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Part II - Instructions and Format

Please answer ALL items briefly but thoroughly.
Follow the format below, itemizing each of the eight topics, followed by your response.

1. Research Project Overview

A. Background

  • Give a brief overview your research project and its purpose.
  • State the significance of the project.

B. Objectives

  • What hypotheses are being tested or what are the questions guiding the research?
  • What results do you anticipate?

2. Methodology

A. Method

  • What is the research design of the project? (experiment, interview, questionnaire, field observation, or other type)
  • How will the study be conducted?
  • Who will supervise the research activities? Discuss the investigator's research experience, especially with this type of research method.
  • Explain how the data will be analyzed to evaluate your question or hypotheses, including any statistical analyses to be performed

B. Involvement of Human Subjects.

  • Provide a brief description of procedures involving human subjects.
  • Define the target population and characteristics of your sample.
  • Describe who your participants will be.
  • Explain the procedure for participant recruitment and selection and include copies of all recruiting announcements to be used.
  • Describe equipment, apparatus, or medications; attach copies of all tests, questionnaires, interview questions, screening techniques, and other materials to be used.
  • Describe, in order, the procedures to be used in collecting data and their settings. Include method of debriefing participants, if applicable.

3. Risks and benefits to human subjects

  • Describe the potential risks: physical, psychological, social, legal, or other-both short- and long-term. These may include risks such as physical discomfort or harm, adverse psychological reaction, invasion of privacy, breach of confidentiality (for the subject and the affected individuals), and other threats to subject's dignity, rights, or welfare. Likelihood and seriousness of potential risks should be assessed.
  • If methods of research create potential risks, describe other methods, if any, considered and why they will not be used.
  • Benefits should be considered in terms of those to be gained by individual subjects, persons similarly situated, and society in general, but should not be understood to include individual or corporate financial gain.
  • Explain how the results of the study will be made available to participants, the institution, and to the scientific community.

4. Safety Measures

  • Detail all procedures for protecting against or minimizing potential risks, such as, screening procedures, medical clearances, legal and insurance considerations, separating identifiers from data, training staff, debriefing, and follow-up procedures.
  • Assess the likely effectiveness of such measures.

5. Informed Consent.
Except in special circumstances (see below or contact the Chair for details), no investigator may involve a human being as a subject in research unless he or she has obtained written informed consent.

  • Describe the procedures for gaining and documenting the informed consent of the human subject and attach copies of all consent forms to be used
  • Those procedures should provide the prospective subject or the subject's representative sufficient opportunity to consider whether or not to participate, and that minimize the possibility of coercion or undue influence.
  • The information that is given to the subject or the representative should be in language understandable to the subject or the representative and may include no language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the University, or its agents from liability for negligence.
  • Identifying information must be collected and stored independent of the data and kept for a maximum of 6 years after completion of the research project

Unless the IRB explicitly waives the requirement (see section below and also Board of Trustees policies for exceptions and waivers), informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form. A written consent document should embody the required elements of informed consent. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator shall give the subject or the representative adequate opportunity to read it before it is signed.

Five standard informed consent forms are available. Contact the IRB Chair or representative if you are unclear about which form to use.

  1. Implied Informed Consent - for use with most surveys that ask no questions relating to the subject's illegal behaviors, for example, drug or alcohol use, or sexual behavior
  2. Informed Consent to Participate in a Survey - 18 Years of Age or Older
  3. Informed Consent to Participate in a Research Project - 18 Years of Age or Older
  4. Parental Informed Consent for Child Under 18 to Participate in a Survey
  5. Parental Informed Consent for Child Under 18 to Participate in a Research Project

The IRB may waive the requirement of a signed consent form for some or all subjects, if it finds:

  1. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. In this case, each subject must be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes in the matter must govern; or
  2. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

When the Board waives the documentation requirement, it may require the investigator to provide subjects with a written statement regarding the research. Special rules apply to research involving minors (children under age 18) and other vulnerable research populations, such as fetuses, pregnant women, prisoners, or other persons with diminished autonomy. Consult the IRB Chair, the UM-System policies, and/or the Grants Office for detailed instructions.

6. Cooperating Agency, Institution, or Individual.
There should be a written cooperative agreement with any other research party which allows the University to have adequate control of project activities for the protection of human subjects.

7. Continuing Review.
If the project will take more than one year to complete, or if the project will be periodically repeated, state the projected duration. Research continuing for more than one year with no changes in the approved research protocol must submit a Continuing Review Form annually.