- Distinction Between Research In Human Subjects And
Clinical Care
The Belmont Report, which defined the Ethical Principles
and Guidelines for the Protection of Human Subjects of Research,
was published in the Federal Register in 1979. The guidelines
put forth in the Report are still accepted as the "gold
standard" for conducting research in human subjects.
An important section of the Belmont Report was a description
of the boundaries between research and clinical practice and,
therefore, the following is quoted directly from the Report:
"It is important to distinguish between biomedical
and behavioral research, on the one hand, and the practice
of accepted therapy on the other, in order to know what activities
ought to undergo review for the protection of human subjects
of research. The distinction between research and practice
is blurred partly because both often occur together (as in
research designed to evaluate a therapy) and partly because
notable departures from standard practice are often called
"experimental" when the terms "experimental"
and "research" are not carefully defined.
For the most part, the term "practice" refers
to interventions that are designed solely to enhance the well
being of an individual patient or client and that have a reasonable
expectation of success. The purpose of medical or behavioral
practice is to provide diagnosis, preventive treatment or
therapy to particular individuals. By contrast, the term "research"
designates an activity designed to test an hypothesis, permit
conclusions to be drawn, and thereby to develop or contribute
to generalizable knowledge (expressed, for example, in theories,
principles, and statements of relationships). Research is
usually described in a formal protocol that sets forth an
objective and a set of procedures designed to reach that objective.
When a clinician departs in a significant way from standard
or accepted practice, the innovation does not, in and of itself,
constitute research. The fact that a procedure is "experimental"
in the sense of new, untested or different, does not automatically
place it in the category of research. Radically new procedures
of this description should, however, be made the object of
formal research at an early stage in order to determine whether
they are safe and effective. Thus, it is the responsibility
of medical practice committees, for example, to insist that
a major innovation be incorporated into a formal research
project.
Research and practice may be carried on together when research
is designed to evaluate the safety and efficacy of a therapy.
This need not cause any confusion regarding whether or not
the activity requires review; the general rule is that if
there is any element of research in an activity, that activity
should undergo review for the protection of human subjects."
- Requirements of Mount Sinai School of Medicine IRB:
1. General Requirements:
All research that is to be conducted in human subjects
by individuals with full-time, voluntary, or part-time faculty
appointments in the Mount Sinai School of Medicine must be
submitted to the Grants
and Contracts Office (GCO) and must be reviewed by the
Mount Sinai School of Medicine
IRB. No research in human subjects can be initiated without
IRB approval (unless specifically categorized as exempt from
IRB review). The period of approval will be indicated in a
written communication with the Principal Investigator. It
is important to note that the IRB is only authorized to approve
a project for a maximum period of 365 days. To renew the approval
period of a project, the investigator must submit an application
to the GCO for review and approval by the IRB. It is the responsibility
of the Principal Investigator to provide an annual submission
for uninterrupted IRB approval. Applications must be submitted
at least one month prior to the date that approval terminates.
The IRB is not authorized to issue an extension of time.
The MSSM IRB meets the first and third Tuesday of each
month. All new and continuing applications that are submitted
to the GCO between the 16th of the preceding month and first
of the month (or the next business day) will be considered
at the IRB meeting on the third Tuesday of that month and
those that are submitted between the second of the month and
fifteenth of the month (or the next business day) will be
considered at the meeting on the first Tuesday of the following
month.
In reviewing research protocols involving human subjects,
the IRB considers the expertise and experience of the investigators
to be a major indicator that risks to the subjects will be
minimized and benefits from the study maximized. The IRB encourages
principal investigators to include co-investigators who are
knowledgeable and experienced in the performance and evaluation
of procedures to be used in the research. The co-investigators
should have an active role in developing the research proposal
and they must assume responsibility for the accuracy and appropriateness
of those parts of the proposal related to their particular
expertise. They are responsible to have knowledge of all study
procedures as well as the risks, benefits and adverse effects.
This information is provided to subjects as part of the informed
consent process.
To document the acceptance of this responsibility and the
agreement to participate in the study once it is approved,
each co-investigator must sign the human subjects research
application in the section of the GCO packet labeled Programmatic
Assurance.
Principal investigators are urged to consult with the appropriate
co-investigators early in the process of protocol development
and arrange to obtain the required signatures before the application
is submitted to the IRB.
2. Requirements for Research in Human Subjects at Affiliates
of MSSM:
In each case in which MSSM is the IRB of record the following
applies:
2.1. Human subjects research committees at affiliates
of MSSM have a liaison serving as a member of the MSSM IRB.
Recommendations of committees at the affiliates will be reviewed
by the MSSM IRB, however, the MSSM IRB will make the final
determination regarding approval of the project. Research
cannot be conducted at an affiliate until approval is granted
by the MSSM IRB.
2.2. For research conducted at affiliate institutions,
concurrent submissions to the affiliate institution and the
MSSM IRB are required. With the exception of components of
the consent document which are not directly applicable to
the affiliate institution, the MSSM IRB requires that consent
documents utilize the MSSM format. The MSSM IRB Policies and
Guidelines Manual and GCO forms for conducting research in
human subjects are available at each affiliate site. When
approval of a project is granted, the MSSM IRB will notify
the investigator as well as the research office at the affiliate
institution.
2.3. Reports of adverse events, requests for approval
of modifications in protocols and/or consent forms or administrative
matters relative to a project must be submitted to the affiliate's
research office. The format for reporting adverse events must
be that used by MSSM investigators. It is the responsibility
of the research offices at each affiliate to promptly transmit
all such information to the MSSM IRB or to require direct
transmission of the information by the investigator to the
MSSM IRB.
- Requirements for Informed Consent
The general requirements for informed consent are published
in the Code of Federal Regulations (CFR), Title 45, Part 46
(45 CFR 46). Based on the Multiple Project Assurance (MPA)
that the Dean of MSSM has signed and the federal agency that
has oversight for human subject research has approved, MSSM
has assured that ALL MSSM investigators, including those at
affiliated institutions, will comply with ALL federal regulations,
regardless of the funding source that supports their research
in human subjects.
Please see the IRB Web
site for administrative information, application forms,
the MSSM Multiple Project Assurance, the IRB Guidelines and
Policy Manual, the IRB Procedures Manual, and links to several
federal documents including the Code of Federal Regulations
(45 CFR 46), FDA information sheets and the Belmont Report.
