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Protection of Human Subjects in Research
<br /> (Attachment to ED 424)
<br /> I. Instructions to Applicants about the Narrative In - (5) Describe the procedures for protecting against or minimizing
<br /> formation that Must be Provided if Research Activities potential risks, including risks to confidentiality, and assess their
<br /> Involving Human Subjects are Planned. likely effectiveness. Where appropriate, discuss provisions for
<br /> ensuring necessary medical or professional intervention in the
<br /> If you marked item 12 on the application "Yes" and designated event of adverse effects to the subjects. Also, where appropri-
<br /> exemptions in 12a , (all research activities are exempt), pro- ate, describe the provisions for monitoring the data collected to
<br /> vide sufficient information in the application to allow a determi- ensure the safety of the subjects.
<br /> nation that the designated exemptions are appropriate. Research
<br /> involving human subjects that is exempt from the regulations is (6) Discuss why the risks to subjects are reasonable in relation
<br /> discussed under H.S. "Exemptions," below. The Narrative to the anticipated benefits to subjects and in relation to the im-
<br /> must be succinct. Provide this information in an "Item portance of the knowledge that may reasonably be expected to
<br /> 12 /Protection of Human Subjects Attachment" and insert result.
<br /> this attachment immediately following the ED 424 face page.
<br /> If you marked "Yes" to item 12 on the face page, and designated II. Information on Research Activities
<br /> no exemptions from the regulations (some or all of the re - Involving Human Subjects
<br /> search activities are nonexempt), address the following six
<br /> points for each nonexempt activity. In addition, if research in- A. Definitions.
<br /> volving human subjects will take place at collaborating site(s) or
<br /> other performance site(s), provide this information before dis- A research activity involves human subjects if the activity is
<br /> cussing the six points. Although no specific page limitation research, as defined in the Department's regulations, and the
<br /> applies to this section of the application, be succinct. Provide research activity will involve use of human subjects, as defined
<br /> the six -point narrative and discussion of other performance sites in the regulations.
<br /> in an "Item 12/Protection of Human Subjects Attachment"
<br /> and insert this attachment immediately following the ED 424 —Is it a research activity?
<br /> face page.
<br /> The ED Regulations for the Protection of Human Subjects, Title
<br /> (1) Provide a detailed description of the proposed involvement 34, Code of Federal Regulations, Part 97, define research as "a
<br /> of human subjects. Describe the characteristics of the subject systematic investigation, including research development, test -
<br /> population, including their anticipated number, age range, and ing and evaluation, designed to develop or contribute to gener
<br /> health status. Identify the criteria for inclusion or exclusion of alizable knowledge." If an activity follows a deliberate plan
<br /> any subpopulation. Explain the rationale for the involvement of whose purpose is to develop or contribute to generalizable
<br /> special classes of subjects, such as children, children with dis- knowledge, such as an exploratory study or the collection of
<br /> abilities, adults with disabilities, persons with mental disabili- data to test a hypothesis, it is research. Activities which meet
<br /> ties, pregnant women, prisoners, institutionalized individuals, or this definition constitute research whether or not they are con -
<br /> others who are likely to be vulnerable. ducted or supported under a program which is considered re-
<br /> search for other purposes. For example, some demonstration
<br /> (2) Identify the sources of research material obtained from indi- and service programs may include research activities.
<br /> vidually identifiable living human subjects in the form of
<br /> specimens, records, or data. Indicate whether the material or —Is it a human subject?
<br /> data will be obtained specifically for research purposes or
<br /> whether use will be made of existing specimens, records, or The regulations define human subject as "a living individual
<br /> data. about whom an investigator (whether professional or student)
<br /> conducting research obtains (1) data through intervention or
<br /> (3) Describe plans for the recruitment of subjects and the con- interaction with the individual, or (2) identifiable private infor
<br /> sent procedures to be followed. Include the circumstances un- mation." (1) Ilan activity involves obtaining information about
<br /> der which consent will be sought and obtained, who will seek it, a living person by manipulating that person or that person 's
<br /> the nature of the information to be provided to prospective su environment, as might occur when a new instructional technique
<br /> jects, and the method of documenting consent. State if the Insti- is tested, or by communicating or interacting with the individ
<br /> tutional Review Board (IRB) has authorized a modification or ual, as occurs with surveys and interviews, the definition of hu-
<br /> waiver of the elements of consent or the requirement for docu- man subject is met. (2) If an activity involves obtaining private
<br /> mentation of consent. information about a living person in such a way that the infor-
<br /> mation can be linked to that individual (the identity of the sub -
<br /> (4) Describe potential risks (physical, psychological, social, ject is or may be readily determined by the investigator or asso-
<br /> legal, or other) and assess their likelihood and seriousness. ciated with the information), the definition of human subject is
<br /> Where appropriate, describe alternative treatments and proce- met. [Private information includes information about behavior
<br /> W
<br /> dares that might be advantageous to the subjects. that occurs in a context in which an individual can reasonably
<br /> expect that no observation or recording is taking place, and in-
<br /> formation which has been provided for specific purposes by an
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