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    DECATUR  PUBLIC SCHOOLS

    INSTITUTIONAL REVIEW BOARD

    GUIDELINES FOR RESEARCH INVOLVING HUMAN SUBJECTS

     

    BACKGROUND

    Informed consent is an ethical requirement of any research study conducted on humans. Horrific things have been done to humans by other humans in the name of scientific progress throughout our history.

    The Tuskegee Syphilis Study, begun in 1932 and lasting until the early 1970’s, the work of Dr. Stanley Milgram at Yale University in the early 1960’s, and the medical “experiments” conducted by the Nazi’s during WWII, are but a few examples of what becomes possible when researchers lose their moral and ethical way. While such dangers can be marginalized due to the scale or scope, or to time passed, to do so is to ignore the teachings of the past. The AIDS virus, stem cell research, cloning, the disposal of nuclear waste, the colonization of space all represent significant problems that present ethical and moral chal- lenges to our future.

    The Nuremberg Code, established after World War II in response to the Nuremberg War Trials and the information that emerged from those proceedings, represents the first internationally recognized code of ethics that governs the treatment of human subjects in research studies. This code was voluntary, so within the United States, the National Research Act signed in 1974, created the National commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This commission was charged with developing the basic ethical principles that should ground all such research. Their findings, published in the Belmont Report of 1979, codified these principles around three basic areas, respect for persons, beneficence, and justice. The most current code for the protection of human subjects can be found in the Guidelines for the Conduct of Research Involving Human Subjects from the National In- stitutes of Health.

    INFORMED CONSENT

    Decatur Public Schools is dedicated to building the capacity of its professional staff in the design, con- duct, and evaluation of research in a variety of fields of study and thus has a moral and legal obligation to attend to the ethics of such work. To this end, the establishment of an Institutional Review Board, or IRB, to oversee all such work by both students and staff is imperative. DPS’s IRB establishes protocols and procedures by which all research is conducted. Membership to the board is by appointment by the Chief Instructional Officer, who also chairs this group. Their obligation is to meet as often as is neces- sary to provide the support for student and staff research. The submission of the IRB Informed Consent Form is a requirement for all research studies conducted by DPS students and staff.

    The concept of Informed Consent becomes of primary concern when conducting research with human subjects. The participant, or subject, of the research, must be given enough information to make a rea- soned judgment regarding the possible risks and benefits to themselves if they choose to participate.

    They should know the purpose of the study, the methods used for data collection, their right to refuse or withdraw from the study at any time, and the assurances of privacy and confidentiality they can expect. The researcher has the full obligation to divulge this information to all potential subjects prior to the

     

    collection of any data. Failure to do so represents not only an ethical lapse, but may also bring with it the complete collapse of their research study. Researchers must hold themselves to the standards and princi- ples of ethical research, while the IRB provides the necessary structure to ensure full compliance for the protection of subjects.

    In the era of collecting human subject research data using the internet, studies that utilize this method- ology deserve special consideration. Email and web surveys allow for greater response rates and thus greater degrees of confidence (potentially) in the data. They also bring greater challenges with ensuring confidentiality and anonymity of responses, as well as with collecting informed consent. Given that some of the research conducted is likely to involve students, how can informed consent from a minor be gained? Two scenarios are possible and permissible:

    • If the subject of the research is of a sensitive nature, involving issues related to drug use, sexuality, conditions of abuse, or other such conditions, informed consent that includes the consent of the parent or legal guardian is required. This decision rests with the IRB
    • If the nature of the research is less sensitive, in that the risks posed to the subject by their partic- ipation are minimal, then the informed consent of the participant alone is sufficient. No parental consent is then required. The student researcher must ensure that all participants are informed of their right to withdraw from the study at any time and that they agree to participate in the study by actively checking a box on the survey to that The language of the question that must appear on a survey is as follows:

    I understand the purpose of this research study and the nature of my participation. I also understand that I may withdraw from this participation at any time. By selecting the I AGREE box on the ques- tion below, I agree to participate in this study.

    In all cases, the researcher must submit the informed consent form to the IRB for approval. Once given, proceeding using either of the two conditions above is permissible.

     

    REFERENCES

    Guidelines for the Conduct of Research Involving Human Subjects, 5th Printing, August 2004. Wash- ington D.C.; U.S. G.P.O. 00-4783

     

     

            IRB Protocol 

      

     

     

      

     

    Please print and fill out IRB_Form and send to Dr. Joshua Peters - Director of Curriculum & Instruction - Secondary