This manual outlines the research protocols for human subject research at American Public University System



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Appendix A: The IRB Checklist


This checklist is provided for your use before submitting a proposal for review by the IRB:

  • IRB Application

  • Is the current version of the application as provided to you by Classroom Support

  • Is filled out thoroughly and completely

  • Is signed by Primary Investigator (PI) and Faculty Advisor (FA) (see IRB Site/Apply:

Creating a Digital Signature in Adobe)

  • Data Usage, Storage, and Destruction Agreement

  • PI and FA are required to be named as having access

  • Researchers who will be using data are named

  • Data storage and security is explained

  • Data usage plans are indicated

  • Data destruction plan is described

  • Consent Forms/Letters of Informed Consent

  • Online Consent Form and/or Consent Form(see IRB Site/Apply: Consent Samples)

  • Parental Informed Consent–if subjects are minors

  • Letter of Assent–if subjects are minors

  • Research Instrument

  • Survey in full(links to surveys are unacceptable)

  • Interview Questions

  • Tests to be administered

  • Observation Checklists

  • CITI Training Completion of Social and Behavioral Investigator Curriculum

  • Please refer to IRB Sit/Training: Registering for the CITI Course

  • If you have already attempted training, you will be able to see if your previous CITI

training fulfills the APUS requirement or if you need to take additional modules to

earn the completion report.



  • You must provide a completion report that shows curriculum/modules taken and

scores. This is printable from the CITI site. Simply select Print Report and save a

PDF version of the report.



  • Recruitment Materials (if applicable)

  • Flyers, Advertisements

  • Letters, documents, or verbiage for recruiting subjects

  • Letter of Permission from external company, organization, etc. if any aspect of the project involves their associates, location, etc. (if applicable)

Please note: If you are planning to use APUS Students, Faculty, or Staff you will need to apply for Internal Research Review Board (IRRB) Approval by emailing research@apus.edu.

Appendix B: IRB Applications



American Public University System Faculty/Staff IRB Application


Instructions: Incomplete forms will delay the IRB review process and may be returned to you. Type your information in the colored boxes and insert an “X” in the applicable checkboxes.

SECTION A: Investigators & Study Personnel

A1. Principal Investigator (P.I.):

Name:




Degree(s):




Title/Position:




Program:




Contact Numbers:




Physical Address:




*APUS or MyCampus Email:




*Once your application is received, we will only communicate with you through your APUS or mycampus email. If you do not know your mycampus email, please contact classroomsupport@apus.edu.

Select the appropriate PI status:

[__] Faculty Member [__] Staff [__] Other

If Faculty Member, please provide your Faculty ID

If other, please explain your connection to APUS

A2. Additional Research Team Members and roles (e.g., Co-PI, Research Assistant, etc.) (if applicable):

Name:




Study Role:




Title/Position:




Email:






Name:




Study Role:




Title/Position:




Email:






SECTION B: Research Information

B1: Title






B2: Introduction

Please provide a brief (350-500 word) summary of your research project, including background and rationale for your study. Be sure to include in your description what kinds of data you are planning to collect as part of your research (e.g., surveys, interviews, observations, etc.).


SECTION C: Review Type

C1. Does the study involve greater than minimal risk? (Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. More than minimal risk will require Full Committee Review.)

Place an “X” next to the appropriate response.



[__] Low/Minimal Risk [__] Greater Than Minimal Risk

C2. Which level of review do you believe best matches your research (Exempt, Expedited, or Full)? For more information, view the categories on the APUS IRB Website.

[__] a. Exempt

[__] b. Expedited

[__] c. Full Board Review

SECTION D: Study Funding

If the study is dependent on grant funding, please submit the protocol after you have received a fundable score or notice of grant award unless the granting agency requires IRB review (or approval) at the time of submission. Check with your funding agency on their requirements.

