institutional review board (irb) human subject delaware state university office of sponsored...

Institutional Review Board Institutional Review Board (IRB) Human Subject(IRB) Human Subject

Delaware State University

Office of Sponsored Programs

HistoryHistory

Research conducted in Germany Research conducted in Germany during World War IIduring World War II

NuremburgNuremburg Generalizing effects on animals to Generalizing effects on animals to

the affects on humans.the affects on humans. Tuskegee study – Public HealthTuskegee study – Public Health

The Institutional Review Board (IRB) is mandated by law for The Institutional Review Board (IRB) is mandated by law for any institution engaging in research. The National Institute of any institution engaging in research. The National Institute of Health (NIH) is one of the primary agencies responsible for Health (NIH) is one of the primary agencies responsible for monitoring and ensuring compliance in all research conducted monitoring and ensuring compliance in all research conducted at any institution.at any institution.

All research involving human subjects must be reviewed by All research involving human subjects must be reviewed by the Institutional Review Board (IRB)- Human Subjects the Institutional Review Board (IRB)- Human Subjects Protection Committee.Protection Committee.

During the review process various guidelines are used in During the review process various guidelines are used in reviewing the research protocol to ensure that it is in reviewing the research protocol to ensure that it is in compliance with federal and state regulations, and in compliance with federal and state regulations, and in accordance with Delaware State University's institutional accordance with Delaware State University's institutional assurance compliance filed with the Office for Protection from assurance compliance filed with the Office for Protection from Research Risks (OPRR).Research Risks (OPRR).

What is the Institutional Review Board (IRB)

Human Subjects Committee

Composition of the Composition of the CommitteeCommittee

ChairpersonChairperson Community MemberCommunity Member University FacultyUniversity Faculty Lay Person (non-affiliated)Lay Person (non-affiliated) PractitionerPractitioner

The ApplicationThe Application

1.1. The Principle Investigator:The Principle Investigator: Student, Faculty, StaffStudent, Faculty, Staff

Co-InvestigatorCo-Investigator Student, Faculty, StaffStudent, Faculty, Staff

2.2. Department, PhoneDepartment, Phone If you are a student, provide the followingIf you are a student, provide the following

Faculty Sponsor, Department, phoneFaculty Sponsor, Department, phone

Is this is a class research project/assignment, thesis or dissertationIs this is a class research project/assignment, thesis or dissertation Yes Yes No _____ No _____

3.3. Title of ProjectTitle of Project

The ApplicationThe Application4.4. Has this project previously been considered by the IRB?Has this project previously been considered by the IRB?

Yes Yes No _____ No _____

5.5. Is a proposal for external support being submitted? Is a proposal for external support being submitted? Yes Yes No _____ No _____

6.6. Provide copies of all pertinent informationProvide copies of all pertinent information Survey instrumentsSurvey instruments Informed ConsentInformed Consent Letter of approval from cooperating institutionsLetter of approval from cooperating institutions Copy of external support proposalsCopy of external support proposals

I. Proposed Research ProjectI. Proposed Research Project

A.A. Provide a brief summary of the proposed research Provide a brief summary of the proposed research (hypotheses and research design)(hypotheses and research design)

Example:Example:

This study is designed to assess students’ This study is designed to assess students’ perception of career choice and income. This perception of career choice and income. This research study will employ a survey design using research study will employ a survey design using graduating college seniors and graduating graduating college seniors and graduating masters-level students.masters-level students.

B. Describe the source(s) of subjects and the selection B. Describe the source(s) of subjects and the selection criteria. Specifically, how did you obtain the potential criteria. Specifically, how did you obtain the potential

subjects and how will you contact them?subjects and how will you contact them?

Example:Example:The subjects for this study will be drawn from the The subjects for this study will be drawn from the

graduating senior class and the graduating masters level graduating senior class and the graduating masters level students at Delaware State University. students at Delaware State University.

First, clearance and cooperation will be negotiated First, clearance and cooperation will be negotiated with University officials that the study will be able to access with University officials that the study will be able to access these graduating students during graduation rehearsal these graduating students during graduation rehearsal (normally the week before graduation). During this time (normally the week before graduation). During this time and at the conclusion of the rehearsal, a request will be and at the conclusion of the rehearsal, a request will be made for students (bachelors and masters) to stop at an made for students (bachelors and masters) to stop at an established station that would have a supply of established station that would have a supply of questionnaires. Each student responding to the request will questionnaires. Each student responding to the request will be requested to complete the survey instrument. It is be requested to complete the survey instrument. It is anticipated that 75 seniors and 50 graduate students will anticipated that 75 seniors and 50 graduate students will participate.participate.

