Informed Consent Process

Informed Consent

ATTENTION: There is now a template for exempt consent forms. Please see the pop-up menu along the bottom of this page for the links to the informed consent forms that should be used for studies determined to have Exempt or Expedited review status.

All participants must be adequately consented to participate in research. It is important to remember that informed consent is a process and not just a document.

Different terms are used to describe the multiple consent types. Consent forms are used to consent participants 18 years or older. Permission forms are used to obtain permission from parents or guardians of participants 17 years or younger. Assent forms are used to obtain agreement from a minor participant to be in a study.

There are certain elements that are required to be in a consent document. To ensure that the consent contains the required elements, please utilize the Model Informed Consent Documents. There are two types of Model Informed Consent Forms. One for Expedited and Full Board studies and one for Exempt Studies.

These forms are provided to assist the researcher in creating an appropriate informed consent form. This form provides general guidelines for the language and format that should be used. These forms should be modified to be appropriate for each study. The model informed consent forms are updated regularly; therefore, researchers should be sure to use the most up to date version for each consent form.

Consent forms should be uploaded in their final form with no tracked changes or incomplete information. The document should be uploaded in the .doc format (not .pdf, or any other format).

To check the reading level of your informed consent document, click the link below.

After a Spelling/Grammar check in Microsoft Word is complete, the readability statistics should appear. If they do not appear, you can use the following steps to turn this feature on:

In Microsoft Word:

  • Click the File tab.
  • Click the word ‘options’.
  • Click Proofing.
  • Make sure ‘show readability statistics’ is selected.
  • Once the spelling and grammar check has been completed (Click Review then the Spelling and Grammar check button) a window will open with the readability statistics.
  • The statistic that the IRB is concerned with is the Flesch-Kincaid Grade Level.

In Microsoft Word 2007:

  • Click the Microsoft Office Button , and then click Word Options.
  • ClickProofing.
  • Make sure “Check grammar with spelling” is selected.
  • Under “When correcting grammar in Word”, select the “Show readability statistics” check box.
  • Complete the spelling and grammar check.
  • Once the spelling and grammar check has been completed a window will open with the readability statistics.
  • The statistic that the IRB is concerned with is the Flesch-Kincaid Grade Level.

In older versions of Microsoft Word:

  • From the Tools menu select Options.
  • A new window will open with all of the available options. Select the Spelling and Grammar tab.
  • Under Grammar, put a check in the box next to Check readability statistics.
  • Click OK. This will close the window.
  • Select Spelling and Grammar from the Tools menu.
  • Complete the spelling and grammar check.
  • Once the spelling and grammar check has been completed a window will open with the readability statistics.
  • The statistic that the IRB is concerned with is the Flesch-Kincaid Grade Level.

Child Assent Procedure

If minors under the age of 18 will be participants in the research, appropriate assent procedures must be in place.

Georgia State University Procedure:

Under 6:

No assent is required. Provide to the IRB information about how you will ensure that the children want to participate and are not getting upset.

Ages 6-10:

Verbal assent must be obtained and documented by PI. Submit an assent script to the IRB for review. The assent script must be age and cognition appropriate for the population.

Ages 11-17:

This age group must sign a separate assent document. The document will explain what will happen, and why, risks involved, any benefits, and the option that they could withdraw e.g., “you don’t have to be in this study, and your parent(s)/legal guardian(s) cannot make you be in it.” Also, a statement which would in effect say that they can “stop being in the study at any time” It does not necessarily need to contain other standard items like alternatives, cost/compensation and disclaimers, new findings, contacts, and confidentiality, but must be age and cognition appropriate for the population. Once the study is explained to the child, he or she should be asked to sign the assent. if signing a form is too intimidating or not appropriate for the population, the researcher can request a waiver of documentation of consent.

Parental Permission:

Consent must be obtained from the parent or legal guardian of children involved in research through a Parent Permission Form. This document needs to be in the format of an informed consent, but should be in third person (i.e. your child). The title of the document should the Parent Permission Form. Only a parent or legal guardian can sign a parental permission form for a child participating in research. A care giver, nanny, or grandparent cannot sign the form unless he/she is the child’s legal guardian.

Should the assenting child decline participation in this study, the PI, the parent(s), or legal guardian(s) cannot force the child to participate.

The Georgia State University IRB may determine that a waiver of consent is appropriate for parental permission for some studies. A waiver of consent for parental permission could also be requested for children 17 years old depending upon the type of research being conducted (i.e., the research study is conducted on a University campus, is a survey or questionnaire, and is determined to be a minimal risk.) The waiver must be requested and justified in the IRB application.

For Imaging Studies Involving MRI Scans:

The following represents the minimal information that must be on informed consent forms for studies using MRIs.  It may be modified or supplemented to fit the particular needs of your study, including any particular guidelines provided by your funding agency, as applicable.  The MRI language is not meant to be a stand-alone consent form.  This language should be inserted into the consent form only if a research study is using MRI scans.  Depending on your study’s participants, the readability of this form may be too high – although some difficult words cannot be avoided, many of the complicated words can and should be simplified for participants who may difficulty reading.

