No investigator may involve a human being as a subject, or use their tissue or data, in a research activity unless the investigator has obtained the informed consent of the subject or the subject's legally authorized representative. There are limited conditions under which this requirement is waived.

A. Criteria for a Waiver of Obtaining Informed Consent

There are two main exceptions to the requirement for obtaining consent:

1. When CORIHS finds that ALL of the following conditions are met:
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.

An investigator may request a waiver of informed consent by providing evidence that the conditions above are met for his/her research activity.

- OR -

2. The Food and Drug Administration(FDA) permits an exception to the informed consent requirement before the emergency use of a test article, under certain conditions. Section 20 (Exemptions from CORIHS Approval Requirement) should be reviewed for details.

The federal regulations allow for a waiver of the documentation of consent (i.e., a signed consent form) if one of the following conditions is met:

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.

Investigators may specifically request a waiver of the documentation of the informed consent requirement by providing information that supports one of the 2 conditions above. Nonetheless, CORIHS will still require submission of either a consent 'script' (i.e., to verbally consent a subject, e.g., over the phone) or a consent letter that does not require the subject to sign, but to, e.g., complete an attached survey. In the latter case, the document is written in letter format ('Dear Subject'), and rather than requiring the subject's signature to verify consent, the investigators will sign the letter as in the sample below:

Sample Consent Letter (on Department Letterhead)

Dear Subject,

You are being asked to volunteer in a research study, (Title).

The purpose of the study is_______________________________________________.

If you agree to participate, your part will be (to complete the attached survey, answer some questions, etc.). It should take no more than ( _____ minutes of your time).

There are no foreseeable risks or benefits to you for participating in this study. (If there are any risks or benefits, say what they are.)

You will (will not) be paid ($) for your participation.

The following procedures will be followed in an effort to keep your personal information confidential (data collected will remain anonymous, be coded, etc…) To ensure that this research activity is being conducted properly, Stony Brook University's Committee on Research Involving Human Subjects and/or applicable officials of SBU, OHRP (Office for Human Research Protections), and the sponsor of the study, ( _name_ ), have the right to review study records, but confidentiality will be maintained as allowed by law.

There are no costs to you for participating in this study. (If there are, so state.)

Your participation is completely voluntary. You do not have to participate if you don’t want to.

If you have any questions about the study, you may contact me at (phone number).

If you have any questions about your rights as a research subject, you may contact Ms. Judy Matuk, Committee on Research Involving Human Subjects, 631-632-9036.

'If you ____________________(e.g., complete the attached survey, answer these few questions, etc.), it means that you have read (or have had read to you) the information contained in this letter, and would like to be a volunteer in this research study.

Thank you, (signatures of investigators)'

Both methods will need to comply with federal requirements regarding mandated elements of informed consent. Refer to Section 14 for mandatory elements of consent.

C. Differences between consent, permission and assent

1. Consent forms are used to consent subjects 18 years or older.
2. Permission forms are used to obtain permission from parents of subjects 17 years or younger (since the subjects themselves cannot consent to being in the study).
3. Assent forms are used to obtain agreement from the minor subject to be in the study.

An important aspect of the consent process is to provide the information in a language understandable to the subjects. CORIHS recognizes 2 methods for obtaining consent from non-English speaking subjects:

1. For those consent forms that must be translated into a foreign language, an affidavit of accurate translation must be provided from an appropriate translator who is unaffiliated with the study. The translated consent form and affidavit must be submitted and approved by CORIHS before use of the consent form.

- OR -

2. The former Office for Protection from Research Risks (OPRR , now OHRP: Office for Human Research Protections) offers guidance on 'Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English', which CORIHS formally accepted on February 22, 2001, as adequately protecting the rights of non-English speaking subjects. This method involves use of a CORIHS-approved English language consent form, a CORIHS-approved short consent form written in the non-English language, and a witness fluent in both English and the language of the subject. The short consent form can only be used for minimal risk studies.
   Details are available at: http://www.hhs.gov/ohrp/humansubjects/guidance/ic-non-e.htm

The consent process is one of the most important elements of all research studies involving human subjects. If consent is not obtained properly, then the rights of the individual research subject have been violated.

Consent must be sought under circumstances where the subject or representative is given enough time to consider whether or not to be in the study, and that minimize the possibility of coercion or undue influence. Information provided to the subject or representative must be written in simple language, so all aspects of the research (e.g., purpose, risks, benefits) are clearly stated and an informed decision may be made.

An assessment of capacity to give consent must be performed in ALL subjects. Section 13 provides full detail on this requirement.

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Last Updated: 2007-06-20