C. Informed Consent: Describe the consent process C. Informed Consent: Describe the consent process and attach all consent documents. Elements of and attach all consent documents. Elements of

informed consent are:informed consent are:

1.1. A clear statement that “the study involves A clear statement that “the study involves research”research”

Example:Example: We are requesting that you participate in this research study.We are requesting that you participate in this research study.

2.2. All the research purposes are clearly statedAll the research purposes are clearly stated

Example:Example: There are three purposes that this study is designed to address:There are three purposes that this study is designed to address:

1. to discern what are the career choices of graduates 1. to discern what are the career choices of graduates 2. to determine what are the perceived income levels 2. to determine what are the perceived income levels associated with career choices, and associated with career choices, and 3. to assess the perceived relationship between career 3. to assess the perceived relationship between career choices and income levels. choices and income levels.



3.3. The expected procedures to be followedThe expected procedures to be followed

Example:Example: The procedures to be utilized in executing this The procedures to be utilized in executing this survey is as survey is as follows. follows.

When graduating students report to the research When graduating students report to the research station, a research station, a research assistant will provide each student with assistant will provide each student with the informed consent the informed consent “Signature Sheet”. “Signature Sheet”.

Students will be asked to take two minutes to read and Students will be asked to take two minutes to read and sign the sign the sheet. After students have signed the sheet, sheet. After students have signed the sheet, they will be given the 2-they will be given the 2- page, 15 item survey instrument to page, 15 item survey instrument to complete. complete.



4.4. The duration of involvement by the subjectThe duration of involvement by the subject

Example:Example: The instrument has been field tested and it is confirmed that The instrument has been field tested and it is confirmed that

the the average student should complete the instrument within 10 average student should complete the instrument within 10 to 15 to 15 minutes. Combined with the two minutes for minutes. Combined with the two minutes for reviewing the reviewing the informed consent “signature sheet”, the total informed consent “signature sheet”, the total time to complete the time to complete the survey process is estimated at a survey process is estimated at a minimum of 12 minutes and a minimum of 12 minutes and a maximum of 17 minutes. maximum of 17 minutes.

5.5. When procedures are experientialWhen procedures are experiential

Example:Example: Does not apply to this study.Does not apply to this study.



6.6. Reasonable foreseeable discomfort and riskReasonable foreseeable discomfort and risk

Example:Example:

Considering that this study is based on student perception and Considering that this study is based on student perception and there are no invasive there are no invasive procedures or information request, no procedures or information request, no discomforts or risks can be identified. discomforts or risks can be identified.

7.7. If more than minimal risk, “In case of injury or severe adverse reaction…”If more than minimal risk, “In case of injury or severe adverse reaction…”

a. is medical care available? by whom? Where?a. is medical care available? by whom? Where?

b. is compensation available? How? b. is compensation available? How?

c. whom should the subject contact?c. whom should the subject contact?

Example:Example:

This study has minimal risks attached to it relative to the participants. This study has minimal risks attached to it relative to the participants. Therefore, Therefore, issues such as medical care and compensation are not issues such as medical care and compensation are not active concerns.active concerns.



8.8. Reasonable expected benefits to subject and others.Reasonable expected benefits to subject and others.

Example:Example:

While the researcher can discern no direct benefits to the While the researcher can discern no direct benefits to the participating subjects, this study will be of benefit to participating subjects, this study will be of benefit to

others by others by enabling understanding of the extent to enabling understanding of the extent to which student perceptions which student perceptions are consistent with reality. This are consistent with reality. This clarification will then enable faculty to clarification will then enable faculty to understand the extent understand the extent to which their curricula are informing students to which their curricula are informing students relative to the relative to the work world. This kind of clarification can lead to work world. This kind of clarification can lead to meaningful meaningful changes in curricula to enable students to have a more changes in curricula to enable students to have a more informed view of the world of work.informed view of the world of work.



9.9. How and where will the data be published?How and where will the data be published?

Example:Example: This study and its data will be presented in a formal paper This study and its data will be presented in a formal paper

submitted to my research mentor and the director submitted to my research mentor and the director of the McNair of the McNair Program. Program.

10.10. The alternatives to the research’s diagnostic method or The alternatives to the research’s diagnostic method or treatmenttreatment

Example:Example: This item is not applicable to the study described in this This item is not applicable to the study described in this

document.document.