An MRI (or magnetic resonance imaging) scan is an imaging technique that uses magnetism, radio waves, and a computer to produce images of body structures. The MRI scanner is a tube surrounded by a giant circular magnet. You will be asked to lie still on a moveable bed that is inserted into a small tunnel inside the magnet. You will be asked to conduct certain activities or to listen to certain instructions/music and the MRI scan will produce the resulting images.  The images produced by the MRI are detailed and can detect changes of structures within the body. For some procedures, contrast agents such as gadolinium may be used to increase the accuracy of the images.
You may experience nausea if you have certain conditions such as migraines, vertigo, anxiety, stress, fatigue, pregnancy, food poisoning, digestive disorders, fibromyalgia, concussion, brain injury, appendicitis, kidney or liver disorders, central nervous system disorders, brain tumors, some forms of cancer, or other illnesses.  If you are currently experiencing nausea for any reason, you should not have an MRI scan until your nausea has subsided.

It may not be safe for you to have an MRI scan if you have certain metals in your body or have certain medical conditions.  If you have any of the following, you will be excluded from this study for your own safety:  Cardiac pacemaker; hearing aid; any other implant metal in your body or eyes, including pins, screws, shrapnel, plates, braces on your teeth, or dentures; Parkinson’s, Alzheimer’s, or other dementia; sickle cell anemia; epilepsy; bipolar disorder; multiple sclerosis; or brain surgery.

If you have tattoos, you could experience some irritation and redness at those sites.  Tattoos on the head, such as eye liner or other permanent makeup, may make it impossible to get clear and usable images.  If you have tattoos or permanent makeup of any type, you should inform us immediately.

[Researchers should also state any other exclusionary and inclusion criteria in this section.]

The following risks or discomforts may occur as a result of your participation in this study.  The MRI room may be cold and you may become tired or bored from lying in the scanner. If you are cold, you may request a blanket.  If you enter the MRI room with any magnetic cards, such as ATM and credit cards, you will risk having the data on the cards erased by the MRI machine.  The MRI scanning procedure requires that you be confined in a small partially enclosed space. Some individuals find this to be uncomfortable and may exhibit symptoms of claustrophobia including nervousness, sweating or other minor discomfort. The sound of the MRI scanner can be quite loud; you will be given special ear plugs to minimize the noise. In addition, the magnetism of the machine attracts certain metals; therefore, people with these metals within their bodies (such as pacemakers, infusion pumps, aneurysm clips, metal prostheses, joints, rods, or plates) will be excluded from the study. The “metal” in dental fillings is less responsive to magnetism and is therefore allowed. The MRI technician will ask you if you have any metals within your body. You will be expected to notify us of any metal in your body, other than dental fillings. There are no other known side effects resulting from exposure to the MRI scan.  If we do see something abnormal in your MRI scan, there is a risk that you may worry for no reason for a period of time until you can see a physician.

[If women of childbearing potential will be enrolled, and if there are no other known risks to them or their possible fetuses, the following statement is required:]  Women of childbearing potential who are considering being in this study should especially note that the risks to fetuses of exposure to MRI are unknown.

The MRI scan being done is designed to answer research questions, not examine your body medically.  The researchers for this project are not trained to perform radiological diagnosis. This MRI scan is not a substitute for one a doctor would order. It may not show problems that would be picked up by a medical MRI scan.  The researchers and Georgia State University are not responsible for failure to find existing abnormalities in your MRI scans. However, on occasion the researchers may notice a finding on a MRI scan that seems abnormal. When this occurs, a radiologist will be consulted as to whether the finding merits further investigation, in which case the researchers will contact you and inform you of the finding as soon as reasonably possible. The decision as to whether to proceed with further examination or treatment lies solely with you and your physician.  The researchers, the consulting radiologist, and Georgia State University are not responsible for any delays in contacting you about any abnormal findings or any examination or treatment that you undertake, or fail to undertake, based upon these findings. No information generated in this study will become part of a hospital record routinely. However, if the study detects an abnormality in your MRI scan, then this information may become part of the hospital record.  If something abnormal is found, such information may keep you from obtaining health or life insurance, depending on the specifics of your scan.  It is possible that you could be unnecessarily worried if a problem were suspected, but not actually found.  If you need to talk to someone about your concerns about an abnormal finding, you will be referred to a counselor at your own expense.
Your MRI pictures are for research only and are not meant to evaluate your health (as they would be if they were part of a clinical, non-research visit to the doctor or hospital).

[If the Principal Investigator intends to provide copies of the images to the participant, then the following sentence should be included:]

However, you will be provided with a copy of the MRI pictures at no cost to you to keep and review as you see fit.