apus irb - american public university web viewadministrative amendment, grammatical corrections: yes...

This manual outlines the research protocols for

human subject research at American Public University

System.

APUS IRBInstitutional Review Handbook

APUS IRB

American Public University System March 2016

Institutional Review Board

TABLE OF CONTENTSTable of Contents........................................................................................................................................................................ 1

INTRODUCTION.......................................................................................................................................................................... 3

APUS POLICY ON RESEARCH INVOLVING HUMAN SUBJECTS...............................................................................3

Scope of Research Subject to IRB Approval....................................................................................................................4

TRAINING: Collaborative IRB Training Initiative (CITI) Training........................................................................4

Research Involving APUS Staff, Students, and/or Faculty........................................................................................4

Working With De-Identified Data Not Collected Through Interaction or Intervention..............................5

IRB Considerations for Class Activities.............................................................................................................................5

Student Research Requiring IRB Approval.....................................................................................................................6

Program Improvement, Assessment of Quality Improvement Studies..............................................................6

Research Exempt from IRB Review....................................................................................................................................6

Criteria for Approval of Research Not Exempt from Committee Review..........................................................7

IRB Decisions are Final and Binding..................................................................................................................................8

PREPARING AND SUBMITTING IRB PROPOSALS........................................................................................................8

INVESTIGATOR RESPONSIBILITIES...................................................................................................................................9

Study Changes.............................................................................................................................................................................. 9

Adverse Events............................................................................................................................................................................ 9

What to Report............................................................................................................................................................................. 9

Annual Renewal........................................................................................................................................................................10

Addition or Deletion of Personnel or Investigators..................................................................................................10

IRB COMPOSITION, PROCEDURES AND RESPONSIBILITIES...............................................................................10

Full Board.................................................................................................................................................................................... 11

1



Expedited and Exempt Applications..................................................................................................................................11

Procedures for Review of Research.................................................................................................................................11

Committee Records.................................................................................................................................................................11

UNIVERSITY POLICY ON ETHICAL CONDUCT IN RESEARCH, SCHOLARSHIP AND EDUCATIONAL ACTIVITIES................................................................................................................................................................................. 12

Procedures.................................................................................................................................................................................. 12

Appendix A: The IRB Checklist...........................................................................................................................................14

Appendix B: IRB Applications.............................................................................................................................................16

Appendix C: Sample Consent Forms:...............................................................................................................................36

Appendix D: Data Usage, Storage, and Destruction Agreement..........................................................................40

Appendix E: Protocol Amendment Form.......................................................................................................................41

Appendix F: Form for Reporting to the IRB Unanticipated Problems that May Involve Risks to Subjects or Others (UPIRTSO)............................................................................................................................................43

Appendix G: Extension Request for Approved Research........................................................................................46

INTRODUCTION

American Public University System (APUS, this includes American Public University APU and American Military University AMU, hereafter referred to as APUS), like many other universities, maintains a research program that is in compliance with the U. S. Department of Health and Human Services (HHS) Office for Human Research Protection's (OHRP) Federalwide Assurance (FWA ) guidelines. At APUS, all human subjects research is guided by ethical principles as described in the federal regulation, the Belmont Report, and “common rule” regulations 45CFR46. Compliance with these regulations is assured through approval and oversight of all institutionally affiliated research by APUS faculty, staff and student researchers.

The APUS Institutional Review Board (IRB) is the committee responsible for ensuring the protection of human subjects in research studies. Specifically, the committee:

Protects the rights and welfare of human subjects; and

2

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

http://www.hhs.gov/ohrp/assurances/assurances_index.html



Insures research is in compliance with all ethical, federal, and university regulations.

The purpose of this handbook is to explain the IRB, outline the process for completing an application, and explain the review and approval processes.

In this handbook, you will find:

Background materials on federal regulations

Guidelines for submitting your application;

Information to assist faculty and students in preparing for CITI training;

The latest versions of all research application forms; and

Informed consent templates.

