PROTECTION OF HUMAN SUBJECTS IN RESEARCH

INSTITUTIONAL REVIEW BOARD

FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH

This form is to be used for requesting IRB review for exempt, expedited and full board studies

Please note that handwritten and/or incomplete forms will be returned to you.

CHECKLIST FOR IRB APPLICATION SUBMISSION

(to be completed by PI before submission to IRB)

Application Form with Signature/ Confidentiality Agreements

 NIH Training Certificate(s)

 Protocol or Attached Research Proposal and/ or Contract/ Grant

 Solicitation Announcements/Recruitment Flyers

 Data Collection Instruments/Research Questions/Questionnaires/Surveys

 Informed Consent Documents

•              Parental/Legal Guardian Permission Form (if applicable)

•              Child Assent Form (if applicable)

 Approval from Study Sites (if applicable)

 Medical Screening Instrument (if applicable)

 Debriefing Plan (if applicable)

 Student as Principal Investigator Worksheet (if applicable)

Effectiveness of the current strategies for managing chronic pain among older women characterized by divorce, separation, and widows.

Project Title

PART I – INVESTIGATOR and RESEARCH PERSONNEL

1) PRINCIPAL INVESTIGATOR

(Undergraduate students cannot serve as Principal Investigator, but may be listed as a Co-Investigator.)

Name:		Dr.   Mr.   Ms.    Professor
Highest Degree Completed:
Investigator Status:	Faculty      Graduate Student         Staff
E-mail Address:
College/Department:
Campus Mailing Address:
Daytime Phone:

2) CO-INVESTIGATOR – 1 (if applicable)

Name:		Dr.   Mr.   Ms.   Professor
Highest Degree Completed:
Investigator Status:	Faculty     Graduate Student         Other	Undergraduate      Staff
E-mail Address:
College/Department:
Campus Mailing Address:
Daytime Phone:

3) CO-INVESTIGATOR – 2 (if applicable)

Name:		Dr.   Mr.   Ms.   Professor
Highest Degree Completed:
Investigator Status:	Faculty     Graduate Student         Other	Undergraduate      Staff
E-mail Address:
College/Department:
Campus Mailing Address:
Daytime Phone:

4) FACULTY SPONSOR (if applicable)

Name:		Dr.   Mr.   Ms.   Professor
Highest Degree Completed:
E-mail Address:
College/Department:
Campus Mailing Address:
Daytime Phone:

5)  STUDENT INVESTIGATORS/RESEARCH ASSISTANTS (if applicable)

Name:		E-mail:		Phone:
Name:		E-mail:		Phone:
Name:		E-mail:		Phone:
Name:		E-mail:		Phone:
Name:		E-mail:		Phone:

PART II – FUNDING INFORMATION

1) Check all of the appropriate boxes for funding sources for this research.  Include pending funding source(s).

Extramural	College	Department
Other:
P.I. of Grant or Contract:
Sponsor:
Contract/Grant No. (if available):
Contract/Grant Title:

***Please provide one complete copy of the proposal submitted to the sponsor with this application.  Please note that submission of your grant application is a regulatory requirement and will be maintained for the record with your application.  The IRB will not utilize the grant during the review process other than to confirm that the grant proposal is consistent with the IRB proposal.  You must submit all necessary documentation for the application in addition to the copy of the grant.

PART III – EDUCATION AND TRAINING

All  research personnel (faculty, staff, graduate students working on a thesis or dissertation, anyone using data for purposes of independent research, students involved in data collection, faculty sponsors, persons receiving grant monies for human subject research or those personnel with management responsibilities) must complete this section.

1) Have all key research personnel completed the required NIH training?       No     Yes

***If No, DO NOT submit this application.  Your application will not be considered until you have completed the IRB training and can provide a copy of your NIH course completion certificate.

(Please include a copy/copies of all certificate(s) with each application.)

***Please note that this NIH training is a mandatory requirement to be completed every three years.

***If you have not completed the NIH training, but have completed a comparable course (e.g. CITI training), please include documentation of those courses.

2) If other necessary training/education is required for completion of this study, please attach copies of certificates or other documentation (e.g., HIPAA training, phlebotomy training).

