The informed consent process is designed to honor the right of individuals to decide whether or not they wish to become research participants. It acknowledges self-determination as an essential human right.

Informed consent requires that individuals are provided with information in a manner comprehensible to them and then given the right to choose to become enrolled in a study. They may also choose to end their participation at any time.

The components of the consent process can be defined as:

1. Full disclosure,
2. Adequate Comprehension, and
3. Voluntary Choice (as opposed to coerced or unduly influenced choice)

Checklist for assessing your consent process and the consent form.

Full Disclosure

Essential Information (a.k.a. Elements of Consent)
“Really” Full Disclosure
Recruitment as Consent
Exculpatory Language
Waivers of Elements of Consent
Deception and Incomplete Disclosure

Essential Information
Federal regulations for protecting research subject include a list of the basic required elements of consent.

Explanatory and qualifying notes are provided in italics.

1. A statement that the study involves research
2. An explanation of the research
3. The expected duration of the study
4. A description of the procedures to be followed
5. Identification of any procedures which are experimental

   This requirement is most applicable to clinical research in which subjects must be made aware when a proposed intervention is experimental. Due to what is referred to as the "therapeutic misconception" some subjects may believe that the research offers known treatment.

6. A description of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.

   The intent of this requirement is to give potential subjects the option to consider alternative approaches, other than that offered by the researcher, to manage their health and/or disorders. Thus it is rarely relevant in social and behavioral sciences. Exceptions might be for behavioral interventions in the treatment of problems such as Post Traumatic Stress Disorder.

7. A description of any foreseeable risks or discomforts.

   If there is absolutely no risk to subjects, such as when the data gathered is innocuous; it is not necessary to tell subjects that there is no anticipated risk. (This assumes that the question of risk has been thoroughly explored by the investigator and the IRB.)

8. A description of benefits to the subject or others which may result from the study

Much research in social and behavioral sciences research has no direct benefit to subjects. As a general rule, when there are no benefits to individual subjects they must be told what the researcher hopes to learn, how that knowledge will contribute to the field of study, or may perhaps benefit others, if indeed such cases can be made.

9. A statement describing the extent, if any, to which confidentiality or records identifying the subject will be maintained.

   Confidentiality procedures should be described in enough detail for potential subjects to be able to make informed decisions about their participation.
   
   Descriptions of confidentiality procedures must be truthful about the extent to which records can be protected. For example, an explanation must be provided about reporting responsibilities of the researchers such as when child abuse or suspected child abuse is revealed during the course of the study.
   
   An explanation that participation is voluntary and that the refusal to participate will involve no penalty, and that the subject may discontinue participation at any time without penalty If a researcher were actually in a position to impose a penalty on subjects if they withdrew from a study, it would probably not be approved by the IRB due to concerns about coercion.
   
   It may be more useful to think about consequences. For example, if students in the Psychology Subject Pool withdraw early, they may or may not receive full credit for their participation, according to the discretion of the researcher.
   
   Researchers should also think about the ways in which subjects might worry about consequences or reprisals from some source other than the researcher. Parents may worry that if they don’t give permission for their school children to participate in a study, the teacher will be mad or will think poorly of the family.
   
   It is important to tell prospective subjects that they don’t have to participate, they may withdraw at any time, and they make skip questions if they don’t want to answer them.

10. An explanation of whom to contact for answers to pertinent questions about the research and subjects’ rights.

    This section should include contacts for the researcher and the Chair of the IRB, although there are circumstance in which provide the contact for the Chair may be waived, i.e. the subjects are illiterate or without access to any communications technologies.

Additional Elements of Consent

A Duke Addition:

• Terms of payment and conditions under which subjects will receive no or partial payment
  

Additional Federal Requirements (not a complete list)
The following elements rarely apply to social and behavioral sciences research.

• For research involving more than minimal risk, an explanation as to whether any compensation is offered and/or whether medical treatments are available if injury occurs, and if so, what they consist of, and where further information may be obtained.
• Additional costs that may result from participation in the research, e.g. travel expenses
• An explanation of whom to contact in the event of research-related injury.
• A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.

“Really” Full Disclosure

In addition to considering the above elements, investigators should attempt to view the matter from the subject's perspective by asking what facts the subjects might want to know before deciding whether or not to participate in the research. Information could be deemed "material" if it might influence the decision of any reasonable person.

Recruitment as Consent

Recruitment is part of the consent process because it begins the disclosure process. Thus all recruitment materials such as fliers, email messages, newspaper ads, phone calls, and so on, must be approved by the IRB before they are implemented.

Waivers of Elements of Consent

The IRB may waive some or all of the elements of consent if it ensures that all the following criteria are met:

1. The research must involve no more than minimal risk.
2. The research could not practicably be carried out without the waiver.
3. The waiver of consent requirements will not adversely affect the rights and welfare of the subjects.
4. Whenever appropriate, the participants will be debriefed after participating in the research.
   

