Human Research Subjects

A Human Research Subject means a living individual about whom a researcher conducting research obtains data through intervention or interaction with the individual or identifiable private information.


It includes both the physical procedures by which data are collected (e.g. triumncing) and manipulations of the subject or the subject’s environment that are carried out for research purposes.


It includes communication or interpersonal contact between the researcher and the subject.

Private information

It includes information about behavior that occurs in a context in which an individual can reasonably expect that it is not being observed or recorded, and information that has been provided for specific purposes by an individual and that an individual can reasonably expect will not be made public (e.g., a medical history). Private information must be individually identifiable (i.e., the identity of the subject is or can be easily ascertained by the investigator or associated with the information) for the collection of the information to constitute human research.

Examples of human subjects

A person who becomes a participant in a research, either as a recipient of a test item or as a control. A subject can be a healthy individual or a patient. They can be:

Data obtained from medical records – even if the data is recorded without identifiers.

Data obtained from surveys – even if the data is recorded without identifiers.

The data obtained from the observation – even if the data is recorded without identifiers.

Data obtained from third parties – the collection of information about family members makes them subjects.

Fabrics used in research that possess or are linked to any type of identifiable information.

The use of tissues from later deceased persons in humans for research purposes (e.g., transplantation of organs/tissues from a deceased individual to a living individual as part of a research protocol) is equivalent to research with human subjects (by the person receiving the tissue).

What is systematic research?

Systematic research is defined as a process that includes the development, testing and evaluation of research designed to develop or contribute to generalizable knowledge. The dictionary defines systematic as a method or plan, possibly related to classification. Definitions of research include a detailed or careful examination, an exploration, or learning the facts about something complex or hidden. Attempting to answer a question or test/disprove a hypothesis are clear indications that an activity is systematic investigation. (Note: the absence of a hypothesis does not automatically mean that an activity is not a systematic investigation.)

What is it to develop or contribute to generalizable knowledge?

It is being developed/contributed to generalizable knowledge if the information produced is to be shared with others, whether in a poster presentation, conference or publication.

Some examples of what is not research

Case reports

They are not considered research because, although they contribute to generalizable knowledge, they are not systematic investigations. The clinician simply shares information about interesting cases for educational purposes. If you try to answer a question, or prove/disprove a hypothesis, it is no longer a case report, but an investigation. in addition, case reports are usually limited to no more than a few patients.

Quality Assurance / Continuous Quality Improvement (QA / CQI)

It is not considered research because, although it is a systematic investigation, there is no intention to share the information with others (contribute to generalizable knowledge). For example, the pharmacy can carry out quality assurance and compare the use of a drug orally versus intravenous administration.

When describing participants in a study, is there any difference in APA standards® between the subject and participant terms?

Thus, although descriptive terms such as college students, children, or respondents provide accurate information about individuals participating in a research project, the more general terms participants and subjects are also in common use. In fact, for more than 100 years the term subjects has been used in experimental psychology as a general starting point for describing a sample, and its use is appropriate.

Subjects and sample are common when talking about certain established statistical terms (e.g., design within and between subjects).

The process of identifying the subject

The search for a research topic is an iterative process and must be done in several stages. But the last formal stage takes place when the research plan is drawn up and the last non-formal stage when the research is actually put into practice. For example, it may be necessary to add a new question or reduce the initial project. However, you should try to plan as well as possible what you are going to do. This way, you will receive better advice and finish earlier.

The most important phases of the process are, broadly speaking, the following

  • Identify a few topics/issues and make a “short list”
  • Explain each potential topic
  • Discuss with your teachers (if you can)
  • Explore the topics (new short list), see: Readings and ideas
  • Draft the research plan and negotiate. See Anticipation of the research plan
  • Make it official (see local procedure)

Identification of a social subject

You should take some time and think about the broader implications of your projects (in addition to getting a title or publishing an article).

Want to learn something? Are there institutional limitations (for example, does your company want you to do something for it)? Are you just looking for intellectual fun?

Some questions you might ask yourself

What should your job be in 3-4 years?

A thesis is part of your “profile”, a “business card”

A thesis will teach you a lot, what do you want to learn?

What about your employer?

Interested in your thesis?