PART IV – INVESTIGATOR ASSURANCE

1.  Institutional Review Board Policy Compliance Agreement

• I certify that the information provided in this application is complete and correct.
• I understand that as Principal Investigator, I have the responsibility for the conduct of the study, the ethical performance of the project and the protection of the rights and welfare of human participants.
• I agree to comply and to assure that all affiliated personnel comply with all South University IRB policies and procedures, as well as with all applicable federal, state and local laws regarding the protection of human participants in research.
• I agree that I have the appropriate expertise to conduct this study.
• I assure that this study is performed by qualified personnel adhering to the South University IRB approved protocol.  Student PI’s must attach student PI worksheet (see appendix A).
• I assure that no modification to the approved protocol and consent materials will be made without first submitting for review and approval by the South University IRB an amendment to the approved protocol.
• I agree to obtain legally effective informed consent from the research participants as applicable to this research and as prescribed in the approved protocol.
• I will promptly report unanticipated problems to the South University IRB by using the Notification Form provided on the IRB website.
• I will adhere to all requirements for continuing review and will complete a Continuance Request form if my research extends beyond one year.
• I will advise the South University IRB of any change of address or contact information as long as this protocol remains active.
• I assure that I have obtained all necessary approvals from entities other than South University IRB that are necessary to conduct this research (e.g., cooperation letters or approvals from other institutions). 

My signature below certifies that I am knowledgeable about the regulations and policies governing research with human subjects and have sufficient training and experience to conduct this particular study in accordance with the research protocol. 

Principal Investigator	Date (mm/dd/yyyy)
Co-Investigator	Date (mm/dd/yyyy)
Faculty Sponsor	Date (mm/dd/yyyy)

•  Confidentiality Agreement

• I have agreed to assist with the research project described in this application.
• I agree not to discuss or disclose any of the content or personal information contained within the data, tapes, transcriptions, or other research records with anyone other than the Principal Investigator, Co-Investigator, or in the context of the research team.
• I agree to maintain confidentiality at all times and to abide by the South University IRB Policy and Procedures Manual. 
• If I am aware of any breach in confidentiality, I am required to report violations of confidentiality to the IRB Committee Director, who will report this information to the College Dean and the Vice Chancellor of Academic Affairs.

Principal Investigator	Date (mm/dd/yyyy)
Co-Investigator	Date (mm/dd/yyyy)
Faculty Sponsor	Date (mm/dd/yyyy)

Student Investigator	Date (mm/dd/yyyy)
Student Investigator	Date (mm/dd/yyyy)
Student Investigator	Date (mm/dd/yyyy)

PART V – ADMINISTRATIVE DATA

1. Proposed duration of data collection/analysis

Start date:         End date:     

***South University 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.

• If this research will result in a thesis or dissertation, please check the appropriate box.

         Undergraduate Level Project   Masters Level Project         Doctoral Level Project    

(Thesis, Capstone)                          (Thesis, Capstone)                             (Dissertation, Capstone)     

• 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     Yes

***If yes, please explain, including any and all possible conflicts:

The study has no conflicts

• Study population

1. Maximum Number of Participants Proposed: 18

• Age Range:  18 to90 (include low/high age range)

• Gender:  Males    Females

• 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.

• 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    Yes

***If yes, explain how clearance will be obtained.  If a screening instrument will be used, please attach a copy to the application.

Not applucable

• Potentially Vulnerable Populations.  Please check any groups included in the study.

Children (under 18 years of age)  Pregnant Women                 Elderly (65 & older)  Psychologically Impaired

Cognitively Impaired  Prisoners                 Native American Tribes and/or Tribal Organizations  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.

• Study Site: New York City

***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.

The focus of this research is chronic pain management. Of specific interest here is the impact that chronic pain has on the patients and their caregivers. With the advent of increasing incidence and prevalence rates of chronic diseases, chronic pain management has assumed a central role in the therapeutic management of such chronic diseases as cancer, diabetes, spine complication, and arthritis among many others. The leading research questions are what is the impact of chronic pain on the patients and the people around them, and how do the patients manage chronic pain by themselves.

• Describe the research design of the study (i.e., state whether the study is correlational, experimental, etc. and define the variables).

This study will adopt a cross-sectional descriptive research design that will help collect the data in six months. The research design will also employ a causal-comparative approach that will seek to assess the disparity between the participants’ dependent variable and the independent variable moderated by the patients’ marital status. Since the study is not experimental, the causal-comparative approach is not meant to determine cause and effect. This will be facilitated by observation and interviews with participants, recording their pain management procedures. This design is attributed to the fact that the sample size is adequately significant to address the research problem and the hypothesis accurately and preserve the available resources

• 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.

