IRB:Informed Consent

Consent and Assent Forms:

Informed Consent Template

INFORMED CONSENT

Informed consent must be obtained from each subject who is legally, mentally, and physically able to provide it. The consent must be in written form and signed by the subject (or his/her legally authorized representative) unless the IRB finds either (1) the consent document is the only link between the subject and the research and the principal harm would come from a breach of confidentiality, or (2) there is no risk of harm to the subject, other than minimal risk and the study involves no procedures for which written consent is normally required outside of a research setting. For subjects not able to provide informed consent themselves, written informed consent must be obtained from others (e.g., parents, guardians). Under certain conditions, the IRB may waive the informed consent provision. (See Title 45 of Code of Federal Regulations 46, 46.116(c), June 18, 1991, or contact the IRB Administrator.)

The IRB will not approve passive informed consent. Failure of a subject, or his/her legally authorized representative, to express an unwillingness to participate, does not constitute consent to participate in the project.

Written Consent

In most cases a written Informed Consent form will be used. This means you will provide research participants with two(2) copies of they consent form for your project. The participants will read the consent form, if they fully understand what the project is asking them to do and they are still willing to participate, they will sign the form and return it to you and begin pariticipation in the project. Two(2) copies are usually provided to enable particpants to keep a copy of the form for themselves.

Essential elements of a written consent form are provided below. A written consent form should include the elements below and it should relate to a specific study. You should use one of the consent templates found on this page, but you consent form should not be a "standard form." You must revise all of the sections in the consent template to fit your project. The consent form must be written in simple language so as to be easily understood by persons with no research or scientific background. A general rule is that potential subjects must be given all information that might reasonably be expected to influence their willingness to participate. The PI should provide two copies of the consent form; one for the subject, parent, or guardian to sign and return, and the other for him/her to keep. The Office for Human Research Protections (OHRP) has suggested that investigators avoid writing the consent forms in the first person language ("I understand that…"). However, the IRB will accept consent forms that are written in either the first person ("I") language or the second person ("YOU") language.

A simple, descriptive title of the research project.
Name and telephone number of the Principal Investigator and Faculty Advisor, if PI is a student.
A statement that the study involves research.
An explanation of the general purpose of the research. If the research involves an experimental treatment for a problem or disorder, that treatment should be identified and any alternative treatments that might be advantageous to the subject.
An explanation of the procedures to be followed.
A statement concerning the approximate number of subjects involved in the study.
A description of all discomforts and risks to be reasonably expected.
A description of benefits to subjects that can reasonably be expected. In addition, you may choose to describe the importance of the knowledge that may be reasonably expected.
A statement concerning the expected duration of the subject’s participation, frequency of trips to the study site, etc.
A statement of any costs to the subjects, if there are any.
A statement, if applicable, about any monetary or other inducements for participation and how those will be prorated.
A statement describing how confidentiality will be maintained and who will have access to the data.
A statement that the subject is free to refuse to participate or to withdraw from the research activity at any time without penalty and without jeopardy.
A statement that the Principal Investigator or Faculty Advisor (include name) may be contacted (list phone number) if the subject has any further questions about the study.
A paragraph containing information about the IRB similar to the following:
You may contact the Saint Joseph’s University Institutional Review Board at the following address and telephone number at any time during this study if you have questions or concerns about your rights as a research subject:
IRB Administrator, Institutional Review Board for the Protection of Human Subjects in Research
215 City Avenue
Saint Joseph’s University
5600 City Avenue
Philadelphia PA 19131
Phone: (610) 660-1298, jfiorava@sju.edu.
Signature of the subject indicating consent. (Signature of parents or legal guardians for subjects who cannot legally represent themselves.)
When appropriate, a simply worded assent form for children who can read and write should be prepared for their signature. This is in addition to the consent form signed by the parent or guardian. (See Section 5 for additional information about research with children.)
For research involving greater than minimum risk to subjects, a statement specifying whether any compensation or medical treatments are available if injury occurs and where further information may be obtained.

Oral Consent
In certain cases, it may be necessary to alter some or all of the required elements of the consent form. In most of this instances, consent is obtained orally and all the applicable elements of informed consent should be verbally explained to the subject before he or she agrees to participate. In most cases, the IRB requires that a written document be given to participants in studies that involve oral informed consent. A copy of this document should be included in the proposal. The document should provide a description of the study and also include the name and phone number of the PI and FA, and the phone number of the IRB. In some questionnaire studies, this written document may be included as a preface to the questionnaire. Refer to the excerpts below to see if your project qualifies for an alteration of consent.

Excerpt from the Federal Code 45CFR46

§46.116 General requirements for informed consent.

(c) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that:

(1) The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and

(2) The research could not practicably be carried out without the waiver or alteration.

(d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

(1) The research involves no more than minimal risk to the subjects;

(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;

(3) The research could not practicably be carried out without the waiver or alteration; and

(4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

§46.117 Documentation of informed consent.

(c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

(1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or

(2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.