IRBConsent

Bard Institutional Review Board
IRB Home Summary: What to Do Frequently Asked Questions Training and Certification Interview Procedures and Oral Histories Is My Project Exempt? Checklist Submit Online Meeting Dates Contact the IRB	Informed Consent Informed consent is an important step in ensuring that research participants are treated ethically. Participants must have enough information to make an informed decision whether to participate in the research study. If participants cannot give informed consent, it must be obtained from their legal representatives. For example, when subjects are minors (under 18) or when they are mentally incapacitated, consent from a legal representative (such as a parent or legal guardian) is required. Consent documents and scripts must be clearly written in plain English so participants can fully understand the implications of participating. Scientific, medical, and technical terms should be avoided if possible or, if they must be included, clearly defined in simple language. The Penn State Hershey IRB links to several glossaries that make it easy to translate medical terms into simple language. Components of Informed Consent A standard consent form must include: A statement that the study involves research An easy to understand explanation of the purpose of the study How long it takes to participate A simple description of the procedures to be followed Identification of any procedures which are experimental If deception is involved, there should be an indication that the research cannot be fully described at this time, but that at the end of the subject's participation an explanation will be provided A description of any reasonably foreseeable risks or discomforts to the subject. These include not only physical injury, but also possible psychological, social or economic harm, discomfort or inconvenience. A description of any benefits to the subject or to others which may reasonably be expected from the research If there is no direct benefit, this should be stated. Please note that payment is not considered a benefit. A statement concerning costs or compensation to the subject, if any. Contact information for those who can answer questions about the research and the subject's rights, and (if applicable) for whom to contact in the event of a research-related injury to the subject. For senior projects, normally participants should be invited to contact the principal investigator or faculty advisor if they have any questions about the research, and to contact the chair of the IRB if they have questions about their own rights as research participants. Description of the extent, if any, to which confidentiality of records identifying the subject will be maintained A statement that participation is voluntary, that neither refusal to participate nor participation discontinued at any time will invoke penalty or loss of benefits to which the subject is otherwise entitled Information about access to the results of the research. For senior projects, you should disclose that the final project will be permanently and publicly available in the Bard College library. In most cases, this disclosure is a courtesy. The participant's signature, as well as their printed name and date should appear on the consent form. A checklist of the required elements of informed consent is available *here. If you would like to see the expanded federal Office of Human Research Protections checklist from which the previous checklist was adapted, please click here. If you would like to see examples of consent forms in Spanish and English, please click here. Exceptional Situations If you wish to have children (those under 18) participate in your research, please click here, provided you have already read the informed consent page in its entirety. Research using prisoners is strictly regulated. Please click here* to view national standards. If your research involves deception, please click here to learn more about debriefing procedures, provided you have also read the Informed Consent page. Whenever feasible, interview research should include a consent form. Please click here to see an example interview consent form. Circumstances in Which a Written Consent Form May Not Be Required There are some situations where a written consent form may not be required: (1) if the principal risks are those associated with a breach of confidentiality concerning the subject's participation in the research (e.g., studies on potentially sensitive topics such as illegal drug use, other illegal conduct, or sexual behavior); (2) if the consent document is the only record linking the subject with the research; or (3) if the research presents no more than minimal risk and involves procedures that do not require written consent when they are performed outside of a research setting. If there is no written consent form, an oral presentation of the research should be provided to the subjects by the investigator, with documentation that such a presentation was made to the subjects. Chart 3 summarizes the conditions under which waiver or alteration of informed consent can be applied. Additional required consent procedures In all cases, you should prepare a verbal script that you will say to each participant just before you hand them a consent form or ask for their verbal consent. Click here to see an example script. Also, in all cases, you should provide each participant with a copy of the consent form, so they can refer to it later if they have any questions or would like to contact you. If the participants decline a copy of the consent form for their own records, you should provide as an alternative a printed slip of paper that has contact information for you, your advisor, and the IRB so the participant has this contact information. If you will be photographing or videotaping your participants, the participants must, in addition, sign a photo release form or a video consent form. This description will occur elsewhere on the IRB website, before researchers click on a link to access this form: “A standard consent form may include statements regarding video and audio recording that will be viewed and coded only by the investigators who were specified in the project proposal as approved by the IRB. Video Image release forms are necessary if and only if the goal of your research is to create a film, photographic stills, or video art in which participants’ images will be publicly displayed. Such purposes include photographic and video installations or web pages viewed by individuals other than the project investigators (some types of documentary film may be exempt). The video image release form is separate from the consent form. The consent form must be presented first. A video image release form should be signed by the participant before video recording begins. It may also be advisable to present the same form again at the end of the recording period so that the participant may change his or her mind about the image release authorization. Click here to see an example video release form. For Additional Information on Informed Consent . . . see the chapter on Informed Consent in Protecting Participants and Facilitating Social and Behavioral Sciences Research (CNSTAT & BCSSE, 2003). Back to Top

Bard Institutional Review Board

Informed Consent

Informed consent is an important step in ensuring that research participants are treated ethically.

