The area is also popular with the local riding club with extensive forest tracks making it ideal for pony trekking and horse riding."Informed consent" is the voluntary agreement of an individual, or his or her authorized representative, who has the legal capacity to give consent, and who exercises free power of choice, without undue inducement or any other form of constraint or coercion to participate in research. "Ethics and Regulations of Clinical Research." New Haven: Yale University Press, 1988.) "Assent" is a term used to express willingness to participate in research by persons who are by definition too young to give informed consent but who are old enough to understand the proposed research in general, its expected risks and possible benefits, and the activities expected of them as subjects. If assent is given, informed consent must still be obtained from the subject's parents or guardian.Thus, an individual 18 years old would be considered an adult for consent purposes, but would also be considered a pediatric subject for study purposes according to CC policy.At the CC, each research participant, or his or her legally authorized representative, must grant informed consent before undergoing any medical activity.The loch is surrounded by forests maintained by the Forestry Commission which make it a natural habitat for birds including thousands of geese which over winter in the area as well as other wildlife.
A special consent is not required for photographs, videotapes, or interviews intended to be used for research or treatment only, although they should be discussed in the protocol consent.
The individual must have sufficient knowledge and understanding of the nature of the proposed research, the anticipated risks and potential benefits, and the requirements of the research to be able to make an informed decision. State laws define who constitutes a "child," and such definitions dictate whether or not a person can legally consent to participate in a protocol.
The State of Maryland considers a person 18 years and older to be an adult and therefore one who can provide consent without parental permission. The 1998 "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" defines "pediatric subject" as an individual under the age of 21.
These discussions with and evaluation of research participants should continue after the protocol consent document is signed and until the protocol is completed or the participant is no longer a part of the protocol.
It is true that many of our patients, sick for some time, are quite sophisticated and have heard a lot of medical talk, have had multiple procedures, and know the difference between a catheter and a biopsy.