Guidelines for Medical Trainee Research with Humans

Medical Trainee Research

Medical trainees who plan to conduct research with humans must comply with a number of requirements in advance of study initiation, including application for IRB approval. The Research Integrity Quickstart guide provides a concise and helpful starting point and overview of requirements, including time commitment expectations, training requirements, the IRBNet protocol submission system, the IRB review process, and basic responsibilities of the principal investigator and researchers following IRB approval.

Medical trainees who plan to conduct research with humans must identify and work with a faculty advisor throughout the process, from design, to IRB review, and throughout conduct of the project. The faculty advisor serves to provide guidance about study design, logistics, assurance of compliance, and as study principal investigator with overall responsibility for the project. Medical trainees serve as co-investigators on projects while also taking a significant role in study execution.

Medical trainees who plan to present at local (Medical Student Research Day) and national conferences must have IRB in place to qualify for acceptance of abstracts, posters, and presentations.

Always consult with the Office of Medical Research about the need for IRB oversight.

Ethical foundations and goal of IRB review

The IRB uses the Belmont Report, written in 1979, as the foundation for review of research with humans, to ensure they receive appropriate protection in research.

The primary concern of the researchers should be the safety of and respect for the research participant, which includes observation of the following principles outlined in the Belmont Report.

Respect for persons refers to the obligation on the part of the investigator to respect each participant as a person capable of making an informed decision regarding participation in the research study.
Beneficence refers to the obligation on the part of the investigator to attempt to maximize benefits for the individual participant and/or society, while minimizing risk of harm to the individual.
Justice refers to equitable selection of participants, i.e., avoiding vulnerable participant populations that may be unfairly coerced into participating, such as prisoners and institutionalized children, unless those populations are the focus and recipient of potential benefits of the research.

Activities requiring IRB review

A basic guideline for when research with humans requires IRB review involves interaction with humans, or access to humans’ identifiable data, and sharing the results beyond the research site. This guideline applies even if the data are gathered anonymously, or de-identified at some point in the research process. If researchers share data in presentations, conferences, educational sessions, and journal articles, these all meet the criterion as generalizing results beyond the site where data were gathered. Activities requiring IRB review are described below.

Master’s Theses/Doctoral Dissertations involving human subjects.

Pilot Studies involving human subjects.

Clinical Investigations including research to increase scientific understanding about normal or abnormal physiology, disease states or development, and research to evaluate the safety, effectiveness or usefulness of a medical product, procedure, or intervention. Vaccine trials, medical device research, and cancer research are all types of clinical investigation.

Behavioral and Social Sciences Studies such as investigations on individual and group behavior, mental processes, or social constructs. These usually generate data by means of surveys, interviews, observations, studies of existing records, and/or experimental designs involving exposure to some type of stimulus or environmental intervention.

Epidemiological Studies such as investigations on health outcomes, interventions, disease states and conclusions about cost-effectiveness, efficacy, efficiency, interventions, or delivery of services to affected populations. This research may be conducted through surveillance, monitoring, and reporting programs. Other methods may include retrospective review of medical, public health and/or other records.

Human Genetic Research such as pedigree studies, positional cloning studies, gene transfer research, longitudinal studies to associate genetic conditions with health, health care, or social outcomes, and gene frequency studies.

Medical Trainee Responsibilities in Conducting Research

Medical trainees must follow the policy on researcher responsibilities, in the Human Research Protection Policy manual, 38. Responsibilities: Researchers.

Faculty Advisor Responsibilities in Conducting Research

A faculty advisor must oversee any medical trainees conducting human subjects research, as well as approve the application prior to submission to the IRB. The faculty advisor is responsible for the legal and ethical performance of the project, ensuring that all research procedures comply with federal, State and University policies pertaining to the protection of humans.

A faculty advisor must meet the criteria for “Principal Investigator” as outlined in policy 35. Requirements for Principal Investigators for Human Subject Research Projects. Research Integrity may grant exceptions to this requirement on a case-by-case basis.

A faculty advisor must provide electronic review and sign off of the project in the online submission system, IRBNet. The faculty advisor thus certifies that the medical trainee is knowledgeable about the regulations and policies governing research with humans and has sufficient training and experience to conduct the study in accordance with the approved protocol.

In addition, a faculty advisor must agree to:

meet with the medical trainee on a regular basis to monitor the study progress;
agree to be available, personally, to supervise the medical trainee in solving problems should they arise during the course of the study;
assure that the medical trainee will promptly report significant or untoward adverse effects according to applicable policies;

Training

All medical trainees and faculty advisors involved in the design, conduct, and oversight of research with humans need to take training in the protection of humans in research, prior to project initiation. The human research protection training webpage provides more detail and links to training courses.

Post Approval Monitoring and Compliance

Medical trainees and faculty advisors need to maintain ongoing reporting about study progress with the IRB for the duration of the project. Researchers need to

Submit renewal requests or project reports for continuing projects for review and approval prior to the expiration date.
Submit proposed changes for review and approval prior to initiation.
Submit proposed changes to personnel and study sites for review and acknowledgement.
Report any unanticipated problemswhich may increase risks to human subjects or unanticipated adverse events to the IRB within five days.

Protection of Participant Identity and Identifiable Data in Research

One of the fundamental items researchers must observe is to protect participant identity, and prevent any disclosure of identifiable research data outside the research team, particularly sensitive data, and private identifiable health data. Researchers need to describe measures to protect both in the research protocol and to ensure data are stored and transmitted in adequate manner. The most expedient means to protect research participants and their data is to avoid collection of identifiers at the study outset, or to de-identify data at the earliest opportunity. See IRB policies 405. Protecting Participant Privacy and 410. Maintaining Data Confidentiality for more on these topics. Bear in mind that UNR email, NevadaBox, and WolfCloud are not considered secure or HIPAA-compliant methods to transmit or store private identifiable data, including healthcare data. See the Data De-identification Instructions for details on how to safely de-identify data for collaboration and data analytics. Contact the Office of Medical Research to request secure cloud-based storage for research data containing identifiers.