Informed Consent

Basic Elements of Consent
Additional Elements of Consent
Glossary of Lay Terms

The process of informed consent is a mandatory and integral component of research involving human participants. An investigator may not involve a human participant in research prior to providing and obtaining informed consent from each participant. This document is to be presented in a format that is easy to follow and easily understood. Therefore, NIH has recommended that the consent document be written at an eighth grade, or lower, reading level for all subject populations. The consent document must contain the basic elements of consent, and if necessary, additional elements of consent may be required. The consent process should allow the participant sufficient opportunity to decide on participation and all attempts to minimize the possibility of coercion or undue influence should be utilized. The consent information should be in a language understandable to the person and no exculpatory language should be used. The consent process should be appropriately documented in accordance with and to the extent required by the regulations.

Basic Elements of Consent

• Provide name, address, and telephone number of investigator (and co-investigators) in case participants have questions at a later date.
• A statement that it involves research.
• A description of the purpose of the study (why you are doing the study) and a clear explanation of what they will be required to do.
• An explanation of any risks or discomforts the subject may experience.
• A statement describing any benefits to the participants or potential benefits to society.
• If applicable, a statement informing participants of alternate means for obtaining treatment that may be helpful for the participant.
• Clearly describe how confidentiality will be maintained.
• A statement informing participants their participation is "voluntary" and they may decline to answer specific questions AND they may refuse to participate or withdraw their participation at anytime without penalty or loss of benefits.
• Participants are to be given a copy of the consent document for their record keeping.
• A statement informing participants the amount of time that will be required for their participation.
• Who to contact in the event of research-related injury.

Additional Elements of Consent

• A statement identifying researcher's affiliation with Penn State.
• Measures (surveys, questionnaires, etc.) must not be attached to the consent form. The consent form is a "separate" document.
• Connecting page numbers (e.g., Page 1 of 2 and Page 2 of 2) are to be noted on the consent document to prove closure to the document. Consent documents that are double-sided must contain the connecting page number in case the consent document is reproduced as a single-sided document.
• A statement informing participants they may contact the Office for Research Protections, 201 Kern Graduate Building, University Park, PA 16802, (814) 865-1775 for additional information concerning their rights as research participants.
• Signature and date lines for the participant to complete.
• An explanation of the amount of compensation a subject is to receive for participating in the research project. If necessary, explain how payment will be prorated if participants withdraw before the research project is complete.
• Participants are to be informed that they may ask questions at any time.
• If extra credit is used as a means of compensation, an alternate comparable means of earning the extra credit needs to be identified.
• An explanation of treatments or procedures that may cause unforeseen risks to the subject.
• A statement explaining conditions that may require the researcher to terminate a subject's participation.
• Significant new findings that may relate to the participant's willingness to stay in the study.
• Any additional costs the subject may incur as a result of their participation.
• The procedure the subject is to follow for withdrawing their participation and consequences that may occur from this decision.
• A statement regarding tape recording (audio/video) that will occur, who will have access to the tapes, where the tapes will be stored, and when the tapes will be destroyed.
• The following injury clause developed by Penn State's attorneys, "Medical care is available in the event of injury resulting from research but neither financial compensation nor free medical treatment is provided. You are not waiving any rights that you may have against the University for injury resulting from negligence of the University or investigators."
• The approximate number of participants.
• For surveys that are conducted electronically, participants must be informed of the limited confidentiality levels that are available for electronic media.
• For surveys that use implied consent, a statement informing participants that completion and return of the survey is considered implied consent. This statement will replace the signature line.
• If FDA regulated research, a statement that the FDA might instpect the research records needs to be included.

* Only to be included in the consent document if applicable to your proposed research. Dependent on the nature of the proposed research, the IRB may request additional information to be added to the consent document.

1. Waiver of Documentation of Consent
   
   In some situations, the IRB may waive the requirement for obtaining a signed Informed Consent Form (45 CFR 46.117(c)). The regulations state that a signed consent form may be waived if the IRB determines that:
   • The only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality; and the research is not subject to FDA regulations; or
   • The research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context.

   Examples of types of studies that fall into the first category are survey or interview studies that contain highly sensitive (e.g., criminal behavior, sexual behavior) questions. Studies that fall into the second category are mail out surveys about topics that could not reasonably damage a participant's reputation or employability or be otherwise stigmatizing.

   For research subject to FDA regulations, The IRB may, for some or all subjects, waive the requirement for documentation of informed consent if it finds that the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside the research context, in accord with 21 CFR 56.109(c)(1).

