INFORMED CONSENT STATEMENT & STUDY INFORMATION SHEET INSTRUCTIONS
An Informed Consent Statement has two purposes: (1) to enable potential research subjects to make an informed choice as to their participation in a study, and (2) to document their decision to participate. In order to make an informed choice, potential subjects must understand the study, how they are involved in the study, what sort of risks it poses to them, and what to do if something untoward happens. The words and language used to describe these factors must be understandable to potential subjects.
A Study Information Sheet enableS potential research subjects to make an informed choice as to their participation in a study. Study Information Sheets are normally used for Exempt studies that do not require signed consent. The subject's participation is considered consent; their signature is not required.
All protocols, except for existing data studies, must include one of these forms. SAMPLES OF INFORMED CONSENT STATEMENTS AND STUDY INFORMATION SHEETS ARE PROVIDED HERE. Following the format of the samples will help to ensure that the necessary criteria for approval are included. Assistance in the preparation of the consent statement or information sheet is available. Contact the IRB Office, 520-4181, A246C, firstname.lastname@example.org.
All sections are required elements of an Informed Consent Statement except those in Purple italics; these should only be included if they are applicable to your research.
- Study Information Sheets for mailed surveys may take the format of a letter, as long as all required information is included.
- For studies done with subjects that speak a foreign language you must submit the Informed Consent or Study Information sheet in both the subject's language and English.
- If your Informed Consent form is more than one page long, there should be a line at the bottom of each page for the subject's initials, except for the last page where the signature is obtained.
- The committee considers the terms “subject” and “participant” synonymous. You can use either term, but be consistent throughout your document.
- All pages must be numbered using the format “Page 1 of 2.”
- Use a type size no smaller than Arial 11-point.
- Leave a blank space of at least 1-1/2" high by 3" wide at the bottom of the last page for the approved and expires stamp that will be affixed by the IRB. A copy of the stamped version will be returned to you for your use.
- Heading Put Study # in the upper right hand corner of the document. The IRB will fill in the number. Then centered on the next line put:
INDIANA UNIVERSITY SOUTH BEND
INFORMED CONSENT STATEMENT or STUDY INFORMATION SHEET
List title of project here
- Opening Paragraph: Invite the subjects to participate (using third person language), state that the study involves research, and describe the purpose.
- Information Section:
- Describe all procedures (interviews, surveys, etc.), preferably in chronological order, which will be employed in the study. Point out any that are considered experimental (i.e. new drug or devise) and explain technical and medical terminology.
- State the amount of time required of the subject per session and for the total duration of the study.
If applicable to your study, describe:
- Alternative procedures or courses of treatment [when experimental procedures are being used].
- The approximate number of subjects involved in the study should be indicated when the subject population is small in number. If subjects might be identifiable in reports because individual responses will be described (possible when the N is small), a statement to this effect should be included in the consent statement or information sheet.
- If you plan to audio tape, videotape or film the subjects, request permission to do so in writing and indicate how you will be using this material (research purposes only?, research and instruction?, who will have access to or view the tapes?, will subjects be allowed to preview the tapes?, what will happen to the tapes at the end of the study?; what will happen to the tapes if the subject withdraws?). All possible uses of the tapes/films/photos (current & future) must be described. If tapes are kept by the PI beyond the end of the study and/or archived, then the following statement must be included: "The tapes/films/photos will not be used for any additional purposes without your additional permission." and signed/documented consent is required.
- If DECEPTION IS USED, include a statement to the effect that the research cannot be fully described at this time, but at the conclusion of participation, an explanation will be provided. (Provide a copy of the debriefing script with your packet for IRB review.)
- Risk Section: Describe any reasonably foreseeable risks or discomforts, if any, of each of the procedures to be used in the study, and any measures which will be used to minimize the risk.
If there is no risk involved, this section does not have to be included in a Study Information Sheet. Even if there is no risk, this section MUST be included in every Informed Consent Document. It can say “We do not anticipate any risk associated with this study.”
If appropriate include a statement that the particular treatment or procedure may involve currently unforeseeable risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant).
- Emergency Medical Treatment Section. If the study is Department of Health and Human Services (DHHS) funded, or if the study involves risk procedures (exercise, medical, stress, alcohol, and so on), you must contact the IRB office for appropriate wording.