D1. Are you applying for research funding for this study? [__] Yes [__] No

D2. If “Yes,” please indicate the source of the funding and the current status of your funding/grant application:










SECTION E: Project Purpose/ Research Question/ Objectives

In non-technical language, address the following:

  1. Topic and scope of the study.

  2. Research questions or hypothesis.

  3. How this study will contribute to knowledge in the field.

  4. Relevant literature pertaining to the proposed research study (a bibliography of sources is sufficient).

1)

2)

3)



4)



SECTION F: Participant Population and Recruitment

(Recruitment materials (e.g. flyers or e-mail recruitment text) should be included in the appendix.)

F1. In non-technical language, address the following:

  1. Who will the participants be? How many participants? What ages will the participants be?

  2. What is the inclusion/exclusion criteria for participants?

  3. Where and how participants will be recruited?

4) Which members of the Research Team will be directly involved in the recruitment process?

1)

2)

3)



4)

F2. This study will involve participants with the following characteristics (place an “X” next to all that apply):

[__] a. Not Applicable (e.g., de-identified datasets)

OR

[__] Individuals who cannot read/speak English

[__] Individuals living outside of the United States

[__] Students of PI or study staff

[__] Students to be recruited in their educational setting (i.e. in class or at school)

[__] APUS Staff, Faculty, or Students

[__] Minors/Children

[__] Prisoners

[__] Individuals with diagnosable psychological disorders

[__] Individuals who are institutionalized

[__] Individuals who are poor/uninsured

[__] Pregnant women

[__] Fetuses

[__] Nursing home residents recruited in the nursing home

[__] Individuals who are cognitively impaired

[__] Individuals who are psychiatrically impaired

[__] Limited or non-readers

[__] Wards of the state (e.g., foster children)

[__] Individuals who are terminally ill

[__] Others vulnerable to coercion (Specify in the box below):




[__] Other (Specify in the box below):






SECTION G: Research Design

In non-technical language, address the following:

  1. State the study activities in chronological order. Describe both the activities conducted by members of the research team and the activities of research participants. (e.g., screening, survey, taking a test, answering questions in an interview, completing a specific task, tasks on a computer, running on a treadmill, debriefing, etc.) If videotaping, photographs, or audio-taping will take place, explain how and why recording will occur.

  2. Which members of the research team will be involved in collecting data from participants?

  3. Explain how the data will be analyzed or studied; that is, indicate the quantitative or qualitative data analysis methods you will use.

  4. Explain how the data will be reported in order to maintain the confidentiality or anonymity of participants (i.e. aggregated, anonymously, names used with consent, participants only identified by professional role, etc.).




1)

2)

3)



4)



SECTION H: Data Collection

Any questionnaires and consent forms used for the study should be included with the IRB application. In addition to obtaining consent for participation in the study, the PI must secure additional consent for any audio or video recording of subjects. This recording consent may be added as a separate item to the consent form.

This study involves the following types of data collection (place an “X” next to all that apply)…

[__] Email Questionnaire(s)

[__] In-person Interview(s)

[__] Phone Interview(s)

[__] Video Interview(s) (e.g. Skype, FaceTime, etc.)

[__] Paper Survey(s)

[__] Online Survey(s) (e.g. Survey Monkey, Kwik Surveys, etc.)



[__]Audio-recording

[__]Video-recording

[__] Photography

[__] Existing datasets

[__] Focus Groups

[__] Internet research, (e.g. collecting data via the internet or researching individuals’ behavior on the

internet)



[__] Observations

[__] Questions that might result in identifying criminal activities

[__] Questions that might result in identifying child or elder abuse

[__] Review of academic records

[__] Review of medical records

[__] Exposure to psychological stress

[__] Use of physiological sensors (e.g. heart rate, skin conductance, BP)

[__] Physical exercise

[__] Collection of blood or biological specimens

[__] Genetic Material

[__] Diagnostic imaging (e.g., MRI, fMRI, X-Rays, etc.)

