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Informed Consent

Frequently asked questions about informed consent

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What does "informed consent" mean?
Being fully informed is a basic requirement in all research with human participants. Ethically and legally, consent is not considered to be "informed" unless the investigator discloses all the facts, risks, and discomforts that might be expected to influence an individual's decision to willingly participate in a research protocol. This applies to ALL types of research including surveys, interviews, and observations in which participants are identified, and other experiments, such as diet, drug and exercise studies.
What types of informed consent exist?

Three types of informed consent exist: (1) signed informed consent; (2) waiver of documentation of informed consent and (3) waiver of informed consent.

What is signed informed consent?

Used most commonly, signed informed consent allows prospective participants to document their agreement to take part in research activities by signing and dating the consent document.

What is a "waiver of documentation" of informed consent?

A waiver of documentation of informed consent is a request whereby a signed consent document is not required. Examples include implied and verbal consent. Consent will still be obtained from participants; however, they will not be required to sign the consent form.

There are only two circumstances when the IRB may waive the requirement to obtain a signed consent form:

  • The only record linking the research participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality (participant must be asked if he/she want documentation) OR
  • The research presents no more than minimal risk of harm to participants and involves no procedure for which written consent is normally required outside of the research context (for example, no risk surveys or interviews)

PLEASE NOTE: The IRB will take into consideration the risks and potential harms involved in the research and consent process before granting a waiver of documentation of informed consent.

What is "implied" consent?

By completing a research task (e.g., completion of a questionnaire, interview, survey, etc.), the participant has provided consent to participate in the research. This is an example of a waiver of documentation of informed consent. Before granting a waiver, the IRB may require the researcher to provide the participants with a written summary or an information sheet about the research, including: (1) purpose of research; (2) time involved; (3) assessment of minimal risk; (4) statement regarding benefit to participants; (5) contact for questions about the research; and (6) contact for questions about rights as a research participant.

For example, you wish to mail out a survey. The survey does not ask for any identifiable information. The cover letter accompanying the survey could be written in such a manner as to serve as the "implied" informed consent form. The letter would need to contain a statement indicating that completion and return of the survey implies consent to participate in the research.

What is a "waiver" of informed consent?

A waiver of informed consent could: (1) alter some or all of the required elements of informed consent or (2) completely waive the requirement to obtain informed consent. The IRB may approve a consent procedure which does not include or alters some or all of the required elements of informed consent provided all of the following are true:

  • The research involves no more than minimal risk
  • The waiver of informed consent will not adversely affect the rights and welfare of the subjects
  • It is not practicable to conduct the research without the waiver or alteration
  • Whenever appropriate, participants will be provided with additional pertinent information after their participation

Examples of types of studies in which some or all elements of consent have been waived include retrospective chart reviews, studies of existing pathology specimens, ethnographic research, studies that require deception or passive (opt-out) consent.

PLEASE NOTE: The IRB will take into consideration the risks and potential harms involved in the research and consent process before granting a waiver of informed consent.

Are there any sample consent forms or consent form templates available for review?
For sample informed consent forms and/or templates for both 'signed' and 'implied' consent, see Guidelines, Templates and Sample Consent Forms

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How is the consent process handled for Internet-Based research?

For Internet-based surveys, it is sometimes appropriate to use implied informed consent. Participants would still need to be presented with the consent information, but would be informed that their consent is implied by submitting the completed survey.

Internet-based surveys can include "I agree" or "I do not agree" buttons on the website for participants to click their choice of whether or not they consent to participate.

If, for study design, the researcher needs to keep track of who participated or the IRB determines that some sort of documented consent is required, instead of "signed" informed consent, the researcher may email the consent form to participants who may then type their name and the date into the spaces provided on the consent form, and return it to the researcher via email. This process may be appropriate for data collected via email, chatrooms, online interviews, etc.

NOTE: Researchers conducting web-based research should be careful not to make guarantees of confidentiality or anonymity, as the security of online transmissions is in question. A statement indicating the limits to confidentiality is typically required. The following statement may be used: "Confidentiality will be maintained to the degree permitted by the technology used. Specifically, no guarantees can be made regarding the interception of data sent via the Internet by any third parties."

For additional information on internet based research, see IRB Guideline X -"Guidelines for Computer- and Internet-Based Research Involving Human Participants."

What are the basic elements of informed consent?

See Guidelines, Templates and Sample Consent Forms.

Are there additional informed consent requirements for the use of children and other special populations as participants in research?
For additional information on obtaining consent from parents and assent from minors, see IRB Guideline I - "Parental Consent and Minor Assent."
Are there any elements needed in the consent form when the research protocol uses audio- and/or video-taping?

Yes, Pennsylvania state law stipulates that all parties must agree to the audio-recording. The agreement is not required to be in writing. If more than one participant is being recorded, all involved individuals must agree before the recording can be used. If you are planning to use audio- and/ video-taping, see IRB Guideline XI - "Research involving Audio, Video or Digital Recordings of Research Participants" for additional information.

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The Human Research Protection Program in the Office for Research Protections ensures compliance with Federal, state, and local regulations as well as institutional policies and procedures regarding the use of humans as participants in research.