GUIDE FOR USING HUMANS AS RESEARCH PARTICIPANTS AT OSWEGO STATE UNIVERSITY

Stephen A. Wurst, Ph.D.

Psychology Department, Oswego State University

In order to conduct research using humans as participants in research at Oswego State University, you must first obtain approval from the Campus Human Subjects Committee (HSC). A member of this committee reviews the proposed research to determine if the research follows the ethical standards set by the Code of Federal Regulations (45 CFR 46). The committee member will review the proposal only in  regard to the ethical nature of the proposal; we do not review the proposal critically for content unless it impacts on the ethical issue (e.g., we may suggest a correlation strategy if we believe the experimental manipulation is questionable ethically). You must obtain approval before you recruit or run any participants.

How is this review accomplished? The researcher needs to submit three major documents to Kristen Link if you are in the Psychology Department and Barry Friedman if you are in any other department:

THE TRANSMITTAL FORM
The transmittal form is a cover sheet that you can obtain from your department chair or a member of the HSC. You can now also download and print a copy of the transmittal form from this website. On this sheet, fill in the researchers' names and the title of the research, and check "yes" or "no" for the questions about your participant population and intended procedures. The information for the protocol is supplied at the bottom of the transmittal form. Also, for student research, obtain the signature of the faculty sponsor.

THE PROTOCOL
The protocol must contain: (a) a brief description of the research; (b) a description of the potential benefits to the participant, and to "science"; (c) a description of how the participants will be used; (d) a description of who the participants are; and (e) a description of any potential risks to the participant. This information can be submitted in paragraph form, or addressed point-by-point.

For part (a), present an overview of what your research entails (a statement of your design would be appropriate). 

For part (b), if you are using undergraduate students in your department, you can mention how participating in the research will help them understand research better. Also mention how your results will improve our knowledge of your research area.

Part (c) can overlap with part (a). What we are looking for here is a statement of what the participant will be doing. Write what manipulations the participant will be exposed to, and what the participant will be asked to do. If you are using a questionnaire or personality test, please attach a copy. (For example, writing that you are using a questionnaire about "suicide" or "sexual behavior" won't help us review research on these sensitive topics if we don't read what is included in the questionnaire).

For part (d), briefly describe your participants. For many projects, introductory psychology students, or students from other classes, are used as participants. If you are using any other populations, specify who they are (e.g., minors, elderly, etc.) and how they will be recruited to participate. (Also see note below about other populations).

For part (e), list any potential risk to the participant and how this risk will be minimized. Most proposed research projects don't pose any risk to the participant. Other projects may seem innocuous, but have potential risks. For example, if you wanted to manipulate "self-esteem:, "frustration level", or "mood", you need to address how the participant will be "un-frustrated", etc. Any conceivable physical risk should  also be mentioned. For example, if you instruct your participants to do a task at a computer screen for two hours, the possibility exists that eye strain and a headache might result. However, this risk certainly would not occur if the participant did the task for five minutes. Try to use your judgment as to what is "conceivable" and what is "highly improbable".

REMINDER: Sign the transmittal form, and have your faculty sponsor sign the form. Also, make sure that you print the title of the research, and all authors (and faculty sponsor when appropriate) in the space provided at the top of the transmittal form.

THE CONSENT FORM
The last major document is a copy of the informed consent form that you give each participant immediately before the research begins. The "consent" form is signed by the participant to allow you to run the participant in your research; "informed" means you must provide enough information about the research so that the participant can make this decision. The consent form must contain the following information (Grunder, 1986):

These points should be written in a readable form. Remember, many of your participants have not been in research studies before, and may be apprehensive. Try to express this information concisely, but without the jargon of your field. These points should all be included, but you don't need to state each one in order. A sample consent form is given below. The numbers written on the sample consent form correspond to the numbered contents above.

You may have noticed many of these points are the same as in your protocol. The risks and benefits (#5 and #6), the method (#4), and the nature of the study (#2), can all be reworked from your protocol.

Additional clarification may be needed for some other points. Note in (#2), the expected duration is required. It is important to let the potential participant know how long he/she can expect to run. Someone may consent to a 30-minute experiment, but not a 2-hour experiment. For (#3), briefly state if group means will be used to report the results, etc. For (#9), include your phone number in case the participant has any later questions about the experiment. Also include the HSC chairperson's name and phone number, but explicitly state that this number is for questions concerning the participant's rights as a research participant.

