Signed risk assessment form_Sameer.docx

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 .

____Sameerkumar Prajapati_______________________________________02/21/2022____________________

NameDate

_DOCTORATE IN COMPUTER SCIENCE___________________Dr. Olabisi Adenekan_____________________

Program or DepartmentSupervising Professor

Data Security in Cloud Services

________________________________________________________________________________________

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: __3_______Minimum risk:_1_________

Moderate risk:__0________High risk:_____o______

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 __February 22, 2022________

RISK LEVEL ASSESSMENT FORM

This checklist is provided to help researchers, reviewers, and the IRB to thoroughly consider 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:

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

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

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

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

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

_ _2__ TOTAL for NO RISK

MINIMAL RISK LEVEL CRITERIA:

__No_ Subjects are interviewed or otherwise contacted to solicit participation.

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

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

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

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

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

__ _1__ TOTAL for MINIMAL RISK

MODERATE RISK LEVEL CRITERIA:

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

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

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

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

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

___no_ 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.

_No___ 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.

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

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

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

_No___ 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.)

___ 0_ TOTAL for MODERATE RISK

HIGH RISK LEVEL CRITERIA:

__No__ 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.

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

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

___No_ 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.

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

___No_ 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).

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

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

__No__ 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.

__No__ 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.

___0_ TOTAL for HIGH RISK