Medical Professional, Educator and School Administrator User Manual

Congratulations and thank you for your support of the Pittsburgh Regional Science and Engineering Fair and the students participating in the fair!

You have been identified as a member of the local institutional review board (IRB) for your school for the purposes of reviewing Pittsburgh Regional Science and Engineering Fair projects involving human participants.

Logging In and Accessing Forms

In order to sign the required form for the student(s), you will need to log in to your account at https://www.STEMisphere.org/PRSEF.

An account was created for you when the student or their adult sponsor added your name to the student’s profile. You should have received an email from CSC STEMisphereInfo at STEMisphereInfo@CarnegieScienceCenter.Org with information about how to log in. Please check your junk mail folder if you do not see this email.

Use the link in the email to set your password and log in. If you cannot find the email, navigate to https://www.STEMisphere.org/PRSEF and use the Forgot your Password link to generate a new email.

Once you have logged in, you should see a list of students and their project titles. For each student, you should also see a list of required forms. Form 4 should be included in this list. Click on the box with the number 4 in it to open and sign Form 4.

If you are filling more than one role for this student or for other science fair students, you may need to switch between profiles to access Form 4. Use the horizontal menu bar just below the black and white speckled area to move between profiles. Click on “Registration / Forms” and then on “Manage Role Name” Forms.

Form Status

The form will remain in Pending Completion status (yellow background) until all three of the signatures have been added successfully. Once all three signatures have been added, the form will be promoted to Ready for Review status (purple). The form will remain in Pending Completion status on the profile of the student and adult sponsor until the signatures of all three members of the local IRB have been provided.

Human Participant Studies

ISEF rules state that projects which involve any of the following require the review and approval of a local IRB.

1) The study includes the student researcher or others participating in physical activities (e.g., physical exertion, ingestion of any substance, any medical procedure).

2) The study includes psychological, educational and opinion studies in the form of surveys, questionnaires, tests.

3) The study includes the student researcher as the subject of the research.

4) The study includes testing of a student designed invention, prototype or computer application by human participants other than student researcher. If the student researcher is the only person testing the invention and the invention does not pose a health or safety hazard, respond No to this question.

5) The study includes a data/record review that with data that is not deidentified/anonymous (e.g., data set that includes name, birth date, phone number or other identifying variables).

6) The study includes behavioral observations that involve any interaction with the observed individual(s) or where the researcher has modified the environment (e.g., post a sign, place an object).

7) The study includes behavioral observations that occur in non-public or restricted access settings (e.g., day care setting, doctor’s office).

8) The study includes behavioral observations that involve the recording of personally identifiable information.

The role of the local Institutional Review Board (IRB)

The local IRB consists of a health professional (a psychologist, medical doctor, license social worker, doctor of pharmacy, or registered nurse), a school administrator (principal, vice principal, school director etc.) and an educator (a teacher who is not the adult sponsor for the project). The health professional must have appropriate training for the topic of research; for example, a psychologist would be best suited to a project which involves emotional risk while a medical doctor would be best suited to a project which involves elevated heart rate. The local IRB can be a formal group or can consist of relevant individuals who come together solely for the purposes of approving this project. The local IRB must evaluate the risk level of the project and the need for informed consent or written parental permission in addition to providing their signatures.

During this review, the members of the local IRB should review the research plan submitted by the student research to determine the level of risk to the participants and any other safety concerns. SRC/IRB approval is required before recruitment of participants or data collection. See the online Risk Assessment Guide (https://sspcdn.blob.core.windows.net/files/Documents/SEP/ISEF/Resources/Risk-Assessment-Guide.pdf) and Online Survey Consent Procedures (https://sspcdn.blob.core.windows.net/files/Documents/SEP/ISEF/Resources/Online-Survey-Consent-Procedures.pdf ) for more detailed information on risk assessment.

The Research Plan

As stated in the instructions for Form 1A (https://www.societyforscience.org/isef/forms/), in addition to the rationale, question, hypothesis, expected outcomes, procedure, method of data analysis and bibliography required for all projects, the research plan for a human participant study should include:

a. Participants: Describe age range, gender, racial/ethnic composition of participants. Identify vulnerable populations (minors, pregnant women, prisoners, mentally disabled or economically disadvantaged).

b. Recruitment: Where will you find your participants? How will they be invited to participate?

c. Methods: What will participants be asked to do? Will you use any surveys, questionnaires or tests? If yes and not your own, how did you obtain? Did it require permissions? If so, explain. What is the frequency and length of time involved for each subject?

d. Risk Assessment: What are the risks or potential discomforts (physical, psychological, time involved, social, legal, etc.) to participants? How will you minimize risks? List any benefits to society or participants.

e. Protection of Privacy: Will identifiable information (e.g., names, telephone numbers, birth dates, email addresses) be collected? Will data be confidential/anonymous? If anonymous, describe how the data will be collected. If not anonymous, what procedures are in place for safeguarding confidentiality? Where will data be stored? Who will have access to the data? What will you do with the data after the study?

f. Informed Consent Process: Describe how you will inform participants about the purpose of the study, what they will be asked to do, that their participation is voluntary and they have the right to stop at any time.

