Research Nursing - Information for Research Nurses

Professional Organization and Links

Recommended Research Nursing Practices

Harvard Catalyst Research Nursing Mission Statement

Nursing staff within the Harvard Catalyst Clinical Research Center (HCCRC) sites provide safe, quality nursing care to participants in research studies of varying complexity. In each center, the nursing staff:

• Collaborates with investigators on their approved protocols to ensure the safe and precise conduct of each study.
• Completes clinical assessments, studies related observations, and administers treatments.
• Assists investigators in developing MD orders and data collection tools.
• Pays great attention to proper sample collection and handling and the timely execution of study interventions.

The nursing staff at each center is CITI-trained and educated in the standard nursing research procedures established within Harvard Catalyst.

The Specialty Practice of Research Nursing:

The specialty practice of clinical research nursing includes care provided to research participants, as well as activities to support protocol implementation, data collection, and human subjects' protection.

In 2007, the National Institutes of Health Clinical Center (NIH CC) released the results of a role delineation project, Building the Foundation for Clinical Research Nursing Domain of Practice for the Specialty of Clinical Research Nursing. This project defined the scope of the clinical research nursing specialty practice in the context of two nursing roles:

Clinical Research Nurses (CRN):  Clinical staff nurses with a central focus on care of research participants. They support study implementation within the context of a care delivery setting, such as the NIH Clinical Center, research units in Clinical Translational Science Award sites and the remaining General Clinical Research Centers (GCRCs), or specialty care programs with a clinical research focus.

Research Nurse Coordinators (RNC):  Nurses primarily responsible for study coordination and data management, with a central focus on managing subject recruitment and integrity, and compliance with regulatory requirements and reporting.

The NIH Role Delineation Project described five dimensions – distinct categories of activities – within the specialty practice of research nursing:

1. Clinical Practice Dimension:  Provision of direct nursing care and support, using the nursing process, to participants in clinical research, their families, and significant others. Care requirements are determined by the scope of study participation, the clinical condition of the patient, and the requirements and clinical effects of research procedures.
2. Study Management Dimension:  Management of clinical and research support activities in order to assure patient safety, address clinical needs, and assure protocol integrity and accurate data collection.
3. Care Coordination and Continuity Dimension:  Coordination of research and clinical activities to meet clinical needs, complete study requirements, and manage linkage with referring and primary care providers.
4. Human Subjects Protection Dimension: Facilitation of informed participation by diverse participants in clinical research.
5. Contributing to the Science Dimension:  Contribution as a research team member to the development of new ideas for study, explorations of innovations arising for clinical research findings to practice.

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Professional Organization and Links

The International Association of Clinical Research Nurses (IACRN)
The International Association of Clinical Research Nurses (IACRN) is a professional nursing organization dedicated to supporting educational and professional needs of clinical research nurses.

Association of Clinical Research Professionals
The Association of Clinical Research Professionals is an organization for research professionals in the pharmaceutical, biotechnology, and medical device industries as well as those in hospital, academic medical centers, and physician office settings. ACRP was founded in 1976 to address the distinct educational and networking needs of nurses and others who support the work of clinical investigations.

Society of Clinical Research Associates
The Society of Clinical Research Associates, a professional membership organization, was developed to provide educational programs, certification, and a forum for research professionals to exchange information. The organization's mission is to provide a forum in which members can learn and exchange information, grow professionally, and build strong foundations for successful clinical research outcomes.

Recommended Research Nursing Practices

These practices were drafted and adopted by a committee of research nurses representing the five HCCRC sites, and are intended to provide guidance only to research nurses in institutions participating in Harvard Catalyst. They have not been accredited or adopted by any professional organization, the NIH, or any other relevant organization or agency.

These recommendations are under constant re-evaluation, and may change over time. Please check back for future updates.

Informed Consent

Purpose:  Informed consent is a critical component of ethically conducting human subject research. The consent is a legal document that requires disclosure of benefits, risks, and alternatives to proposed treatment/research protocols and results in greater safety and protection for patients/subjects.

RN Role in the Informed Consent Process:

• Verify consent – confirm identifiers/signatures, check the validity of consent dates, assess subject understanding, and provide adequate opportunity for questions and clarification.
• Patient/subject advocacy – protect the interests of participants, assess "ongoing consent" throughout the duration of each study, and support subjects' right to withdraw from a study at any time.
• Protect patient/subject dignity – ensure subject confidentiality/HIPPA compliance, identify participant fears, assess the degree of subject comprehension of their involvement in the study, and report participant concerns and needs to the PI, ensure that interpreter services, large print, or a Braille copy of the consent is supplied according to participant needs.
• Patient/subject education – assess the understanding of participants' rights in the research process; evaluate any barriers, concerns, or study implications that may affect the participation and completion of each study.
• Patient/subject safety – ensure protocol adherence, monitor subjects for adverse events, and utilize institutional and Harvard Catalyst resources to resolve issues: subject advocate, IDS, Staff Ed, Clinical Specialists, etc.

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Serial Blood Drawing From an IV/Lock

Purpose:  Provide standardized guidelines for drawing serial blood specimens via a peripheral IV while ensuring the integrity of study samples.

Procedure:

• Access the blood drawing port that promotes the integrity of samples and meets protocol-specific requirements. This will typically be the drawing port closest to the subject's intravenous insertion site to minimize the amount of discard and risk of specimen contamination with IV fluid.
• Samples are not drawn from lines infusing fluids.
• Maintain aseptic technique to diminish risk of contamination and infection.
• The volume of discard is 2 times greater than the volume of tubing between the draw port and the IV insertion site. Prior to each sample collection, assess blood return and ease of blood draw. Consult with PI if access issues are unresolved and affecting protocol compliance.

Tips to Maintain Sample Integrity and Prevention of Hemolysis:

• Draw specimen slowly using minimal suction.
• Avoid re-cleaning the port with alcohol between discard and specimen collection. If necessary, wipe port with sterile gauze pad to remove excess blood and avoid alcohol contamination of sample.
• Use tourniquet to promote blood flow, avoiding excessive restriction to prevent hemolysis.
• Flush using pulsetile technique.
• Where possible, use straight connections when drawing and transferring blood.
• Allow suction of vacutainer to pull specimen into collection tube and do not force fill.
• When transferring blood from syringe to specimen tube, avoid excessive force to prevent hemolysis.

Protocol Review Guidelines:

Purpose:

• Reviewing protocols is conducted to:
  • Ensure participant safety.
  • Verify that the informed consent represents a clear and accurate description of the study and outlines procedures and risks involved.
  • Guide the development of study flow sheets.
  • Plan for operationalizing the protocol.
• Meet with the Principal Investigator (or their designee) to develop flow sheets that will ensure capture of all required data.
• With the study team, develop standardized orders according to the approved protocol.
• Develop blood collection and processing instructions in collaboration with the local and core lab.
• Plan with the study team for the education of involved staff.
• Maintain ongoing dialogue with the study team about amendments, adverse events, or changes to the protocol.

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