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
Assignment/Thesis/ALE/Capstone
conducted for:
Which Category of Approval
are you Requesting?
Research Project
Individual or Group Student
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:
From
Study Site(s):
8 . STUDY POPULATION
To
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.
A survey (see Appendix XX) will be conducted at the South End Community Center in Boston,
Massachusetts. This will be a self-administered survey, using a convenience sample of women with
chronic back pain who access services at the South End Community Center. The purpose of the survey
is to assess and understand different attitudes and beliefs of women regarding acupuncture as a
treatment option for lower-back pain. Participants must be 18 years or older, fluent in English, and have
experienced lower-back pain within the last 12 months. Participants will be recruited from the South
End Community Health Center, which is housed in the same building as Pathways to Wellness. It is a
comprehensive health care facility that serves a diverse community. The surveys can be completed on
the premises for the ease and comfort of the participants.
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.
Jane Doe will set up a table with recruitment flyers and consent forms and gather willing participants for
the survey during the weekly information table sessions held at South End Community Health Center.
Recruitment for survey participants will be ongoing until 150 surveys can be collected. Recruitment
techniques include: displaying copies of the recruitment flyer (see Appendix XX) on the table so
participants can stop by of their own volition during the information sessions; to generate interest before
the information session, there will be recruitment flyers (see Appendix XX) posted on the informational
bulletin boards in the lobby of the South End Community Health Center and the Pathways to Wellness
waiting room. The flyers will indicate when and where participants can stop by to pick up the survey,
should they choose to participate. Once someone approaches the survey table, they will be greeted by
Jane Doe, who will answer any questions they may have about the survey or the research project. She
will ask them if they are interested in participating, and if so, she will give them the survey to complete.
If not, she will thank them for stopping by. Participants will be assured that declining to participate will
have no bearing on their ability to receive services at the South End Community Health Center.
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.
FOCUS GROUP EXAMPLE
Informed consent will be obtained by Jane Doe, who has completed the CITI training for Human
Subjects (see Appendix XX for a copy of the certification document). Informed consent will be obtained
from all focus group participants at the community centter prior to the start of the focus group. The
consent form will be handed to participants when they arrive at the center for the focus group. A copy
of the consent form can be found in Appendix XX. Participants will be made aware of the key elements
of the consent, including the use of audio recording. Participants will be encouraged to ask questions
about the focus groups and the consent process at the time of consent. Participants will be permitted as
much time as is necessary to completely read the informed consent document and ask any questions. It
is estimated that this will require no more than 15 minutes to complete. Before they can participate in
the focus group, participants must hand a signed copy to Ms. Doe.
SURVEY EXAMPLE
The online survey will include an abbreviated form of consent for completing the survey by indicating
“yes” to the first question (see copy of the survey in Appendix XX), which will provide details about the
research project and the survey process and ask potential respondents if they understand their rights as a
participant. If they indicate yes, they will be instructed to continue on with the rest of the survey and
their answers will be included in the study results. If they indicate no, they will not be able to move
forward in the survey to any other questions. It is estimated that the consent portion of the survey will
require no more than 5 minutes to complete.
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.
SURVEY EXAMPLE
Starting March 17, 2013, Jane Doe will set up a table with recruitment flyers and consent forms and
gather willing participants for the survey during the weekly information table sessions held at South End
Community Health Center. Recruitment for survey participants will be ongoing until 150 surveys can
be collected. Recruitment techniques include: displaying copies of the recruitment flyer on the table so
participants can stop by of their own volition during the information sessions; to generate interest before
the information session, there will be recruitment flyers posted on the informational bulletin boards in
the lobby of the South End Community Health Center and the Pathways to Wellness waiting room. The
flyers will indicate when and where participants can stop by to pick up the survey, should they choose to
participate. Once someone approaches the survey table, they will be greeted by Jane Doe, who will
answer any questions they may have about the survey or the research project. She will ask them if they
are interested in participating, and if so, she will give them the survey to complete. If not, she will thank
them for stopping by. Participants will be assured that their participation or not will have no bearing on
their ability to receive services at the South End Community Health Center. Survey participants are
informed that their participation is voluntary and that refusal to participate will involve no penalty or
loss of benefits. They are also informed that they may discontinue participation at any time without
penalty or loss of benefits. Surveys will be anonymous; no identifying information will be provided. The
surveys will be assigned a randomized number prior to printing which will be coded on the survey in
advance of it being given to pregnant women receiving care at the South End Community Health
Center. The randomized numbers coded on the surveys will not be in sequential order, so the research
team will not be able to identify which survey number was given to which person. Jane Doe will hand
out the surveys and participants will drop the completed form in a lock box that only members of the
research team have the key to unlock.
