Reference no: EM131426530
PART V - ADMINISTRATIVE DATA
1) Proposed duration of data collection/analysis
IRB policy dictates that project approvals may be granted for a maximum of one year, although the exact approval term will be determined based on the level of participant risk inherent in the proposal. Should the PIs need an extension beyond the proposed duration, they can apply by completing the Continuance Request Form.
2) If this research will result in a thesis or dissertation, please check the appropriate box.
0 Undergraduate Level Project
0 Masters Level Project
0 Doctoral Level Project
(Thesis, Capstone) (Thesis, Capstone) (Dissertation, Capstone)
3) Conflict of Interest
Is there any potential or perceived conflict of interest between the researcher, sponsor and/or South University associated with this study?
No 0
Yes 0
If yes, please explain, including any and all possible conflicts:
4) Study population
a. Maximum Number of Participants Proposed:
b. Age Range: to (include low/high age range)
c. Gender: 0 Males 0 Females
d. Site of Subject Recruitment:
Please note that if recruitment will be conducted at any physical site other than South University, you will need to include a letter from management of the proposed site indicating their approval of your use of the facility.
e. Will medical clearance or medical screening be necessary for participants to participate because of tissue or blood sampling, administration of substances such as food or drugs, or physical exercise conditioning?
No 0
Yes 0
If yes, explain how clearance will be obtained. If a screening instrument will be used, please attach a copy to the application.
5) Potentially Vulnerable Populations. Please check any groups included in the study.
0 Children (under 18 years of age)
0 Pregnant Women
0 Elderly (65 & older)
0 Psychologically Impaired
0 Cognitively Impaired
0 Prisoners
0 Native American Tribes and/or Tribal Organizations
0 Students currently enrolled in a class instructed by the investigator
If you checked any of the above groups, your proposal will require full board review.
6) Study Site:
Please note that if research will be conducted at any physical site other than South University, you will need to include a letter from management of the proposed site indicating their approval of your use of the facility.
PART VI - SUMMARY OF STUDY ACTIVITIES
Submission of a copy of a grant application or project proposal does not replace completion of this form. If additional space is required, you may attach a separate document, but please respond to each item in this section and label your responses accordingly. Incomplete proposals will be returned to you.
1) Provide background information for the study including the objective of the proposed research, purpose, research question, hypothesis and other information deemed relevant.
2) Describe the research design of the study (i.e., state whether the study is correlational, experimental, etc. and define the variables).
3) Describe the tasks that participants will be asked to perform including a step by step description of the procedures you plan to use with your subjects. Provide the approximate duration of subject participation for each procedure/ instrument and the frequency and setting of each administration. Identify any personnel who will assist with data collection.
You must submit a copy of each study instrument, including all questionnaires, surveys, protocols for interviews, etc.
If someone will be assisting with data collection, but is not indicated as a co-investigator or research assistant in this application (i.e. they will be accessing archival data for you) you must submit a letter of approval indicating that they are willing and capable to assist.
4) Describe the recruitment procedures. Explain who will approach potential participants and take part in the research study and what will be done to protect the individual's privacy in this process.
You must submit a copy of any material used to recruit subjects (e.g., informed consent forms, advertisement, flyers, telephone scripts, verbal recruitment scripts, cover letters, etc.)
5) Describe how participants will be debriefed.
If deception is used, the principal investigator should offer the participant the opportunity to withdraw his/her data after being debriefed, and this information should be included in the debriefing script.
PART VII - PRIVACY PROCEDURES
1) Will data be recorded by audiotape?
No 0
Yes 0
Will data be recorded by videotape?
No 0
Yes 0
Will photographs be taken?
No 0
Yes 0
a. How will subjects be identified in these recordings?
b. Explain your plan for disposal of tapes/photographs/negatives, including when this disposal will occur (i.e. after transcription/development or at the conclusion of the study).
If you wish to retain the tapes/photographs/negatives beyond transcription/development, you must provide justification.
Subjects must be informed of the collection and disposal of the tapes/photographs/negatives via the informed consent process.
2) Will you record any direct identifiers (e.g.,, names, social security numbers, addresses, telephone numbers, etc)? No 0 Yes 0
a. Explain why it is necessary to record these identifiers.
b. Describe the coding system you will use to protect against disclosure of these identifiers.
c. Describe how subject identifiers will be maintained or destroyed after the study is completed.
If you will retain a link between the study code numbers and direct identifiers after the data collection is complete, explain why this is necessary and state how long you will keep this link.
d. Will you provide a link or identifier to anyone outside the research team?
No 0
Yes 0
If yes, explain why and to whom.
3) Where, how long, and in what format (such as paper, digital or electronic media, video, audio or photographic) will data be kept? In addition, describe what security provisions will be taken to protect these data (password protection, encryption, etc).
4) Will you place a copy of the consent form or other research study information in the participant's record such as medical, personal or educational record? No 0 Yes 0
If yes, explain why this is necessary.
This information should be clearly explained in the consent document and/or process.
