PUBH 6036 Week 6 Human Subjects Protocol Example

Protecting the Lease Before the Data: A Human Subjects Protocol for a Composite Cohort Study of Bed Bug Infestation, Children's Sleep and School Attendance in Public Housing

Student Name

Walden University

PUBH 6036: Public Health Research Methods

Instructor Name

Month Day, Year

Protecting the Lease Before the Data: A Human Subjects Protocol for a Composite Cohort Study of Bed Bug Infestation, Children's Sleep and School Attendance in Public Housing

Summary for Families

We are inviting families in the Cedar Hollow family buildings who have a child between 6 and 12 to help us learn whether bed bugs affect children's sleep and school attendance. If you agree, a study worker will visit your home twice, place small plastic cups under bed and sofa legs for one week, ask you some questions about your child's sleep and, with your written permission, collect your child's attendance from the school district. Taking part or saying no will not change your lease, your rent or your place on any list. The housing authority will never see what you tell us or which family's home had insects.

Why This Study Needs Strong Protections

The study team is working with the housing authority, which is also the landlord of every participant. Bed bugs carry stigma, and many leases require tenants to report pests and to prepare units for treatment. A caregiver who tells a researcher about bites, or whose interceptor cups trap insects, could fear that the information will be used against the household: a lease warning, a charge for treatment, or a judgment that the home is not kept clean. Children are involved, and a home visit can reveal far more than pests. These conditions shape every section below. The Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979) sets out three principles any protocol must honor, respect for persons, beneficence and justice, and in this setting respect for persons begins with making sure no family feels obliged to join because their landlord is a partner.

Participants

Eligible households have at least one child aged 6 to 12 listed on the lease roster of one of the nine family buildings. Up to three children per household may be enrolled. Children are included as a group the study is about, not merely as members of a household, so the protections for children in federal regulations apply (45 C.F.R. § 46.404 and § 46.408).

What Each Participant Gives

Caregivers give two home visits of about 45 minutes each, one in September and one in January; a short questionnaire on each enrolled child's sleep in the past week; permission for a trained inspector to look at beds, sofas and baseboards; permission to place interceptor cups for seven days; and written permission for the district to release each enrolled child's attendance for the school year. Children aged 9 and older answer four questions about their own sleep, read aloud, and may decline any of them.

Permission and Assent

Caregiver permission is sought in the caregiver's preferred language by a study worker who is not a housing authority employee. The permission form states, in bold type near the top, that the authority will not learn who took part. Child assent is sought separately for children aged 7 and older, using a one-page picture sheet and a simple question: "Is it okay if we ask you about how you sleep?" A child's refusal is respected even if the caregiver has agreed. The regulations allow a review board to judge assent appropriate for children capable of giving it (45 C.F.R. § 46.408), and the study treats that as a minimum.

Risks

Housing Risk

The central risk is that study information reaches the landlord. The protections are structural. Study data are held only by the university; the housing authority receives building-level summaries with no household identifiers and no building figure based on fewer than 10 apartments. The study will apply for a Certificate of Confidentiality, which bars the release of identifiable research information in most legal proceedings without the participant's consent (Public Health Service Act, 42 U.S.C. § 241(d)).

The Duty to Refer Infestations

A difficult question follows from that firewall: what happens when cups trap bed bugs in a home whose family did not know? Leaving the family uninformed would be wrong. The protocol tells the caregiver privately, gives them a written sheet on how to request free treatment through the authority's ordinary process and offers to place the request on their behalf if they wish. The decision belongs to the family. The study does not report the infestation to the authority itself.

Other Risks

Visits are an intrusion into the home, so workers inspect only sleeping and sitting areas and do not open drawers or closets. Workers are trained to notice and not record unrelated conditions. Questions about sleep carry little risk. Taken together, the study is judged no more than minimal risk to children (45 C.F.R. § 46.404).

School Records

Attendance records are education records, and the district may release them only with written consent from a parent (Family Educational Rights and Privacy Act, 20 U.S.C. § 1232g). The consent names the district, the records requested (daily attendance only, not grades or discipline), the school year and the recipient. Records arrive by secure transfer, are linked to study numbers and are stored apart from names.

Benefits and Compensation

Families gain a free professional inspection and early warning of an infestation they may not have known about. In one New Jersey survey, about half of the infested apartments that a comparable protocol turned up belonged to tenants unaware of the problem (Wang et al., 2016). Each household receives a $25 grocery card per visit, an amount set low enough not to pressure families who would otherwise decline.

Review by Residents

Before submission to the review board, the consent form, the child assent sheet and the sleep questions will be read by four members of the authority's resident council who are not employees. They will be asked one question for each document: would a neighbor believe this promise? Each comment gets a written answer, and resulting changes go to the board. The forms will then be translated into Spanish and Haitian Creole, the two most common languages after English in the family buildings, and back-translated by a second translator to catch shifts in meaning. A resident council review does not replace the review board. It tests whether the protections read as real to the families they are meant to protect, which no regulation can judge from outside the buildings. Council members will receive the hourly rate the authority already gives its community advisors.

Withdrawal and Data Handling

A family may withdraw at any time by phone, text or a note to the study worker, and their records will be destroyed unless they agree otherwise. Identifiable data are kept on encrypted university servers for three years past the final report, then erased.

References

Family Educational Rights and Privacy Act, 20 U.S.C. § 1232g (2024).

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. U.S. Department of Health, Education, and Welfare. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html

Protection of Human Subjects, 45 C.F.R. § 46 (2018).

Public Health Service Act, 42 U.S.C. § 241(d) (2024).

Wang, C., Singh, N., Zha, C., & Cooper, R. (2016). Bed bugs: Prevalence in low-income communities, resident's reactions, and implementation of a low-cost inspection protocol. Journal of Medical Entomology, 53(3), 639-646. https://doi.org/10.1093/jme/tjw018