Researchers must obtain the signed informed consent of participants prior to conducting their research.
"Informed Consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.
Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate."
Provide the potential subject or Legally Authorized Representative (LAR) "the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information."
For participants younger than 18 years of age, the researcher must obtain the signed informed consent of parents or legal guardian and all reasonable attempts must be made to obtain each participant's assent, which is defined as the participant's agreement to participate in the study.
When writing an informed consent document, consider the potential participant's perspective. Read more in Questions to Ask When Deciding Whether to Volunteer for Research (PDF)Listen.
Guidelines for Writing Informed Consent Forms
The following list of topics that the Common Rule departments and agencies indicated generally would encompass the key information required to satisfy §_116(a)(5)(i):
- The fact that consent is being sought for research and that participation is voluntary
- The purposes of the research, the expected duration of the prospective subject’s participation, and the procedures to be followed in the research
- The reasonably foreseeable risks or discomforts to the prospective subject
- The benefits to the prospective subject or to others that may reasonably be expected from the research.
- Appropriate alternative procedures or courses of treatments, if any, that might be advantageous to the prospective subject.
Informed consent must include the following in sequential order and in language which the participants can understand:
- Statement of purpose of the study
- Short description of methodology and duration of participant involvement
- Statement of risks/benefits to the participants
- Statement of data confidentiality
- Statement regarding the right of the participant to withdraw from the study at any time without negative consequences
- An offer to answer any questions the participant may have
- Contact information of all Principal Investigators and the contact information for TCCD’s IRB (817-515-5900)
- Lines for signature of participants and/or parents or legal guardian except for questionnaire research, in which return of questionnaire gives implied consent
- Statement that participant is 18 years of age or older unless parent or legal guardian has given consent
Under the current regulations, secondary research use of identifiable data/biospecimens is permissible through study-specific consent, by obtaining an IRB waiver of consent, or by removal of identifiers.
In the Revised Common Rule, "Broad Consent" is an (optional) alternative consent process
for use only for the storage, maintenance, and secondary use identifiable private
information or biospecimens for future, yet-to-be-specified research. [§46.116(d)]
If an individual is asked to provide broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens, and the individual "refused to consent," an IRB cannot waive consent for the storage, maintenance, or secondary research use of that person's identifiable private information or identifiable biospecimens. See 82 Fed. Reg. 7267 (Jan. 19, 2017).
Tarrant County College District will not be adopting the use of Broad Consent on an institutional level as the tracking requirement may be burdensome. Exemption categories 7 and 8, which are specific to Broad Consent, will not be utilized. The issues of Broad Consent may be entertained in the future pending further guidance from OHRP.
OHRP has provided a template of a Broad Consent form, and may be viewed under forms to show the complexity of the Broad Consent Form.
Using Deception in Research
In situations where participants will be deceived, items 1 and 2 are omitted and participants are told (on the signed form) that disclosure of the purpose and/or methodology could bias the outcome of the study.
In this case, after the study is complete, each participant must be given a written description of the purpose and methodology as carried out and said description must be signed by the participants after the fact in order to guarantee informed consent.
Updated May 09, 2019