SECTION I: Consent/Assent

Describe the following:

  1. How will consent/assent be obtained place. (e.g., signing a consent form in person, online consent form as front page for online survey, etc.)

  2. Which members of the research team will be responsible for obtaining participants’ consent?

  3. If applicable, what procedures are in place to reduce coercion (e.g., if extra credit is offered, what non-research alternatives are available to students who do not wish to participate in research).

  4. If participants are vulnerable populations, explain how you will follow research ethics guidelines for obtaining consent. (If applicable).

  5. If a request for a waiver of consent or waiver of documentation of consent is being sought for this proposal, describe here how the request comports with Federal guidelines as outlined in 45CFR46-listed criteria for a waiver found at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116.

1)

2)

3)



4)

5)




SECTION J: Risks to Subjects

IRBs must evaluate the risk-benefit ratio of proposed human subject research. In approving a protocol, IRBs must determine that the benefits outweigh the risks and that risks to subjects are minimized.

Research risk is the probability of harm occurring as a result of participation in research. In non-technical language, address the following:

  1. The types of risks (e.g., physical, psychological, social, economic, legal, etc.) the subject may reasonably encounter. Include any likelihood that questions may be sensitive or stressful to the participants.

  2. Estimate the frequency/likelihood and magnitude of those risks (cite relevant literature, if available).

  3. Describe the procedures/process which will be used to reduce or minimize risks:

    1. How the data will be safeguarded (e.g., data is anonymous, assigning pseudonyms, aggregate reporting, etc.).

    2. How will subjects be explicitly informed if data will NOT be anonymous (Put “N/A” if using anonymous data)

    3. What actions would you take if a participant gets hurt or upset?




1)

2)

3)



a.)

b.)


c.)



SECTION K: Deception/Incomplete Disclosure

If you cannot adequately state the true purpose of the study to the subject in the informed consent, deception/ incomplete disclosure is involved.

  1. Describe the deception/incomplete disclosure of information to the subjects.

  2. Explain why such deception/incomplete disclosure is necessary.

  3. Explain the debriefing process, or explain why there will not be a debriefing process.

1)

2)

3)



SECTION L: Benefits

Describe any direct benefits participants could potentially receive (excluding compensation for participation). If there are no direct benefits, explain what other potential benefits are gained from the research (benefits to society). This cannot be left blank.






SECTION M: Subject Incentives/Compensations

M1. Does this study involve incentives or compensation to the subjects? For example cash, class extra credit, gift cards, or items. [__] Yes [__] No

M2. If yes, provide details about the nature of the payment (e.g. type, amount, when it will be provided to subjects, contingencies for payment, payment schedule, etc.), what records will be retained regarding payment and who will these records be provided to (e.g. signed payment receipt, names and social security numbers provided to accounts payable for check payments, etc.):






SECTION N: Collaborative Research

N1. Does this study involve collaboration with a researcher who is not affiliated with APUS? [__] Yes [__] No

N2. If yes, describe the role of the collaborating researcher in the proposed study and indicate whether or not IRB approval has been sought/obtained from his/her institution.






SECTION O: Conflicts of Interest

O1. Do any of the study personnel have a conflict of interest related to this study (e.g. potential financial gain linked to the research and/or subject recruitment)?

[__] Yes [__] No

O2. If yes, provide details below.






SECTION P: Additional Information

Use this area to add any additional information that you believe is relevant to the IRB’s review of your study.




SECTION Q: Investigator Assurances

As a PI or Co-PI, I certify the following:

  • I have reviewed this protocol submission and acknowledge my responsibilities as Principal Investigator.

  • The information in this submission accurately reflects the proposed research.

  • I will not initiate this study until I receive written approval from the IRB.

  • I will promptly report to the IRB any unanticipated problems and adverse events, as well as any findings during the course of the study that may affect the risks and benefits to the subjects.

  • I will obtain prior written approval for modifications (amendments) to this protocol including, but not limited to, changes in procedures and/or changes in personnel.

