HUMAN SUBJECTS RESEARCH APPLICATION
Instructions: Please complete this form and attach a copy of the study protocol for all new human subjects research. All the questions
must be addressed in order to provide the Institutional Review Board with the necessary information to review your proposed research
study. IRB approval must be obtained prior to beginning any human subjects research, including recruitment of study participants
Researchers are also required to take the Collaborative Institutional Training Initiative (CITI) online training through Emerson College's
subscription. The IRB will not consider an application unless we have evidence that all investigators named in this application
have completed the online training at the time the application is submitted. If members of the research team completed the
training at Emerson, then we will have an electronic record of it. If a member of the team completed the CITI at another
institution, then please include a copy of the certificate in the appendix of this application.
1. GENERAL INFORMATION:
Protocol Title:
Date:
Research is being
conducted for:
Which Category of Approval
are you Requesting?
Research Project
Individual or Group Student Assignment/Thesis/ALE/Capstone
Other
As an exemption to the Office of Human Research Protections
As an expedited review
As a full IRB committee review
If you are requesting an exemption or an expedited review, please use Section 22 at the bottom of this application to provide a rationale
for the request. Please refer to the specific categories of exemptions and expedited reviews outlined by the U. S. government. The
descriptions of those categories appear on the Emerson IRB website.
2. PRINCIPAL INVESTIGATOR (Students should insert the name of their faculty/staff sponsor) *Note – CITI Certification is required:
Currently CITI Certified:
Yes
No
Name:
School/Department:
Campus Mailing Address:
Telephone Number: (
)
Faculty
Staff
E-mail Address:
3. CO-INVESTIGATOR *Note – CITI Certification is required: If additional space is needed, please add on a separate page.
Currently CITI Certified:
Yes
No
Name:
School/Department:
Campus Mailing Address:
Telephone Number: (
)
E-mail Address:
Faculty
Staff
Student
4. RESEARCH STAFF: If additional space is needed, please add on a separate page. *Note – CITI Certification is required
Name
Currently CITI Certified
Yes
No
Yes
No
Yes
No
5. COLLABORATORS: If you will be conducting this study in collaboration with non-Emerson investigators or in non-Emerson facilities,
please complete the section below. *Note – CITI or Responsible Conduct of Research Training (RCR) required
N/A
Name
Affiliated Institution
IRB Approval
CITI/RCR Certified
Yes
No
Pending
Yes
No
Pending
Yes
No
Pending
Yes
No
Pending
6. FUNDING SOURCES: If the study is funded, please provide a copy of the full grant, proposal and/or award
N/A
External Federal-Fund
Agency:
External Non-Federal Fund Source:
7. INTRODUCTION: Please provide a brief summary of any relevant background information and study aims . Please provide a rationale
for the use of human subjects in meeting your study objectives.
Duration:
Study Site(s):
From
To
8 . STUDY POPULATION
Total Number of Subjects:
Age Range:
Characteristics of Study Population: Please check all that apply. These categories refer to your intended sample, not individuals who
might accidentally become part of your study.
Senior (≥ 65)
Children (< 18)
Emerson Students/Staff
Prisoners
Non-English Speaking
Ethnic Minorities
Mentally Disabled
Pregnant Women
Fetuses /Neonates
Other:
9. SELECTION OF SUBJECTS: Describe the inclusion/exclusion criteria and explain rationale for such. Explain rationale for using special
populations such as children, pregnant women, prisoners, minorities or any vulnerable individuals and describe the additional safeguards
that are in place to protect their rights and welfare. Provide rationale for concluding that the risks and benefits are fairly distributed among
the population that stands to benefit from the research.
10. RECRUITMENT TOOLS:
Please include all tools used to contact in appendix.
11. RECRUITMENT PROCESS: Describe in detail how subjects will be identified, method of initial contact and rationale for such method.
12. INFORMED CONSENT PROCEDURES: Please provide copies as separate attachments for all marked.
Written Informed Consent will be obtained
Waiver of Documentation of Informed Consent per §46.117(c) Please complete appropriate form.
Informed Consent will be obtained via a short form written document per §46.117(b)(2)
Waiver of some of the elements of informed consent per §46.116(d) Please complete appropriate form.
