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Human Subjects Protection University of Houston - Downtown. The first step in the evolution of ethics is a sense of solidarity with other human beings. Albert Schweitzer. Historical Background.
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University of Houston - Downtown
The first step in the evolution of ethics is a sense of solidarity with other human beings.
The moral test of any society is how it cares for the people in the dawn of life: the children; the twilight of life: the elderly; and the shadows of life: the sick and disenfranchised.
Hubert H. Humphrey
Research is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
45 CFR 46.102(d)
“Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data or (2) identifiable private information through intervention or interaction with the individual.”
45 CFR 46.102(f)
determine that all of the following have been
(1) risks to subjects are minimized; (2) risks to subjects are reasonable in relation to
anticipated benefits (if any) and the importance of the knowledge that may be expected; (3) selection of subjects is equitable; (4) informed consent will be sought; (5) informed consent will be documented; (6) when appropriate, data safety monitoring; and (7) when appropriate, there are adequate provisions made
to protect the privacy of subjects and maintain
The UHD application form was designed to assist the applicant in providing all the information needed by the Committee to approve a project. It can be downloaded and filled out on the investigator’s computer before being printed, signed, and copied. It must be submitted 4-6 weeks before IRB approval is needed.
The form can be found on the UHD Human Subjects Protection website:
Thefirst page of the UHD application asks for contact information on the investigator(s), the type of review requested, the title of the project, and the projected time frame for your study. For student applicants, information must also be supplied about the faculty sponsor.
It then requests a lay summary of the project, which means a short summary that a nonscientist can understand. It specifically asks you to include information on the “who” (subjects), “where,” “how” (methodology) and “why” (thesis) of your project.
Please note: Informed consent is a process – not a piece of paper. It must be obtained in a manner that allows subjects to voluntarily agree or decline to participate.
Consent scripts and forms must therefore be requested in language easily understood by all potential subjects, generally considered an 8th grade reading level for the general public. They must include all 8 basic elements of informed consent, and you must give copies to all your subjects.