Informed Consent Document
For guidance from OHRP on aspects of writing Informed Consent forms, go to:
The Informed Consent Form must be printed on Seton Hall University departmental letterhead and must include the following elements stated in terms that the subject can readily understand. To avoid the implication of waiver of rights, use the grammatical 3rd person only in the Informed Consent document.
- The researcher's affiliation with Seton Hall University (college/school, department, program).
- An explanation of the purpose of the research in lay, non-technical terms, and the expected duration of the subject's participation (estimate of the amount of time involved to participate in the research).
- A description of the procedures to be followed in lay terms, and identification of any procedures which are experimental.
- If questionnaires or survey instruments are used in the research, they should be specifically named and briefly described, with a sample of questions to be asked.
- A statement of the voluntary nature of the participation, specifying that refusal to participate or discontinuing participation at any time will involve no penalty or loss of benefits to which the subject is otherwise entitled.
- A statement indicating if anonymity (i.e., no identifying data on subjects to researcher or others) will be recorded, so that no one will ever be able to link the data to any individual.
- A statement of how the subject's data will be securely stored to maintain confidentiality (i.e. identifying information will be collected but efforts will be made to protect the subjects' identities). If the data will be confidential, include an additional statement specifying the measures that will be used to maintain the subjects' confidentiality and the circumstances, if any, under which identifying data may be used or disclosed without the subjects' express consent.
Note: For security reasons, data can no longer be stored electronically on hard drives of laptop or desktop computers. Data must now be stored electronically only on a CD or USB memory key, and kept in a locked, secure physical site.
- A statement describing to what extent records will be kept confidential, including a description of who may have access to research records.
- A description of any reasonably foreseeable risks or discomforts to the subjects, an estimate of their likelihood, and a description of what steps will be taken to prevent or minimize them. If there are no anticipated risks, this should be stated.
- A description of (1) the direct benefits, if any, that subjects may reasonably be expected to receive as a result of participating in the research; and (2) the potential benefits of the knowledge reasonably expected to result from the research. If no direct benefits to subjects are expected, this should be stated. Monetary compensation or other remuneration to subjects is not considered a direct benefit.
- If subjects are to be paid or given any other type of remuneration, the amount of the payment and/or the nature of the other remuneration should be stated in the consent document.
- For research involving more than minimal risk, an explanation and description of any compensation and any medical treatments that are available if research subjects are injured, where further information may be obtained, and whom to contact in the event of a research-related injury must be provided. Similarly, if the activity poses the possibility of causing undue stress or psychological harm to the subject, the research must develop a referral mechanism, e.g., suggest to seek medical or psychological help and provide a list of centers that can be contacted for that purpose.
- A disclosure of appropriate alternative procedures or courses of treatment that might be advantageous to the subject.
- Contact Information: An explanation of whom (that is,  the principal investigator/researcher,  the researcher's faculty advisor,  the IRB office) to contact for answers to pertinent questions about the research and research subject's rights should be identified. Only office addresses and phone numbers should be given. Do not give out home addresses or phone numbers. If researcher is a student, use the address and phone number of the department in which researcher is studying.
- If video or audio-tapes are involved, the Consent Form should ask for the subject's written permission for such taping and should indicate how the subject will be identified on the tape (by name, by code number, etc.), who will have access to the tapes, who will listen or view the tapes, how the tapes will be stored, who will transcribe the tapes, and when the tapes will be erased or destroyed.
- A Clear Statement must be made that subjects are to be given a copy of the signed and dated Informed Consent Form.
The following statement MUST be included in the informed consent form only for projects which pose a risk to subjects:
The Department of Health and Human Services requires that you be advised as to the availability of medical treatment if a physical injury should result from research procedures. No special medical arrangements have been made regarding your participation in this project. If you are a registered student at SHU, you are eligible to received medical treatment at the University Health Service. If you are not a registered student at the University, immediate medical treatment is available at usual and customary fees at the local community hospital.
The Informed Consent Document must be on department letterhead stationary and must contain all the points listed above in separate paragraphs and under headings specific to the point. This is to ensure clarity to the prospective research subject in a simple, efficient way. If the Form is deficient in this, the protocol will not be forwarded to the IRB for review. Rather, it will be returned to the researcher for remediation, which will delay review by at least one month.
The Informed Consent Document must have a place for the subject's signature and date. Subjects are to be given a copy of the signed and dated Consent Form before their participation begins.
Children over age 12 who sign Assent Forms need to have a parent/legal guardian countersign and date the document. Child subjects and their parents/legal guardians are to be given a copy of the signed, countersigned and dated Assent Form before their participation begins.
Children under age 12 need to have a parent/legal guardian sign and date the Oral Assent Procedure or Script. Child subjects and their parents/legal guardians are to be given a copy of the signed, dated Oral Assent Procedure or Script before their participation begins.
Children cannot be approached to be in a study without parental signed approval on a consent form to permit this.
Copies of all completed Consent Forms, Assent Forms, Oral Assent Procedure or Script forms must be retained by the researcher for a period of at least 3 years following termination of the research.