APUS POLICY ON RESEARCH INVOLVING HUMAN SUBJECTSIt is the policy of American Public University System (APUS) that all research involving human subjects and conducted under the aegis of APUS, must be conducted in accordance with accepted ethical and professional standards, and must be in compliance with federal regulations. All such research involving human subjects (unless it is specifically exempt from review as outlined within this handbook) must be reviewed and approved by the University's Institutional Review Board (IRB) before it is conducted. It is the policy of APUS that the IRB committee has the authority to approve, require modifications in, or disapprove any research conducted under aegis of APUS involving human subjects.

The term "research" refers to that which

Contributes to generalizable knowledge;

Is designed in advance;

Utilizes a systematic approach (45CFR46).

The term "human subject" is defined by Federal Regulations as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information” (45 CFR 46.102(f)).

Human participants include those who are actively involved in the research process (being interviewed, filling out surveys, etc.);

They also include those who provided medical samples, left records of their activities through applying for marriage licenses, etc.

3

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm



The IRB reviews research that involves living individuals (1) about whom "an investigator conducting research obtains data through intervention or interaction with the individual" or (2) which contains "identifiable private information" (Title 45 CFR, Part 46.102.f). Secondary analysis of existing datasets where participants are individually identifiable should be reviewed by the IRB.

SCOPE OF RESEARCH SUBJECT TO IRB APPROVALHuman subjects research at APUS, requires IRB approval. If the research is not being conducted at APUS and does not involve APUS students or resources, but involves human subjects outside the institution, the determination of whether IRB approval is required shall be decided by the IRB Chair or their delegate. For example, if the investigator is an employee of APUS and a graduate student at another institution where research is being conducted, the IRB Chair or their delegate should be notified of such activity to determine if APUS IRB approval is needed.

TRAINING: COLLABORATIVE IRB TRAINING INITIATIVE (CITI) TRAININGAPUS requires all IRB applicants undergo CITI training PRIOR to submitting their IRB application. Proof of successful completion of the Social and Behavior Research Investigator Modules is required. Research will not be approved until the training requirements are met. Documentation of training must be provided to the IRB Office with all new applications.

RESEARCH INVOLVING APUS STAFF, STUDENTS, AND/OR FACULTYAny research that involves APUS staff, students and/or faculty must secure not only IRB approval, but also approval from the Internal Research Review Board (IRRB). Researchers interested in conducting research at APUS must complete the “Request to Conduct Research” application. The application should be submitted by the principal investigator. NOTE: There are two different IRB Applications, one for students and one for faculty and staff (see Appendix B for both). If the proposed research is being done as part of a dissertation or advanced course work, the dissertation chair or lead faculty member must sign the form. Contact [email protected] for the application.

WORKING WITH DE-IDENTIFIED DATA NOT COLLECTED THROUGH INTERACTION OR INTERVENTIONThe OHRP has several decision charts designed to provide guidance regarding whether or not obtaining and analyzing data should be considered human subjects research (http://www.hhs.gov/ohrp/index.html). If you are not obtaining either identifiable private information or data through intervention/interaction with living individuals, then the research activity does not involve human subjects.

4

http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html#c1

mailto:[email protected]



If your data falls under this category, please read the following document: Guidance on Research Involving Coded Private Information or Biological Specimens. Based on this, if you believe your study is NOT human subjects research, but would like to be sure, please contact the IRB for official determination. Be aware that identifiable private information is not limited simply to names or student ID numbers, etc., but also includes circumstances under which data can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems.

IRB CONSIDERATIONS FOR CLASS ACTIVITIES

Research conducted as part of an in-class assignment is to be considered generally exempt from IRB review. The purpose of an IRB is to review research conducted using human subjects. For the purposes of APUS’ IRB, research is defined as being both:

1. Systematic2. Generalizable

Most in-class projects where research is conducted using human subjects are not systematic or generalizable. Systematic research includes research development, testing, and evaluation, and it is designed to create generalizable knowledge. Generalizable knowledge involves the creation of new knowledge that may be the basis for scholarly publication. In general, if the project is meant to complete an assignment for a class and will not be published, it does not require IRB review.

Please note: IRB approval cannot be provided retroactively. If a student believes that he/she will want to use the data for from the project for research purposes, then he/she should seek IRB approval prior to undertaking the research. A student who does not secure IRB approval for the class project, but who wishes to present their project to their course or colleagues, can do so as a classroom research project, but not as a research study. Making the data from the project public via a blog, conference presentation, etc. does however, constitute a research study.