In research in social and behavioral sciences waivers of elements of consent are useful when full disclosure could elicit the demand effect and when the deception of subjects is a necessary part of the research design.

Deception and Incomplete Disclosure

Outright deception occurs when a researcher tells a subject that a study is about one thing when it is about another, for example, a study may be presented as research about perception when it is really about susceptibility to peer influence. Deception also occurs when confederates are used or when the researcher disguises his or her identity.

Incomplete disclosure involves not telling subjects the hypothesis of the study in order to counter the demand effect or not telling subjects that they are being primed.

A general rule is that when deception is used, subjects must be debriefed. While deceit should be revealed, whenever possible, simply because it the right thing to do, debriefing should be carefully considered. It may not be appropriate if it could contribute to subjects’ distress or anxiety. The IRB must be particularly concerned in situations where debriefing subjects might harm them, but failure to debrief them would be wrong.

Exculpatory Language

Informed consent may not contain any exculpatory language: Subjects may not be asked to waive, or appear to waive, any of their legal rights, nor may they be asked to release the investigator, sponsor, or institution (or its agents) from liability for negligence.

Adequate Comprehension

Language Issues
Format

Ideally, obtaining consent is a process in which the researcher has the opportunity to explain the research, ask if the potential subject if they have questions, and ask questions of the subject to be sure they understand what is being asked of them. This process is documented with the use of a consent form.

However, much social and behavioral science research is conducted through mailed surveys or initiated with written communications, such as letters sent home with parents. In these instances, reading level and the structure of the document become very important.

Language Issues

• The IRB must ensure that information will be presented to prospective subjects in language they can understand.
  
• One of the most common problems with consent forms is that they are written at a grade level much higher than that of the prospective subjects and include jargon rarely understood by people outside the researcher's discipline.
  
  • It is not possible to prescribe a grade level for consent forms. We know that the average American reads at the eighth grade level, but many read at a lower level.
    
  • Common sense is important. The IRB will not approve consent forms written at a twelfth grade level for distribution in a low-resource neighborhood.
    
  • The best way to ensure comprehension is to pilot consent forms and find out what works and doesn't work.
    
• If English is not the subject population’s primary language, the explanations and the forms should be translated into the subjects’ primary language. The IRB may require an independent confirmation of the translation.
  
• The IRB may ask members of the prospective subject population: e.g., children, to review consent forms and indicate which parts they do not understand.
  
• Consent forms should be written in the second person. “If you agree to be in this study, you will be asked to complete three questionnaires”.
  
• Instructions for signing a consent form should be extremely clear, particularly if the consent is layered, that is there is more than one decision the subject must make. For example a subject may agree to be interviewed, but not agree to be videotaped.

Format

If the material is complex and/or the IRB anticipates that subjects may have difficulty understanding the material, the IRB may suggest that researchers use techniques such as bold-faced titles within the document. One technique is to include enough information in the headings that a subject could get the basic structure of the study if they just read the headings. “You will be asked to complete three questionnaires” as a heading followed by more information about when and where and how long.

Voluntary Choice

Even is a study is innocuous, subjects must be informed that they do not have to participate, they do not have to answers if they so chose, and they may withdraw at any time.

Duke Policy has identified categories of researcher subject relationship in which the possibility of coercion exists. They are when the potential subjects are students or employees of the researcher. This relationship is discouraged and will only be permitted under limited circumstances. Instructors are encouraged to recruit students in classes they do not teach and when students’ identities are protected, both those that do and those do not choose to participate.

The setting and timing of the interaction may be as important as the content of the consent document. For example, undocumented aliens confronting a researcher holding a clipboard might not feel free to decline. Athletes recruited under the watchful eye of their coach might not either.

Subjects must be given adequate time to consider whether or not they wish to participate in a study.

Compensation must be appropriate for a study and not coercive. Determining whether or not proposed compensation is coercive will require a knowledge of the local research context.

Documentation of Consent

Procedures for Documenting Consent
Waivers of the Requirement for Documenting Consent

Procedures

There are two distinct procedures for documenting consent.

1. The subject or the subject’s legal representative signs a form containing all the required elements of consent and any other elements necessary to provide complete disclosure. The person who signed the consent form must be given a copy as a reference and reminder of the information conveyed.
   
2. The consent is done orally and is documented by an impartial witness. The witness confirms that the process took place and confirms the content of the process. Subjects who consent to participate are given short written summaries of the information presented to them. Although they may not be able to read themselves, they may have a family member or friend who may be able to do so. (This becomes moot if the subject population has no written language.)

Waivers of Documentation

Documentation of the consent process is not always required. It may be waived under the following two conditions:

1. The principal risks are those associated with a breach of confidentiality concerning the subject's participation in the research (e.g., studies on sensitive topics such as drug abuse or sexual deviance); and the consent document is the only record linking the subject with the research.
   
2. The research involves procedures for which consent is not normally required outside the research environment, e.g., phone surveys.

