Informed Consent, Parental Permission and Child Assent
According to the federal regulations under 45 CFR 46.116, no investigator may involve a human being as a participant in research unless the investigator has obtained the legally effective informed consent of the participant or the participant's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective participant or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.
The information that is given to the participant or the representative shall be in language understandable to the participant or the representative. Readability levels may be checked using most word processing software. Investigators should refer to our consent form readability tips for further information.
No informed consent, whether oral or written, may include any exculpatory language through which the participant or the representative is made to waive or appear to waive any of the participant's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.
Informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the participant or the participant's legally authorized representative. A copy shall be given to the person signing the form, and the investigator should retain the original. Under certain circumstances, waivers of documentation of informed consent may be allowed. Please see our waiver section, below.
Investigators must use Marywood University's consent, parental permission and assent templates when developing their forms. This ensures that all required elements and language are included. Forms may be found on the Forms & Instructions web page. Forms should not appear on any type of letterhead to ensure that there is no undue influence to participate.
There are two procedures, which may be used to obtain informed consent:
- The participant or a legal representative signs a written informed consent document, which embodies the elements above.
- The participant or a legal representative signs a document indicating that the participant had the above elements explained to him/her orally and that he/she understands this oral description and he/she agrees to participate in the activity described. In this case, however, an auditor witness to the oral presentation must be present. A written summary of the oral presentation must be submitted to and approved by the IRB. A copy of this presentation is to be retained by the IRB.
In clear, non-technical language, participants must be informed of:
- The fact that the study is research;
- The purpose of the research;
- The location of the research and the expected duration of the participant's participation;
- The exact procedures to be followed and identification of any procedures which are experimental;
- Any reasonably foreseeable risks or discomforts;
- The benefits to the participant or to others (including to the field of study), which may reasonably be expected from the research;
- Appropriate alternative procedures or course of treatment, if any that might be advantageous to the participant;
- The extent, if any, to which confidentiality of data and privacy of participants will be maintained;
- For research involving greater than minimal risk, whether any compensation and whether any medical treatments are available if injury occurs, and what party is responsible for payments;
- Whom to contact for answers to pertinent questions about the research, participants' rights, and research related injury to the participant;
- The fact that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, that the participant may withdraw at any time without penalty or loss of benefits to which the participant is otherwise entitled, and an explanation of how to do so;
- How long records will be maintained by the investigator (at least 3 years; See Records Retention), who will have access to the records (i.e. if it is being shared with an agency or other investigators), where records will be stored (i.e. locked file), and when and how data will be destroyed. If records will be kept for future research, it must be stated and described.
Parental Permission and Child Assent
For research involving children aged seven (7) to seventeen (17), an assent form needs to be used in addition to a parental permission form. Research involving children under the age of seven (7) needs to include an assent script in addition to parental permission. Assent forms or scripts should include age-appropriate language. Readability levels may be checked using most word processing software. Investigators should refer to consent form readability tips for further information.
When parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient if the research does not involve greater than minimal risk or if the research involves greater than minimal risk but presents the prospect of direct benefit to the individual child participants.
Where research involves greater than minimal risk with no prospect of direct benefit to individual child participants, but is likely to yield generalizable knowledge about the participant's disorder or condition, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
When research is not otherwise approvable but presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
Waivers of Informed Consent or Parental Permission
If an investigator proposes to obtain informed consent (or parental permission) for the research activity without obtaining the participant's signature on a consent form, s/he must request a waiver of documentation of consent (no signature collected). Waiving the requirement for a signed form does not eliminate the requirement for informed consent via verbal communication or written information sheet, which would follow our consent form template but would eliminate the signature lines. This type of waiver is useful in situations where a signed consent document could have a negative consequence for the participants (if it's the only link to participation and the primary risk is a breach of confidentiality), or for some expedited studies utilizing telephone or Internet survey procedures [45 CFR 46.117(c)].
With expedited research, if an investigator proposes to waive the requirement to obtain informed consent completely, or to alter some of the required elements of informed consent, s/he must submit a Request for a Waiver or Alteration of Informed Consent form to the IRB. S/he must provide a response to all of the following points [45 CFR 46.116(d)]:
- The proposed research presents no more than minimal risk of harm to participants.
- The waiver or alteration of consent will not adversely affect the rights and welfare of the participants.
- The research could not practicably be carried out without the waiver or alteration.
- Whenever appropriate, the participants will be provided with additional pertinent information after participation.
- Alterations or full waivers of informed consent only apply to FDA regulated studies (i.e. studies including drugs, biologics, medical devices, etc.) in one of the following:
- life-threatening situations (21 CFR 50.23)
- certain emergency research (21 CFR 50.24)
- when the research poses no more than minimal risk and the IRB finds and documents the four criteria listed above
- Passive or implied consent, whereby informed consent is assumed unless a participant/parent/guardian "opts out," is not an acceptable practice. For instance, with research in schools, the investigator cannot send a note home and automatically enroll a student unless the parent/guardian declines. Instead, a waiver of parental permission, meeting the above criteria, must be requested and granted. See OHRP's FAQ about waiver of parental permission.
8/14/2013 - Minor language update
1/21/2016 - Clarification and addition of link to OHRP's FAQ on parental permission
8/01/2017 - Addition of the alteration/waiver note for FDA, per FDA guidance issued July 2017