STUDENT RESEARCH REQUIRING IRB APPROVAL All human subjects research requires IRB approval, whether it is conducted by APUS faculty, staff, or students. If you are a student and your study requires your advisor’s approval, IRB approval should only be sought after your advisor has approved your research. It is the responsibility of the student investigator AND the Faculty Advisor to ensure appropriate human subjects protection. In order to assure sufficient oversight of student research, IRB proposals from students must include the signature of the faculty advisor.

PROGRAM IMPROVEMENT, ASSESSMENT OF QUALITY IMPROVEMENT STUDIES

5

http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.htm

http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.htm



Studies and surveys that have limited generalizability may be exempt from IRB review. For example, surveys conducted by the University for internal improvements to programs or services are generally exempt. However, IRB approval may be required if those results form part of a larger research project that will be shared beyond the University.

RESEARCH EXEMPT FROM IRB REVIEWCertain types of research protocols may be exempt from review. The IRB is authorized to decide, consistent with applicable federal laws, guidelines and regulations, whether research protocols may be exempt from review or subject to limited or full review.

If you believe your research falls into the exempt category, complete the IRB form and submit it via this website to Office of the IRB. If the project is exempt, the IRB will notify you.

NOTE: Exemption categories DO NOT APPLY when the research activities include:

- Vulnerable populations such as prisoners, fetuses, pregnant women or human in-vitrofertilization;

- The review of medical records if the information is recorded in such a way that subjectscan be identified, directly or through identifiers linked to the subjects;

- Survey or interview techniques which include minors as subjects;- Techniques which expose the subject to discomfort or harassment beyond levels

encountered in daily life;- The deception of the subject.

Federal categories of research activities eligible for exemption certification are as follows:

1. Research conducted in established or commonly accepted educational settings, involving normal education practices, such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (b) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under (2) of this section, if: (a) the human subjects are elected or appointed public officials or candidates for public office; or (b) federal statute(s) require(s)

6

http://www.apus.edu/community-scholars/institutional-review-board/apply.htm



without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

5. Research and demonstration projects which are conducted by or subject to the approval of, department or Agency heads, and which are designed to study, evaluate, or otherwise examine: (a) Public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs.

6. Taste and food quality evaluation and consumer acceptance studies, (a) if wholesome foods without additives are consumed or (b) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U. S. Department of Agriculture (Code of Federal Regulations (45 CFR 46.101 b))

CRITERIA FOR APPROVAL OF RESEARCH NOT EXEMPT FROM COMMITTEE REVIEWThe IRB reviews proposals for research in accordance with federal regulations governing research with human subjects. It is the policy of APUS that in order for any research proposal to be approved, the IRB must determine that all of the following requirements are satisfied:

1. Risks to subjects are minimized and are reasonable in relation to anticipated benefits of the research;

2. Selection of subjects is equitable given the purposes and the setting of the research;

3. Appropriate informed consent will be sought from each subject or the subject's legally authorized representative, and such consent will be appropriately documented (for sample consent forms, see Appendix C);

4. The research plan makes appropriate provision for monitoring the data (see Appendix D: Data Collections, Storage and Destruction Agreement, collected to insure the safety of subjects;

5. Appropriate provisions are made to protect the privacy of subjects and to maintain the confidentiality of data;

6. Where some or all of the subjects are likely to be vulnerable to coercion or undue

7



influence, appropriate additional safeguards have been included to protect the rights and welfare of these subjects; and

7. All investigators named in the protocol, including students, must have completed approved training on the use of human subjects in research.

IRB DECISIONS ARE FINAL AND BINDINGIt is the policy of APUS that the final decision regarding approval or disapproval of all research proposals subject to the IRB review are final and binding. Any investigator who has a proposal rejected by the IRB must make appropriate modifications and submit a new proposal for review.

PREPARING AND SUBMITTING IRB PROPOSALS1. Prior to proposing or engaging in research, all faculty, staff or student researchers must

successfully complete Human Subjects Training from CITI: www.citiprogram.org

2. Please request your official IRB proposal form via the Request an Application link at http://www.apus.edu/community-scholars/institutional-review-board/apply.htm. Once you complete the Request an Application form, Classroom Support will contact you to generate an IRB dropbox in Sakai, where you will upload your application with all supporting materials. Student researchers shall complete proposal forms in conjunction with a participating faculty member.