FOCUS GROUP EXAMPLE
Both focus groups will be 60 minutes long, and will be conveniently scheduled for potential
participants. The focus group discussion will be conducted at a conference room within the main
hospital location. All participants must complete the Informed Consent Form before participating
(Appendix XX). The informed consent form will explain that the discussion will be recorded by an
audio recorder, and notes will be taken by two observers. The form will also explain that the
participation of each individual is voluntary, confidential, and that once the recording is transcribed,
coded and analyzed it will be destroyed. Once all potential participants have signed the consent form,
the group will commence. The focus groups will be moderated by Jane Doe. As described in the Focus
Group Moderator’s Guide (Appendix XX), the moderator will begin by explaining the ground rules of
the group and having each participant introduce him or herself with first names only. The moderator
will then ask questions on the guide and probe where appropriate. Once the focus group discussion has
been completed, participants will be rewarded with their $10 Coffee Central gift card incentive as a
thank you. Focus group data will be collected through audio recording and supplemented by the notes
of the two observers taken during the discussion.
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.
FOCUS GROUP EXAMPLE
This focus group study presents minimal risk. The primary risk is loss of confidentiality through the
breach of focus group data (audio recording) or disclosure of information by participants upon leaving
the group. This will be guarded against by keeping all recordings of the focus group session stored in a
secured drive accessible only by Jane Doe and the authorized research assistant, who was also
responsible for notetaking and recording the session. We also will instruct focus group participants to
only use first names. Recordings will be digitally destroyed and the computer they were stored on
swept clean of the electronic record using the latest digital erasing software tools available at the
conclusion of the project timeline. Notes taken during the focus group and the completed surveys will be
kept in a locked cabinet accessible only to Jane Doe and the authorized research assistant. Audiotapes
will be destroyed when coding has concluded. To minimize the risk of post-group disclosure of
information, participants will be reminded of the importance of maintaining confidentiality at the start
and conclusion of the focus groups. Participants also may be uncomfortable talking about attitudes and
beliefs related to acupuncture and lower-back pain but the participants of the focus group will be told
that their participation is completely voluntary and that they may terminate participation at any time.
SURVEY EXAMPLE
For the survey participants, there is minimal risk. The primary risk is feelings of discomfort. Participants
may be uncomfortable talking about attitudes and beliefs related to acupuncture and lower-back pain.
Survey participants are informed that their participation is voluntary and that refusal to participate will
involve no penalty or loss of benefits. They are also informed that they may discontinue participation at
any time without penalty or loss of benefits. Surveys will be anonymous; no identifying information will
be provided. Jane Doe will hand out the surveys/recruit participants and they will drop the completed
form in a lock box that only the research assistant has the key to unlock. The research assistant will
enter the data from the survey, having had no contact with the participant. The surveys will be stored in
a locked file cabinet.
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.
Information gained during the focus group will allow the research team Jane Doe to assess and
understand different attitudes and beliefs of women regarding acupuncture as a treatment option for
lower-back pain. This information can be used to create an effective intervention that will benefit other
women with lower-back pain. There is no direct benefit to participants at the time of the study. They
may potentially hear new information or perspectives about acupuncture as a treatment modality for
lower-back pain that they may want to explore, but that is not being advocated by the study.
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.
FOCUS GROUP EXAMPLE
All focus group participants will be fully informed that their participation is voluntary and confidential.
Only Jane Doe and the authorized research assistant will have access to any participants’ responses or
personal information. Responses will not be connected to participants’ personal information in any way.
