Informed Consent Guidelines

All protocols submitted to the IRB must utilize an appropriate recruitment and consent process consonant with the risks involved. It is the responsibility of the PI and research staff to ensure that proper informed consent has been obtained from all research participants.

Assent must be obtained from minors. Assent forms are typically much briefer than consent forms, and the language must be appropriate for the age of the participant.

Consent Document

Unless a waiver is requested (see below), all research projects involving human subjects require a consent form. The body of the document should describe the goals, aim, or purpose of the research project in clear standard English at an appropriate reading level.  For adults from the general population, it is recommended that the consent forms be written at a 9th grade reading level or lower.  Please avoid jargon or other technical terms. The following website is useful for gauging the approximate reading level of a document.

http://www.online-utility.org/english/readability_test_and_improve.jsp

Please see link below for an example of a consent form written at a ninth grade reading level.  The document should conclude with signature lines for the subject (or parent/guardian), and the date when the form is signed.

All informed consent forms shall include the following elements:

  1. Name of the investigator, and organizational affiliation.
  2. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
  3. A clear description of any reasonably foreseeable discomforts or risks which the subject might encounter during participation in the project.
  4. A clear description of any benefits to the subject or to which may reasonably be expected from the research.
  5. A statement describing how confidentiality of records identifying the subject will be maintained.
  6. A statement that participation is voluntary, that refusal to participate involves no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may withdraw or discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. This should include informing the participant of what will be done with data that has already been collected after discontinuing participation.
  7. In cases where this is appropriate (usually where the experimental procedure involves treatment of some type), the consent form must include information about appropriate alternative procedures that would be of advantage to the subject.
  8. For research involving more than minimal risk, an explanation as to whether any compensation or medical treatment is available if injury occurs.
  9. An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject. The investigator must provide their name, phone number, and email address where they can be contacted for information about the study (you may also include the name of a faculty advisor). Dr. Thomas Lyons, Chair of the IRB, 773-995-2241, irb@csu.edu, must be listed as the person to contact if the participant has questions or concerns about their rights or treatment as a research subject.

A sample format for a consent document can be found at the link below. You are not required to follow this format, but your consent document should contain all of the required elements and be written in plain language at an appropriate reading level.

Recommended Format for Consent Document

Waiver of Documentation of Consent

Under certain circumstances the IRB may waive the need for a signed consent from a research participant. This waiver of documentation of consent may be requested in the following circumstances:

  1. When the research presents no more than minimal risk and involves procedures that do not require written consent when performed outside of a research setting
  2. The consent document is the only record linking the subject with the research
  3. The research can not be carried out without the waiver of consent
  4. When the principal research risks are those associated with breach of confidentiality.

PLEASE NOTE: The absence of a signed consent document does not release the researcher from obtaining research subjects’ consent to participate in the study. Participants should be aware that they are in a research study, who is conducting the study and for what reason, and that their participation is voluntary. One approach is to attach a consent -type document with the pertinent information (“elements of consent”), and indicate that completing the survey indicates consent to participate. Individuals may also be given information on the study to take with them. In circumstances when informed consent must be obtained verbally, oral instructions and the script detailing exactly what will be said to the participant are very important.

A waiver of documentation of consent may be requested by checking the appropriate box in the IRB initial application, and explaining why the request is being made, i.e. which of the above criteria applies, and how subjects will be provided the elements of consent.


 

Use of Protected Health Information and HIPAA Privacy Rule

Some healthcare data (Protected Health Information or PHI) is protected by the HIPAA Privacy Rule. For more information, please see

http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/research/index.html

 

Any investigator using Protected Health Information must complete the Responsible Conduct of Research (RCR) module on Information Privacy and Security - Health Privacy Modules.

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