a) How will potential subjects be identified and
b) By whom (e.g. study coordinator, nurse, student) and where will they be approached for participation?
(Procedures that will be used to recruit subjects).
c) Describe any relationship that the recruiters have with potential subjects other than in their role as staff for
the survey study, and how this will be handled if it might lead potential subjects to feel pressure to
participate (e.g., in small communities they may be neighbors, friends, or parents with children in the
d) Describe recruitment materials (ads, letters, flyers, recruitment script, etc) to be used and if
applicable, attach a copy of these materials as an appendix to the protocol.
e) If your project falls within one of the exempt categories (see IRC Request for Exemption Form), you
should be prepared to provide the subjects with an information sheet/cover letter that describes the
following items: (see ECHN IRC cover letter for a survey template)
1. Name and number of PI to contact if the subject has questions.
2. A brief description of the study purpose.
3. A statement that participation is voluntary.
4. A statement that subjects may skip any questions they wish to, for any reason. Explain that
choosing to not participate will not affect any services which the person is receiving at the study
site or for which s/he would otherwise be eligible.
5. Confidentiality considerations.
6. Participation in the survey implies consent.
In addition, surveys that will be administered by students must include:
1. The name of the student
2. The student’s school and class affiliation
3. A description of the curriculum activity that is being fulfilled by the survey.
C- Survey Instrument
a) Submit the survey(s), instrument or interview questionnaire that will be used (e.g., see attached Survey
Instrument titled: “----------------------------.”) and describe the instrument including key points such as:
1. Whether it is hard copy, or web-based survey,
2. The rationale for your questions, i.e. why the type of information you are collecting is necessary
to achieve the goal (e.g., demographics, feeling, beliefs, health status, diagnosis, opinions, pain
management, knowledge, etc.).
3. The type of questions (multiple choice, Likert rating scales, open-ended questions)
4. Who designed and/or reviewed the survey prior to submission (did you give this survey to an
expert for his/her input, is this a standardized survey for which its validity has already been
5. How long you think this survey will take to be completed by each participant?