Can academic work marry the goals of your organization?

What do you really consider “fun”?

Are you intrinsically motivated to do so?

Identification of the central problem

First, you need to understand that a research topic is not just a topic. It must have some academic interest, for example: explain a phenomenon, identify processes, provide scientific arguments for an experience, demonstrate the cognitive ergonomics of some software, demonstrate pedagogical effectiveness, invent new design rules, …

The “big question”

The big central question doesn’t have to match the title of your project (which can only announce a vaguely stated research topic). It’s a summary of your research question may also involve practical goals,



Wrong: “E-learning” in professional teacher training

Good (a): Efficiency of e-learning in …

Good (b): Perception of e-learning ….

Perhaps: Analysis of the practice of e-learning in …

Research objectives and questions

Although he has managed to ask a good “big question,” his intentions are still too vague. You will have to break down your big question and make it more operational, that is, make a minimum of research objectives.

It is absolutely necessary for you to make all your objectives explicit, otherwise you will be looking for conflicts and other problems.

It is mandatory that you ask research questions that cover your objectives.

You can write them as “working hypotheses” if you see fit.

The research question can be detailed in terms of scientific hypothesis and based on a theoretical argumentation.

It is much easier to deal with hypotheses than with more open-ended research questions….

Finding the right research questions/hypotheses is an iterative process.

Usually, you only get it right after you have drafted the literature review.

So, don’t start field research, development, etc., before you’ve done some theory.

Let’s now look at two examples.

Example: Pilot study on ICT implementation and perceptions

Main objective: “To understand the factors that favor the use of ICT by teachers”

The author first defines 8 factors and then postulates also some relationships between them. All 8 factors were found through a review of the literature.

Knowing that a small proportion of teachers use computer equipment in their practice, I wondered if it was possible to identify the factors that promote the integration of ICT.

The main hypothesis postulated a correlation between the following factors and the application of ICT by teachers:

The type of support offered by the institutional framework

Your pedagogical skills

Your technical skills

The training received, whether basic or continuing

Sense of self-efficacy

Perception of technology

Perception of the pedagogical use of ICT

Rationalization and educational digitization

Example: Engineering project: a research-based learning support system (IBL)

The objective of this module is to give a basic structure that can be adapted to teachers who wish to offer a research learning activity to their students. They can easily create computer materials for these learning activities.

The objectives of this research have been implicitly defined by deriving the software module specification from a known research framework:

The teacher can then create a type of worksheet that corresponds to the activity he has in mind, This sheet provides a structure that will allow students to answer questions.

Step 1: Questioning

The teacher sends the activity to the students, who can create an instance of the model sheet to perform the exercise. they then look for information that can help them fill out the various elements of the form

Step 2: Ask questions

Once the information is found, the student fills out his instance of the form

Step 3: Create

Then, by viewing the instances of other students and the ability to comment on them, you can discuss them with the different people who have made the same tab as him.

Step 4: Discuss

Finally, it presents its card instance to the teacher and/or the expert associated with the activity.

Step 5: Reflect

It can be included in the activity in different ways.

This master’s thesis clearly lacked precise research questions

The big questions were: how should we design an IBL support system (and can I do it?)

The operational questions they push were a specification based on a popular IBL model but it was accepted that this development would lay the groundwork for future research, as this tool did not exist before. Only preliminary usability tests were required by the thesis director.

Anticipation of the research plan

As we have said before, at some point you will have to start working on a research plan. Here’s an idea of what’s coming into the research plan.

Readings and ideas

Who/what can help you find a good topic

Examples (other theses in the same field)

Academic articles

Academic websites like this one 🙂

Interviews with academic experts

Interviews with industry experts

Your librarian, your library, online magazines

Internet, in particular: (not!)


Your research topic will be vague at first

Be sure to talk to others besides your advisor.

Engage in a discussion with a written list of precise questions and make sure all questions have been covered at the end of the meeting.

Don’t mail in, make an appointment (unless the teacher tells you otherwise).

Don’t just think, start producing at some point…

Initial reading

Start with 2-3 standard articles/works that contain a study of your topic or related area.