11.11. How confidentiality or anonymity will be maintainedHow confidentiality or anonymity will be maintained

Example:Example: First, student participants are asked to read and sign a First, student participants are asked to read and sign a

separate signature sheet to address informed consent. These separate signature sheet to address informed consent. These documents will be kept in my research mentor’s office in a documents will be kept in my research mentor’s office in a locked file until the data is analyzed and the report is locked file until the data is analyzed and the report is generated. These forms will then be shredded under the generated. These forms will then be shredded under the supervision of the research mentor when the written report is supervision of the research mentor when the written report is accepted. There are no identification included in the survey accepted. There are no identification included in the survey instrument. So there will be no way of identifying responses instrument. So there will be no way of identifying responses with the respondents.with the respondents.



12.12. Who will answer questions about the research itself?Who will answer questions about the research itself?

Example:Example:

The lead researcher will be posted at the reporting The lead researcher will be posted at the reporting station to provide answers to any questions that may be station to provide answers to any questions that may be posed by participants. In addition, a number will be provided posed by participants. In addition, a number will be provided for participants to call should they have questions at some for participants to call should they have questions at some future date.future date.

D. Procedures: Provide a step-by-step description of D. Procedures: Provide a step-by-step description of each procedure, including frequency, duration,each procedure, including frequency, duration,

and location of each procedure.and location of each procedure.

Example:Example:

The procedures are fairly simple. They consist of the following. The procedures are fairly simple. They consist of the following.

At the conclusion of graduation rehearsal, a request will At the conclusion of graduation rehearsal, a request will be made for students (bachelors and masters) to stop at an be made for students (bachelors and masters) to stop at an established station that would have a supply of questionnaires. established station that would have a supply of questionnaires. Each student responding to the request will be requested to Each student responding to the request will be requested to complete the survey instrument. It is anticipated that 75 seniors complete the survey instrument. It is anticipated that 75 seniors and 50 graduate students will participate. and 50 graduate students will participate.

The procedures to be utilized in executing this survey is as follows. The procedures to be utilized in executing this survey is as follows.

When graduating students report to the research station, When graduating students report to the research station, a research assistant will provide each student with the informed a research assistant will provide each student with the informed consent “Signature Sheet”. Students will be asked to take two consent “Signature Sheet”. Students will be asked to take two minutes to read and sign the sheet. After students have signed minutes to read and sign the sheet. After students have signed the sheet, they will be given the 2-page, 15 item survey the sheet, they will be given the 2-page, 15 item survey instrument to complete.instrument to complete.

E. How will confidentiality of the data be maintained?E. How will confidentiality of the data be maintained?

Example:Example:

First, student participants are asked to read and sign First, student participants are asked to read and sign a separate signature sheet to address informed consent. a separate signature sheet to address informed consent. These documents will be kept in my research mentor’s These documents will be kept in my research mentor’s office in a locked file until the data is analyzed and the office in a locked file until the data is analyzed and the report is generated. These forms will then be shredded report is generated. These forms will then be shredded under the supervision of the research mentor when the under the supervision of the research mentor when the written report is accepted. Identification is not included in written report is accepted. Identification is not included in the survey instrument. So there will be no way of the survey instrument. So there will be no way of identifying responses with the respondents.identifying responses with the respondents.

F. Describe all known and anticipated risks to the F. Describe all known and anticipated risks to the subject including side effects, risks of placebo,subject including side effects, risks of placebo,

risks of normal treatment delay.risks of normal treatment delay.

Example:Example:

This study has minimal risks attached to it relative to the This study has minimal risks attached to it relative to the participants.participants.

G.G. Describe the anticipated benefits to subjects, and Describe the anticipated benefits to subjects, and the importance of the knowledge that the importance of the knowledge that may reasonably be expected to result.may reasonably be expected to result.

Example:Example:

While the researcher can discern no direct benefit(s) While the researcher can discern no direct benefit(s) to the participating subjects, this study will be of benefit to to the participating subjects, this study will be of benefit to others by enabling understanding of the extent to which others by enabling understanding of the extent to which student perceptions are consistent with reality. This student perceptions are consistent with reality. This clarification will then enable faculty to understand the clarification will then enable faculty to understand the extent to which their curriculae are informing students extent to which their curriculae are informing students relative to the work world. This kind of clarification can relative to the work world. This kind of clarification can lead to meaningful changes in curriculae to enable students lead to meaningful changes in curriculae to enable students to have a more informed view of the world of work.to have a more informed view of the world of work.

H. Provide a copy(s) of the Letter of Approval from the H. Provide a copy(s) of the Letter of Approval from the attending/employed institution’s IRB committee.attending/employed institution’s IRB committee.

Sample:Sample:

institutional review board (irb) human subject delaware state university office of sponsored...

Documents

research study

research designexample

research purposes

research protocol

graduating students

proposed research hypotheses

research risks oprr

masterslevel students