Guidelines for Written Consent



February 2012

Guidelines for Written Consent

When research involves human subjects, the investigator must obtain prior consent from the participants.  Listed below are the guidelines for composing a written informed consent document, which is to be submitted to the La sierra University IRB as part of the application materials.  If the level of risk is less than minimal in the opinion of the chair, the written consent requirement may be waived.

  1. FORM:  The informed consent document should be printed on La Sierra University letterhead (photocopies are fine).
  2. TITLE OF PROTOCOL: Use the same research title on the form.
  3. LANGUAGE:  Avoid technical terms and use eighth-grade-level language; for younger children, use language appropriate for their level of understanding.
  4. PURPOSE AND PROCEDURES: Describe the purpose, procedures, and duration of the study as completely as possible (without compromising the integrity of the study).
  5. RISKS AND BENEFITS: State any potential risks or benefits of the research to the participants.  State how participants may obtain a report of the results if desired.
  6. PARTICIPANTS’ RIGHTS: Inform the voluntary subjects of their rights to withdraw from the study at any time, without negative consequences.
  7. CONFIDENTIALITY:  Indicate the extent of confidentiality or anonymity that will be maintained and the way in which this will be accomplished (e.g., where, how, and for how long audio or video tapes will be kept; how identification numbers or pseudonyms will be assigned).
  8. CONTACT INFORMATION: Provide contact information for the researcher and an impartial third party whom participants may contact with questions they may have that they do not wish to discuss with the researcher(s) such as about their rights as participants. Possibilities are the chair of the IRB or the dean of the college or school of which the researcher is a part. Note that student researchers must also provide contact information for their faculty mentor.
  9. INFORMED CONSENT: Give the participants an opportunity to ask questions before consenting.
  10. SIGNATURES:  Provide a signature and date line for each subject, parent, or legal guardian as applicable.
  11. PROVIDE A COPY: Provide a copy of the informed consent document to each participant to keep for their own records.

See example here >>