The nature and purpose of the research can also be a tricky issue if you are using a cover story or deception. Try to state your purpose broadly, without telling the participant exactly what your true purpose is. If the deception is not risky, the proposal may receive approval. A debriefing/dehoaxing statement will be especially important in these situations. Refer to the document concerning debriefing participants. (Debriefing statements will be required for other research as well).

You must give the consent form to participants as they come to the room to participate in your research. After verbally explaining the consent form to the participants, and giving the participant ample time to read it, the participant then decides to consent or not. You should have the participant sign TWO copies: one is for the participant to keep; the other is for your files. Label on the PARTICIPANT COPY, and the other the EXPERIMENTER COPY. The experimenter should also sign both forms. (Ideally, a third-party witness should sign, but this is not feasible in most cases and is not necessary). In an effort to save paper, you may be able to put both copies of the consent form on a single 8.5" X 14: sheet, and simply cut the paper in half so both the participant and the experimenter has a complete copy of the consent form.

Also, if your department has a policy of allowing extra credit to students who participate as participants in research, check with your department to see what procedures are used to record extra credit. For example, in the Psychology Department, experimenters fill out credit slips and give these slips to the participants. It is then the participants' responsibility to turn the credit slip to her/his professor to receive the extra credit.

SPECIAL CASES: Some populations are designated as special populations of participants and require additional precautions. One of these populations is children/minors. For example, when using children/minors as participants, you must obtain the signed informed consent from the child's parent or guardian, and obtain the child's verbal assent. Other "special" populations are: prisoners; pregnant women; cognitively impaired persons; elderly persons; and terminally ill or comatose patients. Talk with your faculty supervisor or the HSC chair to find out what additional measures must be taken with these populations.

SUBMITTING YOUR MATERIALS
Submit a PHOTOCOPY of the above documents to the chair of the Human Subjects Committee. These documents are kept on file and WILL NOT BE RETURNED. Four actions are possible at this point:

If accepted without revision, you will receive an "Expedited Review Form" (ERF) and an "Acceptance of Review Form" (ARF). You keep the ERF for your records; complete the ARF and return to the HSC chair. 

If the proposal is tentatively approved with revisions, make the appropriate revisions in your documents and resubmit. You will then receive the ERF and ARF.

A full committee review is time-consuming and probably would not be suitable for a semester course project. (If it is a project you are interested in doing, but deals with sensitive issues or "special" populations, a student could be encouraged to do the project as an independent study that could span two or more semesters).

ANY QUESTIONS?

We hope that this guide answers most of your questions about the HSC's procedures. If you have any other questions, please contact a member of the Human Subject Committee.

EXAMPLE OF AN INFORMED CONSENT FORM

INFORMED CONSENT

The experiment in which you are about to participate investigates the presentation of words or letters at a given rate, and your ability to distinguish these words or letters. The experiment is being conducted by Hugh D’Experimenteur and Milo Budjette, psychology students under the supervision of Dr. Profsname, Assistant Professor of Psychology, and has been approved by the Faculty Research Committee on Human Subjects of Oswego State University.

The experiment is run on a screen, where you will be asked to look at a sequence of words or letters, and make a simple verbal response of what you saw. For example, if you were presented with a sentence one word at a time, you would be asked to repeat the sentence just as you saw it. Or, you may be asked to report the color that the word was presented in. There are no hazards or risks involved, with the exception of possible eye strain or headache.

The experiment will last about 15 minutes.

Each person’s data in this study will be confidential. Your name will not be reported, and the data that will be reported will be the average time for all participants in each condition. At the end of the study, a full explanation of the experiment will be given to you.

By participating in this study, you will increase your understanding of psychological research, and the results will help increase understanding of how we learn information.

Your participation is voluntary, and you are free to discontinue participation at any time without penalty.

If you have any questions about the experiment, please contact Hugh D’Esperimenteur at 555-5555, or Dr. Profsname at 555-7763. If you have any questions about your rights as a research participant, please contact Dr. Friedman, co-chair of the Human Subjects Committee (312-6381) or Dr. Link, co-chair, Human Subjects Committee (312-3465).

I have read the above statement about the purpose and nature of the study, and I freely consent to participate.

Participant’s Signature              Date           Experimenter’s Signature                      Date

Print Participants Name                              Print Experimenter’s Name

The experimenter should give a copy to the subject and keep a signed copy.