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CHECKLIST FOR PROPOSAL SUBMISSIONS TO THE IRB

To avoid delays in the approval of your application:

1. Be sure to answer all questions fully in the application.

AND

2. Review your application to ensure it includes these checklist items. Check-off the items in this list or mark N/A if not applicable.

AND

3. Be sure to provide a separate consent form for each type of interaction with subjects (survey, focus group, interview) used.

This Form Must Be Included with Your Application

Consent Form – Includes:

____ Name(s) of Researcher(s), email address (es), phone numbers(s) - include international dialing codes where appropriate

____ Advisor’s name, title, and department, email address (es), phone numbers(s) - include international dialing codes where appropriate

____ Reference to your affiliation with Clark University

____ For projects involving a foreign language, a statement that the researcher is proficient in the language and dialects of the participants, and if not, a statement that an interpreter will be used

____ For projects involving a foreign language, a translated version of the consent form

____ Brief description of the purpose of the study and the tasks involved

____ Approximate duration of participation

____ Any foreseeable risks/discomforts and/or expected benefits to participant or others

____ Statement that participation is voluntary and may be withdrawn without penalty at any time for any reason

____ Statement that participants may choose to not answer any question that they wish not to answer for any reason

____ For focus groups, an explanation of how a focus group works (number and composition of participants), informal discussion format, whether or not the focus group discussion will be recorded

____ Procedures for ensuring confidentiality (explanation of coding, storage, and disposal of data) 

____ Data will not contain any names or pseudonyms, only code numbers

____ Data and identifying information, such as consent forms, will be stored separately from each other

____ Data will be stored in locked storage on Clark campus accessible only to researchers. Undergraduates must store data with faculty advisors

____ Electronic data will be stored on a password-protected computer accessible only to researchers

____ Date and method of final disposal of any audio or video recordings, or a statement that recordings will be kept indefinitely

____ Statement that when photographs are taken, researchers cannot guarantee confidentiality of participant data

____ Statement that when focus groups are used, there is an inherent risk of violation of confidentiality. Participants should be advised not to share the details of the discussion outside the focus group session

____ Statement that when Skype or similar technologies are used for interviews, there will be a provision for ensuring that the user name will not be associated with the data. Statement that if the interview is recorded, only the audio portion will be stored

____ Where potentially necessary, a list of counseling/support resource(s) phone numbers and addresses

____ Statement of Assent for participants ages 7 through 17 (separate consent form must be addressed to parents/guardians in this circumstance)

____ Statement that participants will be given a copy of the consent form

____ Line above the signature for the participant's printed name

____ The statement: “This study has been approved by the Clark Committee for the Rights of Human Participants in Research and Training Programs (IRB). Any questions about human rights issues should be directed to the IRB Chair, Dr. James P. Elliott (508) 793-7152.”

Attachments – Include the following where relevant to your study:

_____ Recruiting Script(s) (oral script, telephone script, email script, flyer, etc.) which includes the following information:

  • Researcher’s name
  • Advisor’s name and department
  • Reference to affiliation with Clark University
  • Brief description of the task(s)
  • Approximate duration of participation
  • Statement that participation is voluntary and may be withdrawn at any time without penalty
  • Contact information of researchers
  • A statement that if participants are recruited in a class, their participation or non-participation will have no effect on their standing in class

_____ Questionnaires, Surveys (hard copy for on-line surveys) and/or Interview Protocols

_____ Written permissions from schools, agencies, organizations, etc. at which research will be conducted. (If the permission letter is not received by the application deadline, the investigator is encouraged to submit the application for IRB review. The permission letter will become a condition or stipulation of approval.)

_____ Text of debriefing statement when deception is involved in the study

_____ For research being conducted in a foreign country by a student, provide a letter from a local sponsoring institution certifying they have reviewed the research from the perspective of safety for the student and they find it reasonable to proceed. (If the sponsor letter is not received by the application deadline, the investigator is encouraged to submit the application for IRB review. The sponsor letter will become a condition or stipulation of approval.)