13. INFORMED CONSENT/ASSENT PROCESS: Describe consent/assent procedures to be followed, including the circumstances under
which consent/assent will be sought and obtained, the nature of information to be provided to prospective subjects, and method of
documentation.
14. RESEARCH TOOLS: Please provide copies for all marked.
Surveys or Questionnaires (e.g. online surveys, mailed surveys, personal or medical history)
Measurement Instruments (e.g. psychological tests, IQ tests, diagnostic tools)
Record Review (e.g. chart review, public school records, medical records, agency records)
Recorded:
Audio
Video
Interviews
In Person
Phone
Other:
Recorded:
Audio
Video
Focus Groups
In Person
Phone
Other:
Other:
15. RESEARCH PROCEDURES: Describe the study procedures that a research participant should expect during the protocol. Define the
type, frequency, duration of participation (e.g., what is done and when). When applicable, describe which procedures are experimental and
which are routine. If deception is used, describe how subjects will be deceived and/or debriefed.
16. COMPENSATION METHOD: If participants will not be compensated check this box
N/A; skip to section 17.
Amount/value of total compensation?
Type:
Gift Card;
Cash;
Raffle; Other:
If students are being used as research subjects, will they receive course credit (including extra credit)?
Yes
No
If yes, describe an alternate and equitable way to earn this credit without participating as a subject in research. Alternatives must not entail
more time, effort, or stress on the part of the student than the research activity.
17. RISKS: Describe any known or potential risks and/or discomforts (physical, psychological, social, legal or other) and assess their
likelihood, seriousness and potential reversibility. Describe procedures for protecting against these risks and assess their likely
effectiveness. Describe any alternative procedures including the choice not to participate. Please do not say that there are no risks. There
are always risks involved with human subjects research, even if they are minimal.
18. BENEFITS: Describe any potential benefits to the individual subjects and/or to society in general that may be expected from the
research. Describe the importance of knowledge that may reasonably be expected to result from the study. If no direct benefits are
anticipated, please state so.
19. RISK/BENEFIT ANALYSIS: Discuss why risks are reasonable in relation to the anticipated benefits to subjects and in relation to the
importance of the knowledge that may be reasonably be expected to result.
20. RESEARCH DATA
Will personally identifiable information be recorded?
Yes
No; If so, please check all that apply:
Names (First and Last)
Date of Birth
Telephone/Fax Number
Email Address
Social Security Number
Student ID
Street address, city, five digit zip code, county
Internet IP Address
Other:
Will you be sharing any research data with anyone outside of Emerson?
Yes
No
Will the research data be assigned a unique ID?
Yes
No;
If yes, will a link between the unique ID and person’s identifiable information be retained?
Yes
No;
If yes, for how long and how?:
21. PRIVACY AND CONFIDENTIALITY: Describe procedures for protecting privacy and maintaining confidentiality including procedures
for collection, storage and future use of data. Describe whether codes will substitute names and/or identifiable records, who will have
access to study data, whether database will be password-protected or encrypted for online data collection. Describe how long written
records, tapes or recordings will be maintained, in what manner they will be kept or destroyed and for how long.
22. FURTHER INFORMATION: Is there other information that would help the IRB better understand your proposal? Please use this
space to provide a rationale for why this data collection should be considered exempt or receive an expedited review. When filling in this
section, researchers must refer to the specific category of exemption (Categories 1-6) or expedited review (Categories 1-9), as well as give
a rationale on why the research applies to this category. Links to the categories of exempt and expedited review can be found on the IRB
Types of Review page.
23. PRINCIPAL INVESTIGATOR’S SIGNATURE
By submitting this form, I acknowledge and accept my responsibility for protecting the rights and welfare of human research participants as
discussed in the Common Rule (45 CFR 46) and Belmont Report. I certify that I will comply with all applicable regulations and directions of
the Institutional Review Board, which may include:
1. Conducting this research study as approved by the IRB
2. Submitting any changes to the protocol to the IRB for review and approval prior to implementation.
3. Monitoring and supervising investigators and research staff in the conduct of the research.
4. Maintaining accurate, current and complete records of all study materials including all IRB correspondence.
5. Complying with all state and federal laws as well as Emerson College’s institutional policies regarding the conduct of
research with human subjects.
Principal Investigator’s Name: