Guidelines for Developing a Proper Informed Consent Process
The consenting process refers to both the content and procedure for conveying information about your study and securing an agreement to participate.
The content of any consent document should include all of the following:
- Introduction of researcher
- Explanation of purpose of study
- Description of all research activities required of participants
- Explanation of how long the project will last and what kind of time commitment is required of participants
- Description of any potential risks and/or benefits of the study, and information about compensation (if any) for participation
- Statement that participation is completely voluntary, that the refusal to participate in any part of the research will involve no penalty, and that potential participants may withdraw at any time without penalty
- At least one contact person’s name and telephone number should participants have questions about the research
- IRB contact information should participants have questions about their rights as research participants
- A final consent statement and place for date and signature OR for indication of consent (for example: for online surveys)
If appropriate, also include:
- Statement that the project is being done for thesis or dissertation research
- Faculty sponsor name and contact information
- Statement about limits to confidentiality (for example, if a researcher is a mandated reporter)
- Information about audio or video taping and final disposition of tapes
- Suggestion for seeking support for thoughts or emotions stimulated by the research activity (for example: CCSU Counseling & Wellness Center)
Other points to consider:
- Is all information in the form consistent with information in the research protocol?
- Is the drafted information presented in a way that can be understood by the potential participants? Researchers should avoid jargon and legalese and use ordinary language. Readability is the objective, so a consent document is no place for legal or academic jargon.
DETERMINING WHAT TYPE OF CONSENTING PROCESS TO USE
One of the most important ethical rules governing research on humans is that participants must give their informed consent before taking part in a study. In most cases informed consent should be documented by the use of a written consent form approved by the IRB and signed by the participant or the participant’s legally authorized representative.
Please review the following consenting processes to determine which process is appropriate for your study.
A traditional consent document with standard content areas should be signed by the participant and the researcher and retained by the principal investigator (PI) for five years. This form may be read to or read by the participant and/or the participant's legally authorized representative. Adequate time should be given for the conveyance of the content, as well as for answering any questions from prospective participants before requesting signature.
- For studies involving minors: Signed, fully informed permission of parent(s)/guardian(s) as well as the assent of participants are required for studies involving minors except when such studies involve normal classroom activities as determined by the IRB. A parental consent document should contain the same information as a standard consent document but should be written with the minors’ guardians in mind as the target audience. Similarly, an assent document includes the same information but is written for the minor-participant audience. See the “Assent for Minors” guidance on the IRB website for more information.
ORAL BRIEFING WITH WRITTEN SHORT FORM
An oral presentation of content should include content found in a standard consent document AND a written summary of this information. If practicable, the summary should be signed by the participant and the researcher and retained by the PI for five years. This method of consenting may be useful when language or cultural factors favor face-to-face conveyance of the consent information.
- The IRB must approve the oral script and short form consent document to ensure each contain the necessary content.
- A witness must be present for the oral presentation and must sign the summary to document that the oral script was read.
- The short form itself is to be signed by the participant or the representative.
- A copy of the summary shall be given to the participant or the representative, in addition to a copy of the short form.
For online studies, waivers of signed consent may be granted if a study’s sole method of data collection is conducted online. However, a comprehensive written consent statement must be incorporated into the consenting process.
Participants should be allowed to actively indicate their consent by clicking on a “consent” button or otherwise indicating their agreement to participate before the content of the survey is delivered. For example, you may include a statement such as the below sample statement at the end of your consent information:
This information has been provided so you know what to expect if you participate in this study. Your consent will be implied by your completion of this survey. To convey that you understand and agree to participate, please press I CONSENT to continue.
WAIVERS OF CONSENT
In some situations, the IRB may waive some of these consent requirements for studies involving minimal risk. In these cases, if obtaining full written consent is not practicable, and/or the only record linking the subject and the research would be the consent document and the participants’ principal risk would be potential harm from a confidentiality breach, the IRB may permit investigators to provide an information sheet to potential participants and/or forgo getting signatures and/or retaining consent documents.
For these cases, even if some consent requirements are waived, investigators still must gain consent and fully inform subjects of their rights to cease participation as well as convey the full scope of the proposed research interventions before engaging participants in any research activities. Bear in mind that obtaining and documenting full consent from participants is a vital part of ethical research with human subjects, and all consent waiver requests will necessitate a careful review of the consenting process by the IRB to ensure the waiver request adheres to the federal regulations at 45 CFR 46 and the principles of respect for persons, beneficence, and justice as outlined in the Belmont Report.
Adapted from policies issued by the Office for Human Research Protections, U. S. Department of Health & Human Services