Human Studies Council
-Institutional Review Board-
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.Process questions include:
· Will you obtain signed consent or request a waiver?
· Will you provide consent with a written form and/or an oral briefing?
· Is your form or oral script organized into the eight required sections or paragraphs so that information can be easily followed?
Content questions include:
· Is all information in the form consistent with information in the research protocol?
· Is the information drafted in language that could be understood by the potential participants?
· Are all of the following included?
1. Introduction of researcher
2. Explanation of purpose of study
3. Description of all research activities required of participants
4. Explanation of how long the project will last and what kind of time commitment is required of participants
5. Description of any potential risks and/or benefits of the study, and information about compensation (if any) for participation.
6. Suggestion for seeking support for thoughts or emotions stimulated by the research activity (for example: CCSU Counseling & Wellness Center).
7. Statement that participation is completely voluntary; that the refusal to participate in any part of the research will involve no penalty; that potential participants may withdraw at any time without penalty.
8. Contact person and telephone number should participants have questions about the research.
9. HSC Contact information should participants have questions about their rights as research participants.
10. A final consent statement and place for date and signature OR if waived, for indication of consent (for example: for online surveys)
If appropriate, 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 researcher is a mandated reporter).
· Information about audio or video taping and final disposition of tapes.
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. According to the U.S. Office for Human Research Protections (OHRP), the Code of Federal Regulations (45 CFR 46) requires that certain information be provided to research subjects before they participate in a study. This information is outlined in the HSC Sample Consent Documents (link).
Review the following consenting processes to determine which is appropriate for your study. Note that unless a waiver of signed consent is justified by the PI and approved by the HSC, informed consent shall be documented by the use of a written consent form approved by the HSC, and signed by the participant or the participant’s legally authorized representative. A copy shall be given to the person signing the form.
WRITTEN
Consent document (CD) with standard content areas to be signed by participant and researcher, retained by PI for five years. / This is a written document that embodies the eight elements of informed consent. 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 this reading, and conveyance of the content, as well as for answering any questions from prospective participants before requesting signature.
· 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 and are for that reason determined to be exempt by the HSC.
· A Parental Consent Document contains the same information as a standard CD but is 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.
ORAL BRIEFING WITH WRITTEN SHORT FORM
Oral presentation of content found in standard CD. WITH a written summary of this information. The summary is to be signed by participant and researcher, retained by PI for five years. / Federal regulations permit the use of a short form consent document stating that the required elements of informed consent have been presented to the subject or the subject’s legally authorized representative orally, with a witness present. This method of consenting is useful when language or cultural factors favor face-to-face conveyance of the consent information.
· The HSC must approve the oral script and short form consent document to ensure each contain the relevant 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.
WAIVER of signed consent Written or oral briefing as above WITHOUT participant signature or document retention.
Waivers are granted for studies involving minimal risk, and if signed consent poses the sole risk to confidentiality. / The HSC may waive the requirement for the investigator to obtain a signed consent form. This waiver permits investigators to provide an information sheet to potential participants and forgo getting signatures and retaining consent documents. Investigators still must verify that potential participants understand the content of the document before engaging the participant in research activity. A waiver may be granted to supplant a long version consent form OR an oral/short-form consent process if:
· The only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality.
· That the research presents no more than minimal risk of harm to participants, and involves no procedures, for which written consent is normally required outside of the research context.
· Typically a request for a waiver of signed consent form is initiated by the Principal Investigator during the initial HSC submission and review process.
For online surveys: Waivers of signed consent are automatically granted if a study’s sole method of data collection is an anonymous online survey. However, a comprehensive written consent statement must be incorporated into the survey in the recruitment materials (for example, an email invitation to participate) and/or as the opening/introductory page of the survey.
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 the following statement at the end of the 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.
Adapted from policies issued by
the Office for Human Research Protections, U. S. Department of Health & Human Services
Ensure Informed Consent readability:
· Use the sample consent form available on the HSC website as a template. Just be sure to individualize it so it reflects the reality of your protocol.
· Make headings simple and interesting. Use bolded topic descriptions as headings to break up the copy and make it easier for readers to comprehend the content. Readers often find headings with questions simpler to understand-- such as, What will you be expected to do? Or, What are the benefits to you?
· Use bullet points when listing items,. It is better to use bullet lists than writing the points in one long paragraph because bullets imply an order to what is going on, and it is easier for people to look take in the information.
· Avoid jargon and legalese – Use ordinary language. Readability is the objective so a consent document is no place for legal or academic jargon.
Informed Consent Guidelines 1