Ask the experts, use the library, use, use the online magazines

If you don’t find anything:

Look for articles that address topics with similar structural properties (e.g., focus, “how you look at things,” and so on).

Start occupying “islands” (and expand with “circles”)

Find more publications

Follow up on your 2-3 initial articles

Go through specialized indexes

Systematically browse specialized journals

Check the websites of the best-known researchers in your field

Do not rely on randomly found things (e.g. indirect citations) on the Internet

Search the home pages (many researchers publish at least some articles on their site) and so on

Don’t read too much! Stop when

The same information comes back,

You’ve found a good central framework, the analysis grids for your concepts, the experimental designs that give you a good example, etc. (the details depend on your approach),

You can relate your research questions to published papers.

Exploitation of literature and writing of the theoretical part of a Research Subject

Don’t write “summary memos”, it takes too long (IMHO)

Here’s a tip:

Step 1

Read the texts “diagonally”, and limit yourself to marking the most relevant concepts, theories, models, hypotheses, etc.

Step 2

Make a matrix with the most important concepts and you can add some small comments

Step 3

Classify concepts

Mark the most important ones

Look at relationships

Discard the ones you don’t need (the theoretical part should support the empirical part, nothing more)

Step 4

Write a draft

Be synthetic and critical

Do not align one mini-summary after another (i.e. sort by concepts and not by authors!)

End with a conclusion that argues for a central framework, identifying the main dimensions (elements) and corresponding analysis grids

Re-examine your research questions (review them or add/remove things from your draft)

Generating ideas

There are several techniques for generating ideas and you can apply several of them.


Brainstorming takes place in several stages:

Quickly write the keywords (what you want to research, know, etc.) on a piece of paper

Take this list and make it again for each point

Sort/clean and move on to the next steps (see below)

It is important that the brainstorming is done quickly, since what you want is to trigger associations in the brain (and not a reflection), otherwise, it is not a brainstorming…

Organize your ideas

Make drawings, containing the main elements and relationships

As a first step, you can divide a concept or topic of study into its components. To do this, you can use a mind mapping program, but don’t overdo it, as mind maps can generate too much complexity. All you can get is a “go, look how complicated”. Doing research means you have to answer precise questions and simply “map things.”

You could then use concept maps to plot the relationships between important concepts. Another possibility is to use a wiki (be sure to think about tagging categories and creating links). A wiki should not be a simple collection of random entries, but an organized set. If not, you’d better use some blogging software.

The schema

Schematics are useful for carrying out your research plan and for planning difficult chapters such as the theory part.

A scheme will support you for:

Organize your ideas,

Develop a detailed plan of the work to be done (for example, work packages)

Sort your ideas linearly (your thesis will be linear, not a hypertext or a filled concept map).

Trust your brain’s creativity

Have something to write about (always)! Or, as soon as you turn on the computer, write it down.

Good ideas sometimes come out of nowhere at strange times (this is documented in the autobiographies of some really prominent scientists). So make sure you don’t forget the good inspirations.

List of checkpoints and things to do about a Human Research Subject


Talk to experts in the field, to academic experts (in particular to potential advisors)

Political viability

Make sure that you find human subjects willing to participate, that organizations will cooperate (for example, they will give you access to documents), etc.

In some institutions you will have to submit your research plan to an ethics committee.

Theoretical feasibility

Do you have a sufficient overview of existing relevant research?

For example, can you point to theoretical frameworks, analysis schemes, and propositions (hypotheses)?

Methodological feasibility

Have you made a list of the concepts found in your research questions?

Do you have initial definitions for them?

Or do you think you can measure every empirical concept?

Maybe you have an idea of how to analyze relationships (to answer your research questions)

If these suggestions don’t make sense to you, go (again) to the Methodology – Principles of Empirical Research tutorial

Budgetary feasibility

Time is your enemy

Keep your topic as small as possible (but make sure you address an academic issue..)

The general orientation of the research

That is, think about the type of research you plan to do and, in particular, the general approach you would like to use:

Think carefully about the concepts you use

Make sure your list of research questions is complete, that is, it covers everything you plan to do.

Next, identify all the main concepts used in your research questions and start thinking a little about how you will collect the related data.

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You may also be interested in: 7 Data Collection Methods and Tools for Research

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