NTU-IRB may allow waivers or alterations to the standard informed consent procedure if certain criteria or conditions are met. This usually occurs for studies that are of lowest risk and qualify for Exempt review. PIs are to provide protocol-specific justifications in their IRB applications on how your study meets each of the criteria listed. Stating "not applicable" or just re-stating the criteria is not an acceptable response.
For SBER studies
|Waiver for obtaining Informed Consent||IRB must be satisfied that#:|
1) The research involves no more than minimal risk to the participants;
2) The waiver of informed consent or alteration will not adversely affect the rights and welfare of the participants;
3) It is not practicable to conduct the research without the waiver or alteration; AND
4) Whenever appropriate, the participants will be provided with additional pertinent information after their participation.
|Waiver for obtaining Written Documentation||IRB may waive the requirement to document informed consent (e.g. obtain a signature) if these criteria are met^:|
1) The only record linking the subjects and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality; and/or
2) The research presents no more than minimal risk of harm to participants.
|Waiver for obtaining Parental Permission||IRB must be satisfied that:|
1) The research involves no more than minimal risk to the participants and the participants are minors with sufficient understanding and intelligence. The waiver or alteration will not adversely affect the rights and welfare of the participants;
2) The research is of such a private and sensitive nature that it is not reasonable to require permission; or
3) The research involves using individually-identifiable information and the research could not be practicably carried out without using such information in an identifiable form. This is applicable only for low-risk longitudinal studies.
each statement, add the word “because” and then formulate your justification.
^ In cases in which the documentation requirement is waived, the NTU-IRB may require the PI to provide participants with a copy of the participant information sheet (reviewed and approved by NTU-IRB) for their records even when a signed document is not required for the study. If this is not feasible (for example, the only contact is by telephone), the NTU-IRB may ask to see a script of what would be said to prospective participants to evaluate the consent process. The research team should make a note in the Investigator study file of the conversation. To obtain this waiver for written documentation, Study Teams should not be collecting any personal identifiers from participants.
For HBR studies
Full details are available in HBRA Section 13. A summary of waiver conditions are below.
|Waiver for obtaining Appropriate Consent for individually-identifiable
Human Biological Material (HBM) and/or Health Information (HI)||IRB must be satisfied that:|
1) The research may not be practicably carried out unless there is a waiver;
2) The process of obtaining consent from the person will involve a disproportionate amount of effort and resources relative to the research requirements;
3) The research involves no more than minimal risk to subject;
4) The waiver will not adversely affect the rights & welfare of the research subject or donor; AND
5) The research would reasonably be considered to contribute to the greater public good.
|Waiver for obtaining Written Consent||IRB must be satisfied that:|
1) The research or use of the human tissue involves no more than minimal risk to the research subject or donor and involves no procedures for which written consent is ordinarily required outside of a research context; OR
2) The only record linking the subject/donor and the research/tissue is the consent form and the principal risk to the subject/donor is the potential harm resulting from unauthorised disclosure of confidential information.
|Waiver to obtain Parental Consent for research involving minors with
sufficient understanding and intelligence|
IRB must be satisfied that:
1) The research involves no more than minimal risk to the research subjects;
2) Waiver of parental consent will not adversely affect the rights and welfare of the research subjects;
3) Research may not be practicably carried out unless there is such a waiver, AND
4) Research is designed for conditions for a research subject population for which parental consent is not a reasonable requirement to protect the research subjects, and an appropriate mechanism for protecting the minor is substituted; OR
5) Research is of such a private and sensitive nature that it is not reasonable to require permission.
|Waiver of consent for the research use of individually-identifiable
health information that was collected before 1 November 2017|
IRB must be satisfied that:
1) the research cannot reasonably be accomplished without using the health information in an individually-identifiable form;
2) contacting the patients to obtain consent will involve a disproportionate use of effort and resources relative to the study requirements;
3) the use of the individually-identifiable health information involves no more than minimal risk to the research subject; AND
4) the waiver will not otherwise adversely affect the rights and welfare of the research subject.
|Waiver to obtain appropriate consent for Emergency Research||IRB must be satisfied that:|
1) The research subjects are in a life threatening situation and there is no professionally accepted standard of treatment.
2) Research may not be carried out unless there is a waiver.
3) Collection of valid scientific evidence is necessary to determine safety and effectiveness of a particular treatment.
4) There is prospect of direct benefit to the research subjects.
5) Obtaining the appropriate consent is not feasible because the subjects will not have capacity and there will be no proxy available to give appropriate consent.
Provision is made for a medical practitioner who is registered under the Medical Registration Act as a specialist in the specialty relating to the research who is not involved in the research as a researcher or supervisor to certify, prior to the enrolment of the subject to the best of the specialist's knowledge that the conditions above are complied with. AND
The research subject OR proxy is to be informed as soon as practicable after she gains capacity of the subject's participation in the research and given an opportunity to withdraw.
|Waiver of additional restriction for individuals (whether minors or
adults) who lack mental capacity that the tissue must be removed primarily for
a therapeutic or diagnostic purpose||IRB must be satisfied that:|
a) the removal of tissue involves no more than minimal risk or discomfort; AND
b) the proposed area of research cannot be carried out without the use of the tissue from such class of persons.