(A) Ethical acceptability. 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 participant.
(B) Treatment of participants. 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 participants by collaborators, assistants, students, and employees, all of whom, however, incur parallel obligations.
(C) Full disclosure. Ethical practice requires the investigator to inform the participant 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 participant inquires. Failure to make full disclosure gives added emphasis to the investigator's abiding responsibility to protect the welfare and dignity of the research participant.
(D) Deception. Openness and honesty are essential characteristics of the relationship between investigator and research participant. When the methodological requirements of a study necessitate concealment or deception, the investigator is required to ensure the participant's understanding of the reasons for this action and to restore the quality of the relationship with the investigator.
(E) Freedom to decline. 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 participant. The decision to limit this freedom gives added emphasis to the investigator's abiding responsibility to protect the participant's dignity and welfare.
(F) Agreement. Ethically acceptable research begins with the establishment of a clear and fair agreement between the investigator and the research participant that clarifies the responsibilities of each. The investigator has the obligation to honor all promises and commitments included in that agreement.
(G) Risk. The ethical investigator protects participants from physical and mental discomfort, harm and danger. If the risk of such consequences exists, the investigator is required to inform the participant 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 participants. The investigator shall comply with all relevant statutes and administrative rules concerning treatment of research subjects.
(H) Nature of study. After the data are collected, ethical practice requires the investigator to provide the participant 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 participant.
(I) Debriefing. Where research procedures may result in undesirable consequences for the participant, the investigator has the responsibility to detect and remove or correct these consequences, including, where relevant, long-term aftereffects.
(J) Research confidentiality. Information obtained about the research participants 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 any rights that the participants may have to confidentiality as set forth in division (G) of rule 4732-17-01 of the Administrative Code, be explained to the participants as a part of the procedure for obtaining informed consent.
(K) Safeguards. Investigations of human subjects using experimental drugs (for example: hallucinogenic, psychotomimetic, psychedelic, or similar substances) should be conducted only in such settings as clinics, hospitals, or research facilities maintaining appropriate safeguards for the subjects.
R.C. 119.032 review dates: 07/07/2009 and 07/01/2014
Promulgated Under: 119.03
Statutory Authority: 4732.06
Prior Effective Dates: 10/1/90