In cases where the requirement for documentation is waived, the IRB may require the investigator to present a written statement regarding the research to each subject.

Informed Consent in Exempt Research

Exempt research is research with human subjects. It is research that carries no risk and is thus exempt from the provisions of 45 CFR 46. Those provisions include specific requirement for elements of informed consent.

However, the ethical principles in the Belmont Report covers all research with human subjects. Therefore, exempt research must include a consent process. The principle of respect for persons requires that subjects be fully informed in a manner comprehensible to them, and that it be made clear that they do not have to participate and that they may withdraw at anytime.

Checklist for Your Informed Consent Process and Your Consent Form

1. Elements of Consent
2. Waivers of Elements of Consent
3. Waivers of Documentation
4. Comprehensive Checklist for the Consent Process

Required Elements of Consent (OHRP approved checklist)

0 A statement that the study involves research

0 An explanation of the research

0 The expected duration of the study

0 A description of the procedures to be followed

0 Identification of any procedures which are experimental

0 A description of any foreseeable risks or discomforts

0 A description of benefits to the subject or others which may result from the study

0 A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained

0 An explanation that participation is voluntary and that the refusal to participate will involve no penalty, and that the subject may discontinue participation at any time without penalty

0 Terms of payment and conditions under which subjects will receive partial or no payment

0 An explanation of whom to contact for answers to pertinent questions about the research and subjects’ rights

0 A description of appropriate alternative procedures or courses of treatment that might be advantageous to the subject.

0 For research involving more than minimal risk, an explanation as to whether any compensation is offered and/or whether medical treatments are available if injury occurs, and if so, what they consist of, and where further information may be obtained.

0 An explanation of whom to contact in the event of research-related injury.

0 An explanation of reporting responsibilities of the researchers should child abuse or suspected child abuse be revealed during the course of the study

Waiver or Alteration of Elements of Informed Consent
Required Findings

Comprehensive Checklist for Investigators

Full Disclosure

0 Are all relevant elements of consent included in the consent form or script?

0 Is the consent process consistent with the protocol?

0 Is there sufficient information for a potential participant to make an informed decision about whether or not to participate?

0 Are their additional facts a subject might want to have before deciding to participate in the study?

0 Are the subjects members of a vulnerable population, e.g., prisoners? If so, do the disclosure requirements change?

0 If deception is proposed, can it be justified?

0 If any elements of consent are waived or modified, does the waiver meet all four criteria as specified in the regulations? (See page 12) Does the importance of the study justify the waiver? (This applies to research using deception.)

0 Should subjects’ consent be required periodically throughout the research process? For example, in a longitudinal study the capabilities of children to engage in the consent process might change over time. Or perhaps it is unclear what the risks will be at the outset of a study. Once the risks are identified, a new disclosure process might be needed.

0 Are the methods for contacting the investigator and the Chair of the IRB appropriate to the setting?

0 If the research will be conducted abroad, would it be appropriate for a local contact to either replace or serve as in intermediary to the Chair of the IRB?

0 If a layered consent form is proposed is it clear how to use it?

0 Have all recruitment materials been provided for review?

0 Are the recruitment materials consistent with the informed consent documents?

0 If the investigator plans to post recruitment flyers at the Medical Center, have they received permission from the Associate Vice Chancellor for Communications, Office of the Chancellor for Health Affairs?

Adequate Comprehension

0 Will the subjects understand the terminology used?

0 Is the reading level appropriate?

0 If the subjects’ primary language is not English, has the researcher provided the consent form in the appropriate language, in addition to the English version? Is a back translation needed?

0 If written child assent is required, is it appropriate to the children’s developmental stage and situation?

Voluntary Choice

0 Is the researcher in a position of authority over the research subjects? If so, how can the possibility of coercion be addressed?

0 Who will be explaining the research to the subjects? Should someone in addition to the investigator be present? For example, in Haiti, a Duke researcher, although fluent in Creole, included a local compatriot in the consent process. This was because the potential subjects were more likely to ask questions of their compatriot than of a white researcher.

0 Are the timing and setting of the explanation of the research conducive to good decision making?

0 Is the compensation offered appropriate for the study and non-coercive?

0 Is there is any language in the form that asks subjects to waive their legal rights or to release the investigator from liability for negligence? If so, it must be removed.

0 If the researcher wishes to contact the subjects in the future, has it been explained how and why that contact will take place, and do subjects have the option to decline further contact?

Documentation of Consent

0 If the researcher has requested a waiver of documentation, can the waiver be approved in accordance with the regulations? (See Waiver Checklist on page 13.)

0 Has the researcher indicated that the subjects will receive a copy of the consent form? If not, a process for doing so must be added to the protocol.

0 If the subjects are illiterate, and documentation of consent is required, is the procedure respectful and culturally appropriate? For example, in certain parts of China a thumbprint is often used in personal transactions and carries no stigma.

0 If a third-party needs to witness an oral consent process, is the witness truly impartial?