Informed Consent

Scroll Down for Suggested Format

 
 

Remember, all projects, regardless of grade level and relationship to the
human subjects must have SRC/IRB review, and  obtain approval where necessary

 before they start any experimentation. 

Fill out and send in all of the material requested on the
SRC & Informed Consent K-8 Form, or the appropriate ISEF Forms (9-12).
 
Failure to receive approval before experimentation
will result in Failure to Qualify for SARSEF, DCYSC and ISEF

 

The process of obtaining informed consent provides information to the subject about the risks and benefits associated with participation in the research study and allows the subject to make an educated decision about whether or not to participate. Informed consent is an on-going process, not a single event that ends with a signature on a page. It must incorporate procedures that do not involve coercion or deception.


Documentation of informed consent is required:

  • When the IRB determines that a research study involves physical or psychological activities with more than minimal risk
  • When the IRB determines that the project could potentially result in emotional stress to a research subject.
  • When the IRB determines that the research subjects belong to a risk group and the study does not meet any of the criteria below for a waiver.

Documentation of informed consent is required for most research projects.  However, the IRB may waive the requirement for documentation of written informed consent if the research involves only minimal risk and anonymous data collection and if it is one of the following:

  • Research involving the observation of legal public behavior
  • Research involving collection or study of existing publicly available data or records
  • Research involving normal educational practices
  • Research on individual or group behavior or characteristics of individuals where the researcher does not manipulate the subjects’ behavior and the study does not involve more than minimal risk.
  • Surveys and questionnaires that are determined by the IRB to involve perception, cognition, or game theory and do NOT involve gathering personal information, invasion of privacy or potential for emotional distress. If there is any uncertainty regarding the appropriateness of waiving informed consent, it is strongly recommended that informed consent be obtained.
  • Studies involving physical activity where the IRB determines that no more than minimal risk exists and where the probability and magnitude of harm or discomfort anticipated in the research are not greater (in and of themselves) than those ordinarily encountered in DAILY LIFE or during performance of routine physical activities.


 

If a research subject is under 18 years of age, it is recommended that, in all cases, informed consent be obtained. Both the parent/legal guardian and the school age research subject must sign Informed Consent Form, for K-8 researchers, and for HS researchers ISEF Form 4 (Human Subjects and Informed Consent Form). However, an IRB may decide that informed consent is not required because of the allowable exceptions listed above. When the IRB waives informed consent of research subjects under the age of 18 for studies involving surveys or questionnaires, documentation justifying this waiver must accompany Informed Consent Form K-8 or  HS ISEF Form 4.

 

 

There is no single prescribed SARSEF format for obtaining Informed Consent.  K-8 Researchers:  Below is an outline of the information required.  Click below for a printable version.  The form you use must be approved by the SRC/IRB.  It should then be copied for each participant’s appropriate signatures.  These should be kept in your research journal.  They should remain confidential, but may be brought to SARSEF competition for SRC approval before competition, but should then be taken home

Suggested Format for an Informed Consent Form

 Click here for Printable Document

TITLE

You are invited to participate in a research study. The purpose of this study is to determine … (Explain).

INFORMATION

 

  • Methods to be used  (give details).
  • Data will be analyzed … (details of how data will be analyzed).
  • The study will take place during (give expected dates).
  • Depending on the results, data may be used in further analysis by research scientists.

RISKS

 

(Describe the risks.)

BENEFITS

 

This project will …. (state the intended benefit).

CONFIDENTIALITY

 

The information in the study records will be kept confidential. Data will be stored securely and will be made available only to persons conducting the study unless you specifically give permission in writing to do otherwise. No reference will be made in oral or written reports that could link you to the study.  No identifiers (name, age, etc.) will be disclosed to anyone, and all information will be destroyed at the completion of the study.

CONTACT

 

If you have questions at any time about the study or the procedures, (or you experience adverse effects as a result of participating in this study,) you may contact …. (list Adult Sponsor/Qualified Scientist if one is involved, and the phone number/e-mail address for participants to call upon).

PARTICIPATION

 

Your participation in this study is voluntary; you may decline to participate without penalty. If you decide to participate, you may withdraw from the study at any time without penalty.

CONSENT

 

I have read the above information, reviewed the questionnaire (if one is involved) and agree to participate in this study.

 

Participant's name (print) ____________________________________

 

Participant's signature _______________________________________   Date ______________

 

Parent/Guardian's name (print) _______________________________

 

Parent/Guardian's signature __________________________________   Date ______________

 
This site is copyrighted. ALL RIGHTS RESERVED  Since 2001, this site has been designed, produced, maintained and hosted by Add-a-Web.net, Tucson Arizona. (520) 531-1500  
Log-in