3. IRB Applications are due the 15th of each month in order to be considered at that month's meeting. Applications received after the 15th of the month will be considered the following month. Incomplete applications will be returned to the applicant and their review may be deferred to the next month.

4. The IRB will notify the investigator(s) as to whether or not a proposal has been accepted via APUS email. In the event that a proposal is not accepted, the IRB will provide a reason for denial and a list of steps (if any) that would be acquired for the approval of the proposed research.

5. All APUS students who submit an IRB application must first secure the approval their instructor prior to submitting the application. When you request an application via the IRB website, Classroom Support will send you the Student IRB Application.

INVESTIGATOR RESPONSIBILITIESOnce the IRB has approved the research, the investigator will need to interact with the IRB if there are changes in the study protocol, adverse events (should any occur), and/or project renewals.

STUDY CHANGESIf a study changes in such a way that subjects are treated differently than outlined or described in the original protocol, a form (Appendix E) describing such changes must be submitted to the IRB for

8

http://www.apus.edu/community-scholars/institutional-review-board/apply.htm

http://www.citiprogram.org/



approval. Once the change has been approved, you may proceed with your research.

A change in a protocol might require a change in the consent form(s). When consent forms are submitted for review with a change form, you must submit two different consent forms:

1. the original consent form and

2. the proposed new consent form(s) with all the changes noted (boldfaced, shaded, etc.).

ADVERSE EVENTSUnanticipated problems or serious adverse events involving risk to human subjects must be reported to the IRB immediately.

Federal regulations [45CFR46.103(b)(5) and 21CFR56.108(b)(1)] requires investigators promptly report “any unanticipated problems involving risk to subjects or others” (UPIRTSO). UPIRTSO is defined as any problem or event which was unanticipated, has created a new or increased risk to the subjects, and is related to the research procedures. All such events must be reported to the IRB using the UPIRTSO form, see Appendix F. The IRB will determine if the event meets the criteria as a UPIRTSO.

WHAT TO REPORTThe following events meet the IRB’s definition of UPIRTSO and should be reported within the 10 day time frame:

Any event that was unanticipated and involved new or increased risk to subjects or others, and is 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 event 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 researcher.

Any other event which constitutes an unanticipated risk.

For more information on what constitutes “unanticipated problems” and “adverse events” please go to: http://www.hhs.gov/ohrp/policy/AdvEvntGuid.htm

9

http://www.hhs.gov/ohrp/policy/AdvEvntGuid.htm



ANNUAL RENEWALIf the approved study will exceed the one year approved timeframe, the research must be renewed with the IRB before the one-year anniversary as indicated on the initial approval letter. Complete the Extension Request (Appendix G) form and submit that to the IRB prior to the expiration of the one year deadline.

ADDITION OR DELETION OF PERSONNEL OR INVESTIGATORSThe IRB must be notified if investigators are added or removed from the research. Submission of a Protocol Amendment Form (Appendix E). If deemed necessary, additional documentation may be requested from the investigator(s). Approval of deletion or addition of personnel or investigators will be provided to all investigator(s) via email.

IRB COMPOSITION, PROCEDURES AND RESPONSIBILITIESCOMPOSITION OF THE IRB FOR RESEARCH UTILIZING HUMAN SUBJECTS

The IRB Chair shall recommend APUS faculty or staff to fill any vacancies on the IRB. Nominations will then be acted upon by the Provost. Members of the IRB shall be appointed for a term of 2 years. Members wishing to serve another term may do so. No member of the IRB may participate in the IRB review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. In such instances the remaining IRB members will review submitted proposals.

One of these members shall be the IRB Chair (or their designee) and at least two members shall be graduate level faculty. The remaining positions shall be filled at the discretion of the IRB Chair and the Office of the Provost. Faculty members shall represent a diversity of Departments. The full board will always have one member who is not affiliated with APUS and one member from the field of science.

