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Project
Outline
The following information must be provided to the IRB for its consideration,
in addition to the information requested on the Application
Form. Restate each outline heading (as shown below) in your proposal.
Failure to provide information in this format and using these headings
may delay review of your proposal. Please read all of the relevant information
on this site before preparing your Project Outline and Application Form.
A. Project overview.
B. Participants
1. Describe the pool(s) of human participants you will be using:
a. Sex, race or ethnic group, age range, etc.;
b. Affiliation of participants (e.g., institutions, hospitals,
general public, etc.);
c. Participants' general state of health (mental and physical);
d. Number of participants or sample size number.
2. If human participants are minors, mentally ncompetent, prisoners,
or legally restricted groups, give an explanation as to the necessity
for using these particular groups.
C. Procedures
1. Contacting Participants: Describe procedures used for contacting
and enrolling participants (i.e., who contacts them and enrolls
them in the study) and how this is done. Use non-technical language.
2. Data Collection: Describe information to be gathered, and
the means for collecting, recording, and storing the data. Include
a copy of any questionnaire or survey instrument to be used.
3. Personnel: Identify personnel who will be interacting with
the participant(s) and who will have access to the data.
4. Research Location: Indicate at what location(s) the human
participant involvement will occur.
5. Project Duration: State the duration of the project and amount
of time required from each participant.
6. Data Storage: State where the data will be kept after the
project's completion and who should be contacted if there is a need
to inspect the data.
D. Risk/Deception (If applicable)
1. Describe in detail any physical, psychological, social, legal,
economic or other risks you can foresee, both immediate and long
range:
a. Immediate risks;
b. Long-range risks;
c. Rationale for the necessity of such
risks;
d. Alternatives that were or will be considered;
e. Why alternatives may not be feasible.
2. "Non-Beneficial Research" is defined as research
involving investigations of a person, his or her body, life, or
surroundings, which is devoid of benefit to that person. If you
plan to conduct this type of research and believe that there are
no other methods available for obtaining the information needed,
please justify and describe:
a. The extent of the risks (physical, psychological, social,
legal, or other);
b. Why you believe that the value of the information to be
gained outweighs the risks.
3. If deception will be utilized in gathering data, the Principal
Investigator must:
a. Justify and support the deception in the project;
b. Provide a detailed written description of how and when
debriefing will occur.
c. If applicable, provide evidence that the agency from which
the participants will be recruited has been informed that deception
is being used.
E. Safeguarding Participants' Identities
1. How will information obtained from the participants be used?
What elements of your project might be openly accessible to other
agencies or appear in publications?
2. What precautions will be taken to safeguard identifiable records
or individuals? These questions also apply to secondary sources
of data.
a. Immediate data (by you and others);
b. Long-range data (by you and others);
c. Describe specific procedures to be used to provide confidentiality
of data
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