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Informed Consent



General Instructions for all Types of Informed Consent

Informed consent is one of the primary ethical considerations underlying research with human subjects.  More than a piece of paper to be signed, informed consent is an ongoing conversation between researchers and subjects, one which at any point supersedes the importance of any other part of the research.  In other words, subjects must never feel that they cannot stop and ask what is about to become of them.  They should never even wonder what’s happening next unless some element of surprise or ignorance of procedures is built into the approved research design.  Subjects should feel that their participation is voluntary, and that their refusal to cooperate is free of consequence to them. 

Any research with humans involves obtaining informed consent.  For the majority of studies this will involve developing an informed consent form and obtaining written informed consent from the subjects.   For some types of studies that involve no physical risk and only minor psychological risk or inconvenience one may choose to use an abbreviated informed consent form.  For certain studies such as those involving anonymous surveys that do not contain items related to sensitive matters (i.e. drug use, sexual behavior, illegal activities) a letter of invitation with implied consent may be used.   If your study involves the use of specimens from human subjects (blood, hair, saliva, etc.) then subject consent is obtained using a specimens release form

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Informed Consent Form Instructions

The following instructions apply to all consent forms:

  1. The consent form must be written in lay language at the fifth-grade to sixth-grade level.  All medical terminology and technical jargon must be explained in lay language.
  2. The content and details of the consent form regarding purpose, procedures, risks and precautions, and measures to ensure confidentiality must be consistent with the appropriate IRB application form submitted.  For example if an investigator states that he or she will be studying 45 subjects with adult-onset diabetes with no history of heart disease then this information must be consistent in both the consent form and in the IRB application form. 
  3. Subjects must be invited to participate and assured that participation is voluntary.
  4. Investigators must be identified
  5. The procedures of the study must be explained to the potential subjects in such a way that any lay person would be able to understand the exact procedures.
  6. All measures taken to ensure confidentiality must be explained.
  7. All potential risks and precautions that will be taken to reduce the potential risks must be explained to the subjects. 
  8. The approximate number of subjects involved in the study must be identified
  9. Consent forms are typically written in second person using the pronoun “you” throughout. 
  10. Please convert all consent form font to  black, non-italicized, 12-point font (or larger if appropriate)

Please use the standard wording that has been provided whenever possible; however, you must adapt the forms as appropriate for your study.     Please refer to this example of a completed informed consent form  for further assistance.

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Abbreviated Informed Consent Form Instructions

Under certain circumstances (studies involving surveys, interviews, and routine educational practices) the consent form may be somewhat abbreviated.    The abbreviated consent form should follow the same format and use the same wording as the standard informed consent form but certain elements may be omitted.   The abbreviated consent form must include the following:   

  1. Statement of study purpose and  inclusion and exclusion criteria of participants
  2. Identification of investigators (Who are the investigators, and what is their institutional affiliation?)
  3. Explain exactly what you are asking the participants to do.
  4. Explain the risks and measures taken to minimize risks.
  5. Explain procedures to ensure confidentiality
  6. Assure potential participants that participation is voluntary and that they are free to discontinue participation without penalty if they wish to do so. 
  7. Subjects and investigators must both sign the abbreviated informed consent form. 

Please note that abbreviated informed consent forms may not be used in studies involving children or other protected populations. 

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Letter of Invitation and Implied Consent Instructions

Under certain circumstances (surveys that do not involve sensitive matters) an investigator may choose to use a Letter of Invitation and implied consent.

 A letter of invitation contains the following:

  1. Statement of study purpose and  inclusion and exclusion criteria of participants
  2. Identification of investigators (Who are the investigators and what is their affiliation with Belmont University?)
  3. Explain exactly what you are asking the participants to do.
  4. Explain measures to ensure confidentiality
  5. Assure potential participants that participation is voluntary and that they are free to discontinue participation without penalty if they wish to do so. 
  6. The end of the letter should contain the following statement:

    Your completion of this (survey, interview, etc.) implies your consent to participate in this study.  If you choose to withdraw your consent to participate at a later time, please notify________ (name of primary investigator or designee).

