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Guidelines for protection of human subjects
-  In
planning a study the investigator has the personal responsibility to make
a careful evaluation of its ethical acceptability, taking into account these
Principles for research with human beings. To the extent that this appraisal,
weighing scientific and humane values, suggests a deviation from any Principle,
the investigator incurs an increasingly serious obligation to seek ethical
advice and to observe more stringent safeguards to protect the rights of
the human research subjects.
- Responsibility for the establishment and maintenance of acceptable ethical
practice in research always remains with the individual investigator. The
investigator is also responsible for the ethical treatment of research subjects
by collaborators, assistants, students, and employees, all of whom, however,
incur parallel obligations.
- Ethical practice requires the investigator to inform the subject of all
features of the research that reasonably might be expected to influence willingness
to participate and to explain all other aspects of the research about which
the subject inquires. Failure to make full disclosure gives added emphasis
to the investigator's responsibility to protect the welfare and dignity of
the research subject.
- Openness and honesty are essential characteristics of the relationship
between investigator and research subject. When the methodological requirements
of a study necessitate concealment or deception, the investigator is required
to ensure the subject's understanding of the reasons for this action and
to restore the quality of the relationship with the investigator.
- Ethical research practice requires the investigator to respect the individual's
freedom to decline to participate in research or to discontinue participation
at any time. The obligation to protect this freedom requires special vigilance
when the investigator is in a position of power over the subject. The decision
to limit this freedom increases the investigator's responsibility to protect
the subject's dignity and welfare.
- Ethically acceptable research begins with the establishment of a clear
and fair agreement between the investigator and the research subject that
clarifies the responsibilities of each. The investigator has the obligation
to honor all promises and commitments included in that agreement.
- The ethical investigator protects subjects from physical and mental discomfort,
harm, and danger. If the risk of such consequences exists, the investigator
is required to inform the subject of that fact, secure consent before proceeding,
and take all possible measures to minimize distress. A research procedure
may not be used if it is likely to cause serious and lasting harm to subjects.
In addition, guideline #11 applies in all cases
where subjects are at risk.
- After the data are collected, ethical practice requires the investigator
to provide the subject with a full clarification of the nature of the study
and to remove any misconceptions that may have arisen. Where scientific or
humane values justify delaying or withholding information, the investigator
acquires a special responsibility to assure that there are no damaging consequences
for the subject.
- Where research procedures may result in undesirable consequences for the
subject, the investigator has the responsibility to detect and remove or
correct these consequences, including, where relevant, long-term after-effects.
- Information obtained about the research subjects during the course of
an investigation is confidential. When the possibility exists that others
may obtain access to such information, ethical research practice requires
that this possibility, together with the plans for protecting confidentiality,
be explained to the subjects as a part of the procedure for obtaining informed
- When human subjects are at risk for physical, psychological,
or social injury through participation in research, special procedures are
necessary which cannot be violated. These procedures are in keeping with
rules and regulations concerning protection of human subjects established
by the United States Department of Health and Human Services.
- Subjects are considered to be at risk when either of these conditions
is in effect:
- Procedures used in the research are novel and may have unknown
consequences which may result in injury.
- Procedures used in the research place the subject at risk
beyond the ordinary risks of daily life.
- The following procedures must apply:
- Fully informed consent must be obtained. Such consent consists
of the knowing consent of the individual or his legally authorized
representative. The consent must be given under conditions such
that the individual can exercise free power of choice as to participation,
without undue inducements or any element of force, fraud, deceit,
or other forms of constraint or coercion.
- The basic elements of fully-informed consent include:
- A fair explanation of the procedures to be followed
and their purposes including identification of any procedures
that are experimental.
- A description of any attendant discomforts reasonably
to be expected.
- A description of any benefits reasonably to be expected.
- A disclosure of any appropriate alternative procedures
that might be advantageous to the subject.
- Offer to answer any inquiries concerning the procedures.
- An instruction that the person is free to withdraw his
consent and to discontinue participation in the project
or activity at any time without prejudice to the subject.
- The consent must be documented in one of the following three
- Signature by the subject or his legally authorized representative
of a consent form containing all of the above basic elements
of informed consent. The document may be read to the subject
or representative, but the subject or representative must
be given adequate opportunity to read it. Sample copies
of the document must be submitted to, approved by, and
retained by the Institutional Review Board for the Protection
of Human Subjects (IRB).
- Signature by the subject or representative of a short
form consent document indicating that the basic elements
of informed consent have been presented orally to the subject
or representative. The short form is to be signed by the
subject or his representative and a witness to the oral
presentation and the subject's or representative's signature.
- A written summary of what is to be said to the
subject or representative is to be submitted to,
approved by, and retained by the IRB.
- A copy of the approved summary is to be signed
by the person obtaining the consent, typically the
researcher and the witness.
- A modification of either of the procedures outlined
above. Permission to use a modification must be approved
by the IRB and the administration. The following
conditions must be established:
- Possible risk to any subject is minimal;
- Use of either of the primary procedures
stated above would invalidate objectives of
considerable immediate importance; and
- Any reasonable alternative means for obtaining
these objectives would be less advantageous
to the subject. The IRB's reasons for permitting
use of any modified procedures must be individually
and specifically documented in the board's
minutes and reports.
- All proposals where subjects are at risk for injury must
be carefully evaluated by the IRB to ensure that the risk
is justified, that all possible care has been taken to
protect the subjects, and that all steps in Sections A
and B are being followed.
 The first ten principles
are modified versions of the ten principles from Ethical Principles in The Conduct
of Research With Human Participants, American Psychological Association, 1973.
Modifications reprinted with permission.