Human Subjects (IRB)- ISU & Federal Laws

Investigator's Guide

• Consent Process
• Elements of Consent
• New Consent Form Templater
• Assent Process

Waivers

• Waivers of the Consent Process
• Waiver of Documentation of Consent Form
• Waiver of Elements of Consent Form

ISU & Federal Rules & Regulations and History of Human Subjects Protection

ISU & Federal Laws

  ISU Federal Wide Assurance (FWA) 
  Policy on Course-Related Student Projects Involving Human Subjects 
  The Belmont Report & 45 CFR 46 (Code of Federal Regulations)
					

History of Human Subjects Protection

  Declaration of Helsinki
  Nuremberg Code
					

Policy on Course-Related Student Projects Involving Human Subjects

In accordance with federal regulations, Iowa State University requires that all research involving human subjects be prospectively reviewed by ISU's human subjects review committee, the Institutional Review Board (IRB). Accordingly, honors theses, research practica, and Masters or Doctoral theses involving human subjects must be submitted for IRB review.

Iowa State University recognizes that some student projects conducted to fulfill course requirements involve activities that, in a different context, might be viewed as research. As a general rule, when those activities are conducted solely to fulfill a course requirement, an element of the definition of research (the intent to develop or contribute to generalizable knowledge) is lacking. However, it is also the case that some classroom research assignments could place subjects at risk. Therefore, recognizing its role in the protection of human subjects, Iowa State University has determined that some classroom assignments may require review by IRB. Iowa State University considers classroom assignments involving research activities to be educational in nature, and not subject to IRB review, when all of the following criteria are true. If any one of the criteria is not true, then the project must be sent to IRB for review.

Course-Related Student Projects (IRB review is not required if all are true)

1. The project is limited to surveys/questionnaires/interview procedures, observation of public behavior, or standard educational exercises directly related to the topic(s) being studied in an official University course. In general, audio recordings made as part of the interview procedure for the sole purpose of accuracy are allowed.

2. Surveys/questionnaires/interviews, if used, contain no sensitive personal questions (e.g., no questions about alcohol/drug use, sexual behavior/attitudes, criminal activity, medical history, grades/test scores) or other personal information that could "label" or "stigmatize" an individual.

3. The participants are not from a special population that requires extra protections (pregnant women, prisoners, children under age 18, cognitively impaired individuals).

4. EITHER information is recorded without any direct or indirect (code number) identifier linking the participant to his/her data OR if a direct or indirect identifier is used when recording the data, then the questions being asked could not reasonably harm the participants reputation, employability, financial standing, or place the participant at risk of criminal or civil liability.

5. The results of the classroom assignment, including audio recordings, either do not leave the classroom, or, if the project involves gathering data from or about a company, agency, or organization, the data/results are shared only with that company, agency, or organization.

6. No Iowa State University faculty, staff or student is receiving monetary compensation from an external company/organization/agency for collecting, analyzing or reporting the results of this project.

7. Presentation at departmenal or interdepartmental seminars designed to exhibt coursework or to continue the learning process related to presentations does not require IRB approval. If the intention is to publish or present the data collected beyond the circumstances described above, or to publish in the ISU Daily, Ames Tribune or any other media source, the instructor or the student must file the project with the IRB for approval before the study begins.

It is the responsibility of faculty to determine whether an assigned project involving human subjects can be classified as a course-related student project. Faculty should contact the Human Subjects Research Office if assistance in making this determination is needed. It is the responsibility of faculty to discuss general principles of research ethics with the class prior to the initiation of the project.

Disclosure to Participants

All surveys/questionnaires/interviews must be preceded by a disclosure of the following points to the respondent. If an Informed Consent Document is used, these points must be included in that document.

1. The student identifies him/herself as an ISU student who is performing the activity to fulfill a course requirement, and the course is specifically identified.

2. The name of the supervising faculty member to contact for questions is provided.

3. The persons who have access to the individual data and/or summarized results are specified (e.g., instructor only, company/organization/agency).

4. Participants are informed that their participation is completely voluntary, that they can skip any questions they do not wish to answer, and that they can stop answering questions at any time.

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