Please refer to the example of a letter of invitation for further assistance.

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Specimens Release Form Instructions

If a study involves collecting specimens (blood, hair, saliva, cells, etc.) from human subjects then the investigator will need to develop a specimens release form and obtain informed consent using this specimens release form.   Please note that collection of blood from human subjects requires a full IRB review. 

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Recording Permission

If a study involves audio tape, video tape, photographs, or any other likeness of a human subject then the investigator needs explicit, separate, prior consent from each subject taped.

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Research Involving Children and Subjects from Other Protected Populations
Research involving children under the age of 18

If the research involves minors under the age of 18 years, there are special requirements for parental consent as well as child assent and/or child consent.  All subjects under 18 years of age must have parental consent to participate in research.  For children under the age of 18 years a parental informed consent form must be developed and used to obtain informed consent.  The consent form must address the parent and refer to “your child” throughout. 

 Parental Consent
  1. If the proposed research involves no more than minimal risk, or is of possible direct benefit to the child, the consent of one parent is required.
  2. If the research involves greater than minimal risk without direct individual benefit, permission must be obtained from both parents unless there is only one reasonable available parent.  Guardian consent should be substituted for parental under appropriate legal constraints.
  3. The Investigator may request a waiver of parental or guardian consent if the research design does not require such consent to protect the subjects (for example, neglected or abused children), provided an appropriate protection mechanism is substituted.
  4. Special provisions must be made for children who are wards of the state or any other agency, institution, or entity to be included in research involving greater than minimal risk without direct individual benefit.
  5. See the example of a parental consent form for further assistance.

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Assent or Consent of Child

Assent means the potential subject’s affirmative agreement to participate in the research. Mere failure to object should NOT, in the absence of affirmative agreement, be construed as assent! Pediatric informed consent is used with older children who are capable of understanding an informed consent form, but are not of an age to give legally binding adult consent. The following list indicates how assent of children should be handled for children of different ages.

  1. For children under 7 years of age, the child is assumed to be incapable of giving assent. A pediatric assent form or consent form is not required for children under 7 years of age; however a parental consent form is required, along with a waiver of assent.

  2. For children 7-13 years of age, the assent or consent of the child is required or documentation of the reason for waiver of the assent is required. Assent of the child may be waived if the capability of the child to give assent is judged limited by age, maturity, or psychological state.

  3. For children between the ages of 7 and 13, a parent must sign a parental informed consent form, but in addition the child must also sign a pediatric informed consent form or a child assent form if he or she is capable of doing so. A pediatric informed consent form follows the same format as the standard informed consent form and contains the identical information as the parental informed consent form but it addresses the child throughout using the pronoun “you.” The pediatric informed consent form is generally used with older children who are capable of understanding the content of a full pediatric informed consent form. A child assent form is usually used with younger children along with the parental consent form. The child assent form contains a very basic explanation of the study and explains that participation is voluntary. Refer to the blank child assent form and the example of a pediatric informed consent form for further assistance.

  4. Studies involving youth between the ages of 14 and 18 should use both a parental consent form and a pediatric informed consent form, if the child is able of understanding the nature of the study and providing informed consent.

Note that ANY studies involving children and youth under the age of 18 years require a full IRB review.

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Research involving persons from protected populations

Studies involving participants from other protected populations (children, institutionalized persons, prisoners, mentally ill, or any other population that does not have the right or the ability to provide informed consent etc.) require special consideration when developing informed consent. Please consult with the chair of the IRB when considering a study involving members of protected populations. Please note that many studies that use subjects from protected populations require a full IRB review.

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Research involving pregnant women

If the research activities are directed toward pregnant women, both the mother and father must give consent after having been fully informed regarding the impact on the fetus. (NOTE: The Federal regulations do specify certain conditions under which the father's consent is not necessary. For a list of those conditions, contact the IRB Office.)

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Research involving Veterans Administration (VA) patients

If VA patients, deemed incompetent, are to be enrolled in the study, additional requirements may be necessary for the consent form and additional procedures implemented to insure the patient's rights are protected. These additional requirements can be obtained through the Research Office at the Veteran Affairs Medical Center.

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