Human Subject RCR Boilerplate

Sample Grant Text for Human Subjects RCR

Offered twice a year, this RCR course is designed for researchers who work with human subjects or data derived from human subjects (e.g. clinical, survey, EHR, or ethnographic data). The course is comprised of video and in-person lectures, readings, case studies, and weekly real-time small group discussions via Zoom with 10-12 other learners. It addresses requirements and regulations for human subjects research, including IRB approval and consent. 

Responsible Conduct of Research is an 8-week course. Participants are expected to devote at least 4 hours per week to individual work and small group discussion. Small group sessions are led by senior scholars at UCSF. Receiving a passing grade in the course requires attending a one-hour discussion session by Zoom every week. There are no exceptions to this rule.

Instruction in Human Subjects RCR is required for all NIH and NSF funded trainees at all career stages at a frequency of at least every four years and at least once per career stage. Mid- and late-career researchers are invited to participate as small group discussion leaders, as appropriate.

Course Objectives

  1. Identify common ethical issues that clinical, translational, and qualitative researchers commonly face and the ethical guidelines for addressing these issues.
  2. Explain key elements of the federal regulations for research with human subjects.
  3. Analyze the ethical issues in a research protocol, identify where it does not meet regulatory and ethical standards, and suggest how to address those problems.
  4. Provide constructive feedback on colleagues’ ideas regarding ethical issues in research.
  5. Describe the ethical guidelines and federal regulations pertaining to research misconduct and conflicts of interest in research.

Instructional Team

Sara Ackerman, PhD, MPH
[email protected]
Associate Professor, UCSF Bioethics 
Associate Professor, Social and Behavioral Sciences
Spring RCR Course Director

Julia Brown, PhD
[email protected]
Assistant Professor, UCSF Bioethics
Assistant Professor, Humanities & Social Sciences
Fall RCR Course Director

Matty Norstad, MPH
[email protected]
Bioethics Program Manager

Course Content

Human Subjects RCR is structured to cover topics outlined by NIH in NOT-OD-10-019 and NOT-OD-22-055, as well as those outlined by NSF in Section 7009 of the COMPETES Act (42 USC 1862o–1). The course consists of 8 modules, outlined below. Two modules are revised and updated each year to ensure that learners who retake the course are exposed to new issues and up to date content.

Module 1: Course Introduction & Overview of Research Regulations

Module 2: Human Subjects Protection: Informed Consent & IRB Review

Module 3: Legacies of Scientific Racism

Module 4: Research Collaborations: Authorship & Data Sharing

Module 5: Research in Resource-Poor Environments

Module 6: Research Misconduct, Conflict of Interest, & Reproducibility

Module 7: Ethics in Big Data Research and Learning Health Systems

Module 8: AI in Research: Bias and Rigor