Data will be collected through questioners which will be filled in a face to face interview and observe strategies with the 18 participants, selected randomly from a population of Thirty patients and twenty care givers. Participants with physical or cognitive impairments will be helped by their care givers.

• 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.)    

I will personally approach to potential participants through phone calls or face to face. The questionnaire will be designed in such a way that does not affect their personal life. I will receive their filled form to maintain their confidentiality as per the informed consent letter.

• 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. 

I will not do this

PART VII – PRIVACY PROCEDURES

      1)   Will data be recorded by audiotape?    No     Yes

Will data be recorded by videotape?    No     Yes

Will photographs be taken?                 No                 Yes

1. How will subjects be identified in these recordings?

This is not applicable

• 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.

This is not applicable

2)  Will you record any direct identifiers (e.g.,, names, social security numbers, addresses, telephone numbers, etc)?                    No   Yes

1. Explain why it is necessary to record these identifiers. 

This is not applicable

• Describe the coding system you will use to protect against disclosure of these identifiers. 

This is not applicable

• 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.

This is not applicable

• Will you provide a link or identifier to anyone outside the research team?

No         Yes

***If yes, explain why and to whom.

This is not applicable

• 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). 

The collected data will be kept in the form of electronic media in my computer. It will be protected through double password i.e. file encryption and system password.

• 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      Yes

***If yes, explain why this is necessary. 

***This information should be clearly explained in the consent document and/or process.

I need the participants to understand the purpose and implications of the study. The consent form will explain the purpose, procedures used benefits of the study to participants and I, and risks involved. It will be a proof of voluntary involvement of participants to the study.

• Will any record of the subject’s participation in this study be made available to his or her     supervisor, teacher, or employer? No     Yes

***If yes, please explain why this is necessary

.

This is not applicable

• Will you obtain a Federal Certificate of Confidentiality for this research?  No     Yes

***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 http://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 elementsof 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).

• Request for Waiver of Informed Consent:  Are you requesting a waiver of informed consent? 

                  No     Yes

***If yes, provide a written justification for a waiver of informed consent according to Section 46.116 of 45 CFR 46 (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116).

This is not applicable

• 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     Yes

***If yes, provide a written justification for a waiver of documentation of consent according to Section 46.117 of 45 CFR 46 (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.117). 

This is not applicable

PART IX – RISKS AND BENEFITS

1. Does the research involve any of the possible risks or harms to subjects listed below? 

      No        Yes        

***If Yes, independent scientific review may be required to determine if scientific merit justifies this risk.

Check all that apply: 

 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. 

No deception will be involved

Use of confidential records (e.g. educational or medical records)  Manipulation of psychological or social variables such as sensory deprivation, social isolation, psychological stressors  Presentation of materials which subjects might consider sensitive, offensive,       threatening or degrading  Possible invasion of privacy of subject or family  Social, legal, or economic risk  Employment/occupational risk  Students of the researcher  Subordinates and colleagues of the researcher  Residents of any facility (i.e., prison)  Pregnant women  Children and minors  Elderly subjects (65+ years of age)  Wards of the state  Mentally and emotionally disability  Individuals who are not fluent in English  Other risks (specify):

This is not applicable

• Describe the nature and degree of the risk or harm checked above. 

***The described risks/harms must be disclosed in the consent form.

Not Applicable

• 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.

This is not applicable

• Describe the anticipated benefits of this research for individual participants in each subject group.  If none, state “none”. 

The anticipated benefit of this research for individual participants that they will get relief should the study results be adopted.

Not aaplicable

• Describe the anticipated benefits of this research for society, and explain how the benefits outweigh the risks.

Overcoming chronic pain will increase the health outcomes in a society, which are associated with increased happiness and economic growth.

PART X – COMPENSATION INFORMATION

1. Will any compensation or inducements, i.e. course credit, be offered to the subjects for their participation?               No     Yes

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.

This is not applicable

 Appendix A:     Student as Principal Investigator Worksheet

Level:              Masters        Doctorate

This project has been reviewed to determine that the scope, anticipated risks and benefits, and methodology are appropriate for this research by:

 Approval of thesis/dissertation proposal by faculty committee

 My personal review and approval of research proposal

 Other:      

The student researcher is qualified to conduct independent research based on the following credentials (check all that apply):

 has completed a graduate research methods course

 has experience as an independent or closely supervised research assistant

 has completed NIH training

 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.

Print Faculty Sponsor Name     Faculty Sponsor Signature	Date (mm/dd/yyyy)
Print PI Name     PI Signature	Date (mm/dd/yyyy)