  • I have completed the CITI Social and Behavioral Investigator Training Module and have read the Belmont Report.

  • All research personnel involved in the study have been appropriately trained in human subjects’ protection. I accept responsibility for assuring adherence to applicable Federal and State research regulations and APUS polices relative to the protection of the rights and welfare of the subjects enrolled in this study.

  • I have obtained, or will obtain, all necessary permissions from study sites.

  • Unless given Exempt Status, I understand that this study is subject to continuing review and approval by the IRB which will occur at least yearly.

________________________________ ________________________ ________________

Principal Investigator (PRINT NAME) (SIGNATURE) DATE

________________________________ ________________________ ________________

Co-PI (PRINT NAME) (SIGNATURE) DATE

________________________________ ________________________ ________________

Co-PI (PRINT NAME) (SIGNATURE) DATE



American Public University System Student IRB Application

Instructions: Type your information in the shaded boxes and insert an “X” in the applicable checkboxes. Incomplete forms will delay the IRB review process and may be returned.

SECTION A: Investigators & Research Team

A1. Principal Investigator (P.I.):

Name:




Degree(s):




Title/Position:




Program:




Contact Numbers:




Physical Address:




MyCampus Email:




*Once your application is received, we will only communicate with you through your mycampus email. If you do not know your mycampus email, please contact classroomsupport@apus.edu.

Select the appropriate PI status:

[__] Graduate Student [__] Undergraduate Student [__] Other

If Graduate Student or Undergraduate Student, please indicate your Student ID

If other, please explain your connection to APUS

A2. Faculty Advisor (Required):

Name:




Degree(s):




Program:




Course Number:




MyCampus/APUS Email:




A3. Additional Research Team Members and roles (e.g., Co-PI, Research Assistant, etc.) (if applicable):

Name:




Study Role:




Title/Position:




Email:






Name:




Study Role:




Title/Position:




Email:






SECTION B: Research Information

B1: Title






B2: Introduction

Please provide a brief (350-500 word) summary of your research project, including background and rationale for your study. Be sure to include in your description what kinds of data you are planning to collect as part of your research (e.g., surveys, interviews, observations, etc.).


SECTION C: Review Type

C1. Does the study involve greater than minimal risk? (Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. More than minimal risk will require Full Committee Review.)

Place an “X” next to the appropriate response.



[__] Low/Minimal Risk [__] Greater Than Minimal Risk

C2. Which level of review do you believe best matches your research (Exempt, Expedited, or Full)? For more information, view the categories on the APUS IRB Website.

[__] a. Exempt

[__] b. Expedited

[__] c. Full Board Review

SECTION D: Project Purpose/ Research Question/ Objectives

In non-technical language, address the following:

  1. Topic and scope of the study.

  2. Research questions or hypothesis.

  3. How this study will contribute to knowledge in the field.

  4. Relevant literature pertaining to the proposed research study (a bibliography of sources is sufficient).




1)

2)

3)



4)



SECTION E: Participant Population and Recruitment

(Recruitment materials (e.g. flyers or e-mail recruitment text) should be included in the appendix.)

E1. In non-technical language, address the following:

  1. Who will the participants be? How many participants? What ages will the participants be?

  2. What is the inclusion/exclusion criteria for participants?

  3. Where and how participants will be recruited?

4) Which members of the Research Team will be directly involved in the recruitment process?

