GB891 Unit 2 Consent Language Draft Example

Declining Costs Nothing: A Unit 2 Consent Language Draft for a Study Run by a Company's Own Safety Manager

[Student Name]

Purdue University Global

GB891: Doctoral Project II: Project Design and Implementation

Unit 2 Consent Language Draft

[Instructor Name]

[Date]

Corliss Baking Company, its staffing agencies and every document are composite and illustrative; the documents are unsigned drafts, no review board has acted, and the regulations and sources cited are real.

Why the Researcher's Position Shapes Every Document

Under the federal human subjects rules, consent must be obtained in settings that keep coercion and undue influence to a minimum (Protection of Human Subjects, 2018). The Belmont Report grounds that requirement in respect for persons, which includes treating individuals as able to make their own decisions free of pressure (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). At Corliss, the pressure is built into the setting. The candidate is the company's safety manager, whose job includes investigating injuries and recommending discipline for safety violations. An associate asked a question about safety by someone connected to that manager may reasonably fear that an honest answer could cost them. For agency temporaries, who can be removed from an assignment at the host company's request, the fear is sharper.

The documents below address that fear directly rather than in general language about voluntary participation.

Document 1: The Pulse Information Sheet

This one-page sheet is read aloud by the research assistant the first time an associate is asked pulse questions, and a printed copy is offered. Its wording was pitched at roughly a sixth-grader's reading, and it exists in both English and Spanish.

It tells the associate, in plain words: who is asking, a graduate student who does not work for Corliss or for any staffing agency; why, to learn whether supervisors talk about safety on ordinary shifts; what is involved, three questions taking under three minutes, asked at break; who hears the answers, only the research assistant; what supervisors see, the average answer for the whole crew, and only when at least three people have answered; and what happens if the associate says no.

On that last point, the sheet states: "You can say no this week, every week, or any time. Saying no will not be reported to anyone at Corliss or at your staffing agency. It will not affect your job, your assignment, your pay or your schedule. Nothing you say in these questions will be used to discipline you or anyone else."

Because pulse questions are brief and low risk, the draft proposes that the review board allow oral consent recorded by the assistant, without a signature, which the regulations permit for research of minimal risk where a signature would be the only record linking the person to the study (Protection of Human Subjects, 2018).

Document 2: The Climate Survey Sheet

The survey sheet accompanies the baseline and follow-up surveys. It repeats the protections above and explains that each survey carries a crew code rather than a name, that the research assistant holds the only file linking codes to crews, and that no result will be reported for a group of fewer than five people.

Document 3: The Supervisor Interview Consent Form

Supervisors are interviewed in week thirteen, and the conversation is recorded. This form requests a signature. It explains that the interview concerns the feedback sheets and the supervisor's experience of them, that the recording will be transcribed by the research assistant with names removed and then deleted, and that neither the transcript nor anything said in it will be shared with the supervisor's plant manager or used in performance evaluation. Supervisors are also employees in a reporting relationship, so the form states that declining the interview will not be reported to their managers.

Document 4: The Posted Observation Notice

A notice posted at each observed station tells associates that trained observers will record whether safe practices are followed at the station, that observers record no names or badge numbers, that results are reported only as station totals, and that an observer will step in immediately if someone is about to be hurt. The notice is a disclosure rather than a consent form, because the observations record practices at stations, not individuals.

Testing the Language

The pulse sheet was read aloud to seven associates at the pilot plant, who were asked to explain back in their own words who would hear their answers, a paraphrasing probe drawn from cognitive interviewing (Willis, 2005). Two initially believed their supervisor would see individual answers. The phrase "average answer for the whole crew" was moved earlier and repeated, and in a second round all seven explained it correctly.

A consent sheet works only if the associate can say back, in their own words, who will and will not hear the answer.

How the Documents Will Be Delivered

The documents only protect associates if they are delivered in conditions that make the protections believable. The research assistant will first approach each crew at break, away from the supervisor, wearing a university badge rather than any Corliss identification. The pulse sheet will be read in full on the first contact and summarized on later ones. Spanish-speaking associates will hear it from a bilingual assistant, not from a coworker who might translate loosely. And the assistant will never ask questions while a supervisor or line lead is within hearing, a rule written into the protocol so that it does not depend on the assistant's judgment in a busy plant.

What Remains Open

The letters of cooperation from Corliss and both staffing agencies, which commit them not to seek individual answers, are unsigned. The review board has not reviewed these documents. The wording will change if the board requires it.

References

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.

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

Willis, G. B. (2005). Cognitive interviewing: A tool for improving questionnaire design. SAGE.