SCDMH Documents Governing Human Subject Research
Institutional Review Board Manual
SCDMH Documents Governing Human Subject Research
Principles of Ethical Research
The following principles are to be followed by the SCDMH Institutional Review Board (IRB) and all personnel in formulating and implementing research projects that involve human subjects.
- Projects directly involving and/or individually identifying human subjects shall conform to the scientific, legal, and ethical principles which guide all research and shall emerge from a sound theoretical basis and follow accepted research design.
- Ethical aspects of the study must be clearly stated in the project design.
- Projects should be conducted only by professionally and scientifically qualified individuals. When appropriate, medical liaison or supervision should be provided.
The Institutional Review Board shall determine, prior to approving the project, that the Principal Investigator is an individual of sufficient competency and maturity or judgment and is on the staff or sponsored by the facility involved in the project.
- Projects involving human subjects at risk shall not be implemented unless the anticipated risks to the subject are so outweighed by the importance of the knowledge to be gained as to warrant a decision to allow the subject to accept these risks. The evaluation of such risks should include not only possible physical injury, but also psychological or social injury and alterations of personality.
"Subject at risk" means any individual who may be exposed to the possibility of injury, including physical, psychological, or social injury, as a consequence of participation as a subject in research.
If evidence of greater risks than that originally anticipated develops, the Principal Investigator will immediately discontinue the project and promptly report it to the IRB.
- The Principal Investigator shall take all responsible steps and precautions to provide for the safety and welfare of subjects who consent to participate in projects.
- The Principal Investigator shall take all reasonable steps to respect the privacy rights of any human subject.
- Experimentation shall be planned so as to avoid unnecessary pain, embarrassment, suffering, or inconvenience to the subject, or their family or guardian.
- Unless specifically waived by the Institutional Review Board, no project directly involving and/or individually identifying a human being shall be undertaken without the subject's freely given written informed consent.
"Informed consent" means the knowing consent of an individual or the individual's legally authorized representative, so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion.
- The purpose of an Informed Consent is to fully disclose the purpose and risks of participation in the research and let the potential subject decide to participate or not on the basis of that disclosure. This form will have the full information described in this section, as well as the date the consent form was signed and the name and contact information of the individual who supplied the participant with the information.
- The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights or to release or appear to release the investigator, sponsor, the institution, or its agents from liability for negligence.
- Participants who are legally or functionally incompetent shall participate only when the consent has been given by the participant's legally authorized representative. The research subject must be given a copy of the Informed Consent.
- Denial of consent to participate in a project shall not be a cause for denying or altering the indicated services to that patient.
- When children are being solicited as research subjects, the researcher shall consider adequate provisions for obtaining the child's Informed Consent. The researcher shall, in determining whether children are capable of consenting or assenting, take into account the ages, maturity and the psychological state of the children involved. The researcher shall be specific in identifying the ages of children for whom Informed Consent will be solicited, the ages for which parental (or guardian) permission is to be obtained and whether one or both parents must consent. The latter shall be based upon the degree of risk involved in the research study (See section in Table of Contents: Special Population Requirements - Children).
- The participant shall be allowed to withdraw consent and discontinue participation in a project at any time without affecting their status in the program.
- The basic elements of information necessary to such consent include:
- A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subjects' participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
- A description of any reasonably foreseeable risks or discomforts to the subject.
- A description of any benefits to the subject or to others which may reasonably be expected from the research.
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records.
- An explanation of whom to contact for answers to pertinent questions about the research and research subject's rights, and whom to contact in the event of a research-related injury to the subject.
- A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
- An explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
- When appropriate, one or more of the following elements of information shall also be provided to each subject:
- A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.
- Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.
- Any additional costs to the subject that may result from participation in the research.
- The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.
- A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.
- The requirement for obtaining an informed consent may be waived if either:
- The only record linking the subject and the research would be the consent document and the principal risk to the subject would be potential harm resulting from a breach of confidentiality; or
- The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.