FULL BOARDThe IRB consists of eight members. All eight members review applications requiring a full board review. A five member quorum is required for all full board IRB votes.

EXPEDITED AND EXEMPT APPLICATIONSA subcommittee of five members of the full board reviews applications that are expedited. The Director of Graduate Studies and the Assistant Provost for Graduate Studies review exempt requests.

10



PROCEDURES FOR REVIEW OF RESEARCHConsistent with applicable law and regulation, the IRB shall establish procedures for reviewing research proposals not exempt from review, to include procedures for continuing periodic review of research proposals initially approved. It is the University investigator's responsibility to comply with procedures established by the IRB and to keep the IRB informed of any proposed changes in the research that may affect risk to human subjects.

COMMITTEE RECORDS Documentation of IRB activities is maintained by the Office of the IRB Chair for at least three years following the completion of research and includes the following:

1. Copies of all research proposals reviewed, approved consent documents, etc.;

2. Documentation of actions taken through procedures of expedited review;

3. Minutes of meetings in sufficient detail to show attendance; actions taken; vote on these actions for, against, and abstaining; basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution;

4. Records of continuing review activities;

5. A list of IRB members as well as a copy of each member's professional vita.

UNIVERSITY POLICY ON ETHICAL CONDUCT IN RESEARCH, SCHOLARSHIP AND EDUCATIONAL ACTIVITIESAPUS supports and encourages full freedom, within the law, of inquiry, of research and publication, and of teaching. Members of the faculty and staff recognize that accuracy, forthrightness and dignity befit their association with APUS and their position as men and women with a shared commitment to the highest principles of learning.

Public trust in the integrity and ethical behavior of scholars must be maintained if research and other scholarly activities are to continue to play their proper role in our University and society. It is the policy of APUS that research and educational activities carried out by its faculty, staff and students be characterized by the highest standards of integrity and ethical behavior. It is further the policy of the University to inform fully all affected parties where research data or other information related to projects or programs sponsored by, or under the administrative supervision of, the University have been falsified or otherwise misrepresented. Finally, it is the policy of the University to protect to the maximum extent possible the positions and reputations of those persons who, in good faith, make allegations of scientific misconduct and of those persons against whom allegations of misconduct are not confirmed.

11

http://www.legal.uncc.edu/policies/ps-94.html#research



Each member of the APUS community has a personal responsibility for implementing this policy in relation to any scholarly work with which he or she is associated and for helping his or her associates in continuing efforts to avoid any activity which might be considered in violation of this policy. Failure to comply with this policy shall be dealt with according to the procedures specified herein and is considered to be a violation of the trust placed in the faculty, staff and student researchers.

PROCEDURES"Misconduct in research or educational programs" is defined as:

1. Failure to secure IRB approval before conducting human subjects research.

2. Serious deviation, such as fabrication, falsification, or plagiarism, from practices commonly accepted in the research community for proposing or carrying out research, or in reporting the results of research.

3. Material failure to comply with Federal requirements affecting specific aspects of the conduct of research or educational programs. Examples include, but are not limited to:

A. The protection of human subjects and the welfare of laboratory animals;

B. Fabrication, falsification, plagiarism, or other serious deviation from accepted practices in proposing, carrying out, or reporting results.

4. Retaliation of any kind against a person who reported or provided information about suspected or alleged misconduct and who has not acted in bad faith.

Anyone having reason to believe that a member of the faculty, staff member or student researcher has engaged in research misconduct should consult the IRB Chair.

Upon receipt of written allegations, the IRB Chair shall immediately report the concern to the Institutional Review Board

1. Immediately upon receipt of the report, the Institutional Review Board shall conduct an inquiry, consisting of information-gathering and initial fact-finding to determine whether the charge warrants an investigation. The inquiry should normally be concluded within 30 days. If the judgment is made that the charge does not warrant an investigation, no further action is required.

