DRNP1503: Information Systems and the Transformation of Global Health

IRB Application Process Paper

Dr. Kelly Vandenberg

February 14, 2025

Institutional Review Board Application Process

An Institutional Review Board (IRB) is a committee that reviews research proposals to protect human subjects' rights and welfare. The IRB evaluates research ethics, the methods used, and the potential risks and benefits to participants. As a Doctor of Nursing Practice (DNP) student at Midwestern University in Glendale, Arizona, I must apply to the IRB for my project, which involves providing oral health care kits to the underserved population at a community center in urban Phoenix, Arizona.

The IRB focuses on ethics to protect human subjects’ rights and welfare. The IRB will ensure that my DNP project is conducted ethically so that I can support the validity and credibility of the results. Two important ethics my project will implore are justice and beneficence. Justice emphasizes fairness and equality in distributing resources and care. For example, I will ensure that the oral health care kits are distributed equitably among the underserved population. By emphasizing beneficence in my project, I will ensure that my actions are directed toward maximizing the benefits for the underserved population and promoting their oral health and overall well-being. I will provide high-quality kits and educational pieces to teach the underserved population about proper oral hygiene practices.

I must follow specific steps to apply to the IRB for my DNP project. The steps are as follows:

Apply ethical concepts to the project, such as justice and beneficence.
I need to determine if I need IRB approval, which I do because my project involves human subjects (underserved populations).
Complete the Collaborative Institutional Training Initiative (CITI) training program, which provides education on the ethical conduct of research and the use of data. Once I earn my certificate(s) of completion, I will submit those documents to the IRB with the application.
I must create a detailed research protocol outlining my project's objectives, methodology, and procedures. I must include information on participant recruitment, data collection, data analysis, and measures to protect participants' privacy and confidentiality.
I will prepare a consent document, such as an informed consent, that explains the study’s purpose, procedures, potential risks, benefits, and the rights of participants.
The documents I will gather to submit will include recruitment materials, data collection tools, and letters for support from the community center and staff.
I will download and complete the IRB application form from Midwestern University. Then, I will be prepared to answer questions about my study, the research questions, the methodology, the participant population, and how I plan to minimize risks.
Once I have completed the application and gathered the required documents, I will submit it electronically through Midwestern University.
I must be prepared to respond promptly if the IRB requests revisions or additional information.
Then, wait for an approval letter from the IRB.
Once the project begins, I must report to the IRB promptly if there are any changes to the research protocol, unanticipated problems, or adverse events. Also, I must be prepared to submit regular progress reports as required by the IRB.

Research activities that are exempt from the Full Board IRB review:

The Institutional Review Board (IRB) has research activities exempt from full board review to streamline the review process for studies that pose minimal risk to participants. These exemptions help reduce administrative burdens while ensuring that ethical standards are maintained. Here are some reasons for exemptions:

Minimal risk to participants means the likelihood and magnitude of harm or discomfort are not greater than those encountered in daily life or during routine physical or psychological examinations (U.S. Department of Health and Human Services, 2018).
Exemptions allow IRBs to be efficient and focus their resources on reviewing higher-risk research. They ensure that studies with a more significant potential for harm are scrutinized (U.S. Department of Health and Human Services, 2018).
Federal regulations define exemptions and outline specific categories of research that qualify based on their nature and risk level (U.S. Department of Health and Human Services, 2018).

Research activities that meet requirements for expedited review:

The expedited Institutional Review Board (IRB) reviews are for research that poses no more than minimal risk to participants and fits specific federally defined categories as follows:

Clinical Studies of Drugs and Medical Devices:
- Research on drugs for which an investigational new drug application is not required.
- Research on medical devices that are cleared for marketing and used according to their approved labeling.
  (U.S. Department of Health and Human Services, 1998)
Collection of Blood Samples:
- Collection by finger stick, heel stick, ear stick, or venipuncture, considering subjects' health and weight and the collection frequency.
  (U.S. Department of Health and Human Services, 1998)
Prospective Collection of Biological Specimens:
- Collection of biological specimens for research purposes by noninvasive means, such as hair and nail clippings, saliva, or sweat.
  (U.S. Department of Health and Human Services, 1998)
Data Collection from Voice, Video, Digital, or Image Recordings:
- Research involving data collected from voice, video, digital, or image recordings made for research purposes.
  (U.S. Department of Health and Human Services, 1998)
Research on Individual or Group Characteristics or Behavior:
- Research on perception, cognition, motivation, identity, language, communication, cultural beliefs, or social behavior.
  (U.S. Department of Health and Human Services, 1998)

How can I utilize the IRB planning checklist, Decision Tree, and Participation Consent Questions?

I will utilize the IRB planning checklist, Decision Tree, and Participation Consent Questions, which will help me streamline my research process and ensure compliance with ethical standards.

IRB Planning Checklist

The IRB planning checklist is a valuable resource for ensuring that all necessary components of my research proposal are in place before submission. It typically includes items such as:

Ensure my research protocol is detailed and includes objectives, methodology, and data analysis plans.
I must verify that my informed consent documents are complete and understandable to participants.
I must ensure all surveys, questionnaires, and other data collection tools are included and properly formatted.
I must address potential ethical issues and describe how I will protect participants' privacy and confidentiality.

Decision Tree

The IRB Decision Tree helps determine whether my research requires IRB review and, if so, what type of review is needed (exempt, expedited, or entire board). It guides me through a series of questions about my research activities, such as:

Is the activity considered human subjects research? Yes
Does the research involve minimal risk to participants? Yes
Are there any vulnerable populations involved? Yes

Participation Consent Questions

I will clearly explain why the research is being conducted and what I hope to achieve.
I will describe what participants will be asked to do, including potential risks and benefits.
I will emphasize that participation is voluntary and that participants can withdraw at any time without penalty.
I will explain how participants' data will be kept confidential and how their privacy will be protected.

As I apply to the IRB for my DNP project, I must promptly fulfill all the above points. This will ensure that my DNP project complies with ethical standards and regulations as I start applying.

References

U.S. Department of Health and Human Services. (2018). 45 CFR 46: Protection of Human

Subjects. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

U.S. Department of Health and Human Services. (1998). Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review

Procedure. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html