1)

2)

3)



4)

E2. This study will involve participants with the following characteristics (place an “X” next to all that apply):

[__] a. Not Applicable (e.g., de-identified datasets)

OR

[__] Individuals who cannot read/speak English

[__] Individuals living outside of the United States

[__] Students of PI or Research Team Members

[__] Students to be recruited in their educational setting (i.e. in class or at school)

[__] APUS Staff, Faculty, or Students

[__] Minors/Children

[__] Prisoners

[__] Individuals with diagnosable psychological disorders

[__] Individuals who are institutionalized

[__] Individuals who are poor/uninsured

[__] Pregnant women

[__] Fetuses

[__] Nursing home residents recruited in the nursing home

[__] Individuals who are cognitively impaired

[__] Individuals who are psychiatrically impaired

[__] Limited or non-readers

[__] Wards of the state (e.g., foster children)

[__] Individuals who are terminally ill

[__] Others vulnerable to coercion (Specify below):




[__] Other (Specify below):






SECTION F: Research Design

In non-technical language, address the following:

  1. State the study activities in chronological order. Describe both the activities conducted by members of the research team and the activities of research participants. (e.g., screening, survey, taking a test, answering questions in an interview, completing a specific task, tasks on a computer, running on a treadmill, debriefing, etc.) If videotaping, photographs, or audio-taping will take place, explain how and why recording will occur.

  2. Which members of the research team will be involved in collecting data from participants?

  3. Explain how the data will be analyzed or studied; that is, indicate the quantitative or qualitative data analysis methods you will use.

  4. Explain how the data will be reported in order to maintain the confidentiality or anonymity of participants (i.e. aggregated, anonymously, names used with consent, participants only identified by professional role, etc.).

1)

2)

3)



4)



SECTION G: Data Collection

Any questionnaires and consent forms used for the study should be included with the IRB application. In addition to obtaining consent for participation in the study, the PI must secure additional consent for any audio or video recording of subjects. This recording consent may be added as a separate item to the consent form.

This study involves the following types of data collection (place an “X” next to all that apply)…

[__] Email Questionnaire(s)

[__] In-person Interview(s)

[__] Phone Interview(s)

[__] Video Interview(s) (e.g. Skype, FaceTime, etc.)

[__] Paper Survey(s)

[__] Online Survey(s) (e.g. Survey Monkey, Kwik Surveys, etc.)



[__]Audio-recording

[__]Video-recording

[__] Photography

[__] Existing datasets

[__] Focus Groups

[__] Internet research, (e.g. collecting data via the internet or researching individuals’ behavior on the internet)

[__] Observations

[__] Questions that might result in identifying criminal activities

[__] Questions that might result in identifying child or elder abuse

[__] Review of academic records

[__] Review of medical records

[__] Exposure to psychological stress

[__] Use of physiological sensors (e.g. heart rate, skin conductance, BP)

[__] Physical exercise

[__] Collection of blood or biological specimens

[__] Genetic Material

[__] Diagnostic imaging (e.g., MRI, fMRI, X-Rays, etc.)

SECTION H: Consent/Assent

Describe the following:

  1. How will consent/assent be obtained place. (e.g., signing a consent form in person, online consent form as front page for online survey, etc.)

  2. Which members of the research team will be responsible for obtaining participants’ consent?

  3. If applicable, what procedures are in place to reduce coercion (e.g., if extra credit is offered, what non-research alternatives are available to students who do not wish to participate in research).

  4. If participants are vulnerable populations, explain how you will follow research ethics guidelines for obtaining consent. (If applicable).

  5. If a request for a waiver of consent or waiver of documentation of consent is being sought for this proposal, describe here how the request comports with Federal guidelines as outlined in 45CFR46-listed criteria for a waiver found at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116 .




1)

2)

3)



4)

5)




SECTION I: Risks to Subjects

IRBs must evaluate the risk-benefit ratio of proposed human subject research. In approving a protocol, IRBs must determine that the benefits outweigh the risks and that risks to subjects are minimized.

Research risk is the probability of harm occurring as a result of participation in research. In non-technical language, address the following:

  1. The types of risks (e.g., physical, psychological, social, economic, legal, etc.) the subject may reasonably encounter. Include any likelihood that questions may be sensitive or stressful to the participants.

