Course Coordinator: 
Gail Tripp
Human Subjects Research: A Primer

This course is designed to introduce students to research with human subjects. The course will cover study conceptualization, research design, sampling and data collection methods, ethics, and statistical treatment of data. The emphasis will be on behavioral sciences research, but the content will generalize across study fields.

Target Students

The course will be of interest to those undertaking human subjects research or working with human subjects’ data. Those interested in extending their understanding of clinical and behavioral sciences research will also find the course valuable. 

Course Materials

Readings will be assigned. This will include original research articles, research methods papers, and sections of relevant research methods textbooks. The latter will be provided by the faculty member teaching the course. In addition, students will be expected to undertake their literature searches to identify resources for course assignments. 

Assessment items

This course will be fully (100%) internally assessed. Both class participation and assignment completion will contribute to the final grade. 
1. Class participation (30% of grade)

Completion of weekly readings; responses to weekly thought questions; active participation in class discussions. 
Given the importance of active class participation, attendance is expected.

2. Preparation of an information letter(s) and consent form(s) for a human subjects’ research study, (20% of grade)

For this assignment students may prepare materials for their own research (if relevant) or select a research paper describing a study with human participants and prepare the information letter(s) and consent form(s) for that study. Students cannot copy/use existing letters/consent forms in completing this assignment. 

3. Class presentation, a 20-30 minute presentation (20% of grade).

In consultation with the faculty member teaching the class, students will choose a topic (from amongst the course content) to prepare and present to their classmates. 

4. Preparation of a grant application/research proposa (background, hypotheses, methods, statistical analyses, significance) for a human subjects’ research study (30% of grade). 

Students will identify a research question of interest, design a study to address the question and prepare a research proposal/grant application for the study. The faculty member teaching the class will be available to assist students in identifying research topic/question.  


At the end of the course students should be able to: 1. Formulate clear and testable hypotheses. 2. Describe different sampling methods, their strengths and limitations. 3. Identify any ethical issues or concerns for a given research study. 4. Evaluate the strength of different research designs, together with their appropriateness for addressing different research questions. 5. Judge the quality of research methods and measures based on indices of reliability and validity.
Course Content: 

Planning and conceptualizing research (2 sessions)

  • Defining your research question or purpose
  • Formulating testable hypotheses
  • Identifying the variables of interest and their measurement
  • Study validity

Sampling methods and participant recruitment (2 sessions)

  • Sampling methods and what it can mean for data interpretation
    • Random sampling 
    • Systematic sampling
    • Nonrandom sampling
    • Random selection versus random assignment
    • Determining sample size
    • Qualitative sampling methods
  • How to go about recruiting participants. 

Study Design

  • Descriptive studies (2 sessions)
    • Observation
    • Survey research
  • Experimental studies (3 sessions)
    • Control techniques in experimental research
    • Independent group designs
    • Repeated measures designs
    • Complex designs
  • Applied studies (2 sessions)
    • Quasiexperimental designs
    • Single case research designs/small n research 
  • Qualitative research (1 session)

Conducting a research study (1 session)

  • Institutional approval/Ethical approval
  • Obtaining participants 
  • Sample size, power, effect sizes
  • Equipment
  • Procedure
  • Consent
  • Instructions
  • Pilot studies

Human Subjects Ethics (2 sessions)

  • Issues in working with human subjects (Belmont report; informed consent; vulnerable populations; inducements; international research; data archiving; unanticipated consequences/findings) 
  • Ethical dilemmas/Controversies in human subjects’ research 
  • Applying for ethical approval (Japanese regulations)

Preregistering your research; Publishing study protocols (1 session)

  • How and why you should consider this step. 

Methods of data collection (1 session)

  • What is good measurement
  • Why is reliability and validity so important 

Planning your statistical analyses and interpreting your data (2 sessions)

  • Descriptive statistics
  • Inferential statistics
  • Planning data analysis as an essential step in planning your study


Course Type: 
Class participation (30%), Preparation of documents for a human subjects’ research study (20%), Class presentation (20%), Preparation of a grant application/research proposal (30%).
Prior Knowledge: 

There are no prerequisites for this course. Students will be expected to complete assigned readings ahead of class in order to participate fully.