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:
In clear, non-technical language, participants must be informed of:
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.
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 or participant letter, 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 (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)]:
8/14/2013 - Minor language update