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JUDSON UNIVERSITY INSTITUTIONAL REVIEW BOARD

RISK ASSESSMENT FOR RESEARCH INVOLVING HUMAN SUBJECTS

This protocol must be approved by the Judson University Institutional Review Board before data are collected. Please refer to the Judson University IRB Procedures and Policies manual available at www.judsonu.edu/irb.

__________________________________________________________________________________________

Name Date

__________________________________________________________________________________________

Program or Department Supervising Professor

__________________________________________________________________________________________

Title of Proposed Research (from IRB application)

Read the following Risk Level Assessment Form (next page) and mark all items in each risk category that apply to your research. Record the totals from each category below:

No risk: __________ Minimum risk: ___________

Moderate risk: __________ High risk: ___________

Be sure your IRB Application thoroughly describes the following:

If your research involves vulnerable populations, include the following in the IRB application.

1. If your subjects are MINORS: Describe how you will obtain each child’s verbal or written assent as well as written consent from the child’s legal guardian. Note: At ANY level of risk, informed consent must be obtained from both the parent or guardian AND the minor before data is collected. If consent is given by the minor, but not by the parent or guardian, data should not be collected. Describe the means to be taken to reduce risks and to safeguard the subjects. Describe why alternative, less risky methods of research would not be possible.

2. If your subjects are VULNERABLE TO “UNDUE INFLUENCE”: For example, anyone over whom you have authority or anyone in your care is vulnerable to your influence (students, clients, parishioners, employees, etc.). Describe how the subject’s right to decline participation without negative consequences will be preserved. Describe the means to be taken to reduce risks and to safeguard the subjects. Describe why alternative, less risky methods of research would not be possible.

3. Other “VULNERABLE POPULATIONS”: For example, those who are institutionalized or are unable to make their own decisions are vulnerable. Describe the vulnerability of the subjects and how the risk caused will be minimized. Describe actions to be taken to reduce risks and safeguard the subjects. Describe why alternative, less risky methods of research would not be possible.

If the Principal Investigator is a student:

Signature of supervising professor ________________________________________

Date ____________________________

RISK LEVEL ASSESSMENT FORM

This checklist is provided to help researchers, reviewers, and the IRB to consider thoroughly the research proposal in light of the potential risk to human subjects and does not in itself determine the decision or recommendations of the IRB. It is not the intent of the IRB to use this risk level assessment tool to comment on the merits, quality, or design of the research beyond the potential risks to human subjects.

Based on your research purpose, population, and methods, check all items in each category that apply to your research, and indicate the totals on p. 1. It is not uncommon for items to be checked in multiple categories, and it may take only one risk factor to place the entire research project in a particular category. You may be able to justify the value of a research project being at a particular risk level, or you might describe procedures that reduce the potential impact of an acknowledged risk factor in your IRB application.

NO RISK LEVEL CRITERIA:

____ People will be observed randomly in a public place where there is no personal identification of subjects.

____ Subjects are not aware of the observation and do not have direct contact with the researcher.

____ Only public information will be utilized, such as phonebooks, directories, or other widely published lists.

____ Data are collected without any identifying information. There is no possible or imaginable way to trace responses back to subjects.

____ Data will be used collectively in a statistical manner, and no one individual’s response can or will be tracked.

____ TOTAL for NO RISK

MINIMAL RISK LEVEL CRITERIA:

____ Subjects are interviewed or otherwise contacted to solicit participation.

____ Inquiries are made regarding to basic identifying information such as age, gender, ethnicity, etc.

____ Subjects are asked to answer general questions regarding non-personal information.

____ Subjects are asked to give opinions or attitudes toward commonplace matters such as general trends or other benign topics.

____ The research will not in any way influence or affect the subject socially, psychologically, or spiritually.

____ The collection of required information will not take more than 4-5 minutes of the subject’s time.

_____ TOTAL for MINIMAL RISK

MODERATE RISK LEVEL CRITERIA:

____ The subject is asked to reveal personal information regarding individual opinions, background, behaviors, attitudes, or beliefs.

____ Subjects will be selected to participate based upon a particularly unique characteristic or group membership (similar position, training, background)

____ Subjects will be selected to participate based on an extraordinary life experience.

____ Topics or questions raised are politically, emotionally, culturally, spiritually, or psychologically sensitive.

____ Individual or group presentations, phone calls, or questionnaires will be used to solicit participation in the research.

