ÑÇÉ«Ó°¿â

The decision to conduct research should rest upon a considered judgment by the investigator as to the relative contributions of the research activities pondered and their concomitant risks to human subjects. Researchers should thus carry out their investigations with respect for the people who may choose to participate, their families, cultures, institutions, social systems, and the environment. The principles which follow are intended to explicate the investigator's ethical responsibilities toward human subjects in research.

1. In planning a study, the investigator has the personal responsibility to make a careful evaluation of its ethical acceptability, taking into account the previously described principles for research with human subjects. 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 the research subjects by collaborators, assistants, students, and employees, all of whom, however, incur parallel obligations.
   
3. Ethical practice requires the investigator to inform subjects 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 subjects inquire. Openness and honesty are essential characteristics of the relationship between investigator and research subjects. When the methodological requirements of a study necessitate concealment or deception, the investigator is required to ensure subjects' understanding of the reasons for this action. Such deception or concealment increases the investigator's responsibility to protect the welfare and dignity of the research subjects.
   
4. 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 subjects. A decision to limit this freedom increases the investigator's responsibility to protect the subjects' dignity and welfare.
   
5. The ethical investigator must maintain a clear separation of roles between that of researcher and any other position, on campus as well as off campus, that impinges on the study.
   
6. Ethically acceptable research begins with the establishment of a clear and fair agreement between the investigator and the research subjects 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 subjects 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.
   
8. After the data are collected, ethical practice requires the investigator to provide the subjects 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 not damaging consequences for the subjects.
   
9. Where research procedures may result in undesirable consequences for the subjects, the investigator has the responsibility to detect and remove or correct these consequences, including, where relevant, long-term aftereffects.
   
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.

The ÑÇÉ«Ó°¿â Statement of Research Ethics is fully consistent with the text of": Ethical Principles and Guidelines for the Protection of Human Subjects of Research"; issued by the National Commission for the Protection of Human Subjects on April 18, 1979. The Belmont Report constitutes an addendum to the ÑÇÉ«Ó°¿â Statement of Research Ethics. Copies of the HHS Code of Federal Regulations (45 CFR46) and the Belmont Report are available in the Office of the Assistant Dean for Research.