Participants must have enough information to make an informed decision whether to participate in the research study. If participants cannot give informed consent, it must be obtained from their legal representatives. For example, when subjects are minors (under 18) or when they are mentally incapacitated, consent from a legal representative (such as a parent or legal guardian) is required.

Consent documents and scripts must be clearly written in plain English so participants can fully understand the implications of participating. Scientific, medical, and technical terms should be avoided if possible or, if they must be included, clearly defined in simple language. The Penn State Hershey IRB links to several glossaries that make it easy to translate medical terms into simple language.

Components of Informed Consent

A standard consent form must include:

A statement that the study involves research

An easy to understand explanation of the purpose of the study

How long it takes to participate

A simple description of the procedures to be followed

Identification of any procedures which are experimental

If deception is involved, there should be an indication that the research cannot be fully described at this time, but that at the end of the subject's participation an explanation will be provided

A description of any reasonably foreseeable risks or discomforts to the subject.
- These include not only physical injury, but also possible psychological, social or economic harm, discomfort or inconvenience.

A description of any benefits to the subject or to others which may reasonably be expected from the research

If there is no direct benefit, this should be stated. Please note that payment is not considered a benefit.

A statement concerning costs or compensation to the subject, if any.

Contact information for those who can answer questions about the research and the subject's rights, and (if applicable) for whom to contact in the event of a research-related injury to the subject. For senior projects, normally participants should be invited to contact the principal investigator or faculty advisor if they have any questions about the research, and to contact the chair of the IRB if they have questions about their own rights as research participants.

Description of the extent, if any, to which confidentiality of records identifying the subject will be maintained

A statement that participation is voluntary, that neither refusal to participate nor participation discontinued at any time will invoke penalty or loss of benefits to which the subject is otherwise entitled

Information about access to the results of the research.

For senior projects, you should disclose that the final project will be permanently and publicly available in the Bard College library. In most cases, this disclosure is a courtesy.

The participant's signature, as well as their printed name and date should appear on the consent form.

A checklist of the required elements of informed consent is available here.

If you would like to see the expanded federal Office of Human Research Protections checklist from which the previous checklist was adapted, please click here. If you would like to see examples of consent forms in Spanish and English, please click here.

Exceptional Situations

If you wish to have children (those under 18) participate in your research, please click here, provided you have already read the informed consent page in its entirety. Research using prisoners is strictly regulated. Please click here to view national standards.

If your research involves deception, please click here to learn more about debriefing procedures, provided you have also read the Informed Consent page.

Whenever feasible, interview research should include a consent form. Please click here to see an example interview consent form.

Circumstances in Which a Written Consent Form May Not Be Required

There are some situations where a written consent form may not be required:

(1) if the principal risks are those associated with a breach of confidentiality concerning the subject's participation in the research (e.g., studies on potentially sensitive topics such as illegal drug use, other illegal conduct, or sexual behavior);

(2) if the consent document is the only record linking the subject with the research; or

(3) if the research presents no more than minimal risk and involves procedures that do not require written consent when they are performed outside of a research setting.

If there is no written consent form, an oral presentation of the research should be provided to the subjects by the investigator, with documentation that such a presentation was made to the subjects.

Chart 3 summarizes the conditions under which waiver or alteration of informed consent can be applied.

Additional required consent procedures

In all cases, you should prepare a verbal script that you will say to each participant just before you hand them a consent form or ask for their verbal consent. Click here to see an example script.

Also, in all cases, you should provide each participant with a copy of the consent form, so they can refer to it later if they have any questions or would like to contact you. If the participants decline a copy of the consent form for their own records, you should provide as an alternative a printed slip of paper that has contact information for you, your advisor, and the IRB so the participant has this contact information.

If you will be photographing or videotaping your participants, the participants must, in addition, sign a photo release form or a video consent form.

This description will occur elsewhere on the IRB website, before researchers click on a link to access this form: “A standard consent form may include statements regarding video and audio recording that will be viewed and coded only by the investigators who were specified in the project proposal as approved by the IRB. Video Image release forms are necessary if and only if the goal of your research is to create a film, photographic stills, or video art in which participants’ images will be publicly displayed. Such purposes include photographic and video installations or web pages viewed by individuals other than the project investigators (some types of documentary film may be exempt). The video image release form is separate from the consent form. The consent form must be presented first. A video image release form should be signed by the participant before video recording begins. It may also be advisable to present the same form again at the end of the recording period so that the participant may change his or her mind about the image release authorization. Click here to see an example video release form.

For Additional Information on Informed Consent . . .

see the chapter on Informed Consent in Protecting Participants and Facilitating Social and Behavioral Sciences Research (CNSTAT & BCSSE, 2003).

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Informed Consent

Components of Informed Consent

For Additional Information on Informed Consent . . .