Research Protocol
Content
- Title (of the proposed research activity)
- Professional Qualifications (to do the proposed research), including
a description of any necessary support services, facilities, and
equipment. A vita (optional) should be limited to qualifications
applicable to the proposed research.
- Sponsor of the proposed research.
- Purpose of the proposed research, in the
context of a summary of previous research, with an explicit statement of what is and is not known about the topic.
Indicate what the proposed research could add,
stated as benefits to be gained by the discipline and by the
subjects.
- Methods of the proposed research activity,
including appropriateness of the design. Refer to the content of
Section 4 as needed for clarification.
- Procedures to be used, focusing on the experiences of
the subjects in the research.
- Subjects
- a. Subject Selection Criteria for
participation
- b. Subject Exclusion Criteria from
participation and justification
- c. Vulnerable Populations justifying use
of subjects such as children, pregnant women, ethnic minorities,
prisoners, mentally disabled persons, economically or educationally
disadvantaged persons, students in the classroom, or employees in
their workplace.
- d. Risks to Subjects including
psychological harm and possible breaches of confidentiality. Explain
precautions taken to minimize risk.
- e. Managing Adverse Reactions physical or
emotional, of subjects due to participation.
- Informed Consent (see examples
of informed consent forms)
- a. Circumstances Surrounding the Process
including:
- Recruitment of subjects
- Environment or setting
- Time frame
- Condition of prospective subjects
- Primary language of prospective subjects
- Autonomy of prospective subjects
- b. Elements of Informed Consent included
in the procedure used, in accord with Paragraph 46.116 of the
Code (see also Appendix)
- c. Informed Consent Documented in written
form in accord with Paragraph 47.117 of the Code
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