____ The research objective is not revealed at the outset to the subject in a direct and straightforward manner, such as research that requires that the subject be naïve regarding the research in order to participate objectively.

____ Subjects are required to reflect on their own behavior, values, relationships, or self in such a way that one might be influenced or affected, and/or anxiety or concern might be raised about the subject matter of the research.

____ The subject may have regrets, concerns, afterthoughts, or reactions to the research method after data collection is completed.

____ The subject may become tired, weakened, or be mentally or physically affected as a result of the research method.

____ The research may inconvenience subjects by causing a delay or intrusion into their routine or schedule.

____ Involvement in the research will require more than 5 but less than 60 minutes of the subject’s time (outside of normal learning activities if the study is conducted in a classroom.)

____ TOTAL for MODERATE RISK

HIGH RISK LEVEL CRITERIA:

____ Subjects are asked or led to reveal highly personal information in areas such as close relationships, trauma, sexuality, or potentially immoral, unethical, or illegal acts.

____ The topic or research methodology will raise issues that are highly charged politically, emotionally, culturally, psychologically, socially, or spiritually.

____ The research will involve minors who do not have the authority and/or ability to give fully informed consent to participate.

____ The research will intentionally, or by design, involve persons who may be of legal age yet who are dependent on others due to a chronic or crisis health concern, developmental delays, advanced age, a language barrier, and/or incarceration, which may impair the subject’s ability to give fully informed consent.

____ Subjects will be selected to participate based upon a particular diagnosis, disorder, or physical or mental health concern.

____ The subject is likely to be affected emotionally, socially, or psychologically through the research over the short and/or long term, to the extent that debriefing or other reparative interventions are built into the research design (not solely for preventative purposes).

____ The research design calls for deception of the subject at any level.

____ The research involves physical manipulation, contact or touching either with the researcher or between subjects, physical exercise, and/or any medical procedure.

____ The research itself or the information obtained from the subjects may have immediate and/or long term political, legal, economic, and/or social consequences for the subjects.

____ Involvement in the research will require more than 60 minutes of the subject’s time (outside of normal learning activities if the study is conducted in a classroom.) or significantly influence the person’s routine and/or activities.

____ TOTAL for HIGH RISK

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Informed Consent Form

I am conducting a study about (insert general statement about the study). I invite you to participate in this research. You were selected as a participant because (explain how subject identified). Please read this form and ask any questions you may have before consenting to be in the study.

This study is being conducted by: (Indicate name of researcher, name of advisor, if applicable, Department affiliation).

Background Information:

The purpose of this study is (Explain research purpose in clear, lay language. You may also wish to explain the benefits of this research to people other than the subject)

Procedures:

If you participate in this study, I will ask you to do the following things. (Explain all tasks and procedures; subjects should be told about assignment to study groups, length of time for participation, frequency of procedures, etc.). You may ask questions of the researcher at any point in the study.

Risks and Benefits of Being in the Study:

The study has several risks. First ( ), Second ( ), (Risk must be explained, including the likelihood of the risk and provisions made to reduce the risk.

There is no to minimal risk of emotional discomfort if you choose to participate in this study and be recorded. If needed for support, resources can be reached at XXX-XXX-XXXX and website.

There are no immediate benefits to you for participating in this study.

The direct benefits of your participation are: (If no benefit, state that here. Explain only direct benefits to the subject or students).

Confidentiality:

In any publications of the results, pseudonyms will be used in place of names of participants or locations. The records of this study will be kept private. In any sort of report I publish, I will not include information that will make it possible to identify you in any way. Research records will be kept secured; my Judson University research advisor and I are the only people who will have access to the records. (If video or audio recordings are made, explain who will have access, if they will be used for educational purposes, and when they will be erased. Include how any other research records such as paper copies or photographs will be secured and stored for five years).

· Video Recordings

Classroom observations may be video recorded for data analysis, and portions of recordings may be presented in a professional context. Although real names will not be used in presentations of the research, and responses will be treated with confidentiality to anyone outside of the project research staff, participants might be identifiable to people who recognize them in video recorded artifacts. Recordings will be kept until completion of degree and destroyed immediately thereafter. Please sign below if you are willing to have your image recorded. You may still participate in this study if you are not willing to have your image recorded. If you are not willing to be video recorded, the camera will be situated in the classroom at an angle that will avoid capturing your image. Any unintentional video recording(s) of you will be edited to blur their image, causing them to be unrecognizable to viewers.

