Human Subjects Committee

hsc

Overview

The faculty, staff, and students of SUNY Oswego are obligated to comply with Federal Department of Health and Human Services regulations for the protection of human participants in research. Any member of the campus community participating in a research project --including but not limited to surveys, interviews, laboratory experiments, and field studies -- is entitled to be free from possible injury and/or psychological harm and to maintain his/her personal privacy. The committee was formed to ensure that these guidelines are followed, therefore protecting human research participants used by researchers on our campus, which can include subjects off-campus and those not our students, such as K-12 students.

Membership for 2012-2013:

Research Defined

In order to conduct ANY research using humans as participants at SUNY Oswego, you must first obtain approval from Oswego's Institutional Review Board, the 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 proposal will be reviewed only in regard to the ethical nature of the research; 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.

All SUNY Oswego institutional studies and program assessment projects conducted by and or  involving students, faculty and staff of SUNY Oswego need to be reviewed by HSC. To expedite the process, the proposals should be sent Dr. Mehran Nojan mehran.nojan@oswego.edu, director of the Office of Institutional Research and Assessment.

How is this review accomplished? First, each researcher must have completed mandatory training in protection of human subjects in research. Then the researcher submits an online form which describes the research protocol and to which is attached the following documents:

  • Proof of Completion of Mandatory Training
  • Informed Consent Form
  • Debriefing Document
Supplemental material should also be attached (copies of surveys, questionnaires, etc.), as is appropriate.

Mandatory Training

To comply with a federal requirement to provide training and education in the protection of human participants in research, SUNY Oswego requires mandatory and continuing education for all investigators and research personnel involved with human participants. To be certified, research personnel must complete NIH (National Institutes of Health) Training, Sections 1 - 6 and save and print your certificate. This free training course should take approximately two hours to complete. NIH Certification is good for 2 years.

Register for the course or sign in

The Human Subjects Committee is reviewing other training opportunities and if appropriate they will be added as approved alternatives to the NIH program. For students and faculty who have come to Oswego having completed a different training program while at another institution, that certification may be an acceptable substitute. A copy of the appropriate certification must be included in any submission.

Preparing a Submission

 

(External Investigators should read the following document before preparing a proposal: External Investigator Policy)

 

  • Proof of Completion of Mandatory Training You must include a copy of the NIH Certificate indicating that you have successfully completed this training course within the past two years.
  • Transmittal form On this form, 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. Information regarding documents, consent forms, etc., may be attached. Please carefully report official Oswego email addresses, as these will be used in sending the completed form to the research (and supervisor, if appropriate).
  • Research Protocol The protocol must contain the following and can be submitted in paragraph form, or addressed point-by-point:
    1. A brief description of the research. Please present an overview of what your research entails (a statement of your design would be appropriate. There is a limit of 700 characters, about 125 words.
    2. A description of the potential benefits to the participants and to "science." 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. Again, there is a limit of 700 characters, about 125 words.
    3. A description of who the participants are. 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., age, grade levels K-12, , elderly, etc.) and how they will be recruited to participate. 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. There is a limit of 800 characters, about 150 words.
    4. A description of how the participants will be used. What we are looking for here is a statement of what the participant will be doing. Write what manipulations the subject will be exposed to, and what the subject will be asked to do. If you are using a questionnaire or personality test, please attach a copy. 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. The description is limited to 500 characters, about 90 words. You should attach questionnaires, surveys, etc.
    5. A description of any potential risks to the participant, and how these risks will be minimized. Most 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. You should mention any conceivable physical risk. 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". There is a limit of 400 characters, about 75 words.
    6. Finally, does the proposed research involve deception? If so, explain why it is necessary and how the subject will be debriefed in order to minimize the risk to the subject due to the deception. There is a limit of 500 characters, about 90 words.
  • The informed 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 (see http://www.hhs.gov/ohrp/policy/consentckls.html):
    1. A statement that the study involves research and the names of the experimenters
    2. the nature, purpose, and expected duration of the research
    3. a statement that the research has been approved by the Human Subjects Committee
    4. a brief synopsis of the procedure to be followed
    5. any possible hazards, risks, or discomforts to the subject
    6. any benefits that may occur (for the participant or "science")
    7. a statement of confidentiality of any records identifying the subject
    8. a statement that the participant may withdraw from the study at any time without penalty
    9. an offer to answer questions about the research, including phone numbers
    10. consent statement and blank lines for the participant's and the experimenter's signatures

    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. We have provided an example of an Informed Consent document.

    You may have noticed many of these points are the same as in your protocol. The risks and benefits, the method, and the nature of the study, 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 (#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.

    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

  • Debriefing. Finally, you should also provide subjects with a Debriefing document.

Online Forms

(External Investigators should read the following document before preparing a proposal: External Investigator Policy)

RESEARCHERS

As of the Fall, 2010 semester, all submissions for review by the Human Subjects Committee must us the online submittal form:

Online Human Subjects Transmittal Form

The completed form is then sent to the HSC co-chairs, an HSC reviewer, and to the researcher who submits the form.

STUDENTS

Students should first work with their faculty sponsor in learning how to use the transmittal form by using this practice version:

PRACTICE Online Human Subjects Transmittal Form

Submit the PRACTICE transmittal form and include your faculty sponsor's name.  When a student researcher completes this form and clicks on the submit button, a copy is sent electronically only to the student and their faculty sponsor. The faculty sponsor can then review the submission and help the student refine what they submit and ensure all necessary attachments are provided. At that point the student researcher can use the "real" transmittal form, above.


FAQ's

Frequently Asked Questions, and more

The Human Subjects Committee is collecting questions to populate this website, and this page will be updated regularly.

  • The HSC is presenting long (30+ minute) and short (15 minute) presentations at department meetings and other forums. Here we provide the two Powerpoint presentations, along with the .pdf versions of the presentations as handouts.