Informed Consent Topics

 

Who can give informed consent?

Informed consent is a legal agreement between researchers and participants. As such, participants must be competent to enter into a legal agreement to give informed consent. They must be at least 18 years of age and must not be considered legally incompetent (as would be the case if a person had a severe head injury, were mentally retarded, suffered from dementia or another mental illness).

 

When working with individuals who have a limited or diminished capacity to understand an informed consent agreement, it is important to get consent from a legally authorized person as well as to obtain assent from the individual who will be participating.

 

Children (minors) and adults who are not competent to legally give informed consent must be handled differently if they are to be recruited for a research project. Informed consent must be obtained from a person who is legally authorized to give consent on behalf of the individual (e.g., a parent or legal guardian). In addition, the participant should also given a reasonable explanation of the procedures and must give their assent to participate in the research.

 

In some cases, permission must be obtained from additional sources. For example, when conducting research in a public school setting, permission must be obtained from the school board, the principal, and the classroom teachers to recruit students from the school setting as well as obtaining informed consent from parents or legal guardians and assent from the students. Similarly, research conducted within hospitals or other institutional settings may require permission from administrators within these organizations. Hospitals and some other institutions may have their own IRBs that must review any research conducted at that institution. In this case, researchers will be required to seek review and approval of their project by several IRBs. (This also occurs when researchers from several universities collaborate on a research team - the research project must be reviewed and approved by the IRB at each host university.)

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Archival Research

 

Some archival records are considered private and confidential records and can not be released for research purposes without the written consent of the person whose data are recorded in these records (e.g., school records, medical records).


Other data can be strippe
d of personal identifiers by the agency and provided to researchers without consent of the people represented in these data sets. Use of this information may still require permission of the agency that houses these records.


Other data are public records that can be accessed by anyone (e.g., records of real estate transactions).

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Naturalistic Observation

 

Public behavior exhibited in restaurants, museums, libraries, and other public places is not considered confidential. Naturalistic observation of these behaviors does not require informed consent. However, care should be taken to ensure that the locations are truly "public" and do not carry an assumption of privacy (e.g., public restrooms, locker rooms, changing rooms in clothing stores).

 

Researchers should evaluate the risk to themselves and others posed by the collection of naturalistic observations. For example, they should take care that they do not present an impediment to safe behavior (e.g, by obstructing a roadway) or create a hazardous distraction (as can occur when events such as a simulated mugging or an automotive breakdown by the side of the road are staged to create an opportunity for naturalistic observation).

 

Recording naturalistic behavior creates the potential for loss of confidentiality. Participants must be contacted to get informed consent to maintenance of the recording of the behavior.

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Making Films or Tapes of Behavior During Data Collection

 

Researchers must ask participants for specific consent to be filmed, videotaped, or audiotaped during data collection.

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Questionnaires

 

Research that involves the completion of anonymous questionnaires does not require informed consent if the questionnaires are administered in such a way that the researcher can not identify who does and does not choose to participate. Usually researchers will include a cover letter that explains the nature of the research project and requests the recipient to complete and return the questionnaire. These cover letters usually include the type of information customarily included in an informed consent. In these cases, respondents are assumed to tacitly give their consent by completing and returning the questionnaire.
 

When questionnaires and surveys are administered in a classroom setting, students may feel compelled to complete the questionnaire (especially if these are collected immediately in the class) and may feel that their failure to turn in a completed questionnaire would be noticed by the researchers. It would be better to provide a separate location where questionnaires are returned or to ask for explicit informed consent in these situations.

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Elements of Informed Consent

INTRODUCTION

 

The ethical principle of respect for persons requires that human research participants be given the opportunity to choose what shall and shall not happen to them. Valid informed consent requires: (1) disclosure of study procedures and potential risks to prospective research participants; (2) their comprehension of the information, and (3) their voluntary agreement, free of coercion and undue influence, to research participation.

 

All written informed consent documents must be complete and clearly written so as to promote informed decision-making by research participants in research activities.

 

REQUIREMENTS FOR INFORMED CONSENT

 

Unless otherwise waived by the IRB, research investigators should obtain valid informed consent from all research participants (or their legally authorized representatives) who participate in their research studies. Generally, after the investigator has explained the research study to the research participant, the research participantís informed consent is documented by signing the protocolís written consent document, which the IRB must have previously reviewed and approved. The research participant is given a copy of the signed document. The original signed consent document is filed in a manner that ensures protection of the research participantís confidentiality.

 

BASIC ELEMENTS FOR WRITTEN INFORMED CONSENT

 

Unless otherwise authorized by the IRB, research investigators must provide the following information to each research participant in writing:
 

  1. A statement that the study involves research.

  2. An explanation of the purpose of the research and the expected duration of the research participantís participation.

  3. A description of the procedures to be followed and identification of any procedures that are experimental.

  4. A description of any foreseeable risks or discomforts to the research participant, an estimate of their likelihood, and a description of what steps will be taken to prevent or minimize them.

  5. A description of any benefits to the research participants or to others that may reasonably be expected from the research.

  6. A disclosure of any appropriate alternative procedures or courses of treatment that might be advantageous to the research participant.

  7. A statement describing to what extent records will be kept confidential, including a description of who may have access to research records.

  8. For research involving more than minimal risk, an explanation and description of any compensation and any medical treatments that are available if research participants are injured, where further information may be obtained, and whom to contact in the event of a research related injury.

  9. An explanation of whom to contact for answers to pertinent questions about the research and the research participantís rights.

  10. A statement that participation is voluntary and that refusal to participate or discontinuing participation at any time will involve no penalty or loss of benefits to which the research participant is otherwise entitled.

 

Information found at: http://www.research.uwf.edu/boards-committees/irb/documents/IRB-IC.doc

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Legal Issues in Informed Consent

 

Some individuals are not legally empowered to give informed consent (see vulnerable populations). When seeking participation from these individuals in research, consent must be obtained from a person who is legally empowered to give informed consent on behalf of the individual. Informal assent from the individual to participate must also be obtained.

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Stanny, Wheeler, and Kass