Human Informed Consent Form

The purpose of the human informed consent form is to give the human participants enough information about the project and their role in it to make an educated decision about taking part in the study.

This form is used to document written informed consent, minor assent, and/or parental permission. If the form is serving to document parental permission, a copy of any survey or questionnaire must be attached. Parental permission for all participants under the age of 18 is required.

This form is required if the study will involve human participants beyond the experimenter(s). This includes the administration of surveys and questionnaires.

The student researcher must print and have the participants sign the informed consent form before they participate in the study. When written documentation is required, the researcher keeps the original, signed form. The student should collect and retain the hard copies of the signed forms until after the date of the fair.

The local IRB should review this form to ensure that all applicable and relevant information and risks are communicated to the participants. The signatures of the local IRB are not required on this form.

Form 4 Human Participants

This form is intended to ensure the safety and well-being of all human participants in studies conducted by the student researcher(s). It is required if the study will involve people beyond the experimenter(s). This includes the administration of surveys and questionnaires. The signatures of all three members of the local IRB are required on this form before the project can be reviewed by the PRSEF Scientific Review Committee and conducted by the student.

Form 4 identifies the level of risk involved in the study, verifies the ages of the participants and documents the review and approval of the local IRB.

If you have any questions, please contact PRSEF@CarnegieScienceCenter.org.

How to Complete Form 4

The student researcher has provided most of the information needed to complete this form. Review the attached research plan and Human Informed Consent Form and your familiarity with the project to respond to the last three questions on this screen and then click on the Sign Form button to review the information provided by the student research and to add your electronic signature to the form. If the last three questions on this form have already been answered by another member of the local IRB, click on the Sign Form button to complete your approval and add your signature.

I have reviewed the Research Plan / Project Summary which addresses ALL areas indicated in the Human Participants Section of the Research Plan / Project Summary Instructions attached to Form 1A – Student Checklist – When all of the requirements below have been fully addressed in the attached research plan, check “Yes”.

The Human Participants Section of the Research Plan / Project Summary requirements on Form 1A indicate that the following be included in the research plan:

b. Recruitment: Where will you find your participants? How will they be invited to participate?

Risk level of this project – As stated in the ISEF rulebook which can be found at https://www.societyforscience.org/isef/international-rules/

“All human participant projects are considered to have some level of risk.

No more than minimal risk exists when the probability and magnitude of harm or discomfort anticipated in the research are not greater (in and of themselves) than those ordinarily encountered in everyday life or during performance of routine physical or psychological examinations or tests.

More than minimal risk exists when the possibility of physical or psychological harm or harm related to breach of confidentiality or invasion of privacy is greater than what is typically encountered in everyday life. Most of these studies require documented informed consent or minor assent with the permission of parent or guardian (as applicable).”

If you are unsure of which risk level to choose after reading the research plan, see the ISEF rulebook for specific examples of each risk level and see the online Risk Assessment Guide (https://sspcdn.blob.core.windows.net/files/Documents/SEP/ISEF/Resources/Risk-Assessment-Guide.pdf) and Online Survey Consent Procedures (https://sspcdn.blob.core.windows.net/files/Documents/SEP/ISEF/Resources/Online-Survey-Consent-Procedures.pdf ) for more detailed information on risk assessment.

Are there any human participants who are minors? – If there are any human participants under the age of 18, select “Yes” to answer this question. If the student researcher is the subject of the study, they should be considered a human participant. If the student researcher is studying other individuals, they should not be considered a human participant.

Are there are any human participants who are over the age of 18? If there are any human participants over the age of 18, select “Yes” to answer this question. Members of the student’s family should be considered human participants if they are part of the group of individuals being studied or have participated in the project in more than an advisory capacity.

Sign Form – Click on the Sign Form button to confirm your responses and add your signature to the form. Wait for the system to load the form in the gray box before continuing.

I confirm all form information is correct – Wait for the system to load the form in the gray box before continuing. Review the form which has loaded in the gray box and confirm that your responses were recorded correctly. Click in the box next to the word “Yes” to confirm your responses.

Signature – Click in the space below the word Signature and above the signature line. Use your mouse or touch pad to add your electronic signature in the box. If your signature is not legible, click on the Clear button to try again. If you are happy with your signature, click on the Accept button. You must click on the Sign button to confirm your signature.

Date of Approval: Enter the date when the idea for the project was first reviewed with the student researcher and experimentation was approved by the adult signing the form. This does not need to be today’s date. The adult signing this form must review and approve the project before the student begins experimentation.

Printed Name – Type your name into the Printed Name box below the signature. You must click on the Sign button to confirm your signature.

Experiments which were completed over the summer or for a school science fair will have experimentation dates which are before the date this form was completed. Use this field to enter the date the project was reviewed and approved by the adult signing this form, not today’s date. The Date of Approval must be before the tentative start date or actual start date listed by the student on Form 1A.

How to check your signature

Once you have completed and signed the form, click on “Return to forms manager” in red font or on “Registration / Forms” and then “Manage Role Name Forms” on the horizontal menu bar just below the black and white speckled area. Role names for members of the IRB include Medical Professional, Educator, and School Administrator.

Click on the form you would like to check then look for the red Form Status box on the right side of the screen. Click on View PDF of Form. Scroll to the bottom of the form to check your signature.