Focus group participants will be provided with an Informed Consent Form (see Appendix XX) prior to
their agreement to participate. Once at the site of the focus group participants will be verbally reminded
of their confidentiality prior to the start of the focus group. Although the participants will be asked to
maintain confidentiality for each other as well, the research team realizes that compete confidentiality
cannot be guaranteed. During these sessions, the respondents will be instructed to use only their first
names. The focus group recordings will be kept only long enough to be transcribed. They will be kept
on a secured computer drive and accessible only by Jane Doe and the authorized research assistant, who
was also responsible for notetaking and recording the session. Once transcriptions are made and data
analysis is complete, recordings will be digitally destroyed and the computer they were stored on swept
clean of the electronic record using the latest digital erasing software tools available at the conclusion of
the project timeline. Transcriptions made from the recordings and written notes made during the focus
group will be stored in a locked file cabinet and accessible only by the research assistant and Jane Doe.
The transcripts and notes will be shredded after three years.
SURVEY EXAMPLE
Survey respondents will be anonymous; no identifying information will be provided. The surveys will
be number coded in advance and be given to women receiving care at the South End Community Health
Center. The surveys will be placed in random order prior to distribution so, for example, the survey
marked #1 will not likely be the first survey returned. Jane Doe will hand out the surveys to
participants, and they will drop the completed form in a lock box that only the research team has the key
to unlock. The research assistant will enter the data from the survey having had no contact with the
participant. The surveys will be stored in a locked file cabinet. The surveys will be shredded after three
years.
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.
EXPEDITED REVIEW EXAMPLE FOR INTERVIEWS
The Federal government specifies the research activities that (1) present no more than minimal risk to
human subjects, and (2) involve only procedures listed in one of several categories, may be reviewed by
the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110.
Category 7 in that list specifies that one form of research that can receive an expedited review is
research on individual or group characteristics or behavior (including, but not limited to, research on
perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and
social behavior) or research employing survey, interview, oral history, focus group, program evaluation,
human factors evaluation, or quality assurance methodologies. This study will use interviews. The
Federal guidelines also specify that for a project to qualify as expedited that identification of the
subjects and/or their responses would not reasonably place them at risk of criminal or civil liability or be
damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing,
unless reasonable and appropriate protections will be implemented so that risks related to invasion of
privacy and breach of confidentiality are no greater than minimal. For these interviews, we believe that
asking participants about their opinions of comic book material about a health issue poses no more than
minimal risk to the participants, because identification of their responses would not reasonably place
them at risk of criminal or civil liability or be damaging to the subjects’ financial standing,
employability, insurability, reputation, or be stigmatizing. We also have taken measures to make sure
that there is not a breach of confidentiality. HHS further defines minimal risk as "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." We believe that talking about comic book material will cause no greater harm
or discomfort than if the research participants were talking about these topics with family, friends, and
colleagues in daily life.
EXEMPTION EXAMPLE FOR AN ANONYMOUS ONLINE SURVEY
We believe that the collection of these data should be exempt from IRB review based on Exemption #2
of the HHS Human Subjects Research Regulations at 45 CFR Part 46. The criterion states that
exemptions can be granted for:
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures or observation of public behavior, unless:
1. information obtained is recorded in such a manner that human subjects can be identified, directly or
through identifiers linked to the subjects; AND
2. 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.
This is an anonymous survey that does not meet the first "unless" condition (i.e., respondents cannot be
identified, directly or through identifiers linked to the subjects). Thus, we believe that any survey that is
totally anonymous such as this one should be exempt by definition.
EXEMPTION EXAMPLE FOR FOCUS GROUPS
We believe that the collection of these data should be exempt from IRB review based on Exemption #2
of the HHS Human Subjects Research Regulations at 45 CFR Part 46. The criterion states that
exemptions can be granted for:
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures or observation of public behavior, unless:
1. information obtained is recorded in such a manner that human subjects can be identified, directly or
through identifiers linked to the subjects; AND
2. 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.
We will be conducting a focus group. Focus group subjects, of course, can be identified, but we believe
that the project does not meet the second “unless” condition. We can guarantee confidentiality but not
anonymity to the participants, but even if responses were disclosed outside of the research, we do not
believe that the information obtained would reasonably place anyone at risk for criminal or civil
liability, nor do we believe that there is any reasonable risk of damage to someone's financial standing,
employability, or reputation. When you see the moderator's guide, you will see that all of the questions
relate to opinions about a new phone application for tracking physical activity. We are not asking
participants to disclose any personal information.
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: