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Guidelines for protection of human subjects

1. ^[1] 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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 consent.
11. 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.
    1. Subjects are considered to be at risk when either of these conditions is in effect:
       1. Procedures used in the research are novel and may have unknown consequences which may result in injury.
       2. Procedures used in the research place the subject at risk beyond the ordinary risks of daily life.
    2. The following procedures must apply:
       1. 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.
       2. The basic elements of fully-informed consent include:
          1. A fair explanation of the procedures to be followed and their purposes including identification of any procedures that are experimental.
          2. A description of any attendant discomforts reasonably to be expected.
          3. A description of any benefits reasonably to be expected.
          4. A disclosure of any appropriate alternative procedures that might be advantageous to the subject.
          5. Offer to answer any inquiries concerning the procedures.
          6. 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.
       3. The consent must be documented in one of the following three ways:
          1. 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).
          2. 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.
             1. 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.
             2. A copy of the approved summary is to be signed by the person obtaining the consent, typically the researcher and the witness.
             3. 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:
                1. Possible risk to any subject is minimal;
                2. Use of either of the primary procedures stated above would invalidate objectives of considerable immediate importance; and
                3. 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.
          3. 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.

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