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

Appendix C: Sample Consent Forms:

Welcome to "Motivation and Psychology," a web-based experiment that examines some of the finer points of what motivates a person. Before taking part in this study, please read the consent form below and sign at the bottom of the page that you understand the statements and freely consent to participate in the study.

Participation in the study typically takes 50 minutes and is strictly anonymous (or confidential; whichever is applicable). Participants (description of what participants will do. e.g. begin by answering a series of questions, after which they watch several randomly assigned video vignettes. These vignettes involve either direct motivational prompts or neutral contexts. After watching a random sample of 9 vignettes, participants rate whether or not the vignettes were meaningful.)

All responses are treated as anonymous or confidential and in no case will responses from individual participants be identified. Rather, all data will be pooled and published in aggregate form only. Participants should be aware, however, that the experiment is not being run from a "secure" https server of the kind typically used to handle credit card transactions, so there is a small possibility that responses could be viewed by unauthorized third parties (e.g., computer hackers).
Many individuals find participation in this study enjoyable, and no adverse reactions have been reported thus far. Other visitors are welcome to complete the study…

Participation is voluntary, refusal to take part in the study involves no penalty or loss of benefits to which participants are otherwise entitled, and participants may withdraw from the study at any time without penalty or loss of benefits to which they are otherwise entitled. Participants may skip any questions they do not feel comfortable answering.

If you have further questions or concerns about your rights as a participant in this study, contact the American Public University System, IRB Chair at: apus-IRB@apus.edu .

_____ I consent to be photographed/audio-recorded/video-recorded.

_____ I DO NOT consent to be photographed/audio-recorded/video-recorded.

By signing below I verify that I am 18 years of age or older, understand the statements above, and freely consent to participate in the study

_______________________________________________________ ___________________

Signature Date

Witness (Signature or name with supporting email) Date

Research Title

The purpose of this research project is (insert text accordingly here).

This is a research project being conducted by (insert your name here), a (insert appropriate affiliation (student/staff member/faculty member) here) at American Public University System.

You are invited to participate in this research project because you are (insert text accordingly here).

Your participation in this research study is voluntary. You may choose not to participate. However, if you decide to participate in this research survey, you may still withdraw from the study at any time. If you decide not to participate in this study or if you withdraw from participating, you will not be penalized.

The procedure involves filling an online survey that will take approximately XX minutes. Your responses will be (select one: confidential/anonymous) and we will not collect identifying information such as your name, email address or IP address.

The survey questions will be about (insert text accordingly here).

All data is stored in a password protected electronic format. To help protect your identity, the surveys will not contain information that would personally identify you. The results of this study will be used for scholarly purposes only. (If you are a student, please add: The data may be shared with my faculty advisor).

This research has been reviewed according to American Public University System IRB procedures for research involving human subjects. If you have any questions about the research study, please contact: the IRB Chair at American Public University System, apus-irb@apus.edu.

By selecting DISAGREE, you do not wish to participate in the research and may exit your browser.

By selecting AGREE, you consent that:

• You have read and understand the information above regarding this study;

• You are voluntarily agreeing to participate in this study and understand that I can opt out

at any time without penalty; and

• You are at least 18 years of age.

Please select your choice below:

• 
  AGREE
  
• 
  DISAGREE
  

Appendix D: Data Usage, Storage, and Destruction Agreement

I_________________________________ agree to keep the data collected as part of my research for a period of 5 years.

1. The following people will have access to this data: NOTE: If you are a graduate student, your faculty advisor should also have access to your data. Be sure to indicate that here.

__________________________________________

__________________________________________

2. The data will only be used by the following people:

__________________________________________

__________________________________________

3. The data will be stored (location): ____________________________________________________________________________________________________________________________________________________________________________________________________________________________________

4. I will destroy the data in the following manner after the agreed upon timeframe:

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________

5. The data will be used for the following purpose:

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________

I agree to limit the data usage to the purposes indicated on the application. If, after the one year IRB approval has expired, I intend to use the data again, I agree to seek additional IRB approval.

Further, if my future use of the data departs significantly from the purposes indicated on my IRB approved application, I agree to seek new consent from participants.

If you have further questions or concerns about your rights as a participant in this study, contact the IRB Chair at: apus-IRB@apus.edu.

By signing below I verify that I agree to the conditions listed above.

_____________________________________________________ __________________

Signature Date

Appendix E: Protocol Amendment Form

Investigators are required to inform the IRB Chair and the Institutional Review Board (IRB), in writing, of protocol changes prior to their initiation.

Protocol Title:

IRB#:____________Principal Investigator:___________________________ Phone: (____)___________________ E-mail:______________________________­­­__; Faculty Advisor Email (if student)____________________________

Type of review requested: Expedited (Minor changes in previously approved research)

Full Board (Significant protocol changes)

Answer questions 1-4. Submit original plus a copy of Protocol Amendment Form and a copy of supporting documentation (i.e., protocol revision summaries, consent form). Changes must be highlighted.

