Part 4 – Informed Consent

Informed consent is one of the key elements of social science research, as it allows the participates the autonomy to make a rational and informed decision on whether or not to participate. There are many situations where it may be necessary to modify, expand or shorten the consent process however, and we will examine the protocol for reach.

       What is Informed Consent?

In short, an informed consent gives a prospective participant all the information they need to know about the study – what is expected of them, what the results will be used for, why the study is being done, and the like. And then, it allows them to formally and voluntary agree to be a part of the study, and document that this agreement.

The federal regulations on informed consent dictate the following eleven factors are to be included in social science research project informed consents:

1. An explanation of the purposes of the research and what is hoped to be discovered
2. The expected duration of the participant’s involvement
3. A description of the study procedures (identifying any that are experimental)
4. A description of any reasonably foreseeable risks or discomforts
5. A description of benefits that may be expected for the participant of the study field as a whole (what the application of the findings might be)
6. A description of any alternative procedures a subject may choose during the study
7. A statement explaining the extent of confidentiality the findings will be held to (if any). Note, mandated reporting requirements (such as child abuse) must be listed here.
8. In the event a study has more than minimal risk, a description of medical treatments that will be available and expected compensation must be outlined.
9. Contact info for who to reach out to for questions and concerns related to the research and the subject’s rights (including who to contact in case of injury or emergency).
10. It must be reiterated that participation is voluntary, and subjects can opt out at any time without penalty.
11. If there is private information gathered in the study and identifiers will be removed and could be used in future research or distributed to other parties without informing the subject, this must be outlined. Otherwise, there must be a statement saying the results will not be used for another research study.

       Special Considerations

If any of the following are relevant, they must be included in the informed consent as well:

1. Any risks that may be associated to pregnant women specifically
2. Any circumstances where the researcher can terminate the subject’s participation, with or without consent
3. Any costs that the subject may be required to bear to participate
4. Any consequences if a subject chooses to withdraw, such as what will be done with a subject’s compensation if they withdraw before completion, or if the data gathered will still be used.
5. A statement that if any new findings arise during the study that may change the subject’s willingness to participate, they will be informed
6. An approximate number of subject involved in the study
7. A statement outlining whether or not findings will be disclosed to the subject

       Presentation of Informed Consent

Informed Consent forms are usually reviewed and discussed with participants by research staff to answer any questions. In the event that a legally authorized representative (LAR) is enrolling an individual on their behalf, such as the parent of a minor, a guardian of a decision-impaired adult or a prisoner, they will assume the role of authorizing the research.

There must be special attention given to not infringing on the voluntary consent of the participants. There should be ample time to review the information and make a consideration, no undue influence from research incentives, and an environment that does not pressure participants into agreeing (such as close proximity to parents or peers who are agreeing to the same research). Further, a subject must never be asked to or even appear to waive any legal rights, or release a researcher or institution from liability.

Finally, informed consent must be written in a format that is comprehensible for its readers and signatories. This includes being in the proper language for all prospective participants, and also at the correct reading level for the participants. This increases the value of the explanatory power of the research staff discussing the informed consent with the participants.