Access the resources of five Harvard Catalyst clinical research centers. Harvard Catalyst Clinical Research Center (HCCRC)

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. The clinical research nurse has in-depth knowledge of good clinical practices, federal regulations that guide research, and the details of specific study protocol(s), along with clinical knowledge and judgment. Their combined training gives these nurses unique abilities and insight related to clinical trial implementation and subject protection, particularly for trials involving medically complex populations.

Research nurses in institutions that participate in Harvard Catalyst support the conduct of clinical research studies in in- and outpatient settings, within and outside the clinical research centers, and in the community.

Information for Research Nurses

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.

Pie chart

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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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Information for Investigators

Resources Available for Investigators

To request use of these services, use the HCCRC Protocol Review form.

Research Nursing Clinical Roles

Research nursing is a growing specialty practice within nursing, divided into two principal clinical research 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 research units in clinical translational science center sites 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. These nurses are often hired by a PI to help implement and coordinate a trial or a small group of research studies.

Research nurses in institutions that participate in Harvard Catalyst support the conduct of clinical research studies in in- and outpatient settings, within and outside the clinical research centers, and in the community.

Research Nursing Staff Services

The research center nursing staff is specially trained to provide the following services:

  • Assist investigators with the planning and implementation of clinical research protocols; develop data collection sheets and MD orders.
  • Perform clinical assessments, observations, and treatments.
  • Provide patient care while adhering to the detail of research protocols.
  • Collect and maintain the integrity of research specimens.
  • Process research specimens using basic techniques.
  • Advocate for subjects and their families who are volunteering to participate in research.
  • Monitor, identify, and report adverse events.
  • Research nurse coordinators can assist with study coordination either alone or in concert with study coordinators.

Guidance for Delegation of Responsibilities in a Clinical Study

Investigators often have questions about which study-related responsibilities can and should be delegated to a study coordinator rather than a licensed personnel, such as a research nurse. In 2009, the Food and Drug Administration (FDA) released a document intended to provide such guidance in the contest of FDA-regulated research studies.

Standard and Above Standard Services for Investigator-Initiated Studies*

*To be implemented for all NEW studies as of January 1, 2013

As of January 1, 2013, HCCRC is implementing a set of categories for services available for all HCCRC research investigators conducting investigator-initiated studies:

  • Standard services are free up to a certain defined level, beyond which there will be a fee incurred.
  • Above Standard services have fees incurred for use.

The description of services with their new levels is below.

Implementation

Implementation of the new Standard/Above Standard guidelines for new protocols submitted to Protocol Review January 1, 2013, or later will be immediate.

For protocols submitted to Protocol Review prior to January 1, 2013, you will be charged the old Standard/Above Standard rates and service fees until December 31, 2014. These older protocols will be required to change to the new guidelines by January 1, 2015. However if your study will benefit from the new Standard/Above Standard guidelines by incurring fewer fees under the new guidelines, you are encouraged to switch immediately.

Please note: Industry-initiated studies do not benefit from Standard Services discounts and fee-waivers.

If you have any questions regarding this, please contact the Nursing Director or Administrative Director at your local site.

Determining potential associated fees for Research Nursing Staff

Nursing Standard and Above Standard definitions are based on frequency and duration of accumulated Research Nurse Service requirements during the visit. If your study requires services from RN staff every 30 minutes or less, AND the total number of hours used is two or more in duration, this would be Above Standard.

For example, if your study required RN services for blood draws every 30 minutes for 1.5 hours total, this would be Standard Services. If you required blood draws every 30 minutes for 3.0 hours total, this would be Above Standard. However, if you required blood draws every 45 minutes for 10.0 hours total, this would still be Standard, as it is less frequent than every 30 minutes.

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HCCRC Research Nursing Contacts

To discuss the nursing requirements for your study, please contact the nurse director for your institution's Harvard Catalyst Clinical Research Center site:

Beth Israel Deaconess Medical Center
Linda Godfrey-Bailey, MSN, ACNS, BC
Nurse Director
617-667-3354
Email

Boston Children's Hospital
Cindy Williams, MSN, PNP-BC
Nurse Director
857-218-4383
Email

Brigham and Women's Hospital
Sheila Driscoll, MSN, RN
Nurse Director
617-732-7764
Email

Massachusetts General Hospital
Kathy Hall, MS, ANP-BC, NE-BC
Nurse Director
617-726-3295
Email

Massachusetts Institute of Technology
Catherine Ricciardi, DNP, ANP-BC
Nurse Director
617-253-6332
Email