Human Subjects Research: A Primer

Course Aim

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 Description

Explore and discuss the particular requirements of research with human subjects with reference to conceptualization, research design, sampling and data collection methods, ethics, and statistical treatment of data.  Learn how to formulate clear and testable hypotheses; describe different sampling methods, their strengths and limitations; identify any ethical issues or concerns for a given research study;  evaluate the strength of different research designs, together with their appropriateness for addressing different research questions; judge the quality of research methods and measures based on indices of reliability and validity. Prepare information letter(s) and consent form(s) and develop a grant application/research proposal (background, hypotheses, methods, statistical analyses, significance) for a human subjects research study. Present a research report on a topic of interest. The emphasis is on behavioral sciences research, but the content can apply to many fields of study.

Course Contents

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)
-- Quasi-experimental 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)

Pre-registering 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

Assessment

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

Prerequisites or 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.

Textbooks

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.

Research Specialties