Human Subjects

When students conduct research with human subjects, the rights and welfare of those participating in the study must be protected. There are federal regulations protecting human subjects that require the prior review of human subjects research by an Institutional Review Board and, in most cases, the informed consent of research subjects.

Rules

Here are the Rules that were developed to help student researchers adhere to the Federal regulations and to, therefore, protect the rights and welfare of both the research subjects and the student researcher.

For more information, go to the Human Subjects section of 2006 Rules

Review Process

1. A student interested in doing a human subjects research project must first review the rules, choose a study group and consider the risks of their proposed research. The student must work with their Adult Sponsor who can guide them to a Qualified Scientist, if necessary, to help in the development of their research plan.
   
   
2. The student must complete the Research Plan (1A) and Attachment, Human Subjects Form (4) and submit this information along with a copy of any questionnaire, survey or instrument used to collect human data to the Institutional Review Board (IRB). Submission of the appropriate forms does not give the student permission to begin the research. The IRB must sign the Approval Form (1B) and Human Subjects and Informed Consent Form (4), approving the project, before the research can begin.
   
   
3. To complete the IRB review process, the IRB must designate the risk-status of the project and other requirements by checking the appropriate box(es) on Human Subjects Form (4). The IRB may require one or more of the following:
   1. Documentation of written Informed Consent on the Human Subjects Form (4). When the IRB waives informed consent of research subjects under the age of 18 for studies involving surveys or questionnaires, justification of this waiver must be stated on Form 4.
   2. Qualified Scientist Form (2) Ð The IRB will require the project to be overseen by a Qualified Scientist when there is more than minimal risk involved. If the Qualified Scientist is unable to directly supervise the project, a trained Designated Supervisor (and the Designated Supervisor Form (3)) will also be required.
   3. Changes to the Research Plan Ð If the IRB requires changes or modifications of the Research Plan, the student must incorporate those changes into the written Research Plan before the IRB approves the project.
   
   
4. After the IRB has approved the project and all committee members have signed the Human Subjects Form (4), the student may begin recruiting and/or interacting with human subjects.
   
   
5. After experimentation and shortly before fair competition, the SRC reviews and approves previously approved projects to make sure that students followed the approved Research Plan (1A) and the rules.
   
   
6. The following forms are required:
   1. Checklist for Adult Sponsor
   2. Research Plan (1A) and Attachment
   3. Approval Form (1B)
   4. Human Subjects Form (4)
   5. Regulated Research Institution Form (1C) - if applicable
   6. Qualified Scientist Form (2) - if applicable
   7. Designated Supervisor Form (3) - if applicable