NonSub Change Request - Temporary Use of Verbal Consents

To: Josh Brammer

Office of Information and Regulatory Affairs (OIRA)

Office of Management and Budget (OMB)

From: Nicole Constance, Hilary Bruck, and Amelia Popham

Office of Planning, Research, and Evaluation (OPRE)

Administration for Children and Families (ACF)

Date: April 15, 2020

Subject: Non-substantive Change Request – Health Profession Opportunity Grants (HPOG) Second Generation National and Tribal Evaluation (OMB Control Number 0970-0462).

This memo requests approval of non-substantive changes to the approved information collection, Health Profession Opportunity Grants (HPOG 2.0) Second Generation National and Tribal Evaluation (OMB Control Number 0970-0462).

Background

The Health Profession Opportunity Grants (HPOG) Program provides healthcare occupational training for Temporary Assistance for Needy Families (TANF) recipients and other low-income people. The informed consent documents for the HPOG 2.0 National and Tribal Evaluation were approved under OMB #0970-0462 in August 2015 and they were revised and approved in January 2016. The consent forms have been renewed in each subsequent OMB approval (June 2017, June 2018, and July 2019). Under normal study enrollment procedures, local HPOG 2.0 grantee staff conduct face-to-face intake interviews and administer informed consent. As part of the consent process, study participants sign the form in ink. As a result of the recent COVID-19 outbreak, most HPOG programs have changed to operate their programs virtually, including asking staff to work remotely and offering participant trainings online. These restrictions have brought the face-to-face intake and enrollment sessions to a sudden halt in many locations. However, grantees are eager to continue enrollment in the interest of serving the healthcare workforce needs in their communities.

Overview of Requested Changes

In order to facilitate grantees’ continued enrollment of new participants while their programs operate remotely, we have developed a new set of consent forms to allow grantee staff to obtain informed consent verbally. The new set of forms include only minor revisions from the already approved versions for written consent to allow for verbal consent. The Abt and NORC IRBs have reviewed and approved the new forms and procedures included in this request:

• Attachment B: National Evaluation informed consent form C (Lottery Required)_Verbal

• Attachment B: National Evaluation informed consent form D (Lottery Not Required)_Verbal

• Attachment B2: Tribal Evaluation informed consent form C (SSNs)_Verbal

• Attachment B3: Tribal Evaluation informed consent form D (Unique identifiers)_Verbal

• Procedures to obtain consent verbally, as described below.

The non-substantive changes to the forms and procedures in this request will allow the National and Tribal Evaluation teams to temporarily allow participants to verbally consent into the study. In instances where face-to-face enrollment is not feasible due to issues related to COVID-19, verbal consent will ensure that participant enrollment can continue and that grantees are able to serve the participants and sustain program operations during this time.

Verbal consent is vital to maintaining the rigor of the evaluation by ensuring that the participants enrolled during this period can be included in impact and descriptive evaluations of the National Evaluation and in the Tribal Evaluation. These participants are not part of any survey data collection efforts at this time. Thus the administrative data from the National Directory of New Hires (NDNH) is crucial for measuring employment and earnings outcomes for this group of participants.¹

The procedures for obtaining verbal consent are documented in Supporting Statement B, Section B2. The procedures were designed to ensure that participants understand what the study is about, what is being asked of them, and the risks and benefits of participating. Grantee staff will email a copy of the consent form to prospective participants in advance of the call.

Once normal operations resume, the grantee staff member will make a copy of the signed form for their program’s records and send the original form, with the attestation signed by the grantee staff member, to Abt Associates (non-tribal) or NORC (tribal) for the evaluation’s records. Verbal consent will substitute for written consent for these participants; there will be no need for the grantee to ask these participants to sign a consent form. Grantee staff will return to written consent procedures using the previously approved informed consent forms once normal operations resume.

Time Sensitivities

Grantees have participants waiting to enroll in the study and are anxious that these applicants may lose interest in the program. They are also concerned that delayed enrollment will raise concerns about the credibility of the HPOG Program at a time when there is a critical need for healthcare workers. Thus ACF is seeking rapid approval of the requested changes to the previously approved consent forms.

1 The Office of Child Support Enforcement (OCSE), which maintains the NDNH, typically requires written consent to allow the evaluation contractor to match study participant identifiers to the NDNH data. OCSE has agreed to amend the study’s Memorandum of Understanding to temporarily allow the collection of NDNH data with verbal consent.