Title of Study: Data Governance: Building A Framework For Large Scale AMR Data Collection And Utilization In Domesticated Animals
Investigators:   Paul Plummer, Amanda Kreuder

Invitation to be Part of a Research Study

You are invited to participate in a research study. This form has information to help you decide whether or not you wish to participate—please review it carefully. Research studies include only people who choose to take part—your participation is completely voluntary, and you can stop at any time.

Please ask the project staff any questions you have about the study or about this form before deciding to participate.

Introduction and Purpose of the Study

The first purpose of this study is to present data security measures to veterinary diagnostic laboratories (VDLs) and determine the measures that are necessary to engage VDLs in sharing of antimicrobial susceptibility testing (AST) raw data. The second purpose is to determine what metadata VDLs are willing to provide with the AST data.

This study is funded by United States Department of Agriculture, Animal and Plant Health Inspection Service.

Eligibility to Participate

You are eligible to participate in this study if you either are in a leadership position within a veterinary diagnostic laboratory broadly, or within the bacteriology section of a veterinary diagnostic laboratory.

You should not participate if you are under the age of 18.

Description of Study Procedures and Expected Duration of Participation:

If you agree to participate, there will be three different steps that we will ask participants to complete; your participation will last for approximately 2 hours over the course of several weeks:

  1. Enrollment (5 min)
  2. Zoom focus group meeting (90 min)
  3. Post-meeting online survey (15-20 min)

Risks or Discomforts

While participating in this study, we do not expect for you to experience any risks or discomforts. There may be unknown risks or discomforts that are currently unforeseeable at this time. We will tell you about any significant new information we learn that may relate to your willingness to continue participating in this study.

Benefits to You and to Others

There is a need to increase data sharing related to antimicrobial resistance in order to assure active surveillance for resistance that could threaten human, animal or plant health. It is hoped that the information gained in this study will benefit society by providing key underlying governance framework for a dashboard that can be used to collect and monitor the emergence of this resistance. Getting information from key stakeholders on their concerns and needs are critical to assuring that the outcomes are relevant and acceptable to stakeholders. Thus, the primary impact of this project will be a mutually agreeable data governance and security framework that will allow for confident sharing of data from veterinary diagnostic laboratories. Society in general will benefit from data sharing of this anonymous antimicrobial resistance data.

You are not expected to directly benefit from participation in the study.

Your Rights as a Research Participant

Participating in this study is completely voluntary. You may choose not to take part in the study or to stop participating at any time, for any reason, without penalty or negative consequences. During the surveys or focus group meeting, you can skip any questions that you do not wish to answer.

If you have any questions about the rights of research subjects or research-related injury, please contact the IRB Administrator, (515) 294-4566, IRB@iastate.edu, or Director, (515) 294-3115, Office of Research Ethics, Iowa State University, Ames, Iowa 50011.

Confidentiality

Research records identifying participants will be kept confidential to the extent permitted by applicable laws and regulations and will not be made publicly available without your permission. However, it is possible that other people and offices responsible for making sure research is done safely and responsibly will see your information. This includes federal government regulatory agencies, auditing departments of Iowa State University, and the Institutional Review Board (a committee that reviews and approves human subject research studies) may inspect and/or copy study records for quality assurance and data analysis. These records may contain private information.

To protect confidentiality of the study records and data, participant contact information will not be collected during the surveys or focus group meetings and will be stored separately on password protected accounts from the survey and focus group results. Any identifiable information provided by the participant will be coded or removed. Only the research team will have access to audio recordings or original survey results, and these results will be stored separately on password protected accounts.

To protect your confidentiality when results of the study are reported, only de-identified data will be shared with the funding agency or in future publications related to this work at the conclusion of the study.

Future Use of Your Information

Information about you collected for this study may be shared with other researchers. It may also be used for other research studies. These studies may be similar to this study or completely different.  We will make sure that your identity cannot be linked to the information we share. We will not ask you for additional permission before sharing the information.

Questions

You are encouraged to ask questions at any time during this study. For further information about the study, contact Dr. Amanda Kreuder (akreuder@iastate.edu) or Dr. Paul Plummer (pplummer@iastate.edu).

Your Consent

By clicking on the enrollment form, you are agreeing to participate in this study and certifying that you are 18 years of age or over. Make sure you understand what the study involves before you agree. If you have questions about the study after you agree to participate, you can contact the research team using the information provided above.

You may print a copy of this form for your files.