Attachment 7_Waiver of Consent Request

aTTACHMENT 7 - Revised

WAIVER OF CONSENT

WAIVER OF CONSENT REQUEST

Waiver of Consent

If you are requesting that the IRB approve a waiver of consent (you will not obtain informed consent from subjects) complete this section (not applicable for FDA regulated studies). In order for the IRB to approve waiver of informed consent the IRB must determine that the criteria listed below are met. In the box below, support how the study meets each criterion:

1. The study is not greater than minimal risk:      

2. Waiving the requirements for informed consent will not adversely affect the rights and welfare of study subjects:      

3. The research cannot be practicably carried out without the waiver of informed consent or alteration of the consent process:      

4. (If applicable) there would be a plan to disseminate pertinent information to study subjects after the study is completed:      

Waiver of Documentation of Consent/Verbal Consent

Indicate in the text box below if you are requesting a waiver of documentation of informed consent/assent (also called “verbal assent”) for this study. The IRB can only allow a waiver of documentation of consent if the study meets one of the two procedures listed below (also subject to applicable regulations). In the text box explain how the study design meets one of the following criteria:

1. The only record linking the subject to the research would be the consent document and the principal risk of having a signed consent form would be potential harm resulting from a breach of confidentiality:      

2. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context:

The research submitted as part of the approved study, “Planning Grants to Develop a Model Intervention for Youth/Young Adults with Child Welfare Involvement As-Risk of Homelessness,” presents no more than minimal risk of harm to research subjects and securing written consent is not general practice for site visit interviews or focus groups. For the site visit interviews and the focus groups, the grantee staff is generally required to cooperate with our cross-site study as a condition of their grant. However, staff and partners will have the opportunity to decline participation at any stage of the process or decline to answer any question they do not wish to answer. During the site visit interviews and focus groups, participants will be read a consent statement and informed of their rights and protections as a human subject. They may wish to leave the interview and not complete it at that time.

We anticipate no risks arising from participation in site visit interviews or focus groups. Participation is voluntary and no respondent views will be attributed to them by name or other identifiable characteristics in written or verbal reports. We will state clearly at the start of interviews and focus groups that participants should decline to answer any questions that they find personally sensitive and prefer not to answer. Participants will not be asked or required to provide information that could be legally or professionally damaging. During the consent process, we will emphasize that nothing reported during the site visit discussions or focus groups will affect the employee’s future role with regard to YARH or their employment.