1. Amendment in study design or protocol Yes No (If yes, summarize below)

2. Administrative amendment, grammatical corrections: Yes No (If yes, summarize below)

3. Consent form amendment: Yes No (If yes, submit 5 copies. Changes must be highlighted in 1 copy.)

4. Change in Investigator/Study Coordinator: Yes No (If yes, complete information below)

Addition* Investigator(s) - Name/title:

Study Coordinator - Name/title:

Please provide copy of the individual’s CV. New individual(s) must sign below.

• 
  Signature:______________________________________________________________________
  

Deletion Investigator(s) - Name/title:

Study Coordinator - Name/title:

Deleted individual(s) must sign below

• 
  Signature:__________________________________________________________________
  

*Investigators and study coordinators must be trained in the protection of human subjects.

Signature of Principal Investigator:___________________________________ Date:_______________

FOR IRB USE ONLY  Approved Full Board Review Expedited Review

Signature of IRB Chair:___________________________________ Effective Date:_____________

Appendix F: Form for Reporting to the IRB Unanticipated Problems that May Involve Risks to Subjects or Others (UPIRTSO)

Federal regulations [45CFR46.103(b)(5) and 21CFR56.108(b)(1)] require the IRB to ensure that investigators promptly report “any unanticipated problems involving risk to subjects or others” (UPIRTSO). The IRB defines UPIRTSO as any problem or event which in the opinion of the local investigator was unanticipated, reflects new or increased risk to the subjects and was possibly related to the research procedures. These should be reported to the IRB within 10 working days using the attached form signed by the principal investigator.

The IRB will make the determination of whether the unanticipated problem meets the criteria as a UPIRTSO. The following events meet the IRB’s definition of UPIRTSO and should be reported within the 10 day time frame:

Any event (including on-site and off-site adverse events, injuries, side effects, deaths or other problems) which in the opinion of the local investigator was unanticipated, involved new or increased risk to subjects or others, and was possibly related to the research procedures;

Any accidental or unintentional change to the IRB-approved protocol that increases risk or has the potential to recur;

Any deviation from the protocol taken without prior IRB review to eliminate apparent immediate hazard to a research subject;

Any publication in the literature, safety monitoring report (including Data and Safety Monitoring Reports), interim result or other finding that indicates an unexpected change to the risk/benefit ratio of the research;

Any breach in confidentiality that may involve risk to the subject or others;

Any complaint of a subject that cannot be resolved by the research staff; or

Any other possibly related event which in the opinion of the investigator constitutes an unanticipated risk.

Anticipated (expected) problems are those that are already described as potential risks in the consent form, listed in the Investigator’s Brochure or part of an underlying disease. These do NOT meet the IRB’s definition of UPIRTSO and should be reported in summary form only at the time of IRB continuing review. For example, if death is an expected outcome, this event should be reported only at the time of continuing review. Problems/events that are unanticipated and involve new or increased risk to subjects should be reported to the IRB within 10 days only if in the opinion of the local investigator they are possibly, probably or definitely related to the research procedures. Those unanticipated problems/events that the local investigator deems unlikely or not related do NOT meet the IRB’s definition of UPIRTSO and should be reported in summary form only at the time of IRB continuing review. All problems/events that do NOT meet the IRB’s definition of UPIRTSO should be reported to the IRB in summary form (using a table or spreadsheet) at the time of continuing review. Accompanying documentation (sponsor report forms, etc.) should NOT be included with this summary. If received, such accompanying documentation will be returned to the investigator.

Reporting Form for Unanticipated Problems that May Involve Risks to Subjects or Others

IRB Study Number:
Current Principal Investigator:
Primary Title:

Provide the following information for each unanticipated problem/event that reflects new or increased risk and is possibly related to the research procedures. Attach any summary or report from sponsor or DSMB with corresponding reference #.

Reference #:
Date of Event:
Primary Title:

On-site Off-site Initial report Follow up report

Does this problem/event alter risk to past, present or future subjects?



Yes No Don’t Know (Insufficient Information)

Based on your, the local investigator’s judgment, should this problem/event be added to the consent form as a potential risk?



Yes Provide revised consent form with changes highlighted.

No Explain why not:



Based on your, the local investigator’s, analysis of this problem/event,

should currently enrolled subjects be notified? Yes No

should subjects who have completed the study be notified? Yes No

Explain:

________________________________ ___________________

Principal Investigator’s Signature Date

Appendix G: Extension Request for Approved Research

IRB protocols are approved for one year with the expiration date indicated on the investigator's approval letter. Investigators wishing to collect data beyond the IRB approval expiration date must file an extension request before the protocol expires.

Please attach any protocol documents that have changed to this form and mail to: Apus-irb@apus.edu

Include the Principle Investigators name/s, email address, and telephone number. Also, include a copy of the approval letter.

If there are no changes to a research project previously approved by the IRB, the researcher should submit a written request to the IRB for an extension, documenting the following:

• 
  The date the research approval expires;
  
• 
  Confirm that the research is being conducted by the methods previously approved by the IRB;
  
• 
  If new investigators will be assisting with the research, provide updated name(s) and detail the experience/coursework which demonstrate they have had training in the ethical conduct of research conduct.
  

The approval of the extension requested is for a period of one year.

If there are changes to a research project previously approved by the IRB, the researcher should submit a new proposal for consideration by the Board.

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