IRB Proposal Review

IRB Proposal Review
Note to all Prescott College students, Prescott College employees (faculty, staff, and administrators), and nonemployees acting on behalf of the college to conduct research with living participants or systems: Please submit this form, with all other appropriate preliminary documentation (including interviews, surveys, consent forms, etc.), to the Review Board. If you have questions about the process, please email irb-board@prescott.edu
Principal Investigator Name (Supervising Faculty)*

First NameLast Name
Project Author Email*
example@example.com
Project Title*
Title on consenting documents (if different from project title)
Identification of Research Oversight

Please identify the Investigator(s) and Oversight individuals
All individuals conducting research involving human subjects (with or without financial support of any sponsoring organization or agency) must complete the Human Subjects Research Training Course through the Collaborative Institutional Training Initiative (https://about.citiprogram.org/en/homepage/). Principal Investigator, Additional Investigators, Faculty and Mentors must all complete the required training and submit a certificate number.

Instructions
- Examples of Co-Investigator's: Student, collaborating researcher
- External Mentor
All individuals conducting research involving human subjects (with or without financial support of any sponsoring organization or agency) must complete the Human Subjects Research Training Course through the Collaborative Institutional Training Initiative (https://about.citiprogram.org/en/homepage/). Principal Investigator, Additional Investigators, Faculty and Mentors must all complete the required training and submit a certificate number.
Principle Investigator Name*

First NameLast Name
Principle Investigator Email*
example@example.com
Principal Investigator Phone Number*

Area CodePhone Number
Principal Investigator Degree
Principle Investigator Specialty
CITI Certificate Number*
Co-Investigator Name*

First NameLast Name
Co-Investigator Email*
example@example.com
Co-Investigator Phone Number*

Area CodePhone Number
Co-Investigator Degree
Co-Investigator Specialty
CITI Certificate Number*
- Mentor Name
  
  First NameLast Name
- Mentor Email
  example@example.com
- Mentor Phone Number
  
  Area CodePhone Number
- Mentor Degree
- Mentor Specialty
- CITI Certificate Number*
- Core Faculty Advisor Name
  
  First NameLast Name
- Core Faculty Advisor Email
  example@example.com
- Core Faculty Advisor Phone Number
  
  Area CodePhone Number
- Name Noted on CITI Certificate
  
  First NameLast Name
- Project Information
  
  Please provide answers to the following questions
- Project Start Date*
  
  MonthDayYear
  Date
- Project End Date*
  
  MonthDayYear
  Date
- YesNo
- Sponsoring Agency(ies)
- PROPOSAL ABSTRACT
  In the space below, provide an abstract of the project in 500 words or less. Include information about (a) the background and rationale for the study; (b) the purpose and objectives; (c) methods to be employed; (d) significance of the study; (e) a short bibliography of existing literature this study will build upon.
- Proposal Abstract*
  
  0/500
- Population/Sample
- Number of persons to be recruited for participation in the study.*
- Describe the population to be recruited and rationale for their participation (indicateage range, gender, and ethnicity). *
  Note any special efforts to encourage the recruitment of women and/orrepresentatives from racial or ethnic minoritygroups.
- Does your study involve persons from socially stigmatized groups (gay/lesbian, disabled,homeless, older persons); and/or vulnerable populations such as children,pregnant women, prisoners, or cognitively impaired subjects; and/or populations at risk of transitioning into one of these stigmatizing/vulnerable categories during the course of your study (e.g., a longitudinal study involving illegal drug users who are at risk of becoming incarcerated while in the study? If Yes please provide details*
- What are the inclusion and exclusion criteria for study participation?*

RECRUITMENT AND CONSENT PROCEDURES.
- For each response in this section, note whether the activity will be done orally, in writing, or both.
- Include all consent documents in Appendix A (1-3).
- Include copies of any visual material (advertisements, flyers, web announcements, etc.) in Appendix B for approval.
For each response in this section, first note whether the activity will be done orally, in writing, or both, then proceed to discuss in clear, specific detail, the issue(s) suggested in each numbered item.
List points to be covered in an oral or written presentation here.*
Describe how potential participants will be identified and how you will respect andprotect their privacy during recruitment.*
Describe how you will contact individuals who may become participants in the study (e.g., web site, email,flyers, phone calls, advertisements).*
Describe how the project will be explained to individuals when yourecruit them for participation (include the text of advertisements, phonesolicitations, etc.). Include any pre-screening questions or surveys that may be used.*
Describe how informed consent will be obtained. If the participants are minors or of another vulnerable population, explain how assent or legal consent will be secured. Include (if appropriate) the steps you will take to allow sufficient time for participants to think about their participation or time to review the consent form with family or friends, prior to consenting. If an informed consent document is inappropriate for your project, explain why and how you will ensure informed consent.*
How will you make it clear to the recruits that their participation isvoluntary and that they may withdraw at any time?*
Describe the additional safeguards you will use to protect participantsfrom coercion or undue influence, during recruitment and throughout the study (e.g., if the participants are students and the investigator is their teacher).*