   Waiver of documentation of consent may mean that no written document is provided to the participant at all, for example, in a random-dial telephone survey study. In this type of study, the telephone interview would begin with a script that includes all of the required elements of consent, but the study participants would receive no written information about the study, either before or after the interview. The telephone script containing the elements of consent must be included in the application.

   On the other hand, the waiver of documentation of consent may mean only that the participant's signature does not have to be obtained. The regulations stipulate that the IRB Chair or his/her designee may still require that the investigator provide the participant with a written statement about the research when granting a waiver of documentation. That document, if required by the IRB, is reviewed and approved by the IRB. For example, in a mailed-out survey study, the IRB Chair or his/her designee may determine that it is reasonable for the investigator to provide the participants with a cover letter containing all of the basic elements of consent. The letter would simply conclude with a statement that returning the survey or questionnaire would be considered agreement to participate.

2. Waiver of Elements of Consent or Waiver of Consent
   
   Some research studies would not be possible if informed consent from participants were required. The IRB may consider waiving the requirement for some or all of the elements of informed consent (45 CFR 46.116(d)). The regulations state that informed consent may be waived in full or in part if the IRB determines that:
   • The research involves no more than minimal risk to the participants; and
   • The waiver or alteration will not adversely affect the rights and welfare of the participants; and
   • The research could not practicably be carried out without the waiver or alteration; and
   • Whenever appropriate, the participants will be provided with additional pertinent information after participation; and
   • The research is NOT subject to FDA regulations unless the research involves human specimens that are not individually identifiable for FDA-regulated in vitro diagnostic device investigations as per FDA guidance (OMB Control No. 0910-0582).

   Some examples of research whereby all of the elements of consent have been waived include retrospective chart reviews, or studies of existing pathology specimens (all specimens to be studied have already been collected and are "on the shelf" at the time of the application). Presuming that the study can be classified as minimal risk and that adequate provisions for protecting the confidentiality of the data are in place, the IRB Chair or his/her designee generally finds that obtaining consent is impracticable (not possible) for this type of research.

   Examples of types of studies in which some of the elements of consent have been waived include certain types of ethnographic research, and studies that require deception. For example, in a minimal risk study involving playing a computer game to test participants' responses to differential pay-offs or reinforcements, the investigator might indicate in the Informed Consent Form that the purpose of the study is to test reaction time. This deception may be necessary because the study would be compromised if participants were told the true purpose. In this scenario, one of the basic elements of consent -- the purpose of the study -- could be waived by the IRB Chair or his/her designee and not included in the Informed Consent Form.

   If the investigator seeks a waiver of any or all of the elements of consent, the application should describe the reasons for the request, paying particular attention to why the research study would be "impracticable." The term "impracticable" means more than simple inconvenience - it means that the research could not be conducted without the waiver.

Additional information concerning the elements of consent may found in the 45 CFR 46.116 or 21 CFR 50.25 by contacting the Office for Research Protections at (814) 865-1775.

Click here to access the Code of Federal Regulations.

GLOSSARY OF TERMS

To assist researchers in developing consent documents in terms that are more easily understood by the lay person, the following terms are recommended by both the Social Science and Biomedical Institutional Review Boards. This glossary does not represent all terms specific to the research/scientific community, but will provide guidance in developing consent documents that may more easily meet the NIH recommended eighth grade reading level.

adverse event - something that happens to the subject which violates the stated level of expected risk

assess - to study, learn about

anonymous - no identifying information is collected

buccal - mouth

cessation - quitting, stopping

cognizant - aware, fully informed

confidential - participant identity is protected, accessible only to investigator

drink well - drink lots of water, juice, _____.

effusion - escape of fluid into a body part; edema

electromyogram - a graphic record of the contraction of a muscle electrically stimulated

fasting - do not eat for _____ hours

genome - all of an individual's DNA on the chromosomes (two copies of the genome are passed down from parents - one copy from the mother, one from the father)

goniometer - an instrument to measure movement

glycemic index - a measure of glucose-raising effects that carbohydrates have when consumed

monitor - to watch carefully, to check on

motor skills - movements

ml - teaspoons, tablespoons

myocardial infarction - heart attack

osteoporosis - softening of bone (increased porosity)

random - no particular means of choosing, by chance

saline - physiological salt solution; a teaspoon of table salt in a pint of water

sarcopenic - loss of muscle mass

trait - an inherited characteristic of an individual

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