Human Subjects Rights
All activities involving humans as research participants must provide for the safety, health, and welfare of every individual. Rights, including the right to privacy, must not be infringed. No participant in a research activity shall be exposed to unreasonable risk to health or well-being.
An individual does not abdicate any rights by consenting to be a research participant. A participant has the right to withdraw from a research project at any time or can refuse to participate without loss of benefits to which the subject would otherwise be entitled. Further, a participant has the right to receive appropriate professional care, to enjoy privacy and confidentiality in the use of personal information, and to be free from undue embarrassment, discomfort, anxiety, and harassment.
The direct or potential benefits to the participant, or the importance of the knowledge to be gained, must not preclude consideration of the inherent risks to the individual.
The confidentiality of information received from participants in experiments or respondents to questionnaires or surveys shall be fully protected, both during and after the conduct of a research activity, within the limits of the law.
Participation in projects must be voluntary. Informed consent must be obtained from all participants and must be documented (unless the requirements for documentation of consent is specifically waived by the IRB). Methods in accordance with the requirements of 45 CFR 45.116 and 45.117, appropriate to the risks of the research, must be used to obtain the participants’ informed consent.
In research involving more than minimal risk or substantial stress or discomfort, such risk, stress, or discomfort shall be carefully explained to the participant before his or her participation and justified by the expected benefits of the research. The investigator shall be satisfied that the explanation has been understood by the participants, and the written consent of the participant (unless otherwise waived by the IRB), containing the substance of the explanation, shall be obtained and kept as a matter of record.
Responsibilities of the Investigator
Safeguarding the well-being of and information about an individual is a primary responsibility of the investigator. In accordance with the provisions of the College’s Federal Assurance Filing, research investigators who conduct human participants research under the auspices of the College (faculty, staff, students and affiliated researchers), acknowledge and accept their responsibility for protecting the rights and welfare of human research participants.
When the investigator is a student, responsibility for the conduct of the research, and for the welfare and supervision of human participants lies with both the students and the faculty sponsor. All student research must have a faculty sponsor.
45 CFR 46.115(b) and 21 CFR 56.115(b) require that all IRB records be retained for at least 3 years, and records relating to research which is conducted be retained for at least 3 years after completion of the research. Additionally, all IRB records must be shredded, deleted, or purged after 7 years unless the research is ongoing.