DO NOT INCLUDE THE EMERGENCY MEDICAL TREATMENT SECTION IF IT IS NOT APPLICABLE TO YOUR STUDY
- Benefit Section: Describe any benefits to the subject or to others; or the extent of contribution to the body of literature/knowledge. If there are no benefits to the participants indicate with language such as: "While there are no direct benefits to you for participating in this research, we hope to learn…”
- Confidentiality Section: Describe the extent, if any, to which confidentiality of records identifying the subject will be maintained. If subjects are identified in reports, signed consent is required. If research is conducted over the Internet, you must tell subjects that you cannot guarantee confidentiality while their data are being transferred across the internet.
- Compensation Section: State the terms of subject compensation for study participation, if any. If the subjects will be paid (or receive other compensation) for participation, state how and when they will receive payment and/or compensation (i.e., compensation = toys, books, gifts, etc.). List value of gifts or service. If class credit will be given, list the amount. List alternative ways to earn the same amount of credit. Explain the amount of partial payment if the subject withdraws prior to completion of the study. (See policy at http://www.ws1.iusb.edu/irb/compensation.html)
DO NOT INCLUDE THE COMPENSATION SECTION IF IT IS NOT APPLICABLE TO YOUR STUDY
- Contact Section: Include an invitation for the subject to ask any questions at any time about the study and its procedures, or their rights as subjects. Include the principal investigator's name, office address, telephone number, and e-mail address that the subject may use to ask questions and report any study related problems. If there are co-investigators you can include their information here but only one contact person is absolutely necessary. For student studies include your sponsor's information as well. For studies done outside the USA, list both foreign and USA contact information and the dates that apply to each. Include the IUSB IRB office as the place to contact with questions about participants' rights. You must include this specific paragraph verbatim:
If you feel you have not been treated according to the descriptions in this form, or your rights as a participant in research have been violated during the course of this project, you may contact the Indiana University South Bend Institutional Review Board for the Protection of Human Research Subjects, 1700 Mishawaka Ave., A247, South Bend, IN 46634, 574-520-4181, by e-mail at email@example.com.
If appropriate to your research include a statement that if the subject experiences adverse effects, the investigator should be contacted immediately – contact the IRB for appropriate wording.
- Participation Section: Tell the subject that participation is voluntary. Further, state that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled. The Federal regulations for the protection of human subjects require these words or an equivalent statement. Tell subjects what will happen to their data if they withdraw from the study. If the data include identifiers you must describe what will happen to it if the subject withdraws. If the data do not include identifiers then it is impossible to either return or destroy it.
If appropriate to your research give any anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent. Also, if appropriate to your research include a statement that says that significant new findings developed during the course of the research, and which may be related to the subject's willingness to continue participation, will be provided to the subject.
- Consent Section: Include a statement that says the subjects have read the consent form, have had questions answered to their satisfaction, acknowledge receiving a copy of the form, and agree to take part in the study. Provide a line for signature(s) and the date. Provide two copies of the Consent Form, one to be retained by the subject and one to be submitted for the research records. The submitted copy must be signed by the subject and, if applicable, the subject's parent(s)/guardian/legal representative. The signed submitted forms must be retained by the researcher for three years after the completion of the study. This section does not need to be included in a Study Information Sheet.
If subjects are minors use the following guidelines for obtaining consent/assent:
- 6 years old and younger - only parent(s)/guardian/legal representative need sign;
- 7- 8 years old - signature of minor is optional, requires signature of parent(s)/guardian/legal representative;
- 9 through 17 years old - requires signature of both minor and parent(s)/guardian/legal representative.
When young children are subjects, a script that will be used to explain the study to the children may be required. Check with the IRB office.If the subject or legal representative is unable to read and/or understand the written consent form, it must be verbally presented in an understandable manner and witnessed (with signature of witness) by someone not associated with the study. This might apply in cases where subjects are: MENTALLY DISABLED, SERIOUSLY ILL, INSTITUTIONALIZED, INCARCERATED (PRISONERS), or A MEMBER OF ANOTHER VULNERABLE GROUP.
If appropriate to your research disclose any additional costs to the subject that may result from participation in the research. (If subjects will be charged for participation in the research project, then all costs must be itemized on the consent form. If alternative, non-investigational procedures are available, then these procedures should be discussed and the average costs included in the consent form.)