2. If no violation is found to have occurred, the research may continue.

3. If the investigation finds a violation has occurred, the IRB Chair, in consultation with the Provost and the Institutional Review Board, shall (a) take appropriate action to preserve and protect the data and other records relevant to the charge, and (b) notify the individual of the initiation of the investigation and of his or her opportunity to appear on his or her own behalf before the IRB, and (c) take the appropriate steps to notify sponsors in

12



accordance with applicable law and regulations. The IRB Chair may also suspend the individual accused from the project or activity in question. All data collected from human subjects without IRB approval must be destroyed and the research must stop immediately. Throughout the investigation the committee shall be sensitive to the effects of the proceedings on the individual, protecting his or her rights, and avoiding disclosure except to individuals who need to be involved in the investigation.

4. Any breach of the APUS Responsible Conduct of Research (RCR )policy is a serious violation of professional standards and will result in sanctions. Sanctions may vary depending upon the severity of the infraction, but may include written warning, termination, expulsion, termination of research, and/or the destruction of research data. Actions taken by the IRB and the University also will be subject to Federal reporting guidelines.

13



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

14



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 [email protected].

15



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 [email protected].

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:

16




Title/Position: Email:

Name: Study Role:


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

17



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.)

18

http://www.apus.edu/community-scholars/institutional-review-board/resources.htm



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

19



[__] 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


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)

20



[__] 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).

21



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:a. How the data will be safeguarded (e.g., data is anonymous, assigning pseudonyms,

aggregate reporting, etc.). b. How will subjects be explicitly informed if data will NOT be anonymous (Put “N/A” if using

anonymous data)c. What actions would you take if a participant gets hurt or upset?

1)

2)

3)

a.)

b.)

c.)

SECTION K: Deception/Incomplete Disclosure

22

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html%2346.116



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.):

23



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

24



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

________________________________ ________________________ ________________


25



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 [email protected].

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):

26




Name: Study Role:


Name: Study Role:


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.)

27



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


5) Topic and scope of the study.6) Research questions or hypothesis.7) How this study will contribute to knowledge in the field.8) 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:

4) Who will the participants be? How many participants? What ages will the participants be?5) What is the inclusion/exclusion criteria for participants?6) 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)

28

http://www.apus.edu/community-scholars/institutional-review-board/resources.htm



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):

29



SECTION F: Research Design


5) 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.

6) Which members of the research team will be involved in collecting data from participants?7) Explain how the data will be analyzed or studied; that is, indicate the quantitative or qualitative

data analysis methods you will use. 8) 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

30



[__] 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:

6) 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.)

7) Which members of the research team will be responsible for obtaining participants’ consent?8) 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).9) If participants are vulnerable populations, explain how you will follow research ethics guidelines

for obtaining consent. (If applicable). 10) 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)

31

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116



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:

4) 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.

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

6) Describe the procedures/process which will be used to reduce or minimize risks:a. How the data will be safeguarded (e.g., data is anonymous, assigning pseudonyms,

aggregate reporting, etc.). b. How will subjects be explicitly informed if data will NOT be anonymous (Put “N/A” if using

anonymous data)c. 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.

4) Describe the deception/incomplete disclosure of information to the subjects.5) Explain why such deception/incomplete disclosure is necessary.6) Explain the debriefing process, or explain why there will not be a debriefing process.

1)

2)

32



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.

33



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

34



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

________________________________ ________________________ ________________


________________________________ ________________________ ________________


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

35



APPENDIX C: SAMPLE CONSENT FORMS: In Person Consent Form (Place Title of Research Here) *Rewrite or delete red text (including this statement) to tailor this document to your research project.

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.

This study involves a web-based experiment designed to understand how people are motivated. The study is being conducted by Professor (Name), and it has been approved by the University Institutional Review Board. No deception is involved, and the study involves no more than minimal risk to participants (i.e., the level of risk encountered in daily life).

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: [email protected] .

_____ 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

36



_______________________________________________________ ___________________Witness (Signature or name with supporting email) Date

37



ONLINE SURVEY CONSENT FORM

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, [email protected].

ELECTRONIC CONSENT:

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:

o AGREEo DISAGREE

38




Thank you for your time and participation.

39



APPENDIX D: DATA USAGE, STORAGE, AND DESTRUCTION AGREEMENTI_________________________________ 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: [email protected].

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

_____________________________________________________ __________________

40



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:

41



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:_____________

42



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

43



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)

44



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

45



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: [email protected]

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.

46

apus irb - american public university web viewadministrative amendment, grammatical corrections: yes...

Documents