a subscription for members to
"IRB Ethics & Human Research" and
"Human Research Report," and also offers
members the opportunity to attend PRIM&R conferences.