5) Will any record of the subject's participation in this study be made available to his or her supervisor, teacher, or employer? No 0 Yes 0
If yes, please explain why this is necessary
6) Will you obtain a Federal Certificate of Confidentiality for this research? No 0 Yes0
If yes, submit documentation of application (and a copy of the Certificate of Confidentiality award if granted) with this application form.
If the data collected contain information about illegal behavior, visit the NIH Certificates of Confidentiality Kiosk
https://grants1.nih.gov/grants/policy/coc
for information about obtaining a Federal Certificate of Confidentiality.
PART VIII - INFORMED CONSENT INFORMATION
1) Informed Consent: Please attach, as an appendix, an informed consent document to this application. South University IRB requires that all activity involving human subjects be carried out only AFTER obtaining proper consent from the participants of the research. Thus an information sheet or cover letter that contains all required elements of informed consent must be attached to this application.
You may access a template for this form on the South University IRB website. (Please attach an assent form for children/youth participation and permission forms for parents/legal guardians; or consent forms for adult participation).
2) Request for Waiver of Informed Consent: Are you requesting a waiver of informed consent?
No 0 Yes 0
If yes, provide a written justification for a waiver of informed consent according to Section 46.116 of 45 CFR 46
(https://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116).
3) Request for Waiver of Documentation of Consent (applies to studies that do not wish to have signatures of the participants, i.e. internet research): Are you requesting a waiver of documentation of consent?
No 0
Yes 0
If yes, provide a written justification for a waiver of documentation of consent according to Section 46.117 of 45 CFR 46
(https://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.117).
PART IX - RISKS AND BENEFITS
1) Does the research involve any of the possible risks or harms to subjects listed below?
No 0
Yes 0
If Yes, independent scientific review may be required to determine if scientific merit justifies this risk.
Check all that apply:
0 Use of deception
If deception is used, describe in detail here, including the debriefing process and script.
If deception is used, the principal investigator should offer the participant the opportunity to withdraw his/her data after being debriefed, and this information should be included in the debriefing script.
0 Use of confidential records (e.g. educational or medical records)
0 Manipulation of psychological or social variables such as sensory deprivation, social isolation, psychological stressors
0 Presentation of materials which subjects might consider sensitive, offensive, threatening or degrading
0 Possible invasion of privacy of subject or family
0 Social, legal, or economic risk
0 Employment/occupational risk
0 Students of the researcher
0 Subordinates and colleagues of the researcher
0 Residents of any facility (i.e., prison)
0 Pregnant women
0 Children and minors
0 Elderly subjects (65+ years of age)
0 Wards of the state
0 Mentally and emotionally disability
0 Individuals who are not fluent in English
0 Other risks (specify):
2) Describe the nature and degree of the risk or harm checked above.
The described risks/harms must be disclosed in the consent form.
3) Explain what steps will be taken to minimize risks or harms and to protect subjects' welfare. If the research include protected populations (See Part V, Item 5 above), please identify each group and answer this question for each group.
4) Describe the anticipated benefits of this research for individual participants in each subject group. If none, state "none".
5) Describe the anticipated benefits of this research for society, and explain how the benefits outweigh the risks.
PART X - COMPENSATION INFORMATION
1) Will any compensation or inducements, i.e. course credit, be offered to the subjects for their participation? No 0 Yes 0
If yes, describe those inducements and include a statement in the informed consent document explaining how compensation will be handled in the event the participant withdraws from the study.
If yes, describe those inducements.
The informed consent document must include a statement explaining how compensation will be handled in the event that the participant withdraws from the study.
APPENDIX A: Student as Principal Investigator Worksheet
Level: 0 Masters 0 Doctorate
This project has been reviewed to determine that the scope, anticipated risks and benefits, and methodology are appropriate for this research by:
0 Approval of thesis/dissertation proposal by faculty committee
0 My personal review and approval of research proposal
0 Other:
The student researcher is qualified to conduct independent research based on the following credentials (check all that apply):
0 has completed a graduate research methods course
0 has experience as an independent or closely supervised research assistant
0 has completed NIH training
0 Other:
FACULTY SPONSOR'S ASSURANCE
By my signature as sponsor on this research application, I certify that the student is knowledgeable about the regulations and policies governing research with human subjects and has sufficient training and experience to conduct this particular study in accordance with the research protocol. Additionally,
• I hereby confirm that I have thoroughly reviewed this IRB application, including the protocol narrative, and deem it ready for submission.
• I agree to meet with the investigator on a regular basis to monitor study progress.
• I agree to be available, personally, to assist the investigator in solving problems, should they arise during the course of the study.
• I assure that the investigator will promptly report unanticipated problems and will adhere to all requirements for continuing review.
• If I am unavailable, e.g. sabbatical leave, vacation, or resignation, I will arrange for an alternate faculty sponsor to assume responsibility during my absence, and I will advise the South University IRB, in writing, of such changes.
• The research is appropriate in design.
Attachment:- suo_nsg6101_informed_consent_letter_example.rar