_______________________________ ______________

Signature Date

· Audio Recordings

Interviews may be audio recorded for data analysis, and portions of recordings may be presented in a professional context. Although real names will not be used in presentations of the research, and responses will be treated with confidentiality to anyone outside of the project research staff, participants might be identifiable to people who recognize them in audio recorded artifacts. Recordings will be kept until completion of degree and destroyed immediately thereafter. Please sign below if you are willing to have the interview(s) audio recorded. You may still participate in this study if you are not willing to have the interview(s) audio recorded.

_______________________________ ______________

Signature Date

Voluntary Nature of the Study:

Your participation in this study is entirely voluntary. Your decision whether or not to participate will not affect your current or future relations with your employer or Judson University. If you decide to participate, you are free to withdraw from the study at any time without penalty. Should you decide to withdraw from the study, data collected about you, or your students will only be used up to the point of your withdrawal.

Contacts and Questions

My name is (Insert researcher name here). You may ask any questions you have now and at any point through the research process. If you have questions, you may contact me at (Insert email address. If researcher is a student, include Judson University advisor’s name, email, and telephone number here.)

You will be given a copy of this form to keep for your records.

Statement of Consent:

I have read the above information. My questions have been answered to my satisfaction. I give consent to participate in the study.

___________________________ ________________

Printed Name of Participant Date

___________________________ ________________ Signature of Study Participant Date

___________________________ ________________ Signature of Researcher Date

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Principal Investigator:

Study:

APPLICATION FOR APPROVAL OF RESEARCH

Institutional Review Board

Principal Investigator

1. Principal Investigator:

a. Full name:
b. University department, program, and position:
c. Email address:
d. Phone number:

b. Co-Principal Investigator (if applicable):

a. Full name:
b. University department, program, and position:
c. Email address:
d. Phone number:

c. Person completing this application (if not PI):

a. Full name:
b. Email address:
c. Phone number:

d. If the PI is a student, the supervising professor or academic advisor:

a. Full name:
b. Email address:
c. Phone number:

e. Has this study been approved by a committee?

f.

Yes

No

5. Submission Category (please check one):

Exempt – no human subjects involved

Expedite – minimal risk to human subjects

Full Review – moderate to high risk to human subjects

6. Publication Audience:

Internal – research intended for teaching purposes only within courses at Judson University.

Public – research may be published outside of Judson University.

Research Study Identification and Overview

1. Title of study:

2. Full description of the research, its objectives, methods, and what subjects will be asked to do.

3. Dates for conducting study:

4. Site(s) of study:

5. Description of the population/subjects participating in the research study, recruitment of the subjects, and the criteria for inclusion as a participant of the study.

6. Identification of special subjects/ populations, if any, such as children and minors, pregnant women, cognitively-impaired persons, prisoners, traumatized and comatose patients, terminally ill persons, elderly, minorities.

7. Full description of provisions to care for subjects where there is risk of physical or emotional research-related harm.

8. Description of confidentiality provisions and measures to protect the identity and privacy of subjects.

9. Description of obtaining consent from subjects and, if the subjects are minors, obtaining consent from the child’s legal guardian.

10. Risk Assessment scores (taken from the Risk Assessment form).

No Risk: Minimum Risk: Moderate Risk: High Risk:

As principal investigator, I assure that the information provided is correct, that I will seek Judson University IRB approval for any substantive modifications in the research study, and that I will report to the IRB Chair promptly any incidents or anticipated problems that may occur during the course of the study that may affect subjects adversely or change the risks and benefits described.

Signature of principal investigator __________________________

Date of signature _____________________________

If the PI is a student:

Signature of supervising professor ________________________________

Date of signature _______________________________

Email the following documents to [email protected]

· This application saved as 1 Lastname IRB application

· Study proposal (if applicable) saved as 2 Lastname Proposal

· Completion certificate of ethics training saved as 3 Lastname Certificate

· Risk Assessment form saved as 4 Lastname Risk Assessment

· Instruments used in the study saved as 5 Lastname Instrument Name (repeat for additional instruments)

· Consent forms sent as WORD DOCUMENTS and saved as 6 Lastname Parent Consent, 6 Lastname Student Consent, 6 Lastname School Consent, as necessary

This study has been approved by Judson University’s Institutional Review Board.

Signature of IRB Chair ___________________________________

Date of signature ______________________________

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