  2. Estimate the frequency/likelihood and magnitude of those risks (cite relevant literature, if available).

  3. Describe the procedures/process which will be used to reduce or minimize risks:

    1. How the data will be safeguarded (e.g., data is anonymous, assigning pseudonyms, aggregate reporting, etc.).

    2. How will subjects be explicitly informed if data will NOT be anonymous (Put “N/A” if using anonymous data)

    3. What actions would you take if a participant gets hurt or upset?




1)

2)

3)



a.)

b.)


c.)



SECTION J: Deception/Incomplete Disclosure

If you cannot adequately state the true purpose of the study to the subject in the informed consent, deception/ incomplete disclosure is involved.

  1. Describe the deception/incomplete disclosure of information to the subjects.

  2. Explain why such deception/incomplete disclosure is necessary.

  3. Explain the debriefing process, or explain why there will not be a debriefing process.

1)

2)

3)

SECTION K: Benefits

Describe any direct benefits participants could potentially receive (excluding compensation for participation). If there are no direct benefits, explain what other potential benefits are gained from the research (benefits to society). This cannot be left blank.






SECTION L: Subject Incentives/Compensations

L1. Does this study involve incentives or compensation to the subjects? For example cash, class extra credit, gift cards, or items. [__] Yes [__] No

L2. If yes, provide details about the nature of the payment (e.g. type, amount, when it will be provided to subjects, contingencies for payment, payment schedule, etc.), what records will be retained regarding payment and who will these records be provided to (e.g. signed payment receipt, names and social security numbers provided to accounts payable for check payments, etc.):






SECTION M: Collaborative Research

M1. Does this study involve collaboration with a researcher who is not affiliated with APUS

[__] Yes [__] No

M2. If yes, describe the role of the collaborating researcher in the proposed study and indicate whether or not IRB approval has been sought/obtained from his/her institution.






SECTION N: Conflicts of Interest

N1. Do any of the study personnel have a conflict of interest related to this study (e.g. potential financial gain linked to the research and/or subject recruitment)?

[__] Yes [__] No

N2. If yes, provide details below.






SECTION O: Additional Information

Use this area to add any additional information that you believe is relevant to the IRB’s review of your study.






SECTION P: Investigator Assurances

As a PI or Co-PI, I certify the following:

  • I have reviewed this protocol submission and acknowledge my responsibilities as Principal Investigator.

  • The information in this submission accurately reflects the proposed research.

  • I will not initiate this study until I receive written approval from the IRB.

  • I will promptly report to the IRB any unanticipated problems and adverse events, as well as any findings during the course of the study that may affect the risks and benefits to the subjects.

  • I will obtain prior written approval for modifications (amendments) to this protocol including, but not limited to, changes in procedures and/or changes in personnel.

  • I have completed the CITI Social and Behavioral Investigator Training Module and have read the Belmont Report.

  • All research personnel involved in the study have been appropriately trained in human subjects’ protection. I accept responsibility for assuring adherence to applicable Federal and State research regulations and APUS polices relative to the protection of the rights and welfare of the subjects enrolled in this study.

  • I have obtained, or will obtain, all necessary permissions from study sites.

  • Unless given Exempt Status, I understand that this study is subject to continuing review and approval by the IRB which will occur at least yearly.

________________________________ ________________________ ________________

Principal Investigator (PRINT NAME) (SIGNATURE) DATE

________________________________ ________________________ ________________

Co-PI (PRINT NAME) (SIGNATURE) DATE

________________________________ ________________________ ________________

Co-PI (PRINT NAME) (SIGNATURE) DATE



SECTION Q: Faculty Advisor Assurances

As Faculty Advisor, I certify the following:

  • I have reviewed this protocol submission and accept responsibility for overseeing my advisee’s research for adherence to human subjects’ protection policies and procedures.

  • The information in this submission accurately reflects the proposed research.

  • I have completed the CITI Social and Behavioral Investigator Training Module and have read the Belmont Report.

________________________________ ________________________ ________________

Faculty Advisor (PRINT NAME) (SIGNATURE) DATE


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