METHODOLOGY AND DATA COLLECTION PROCEDURES
Is your project evaluating an active intervention or treatment procedure (todetermine whether an intervention/treatment is effective for the peopleundergoing it)? *
If yes, in lay terms provide a summary of the intervention and/or treatment methods and procedures to be employed:
Questionnaires/SurveysInterviews/Focus GroupsObservationsRecordsReview (medical, education, etc.)VideotapingAudio RecordingPhotographyParticipant ObservationOther (including electronic media, please define)
In lay terms, provide a detailed description of the research methods (includingdeception) and procedures for data collection that will be employed. Describethe procedures you will use to respect and protect the research participant’sprivacy (physically, behaviorally, or intellectually) during the datacollection process (e.g., during the interview the participant will meet withthe researcher in a location away from her/his place of employment).*
Describe (when appropriate) how the research plan makes adequate provision formonitoring of data when participant safety is a concern, or identification ofor support for distressed participants to ensure their safety (e.g.,Participants who may experience trauma as a result of this study will beprovided with referral information so they may seek professional help.)*
Where will the project be conducted? If studyis to be conducted outside of the Prescott College campuses (e.g., in anotheruniversity campus, at an off-campus agency or organizational location), includea letter of authorization in Appendix E, or state when it will be provided tothe IRB Committee. If your project takes place off-campus but siteauthorization is inappropriate, explain why.*
Thoroughly describe how data will be synthesized, analyzed, and reported. The procedures described may vary depending upon the instruments and methods used (no more than 400 words).*

CONFIDENTIALITY OF PERSONAL IDENTIFYING INFORMATION
What procedures will be followed to ensure that the information obtained about theparticipants will be stored in a secure manner? (Specify how the confidentialityof data will be maintained throughout the research.)*
What are the plans for retention and/or destruction of linkages between study dataand personal identifying information? (Specify when and how all data (includingpersonal identifying information) will be destroyed.)*
If these linkages will not be destroyed, explain how you will maintainconfidentiality of the personally identifyinginformation.*
In the event that personally identifying information will not be keptconfidential, explain why not and explain how you will ensure that theparticipants are consenting to your sharing this information.*
Will a Certificate of Confidentiality (through DHHS or another Federal agency) be utilized?*

BENEFITS, COSTS, COMPENSATION AND RISKS
What are the potential benefits directly to the participants, if any?*
What are the potential broader benefits and significance of the study?*
Costs: What are the costs to the participants (monetary, time, emotionalvulnerability, etc)?*
Compensation: Will monetary or other compensation be offered to the subjects? (If so, identify the amount and type of compensation and method of payment.)*
What risks to the participants could be encountered through participation in thisproject (physical, psychological, sociological, financial, economic, etc)?*
Describe the approaches you will take to minimize these risks and/or to minimize theirimpact on the participants.*
Appendice
Instructions:

For the items below combine all files into a single pdf then upload below

1.    Attach the following appendices, in the order specified

2.    Label each appendix as indicated.

3.    Include a table of contents identifying all appendix materials.

4.    Use titles that are consistent with those used in the text of your IRB Proposal.

A.1 Participant Informed Consent Form

A.2 Guardian or Parental Informed Consent Form

A.3 Minor Assent Form

B. Recruitment Materials

C. Data Collection Instruments

E.1 Site Authorization Letter (if study is conducted away from Prescott College)

E.2 Site Authorization (if study requires access to administrative records)

F. Grant Applications

G. HIPAA documentation.

H. CITI Training Certificates for all members of the research team
Please upload Appendices*

Browse Files
Combine all files into one pdf file. Cancelof
Should be Empty:

IRB Proposal Review

Identification of Research Oversight

Project Information

METHODOLOGY AND DATA COLLECTION PROCEDURES

CONFIDENTIALITY OF PERSONAL IDENTIFYING INFORMATION

BENEFITS, COSTS, COMPENSATION AND RISKS

Appendice