Overview
Maine Medical
Center’s Institutional Review Board (MMC IRB) is a standing committee
responsible for protecting the rights and welfare of people who are
subjects in research activities. The MMC IRB Policies and Standard
Operating Procedures sets forth the IRB’s basic operational procedures.
The IRB
reviews and oversees research to ensure that it meets well established
ethical principles and that it complies with federal regulations at
45 CFR 46 and 21 CFR 50 and 56, that pertain to human subject protection,
as well as any other pertinent institutional, federal or state regulations
and guidelines.
All MMC
research activities proposing to involve human subjects must be reviewed
and receive written, unconditional approval from the IRB before commencing. This
policy applies to ALL research regardless of whether it is funded or
not.
The IRB
meets once a month, most always on the last Tuesday of every month. Submission
deadlines and meeting dates can be downloaded here.
All applications
for review and correspondence with the IRB should be directed to the
Research Compliance Office at MMCRI. For forms, application information,
administration concerns and general inquires please see additional
information or feel free to contact us.
Researcher
Responsibilities
- To conduct
research according to ethical principles, federal regulations, and
internal procedures.
- To ensure
participants are informed prior to enrollment and that communication
continues throughout the study.
- To protect
the rights and welfare of human research participants.
- To keep
Co-investigators and all research staff informed about the nature
and goals of the project.
- To obtain
IRB approval for revisions prior to initiation.
- To report
progress in a continuing review of approved research to the IRB Office
at least once a year.
- To report
to the IRB any serious injuries or other unanticipated problems involving
risks to participants or others.
Informed
Consent
The consent
process must provide potential participants with sufficient information
to make informed choices about either beginning or continuing participation
in research. The process involves a dynamic and continuing exchange
of information between the research team and the participant throughout
the research experience. The consent form is a tool to assist the researcher.
IRB Education
Requirement
IRB Fees
Categories
of Review for Research Protocols
The IRB
office maintains specific definitions according to federal regulations
and will refer to the regulations in finalizing the review determination.
1. Exempt
from further review
- Anonymous
survey / interview procedures or observation (without intervention)
of public behavior.
- Survey
/ interviews in which the participant can be linked and information
obtained is innocuous. Disclosure of this information would NOT reasonably
place the participant at risk of criminal or civil liability or be
damaging to the participants’ financial standing, employability
or reputation.
- Study
of existing data or pathological specimens if information is recorded
anonymously.
2. Expedited
Review
This includes
research involving no more than minimal risk. Minimal risk is defined
as a risk level similar to what is encountered in everyday activities:
- Surveys
which can be linked to participant and may request "sensitive" information,
- Blood
draws
- Non-stressful
research on individuals or group behavior,
- Study
of existing data or pathological specimens if information recorded
can be linked to participant,
- Recording
of data using non-invasive procedures.
Submission
Procedure
Review
Procedure
Continuing
review (renewal) required.
3. Full Committee Review
- Criteria
for exempt or expedited review are not met,
- Invasive
medical treatments,
- Physical
or psychological risk,
- Special
populations (minors, prisoners, incompetent participants).
Submission
Procedure: Full Committee Review materials
Review
Procedure
Continuing
review (renewal) required.
