Informed consent is an essential component of research involving human subjects. Informed consent means the knowing, legally effective consent of an individual or his/her legally authorized representative. Individuals who choose to participate in research must be given sufficient information about the research, understand the information provided to them, and must be able to voluntarily participate in research under non-coercive conditions.
Written signed consent is required for research involving human subjects, unless there are compelling reasons to waive consent. Research investigators need to provide justification for any proposed changes to consent procedures.
Assent generally is required for research where minors are involved. Minors age 12 and over are considered capable of giving written assent and minors age 7-12 generally are able to give verbal assent.
Research Cover Letter:
Certain kinds of exempt research where the identity of the subjects is not known by the investigator may use a research cover letter instead of a consent form. The researcher must provide participants with a cover letter or set of instructions that includes the following information: a) a statement that participation is voluntary; b) a statement that they are being asked to participant in research and the reason for such (i.e., classroom exercise, masters thesis, etc.); c) a statement explaining the purpose of study--what is being investigating and why; d) a statement that the participants' responses will be kept confidential or anonymous explaining if a participant's name is to be reported or disclosed; e) a statement that participants do not have to answer every question; f) a statement that a decision not to participate or to withdraw from the study will not result in any negative consequences for the participants; g) the names and telephone numbers of the principle investigator (PI), faculty sponsor (if PI is a student), and IRB (email@example.com, 410-617-2188). These names will serve contact sources should a participant have any questions or concerns about the research; and h) a statement that the research was reviewed by the LOYOLA UNIVERSITY MARYLAND INSTITUTIONAL REVIEW BOARD.
"Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied."
-The Belmont Report, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979