Human Subjects

SRC/IRB review of the Research Plan is required prior to experimentation for ALL projects involving human subjects except those specifically noted below.

The Metro Richmond Science Fair rules regarding human subjects in experimentation follow ISEF guidelines and those of the federal government. The rules exist to protect the rights and welfare of individuals who participate as research subjects and to protect the student researcher. When students use human subjects, they are directly responsible for ensuring the rights and welfare of those subjects. (If in doubt about any regulations, consult the Belmont Report and CFR Title 45 Part 46.)

In general, if a student interacts or intervenes with a human to collect data or collects identifiable private information then that project must be reviewed and receive official approval before the experiment may be started.  All students conducting human subject research projects, including surveys, professional tests, questionnaires, and studies in which the student is the subject of his/her own research, must submit a research proposal to the SRC/IRB and have it approved before beginning research.  Many Human Subjects projects also require that a student obtain written consent from the subjects before they participate in the experiment. 


ALL human subjects must have the opportunity to give their voluntary and informed consent/assent to participate in an experiment.  In order to do this they must be aware of EVERYTHING they will be expected to do, including any risks involved.  This consent/assent may be verbal or written depending on the amount of risk involved in the project.  It is VERY important that all subjects know that their participation in the experiment is completely voluntary and that they are free to stop at any time without penalty.


Exempt Projects

Experiments involving humans that DO NOT require prior SRC/IRB approval or human subject paperwork
These projects are not considered restricted human subject projects as long as they meet the following criteria.

    •   the testing of student inventions, usually for engineering projects, computer programs, etc., that meets the following requirements:
      •  does not pose a health hazard to the person testing the invention
      •  does not collect or use any personal data from the "tester"
      •  feedback received is in direct reference to the product
      •  includes Form 3 (Risk Assessment) if teacher or SRC requires due to nature of testing (all testing of this type should be supervised by an adult)

    •   publicly available internet or published data, such as sports statistics, health statistics, etc.

    •   data sets or records from which all personally identifiable information has been removed before being seen by the researcher (must include written documentation from the person supplying the data which states that the records were de-identified),

    •   behavioral observations if the researcher:
      •  does not interact with the subjects in any way,
      •  does not change or manipulate the environment in any way,
        AND
      •  does not record any information or data which could be used to identify the subject.



Restricted Human Subject Projects

Projects involving humans that DO require prior SRC/IRB approval and human subject paperwork
 SRC/IRB approval needed if they involve any of the following:

    •   people engaging in any physical activity, including exercise, eating or tasting anything, medical procedures, etc.

    •   surveys, questionnaires, educational testing, psychological testing, personal opinion, etc.

    •   studies using the researcher as the subject of the experiment

    •   viewing records or data sets which include identifiable information (requires a Qualified Scientist and written informed consent from       subjects)

    •   behavioral observations if the researcher:
      •  interacts with the subjects or modifies the environment in any way (e.g., posting a sign),
      •  conducts the experiment in a non public area, such as a day care or nursing home,
      •  uses any information that would identify the subject.


Rules for Restricted Human Subjects Projects

  1. Students using human subjects in any project must have their research plan approved by an SRC/IRB before they begin their experiment phase.  The following must be included with a Research Proposal which is submitted for approval:  
    •  Form 1
    •  Form 1A
    •  a written, complete research plan that includes ALL of the information outlined in the human subject portion of the Research Plan Instructions (found with Form 1A)
    •  Form 1B
    •  Form 4 (Human Subjects Form) with all of the items in the top section completed
    •  a completed sample of the Informed Consent Form that will be used if needed (do not include signatures)
    •  any other forms that may apply to the project (Form 2, Form 7, etc.)
    •  a copy of any survey, questionnaire or pictures that are used in the experiment

  2. The Human Subjects Form (Form 4), in conjunction with the Informed Consent Form, is designed to be used as a Risk Assessment for projects using human subjects.  There are almost always risks involved when using human subjects and your subjects MUST be informed of those risks in advance, on an Informed Consent Form.  For more complete information on assessing and minimizing the risks to human subjects see the MRSF Risk Assessment for Human Subjects or the ISEF Risk Assessment Guide.  The SRC/IRB will make the final determination of the risk level and will sign Form 4 in the appropriate area.  

  3. All human subjects must give their verbal permission to participate in an experiment after reading an Informed Consent Form.   In many cases, it will be necessary for students to obtain written permission from their subjects as well.  This occurs if their projects are considered by the SRC/IRB to pose more than minimal risk to the subjects, such as eating, drinking or smelling substances or physical exercise.   

    If a subject is under 18 they can only give their "assent".  It will then be necessary for a parent or guardian to give their "consent" in addition to the "assent" of the subject.  This must be done by using an Informed Consent Form.  Students may use the online Sample Informed Consent Form, or they can create their own, making sure to include ALL of the information that is on the sample.  For more information on consent procedures see Informed Consent.

  4. Any survey or questionnaire that will be used in a project MUST be approved by the classroom teacher and then must be submitted with the Research Proposal to the SRC/IRB.  Both the subject and, if under 18, the parent/guardian must see and approve it as well. 

