Module Components

• Overview
• Assignments

Topics

• Non-Human Subject Research (NHSR)
• NHSR Application Example
• NHSR Application Process
• NHSR Determination

NDNP 811 - DNP Project Development

Module 2:HRPO Submission Process

Non-Human Subject Research

Research is understood as a systematic investigation designed to develop or contribute to generalizable knowledge. Generalizable knowledge is new information that expands the science of a discipline or field of study. A human subject is understood to be a living individual whom an investigator obtains private data through an intervention or interaction that may be identifiable.

Non-Human Subject Research is an initiative that does not involve research, as previously defined, or does not involve human subjects such as animal studies. Quality improvement, program evaluations, and case reports are examples of non-human subject research so long as the project does not involve activities designed to develop generalizable knowledge using human subjects.

All DNP projects are expected to involve humans and the collection of private data; however, the purpose of a DNP project is to change healthcare-related structures and process to improve quality and outcomes. Therefore, DNP projects are deemed to be quality improvement initiatives that meet the definition of Non-Human Subjects Research. Your HRPO application is the official means by which that determination is made.

Individuals conducting a project that is Non-Human Subjects Research are expected to adhere to ethical principles for research including sound design and procedures and privacy and confidentiality protections of health information

PROTECTED HEALTH INFORMATION (PHI)

Protected health information is information about the past, present, or future physical or mental health of an individual that identifies or could be used to identify the individual and is created or received by covered entities. (45 CFR 160.301, 164.501). Information about the provision of health care and payment for health care is included; some educational and employment records are excluded.

The HIPAA Privacy Rule provides federal protections for personal health information held by covered entities and gives patients an array of rights with respect to that information. At the same time, the Privacy Rule is balanced so that it permits the disclosure of personal health information needed for patient care and other important purposes.
Examples of PHI and PHI like data include:

• Names
• Addresses (all geographic subdivisions smaller than a State)
• All elements of dates (except year) directly related to an individual, including birth date, admission date, discharge date, date of death
• Telephone numbers
• Electronic mail addresses
• Social security numbers
• Medical record numbers
• Health plan beneficiary numbers
• Account numbers
• Full face photographic images and any comparable images
• Any other unique identifying number, characteristic, or code

Students are permitted to collect data and PHI from patients, families, and staff in conjunction with the quality improvement project with the (a) consent of the project site by virtue of project approval and (b) HRPO Non-Human Subject Research determination.

PROTECTION OF STAFF

You may collect identifiers of staff or clinicians from the EHR or other site records. This allows you to identify and have conversations with the staff/clinicians who are not compliant with the practice change. However, you must be cautious as to how these data are stored and shared to protect the privacy and confidentiality of these individuals. It is a best practice to keep staff/clinician data de-identified when discussing their project unless you are specifically asked by an administrator and it is the organizational culture to use identifiable data.

You may also interview staff about the project, if the purpose of interviewing the staff is for quality improvement (e.g., such as to determine their perception of facilitators and barriers to the practice change or for sustainability of the QI initiative).

ELECTRONIC HEALTH RECORD (EHR) RETRIEVAL

You and your faculty may have HIPAA concerns about your ability to access the EHR for retrieval of project data. Quality Improvement is considered a "health care operation" under HIPAA. It is part of quality care -- an imperative that we do it as ethical health care providers. When you are working with organizations in a precepted or practicum experience, you are working with the provider/nurse and you may access the EHR. Similar to accessing medical records during clinicals, you may access them during your practicum for your DNP project. Of course, you have to follow the organization’s policies as well, but HIPAA concerns should not be a reason for you to not access records. The U.S. Health and Humans Services website specifically states that you may have access to medical records:

https://www.hhs.gov/hipaa/for-professionals/faq/209/does-minimum-necessary-allow-students-to-access-patient-information/index.html

Your training is considered a "health care operation" and so is quality improvement -- just part of doing the business of health care.

HRPO Application Considerations

Your HRPO application is required to sufficiently describe your project purpose, methods, and actions to protect privacy and confidentiality such that the HRPO can make an appropriate determination regarding your project. Without a NHSR determination from the HRPO, the said initiative cannot be implemented.
The Project Summary in the HRPO application is a brief, succinct, description of the following:

• Title: abbreviated and full can be the same – precede with NDNP811
• A brief statement of the clinical problem at the practice site (name the site), with site evidence
• The purpose of the DNP project, timeframe, identifying who/what is expected to benefit Avoiding use of the terms “research” and “study”. Use terms such as “…to implement a quality improvement project”
• Published evidence to support the practice change – brief synthesis
• A summary of the implementation plan. Describe who will be involved in the project, what you will be doing as an intervention, and how data will be collected, recorded. Identify by name the instruments or tools that will be used
  • Naming in the summary must exactly match the naming of the files attached with the application. For example "Summary statement: Beck’s Inventory will be used to collect data regarding depression (Appendix A)
  • Attached file title: Appendix A Beck’s Inventory
• Discuss actions that you will take to protect the privacy of individuals. Privacy refers to a person’s access to themselves and does not involve data. It is helpful to briefly describe the personal space within the practice location and how you intend to protect privacy within that environment.
• Discuss actions that you will take to protect the confidentiality of data. Correctly distinguish the terms appropriate to your project (coded, anonymous, and de-identified are all different from each other):
  • Anonymous: initially collected without identifiers
  • De-identified: initially collected with identifiers or other information that may link a person to his/her data, but the identifiers are later removed with no way of ever linking back to the data
  • Coded: initially collected with identifiers or other information that may link a person to his/her data, but the identifiers are replaced with a code to protect confidentiality of data. A code key file will link the assigned code to the patient identifier for future data retrieval. The code key file must be stored separately from the project data.
• Discuss why the findings from the project are not generalizable based on your intent. (You may find it helpful to review the topic in Module 1 on the differences between QI and Research. Simply stating “this is QI and not research” is not sufficient.
• Dissemination: aggregate project data will be presented to the site for evaluation of the project and may be shared externally with site permission