  5. If music, pictures, video games or videos are used in a project then these MUST be viewed and approved by the classroom teacher and be made available to the SRC/IRB if requested.  Pictures must be sent with the proposal for SRC/IRB approval.  The consent form should describe the media, including any "ratings" such as "PG".  The parents or guardians of subjects under 18 must also have the opportunity to approve the media being used.  All media must be age appropriate and use appropriate language and images.  See the ISEF Risk Assessment Guide for more complete information.

  6. Physical activity can be very risky for one person and of minimal risk for another.  Therefore it is necessary to identify the subjects being used in the research plan.  If a student researcher is asking subjects to run a mile, it's important for the SRC/IRB to know the general physical condition of the people running.  Subjects who run a mile on a regular basis, such as members of a sports team or students who run regularly in gym class, are not as much at risk as people in their 60's who rarely exercise.  The selection of subjects can dramatically change the risk level of the project.

  7. Collecting data from human subjects without using any names or identifying information greatly reduces some of the risks involved in research.  All data should remain anonymous (including to the student researcher) in as many projects as possible.  This is especially true if the student is collecting information on grades, IQ's, or SAT scores, etc.  It is helpful for the SRC/IRB to know how students are collecting their data and if the information will be kept anonymous.

  8. It is required that students work with a Qualified Scientist if their research involves more that minimal risk to their subjects. This includes, among others, some forms of exercise and any experiment which requires subjects to eat, drink or smell something out of the ordinary.  Foods or drinks that are commonly available in this area, or some physical activities may be considered minimal risk by the SRC/IRB.  Therefore, it is important to include precise information on the foods or activities in the research plan so that the review board may make an informed decision.

    The school nurse may act as the Qualified Scientist if she/he is an R.N. and is approved by the SRC/IRB.  If the Qualified Scientist is unable to directly oversee the activity, then a Designated Supervisor must be appointed (teacher or other adult) and trained. In this case, the Qualified Scientist would fill out the Qualified Scientist Form (Form 2) and the Designated Supervisor would sign the box at the bottom of the form. See     Risk Assessment for Human Subjects for additional information.

  9. If the student is planning to conduct human subject research in a federally registered research institution (university lab, etc.) then the project must be reviewed and approved by that institution’s IRB.   Documentation stating that the student’s particular work was officially approved (the project must be identified in the research plan) must be included in the submission of the project to the Fair. A letter from the mentor is not sufficient. If a student is unable to obtain documentation of official approval from the institution then the project must be reviewed and approved by the Fair SRC/IRB.

  10. The practice of medicine by students is illegal and is not permitted. With documentation of direct and complete supervision by a licensed professional (Qualified Scientist), students may observe and collect data for analysis of new procedures and medications. Students are not allowed to administer medications to or perform invasive medical procedures on human subjects.

  11. It is illegal to publish or display information, including photographs, that could directly or indirectly identify any human subject without written consent from the subject (and the parent/guardian if the subject is under 18).  The ISEF Sample Informed Consent Form does not have a statement giving permission to use data or photos of a subject and therefore cannot be used in this way.  Student researcher must develop their own permission form to use in these cases and they must be signed by the subject and the parent/guardian if the subject is under 18.   This signed form must be available for inspection by the safety committee at the Fair set up.

  12. All standardized tests that are not in the public domain must be administered, scored and interpreted by a Qualified Scientist as required by the test publisher. Any use of this type of test must follow the guidelines set by the publisher, including obtaining copies of the test.   Results of testing should never be divulged by a student researcher to the subjects and tests should be conducted as anonymously as possible.

  13. Students may use the internet and email to collect data for human subject projects, but this type of data collection is challenging. It is difficult to make sure that your subjects are of the proper age or are not returning multiple responses.  It is also difficult to collect anonymous data or to obtain Informed Consent.  The responses may need to be channeled through a Qualified Scientist, such as a school counselor, who will then collect the data and de-identify the people sending it.  The Intel ISEF has a more detailed discussion of the use of internet surveys and has developed some guidelines on obtaining Informed Consent in their Risk Assessment Guide.




Links to Additional Rules and Information

Risk Assessment for Human Subjects

Informed Consent

Intel ISEF Risk Assessment Guide for Human Subjects

    This guide gives some specific examples of projects to help students determine risk.

 

Sources of Additional Information


Belmont Report, April 18, 1979
http://ohsr.od.nih.gov/guidelines/belmont.html

OPRP – NIH, Institutional Review Board (IRB) Guidebook

R. I. Penslar
http://www.hhs.gov/ohrp/irb/irb_guidebook.htm

Standards for Educational and Psychological Testing
http://www.apa.org/science/programs/testing/standards.aspx

American Psychological Association Information for students:
http://www.apa.org/science/leadership/students/information.aspx

Educational and Psychological Testing
Testing Office for the APA Science Directorate
http://www.apa.org/science/programs/testing/index.aspx

See the ISEF website for additional resources.
http://www.societyforscience.org/Page.aspx?pid=317

 
Updated 9/14/10