The document provides guidelines for completing an Institutional Review Board (IRB) application at HCCS. It outlines 16 sections that must be completed in the application, including general information about the researchers and project, an overview of research questions, descriptions of participant recruitment, data collection procedures, risks and benefits to participants, and confidentiality measures. The application requests details to allow the IRB to determine if the project qualifies as research and to assess the level of review needed to ensure compliance with regulations for protecting human subjects.
Professor Justin Waring - Implementing evidence and improvementCLAHRC-NDL
Professsor Justin Waring presentation on Implementing evidence and improvement, delivered at NIHR CLAHRC East Midlands launch event on 14 February 2014, Loughborough.
Transferring the purchasing role from international to national organizations...valéry ridde
Presentation of Isidore Sieleunou realised for an organised session on Application and challenges to the use of mixed methods in health systems research, held at HSR 2016, the Fourth Global Symposium on Health Systems Research, Vancouver, 14-18 november 2016.
A presentation by Osman Sankoh as part of the Sustainability and Ownership panel discussion at the International Symposium on Cohort and Longitudinal Studies in Developing Contexts, UNICEF Office of Research - Innocenti, Florence, Italy 13-15 October 2014
A presentation by Emla Fitzsimons as part of the Sustainability and Ownership panel discussion at the International Symposium on Cohort and Longitudinal Studies in Developing Contexts, UNICEF Office of Research - Innocenti, Florence, Italy 13-15 October 2014
What must be done?Capacity building for health systems research in low & mid...IDS
This presentation was given in plenary by Sara Bennett of the Future Health Systems Consortium at the Global Symposium on Health Systems Research, November 2010.
Professor Justin Waring - Implementing evidence and improvementCLAHRC-NDL
Professsor Justin Waring presentation on Implementing evidence and improvement, delivered at NIHR CLAHRC East Midlands launch event on 14 February 2014, Loughborough.
Transferring the purchasing role from international to national organizations...valéry ridde
Presentation of Isidore Sieleunou realised for an organised session on Application and challenges to the use of mixed methods in health systems research, held at HSR 2016, the Fourth Global Symposium on Health Systems Research, Vancouver, 14-18 november 2016.
A presentation by Osman Sankoh as part of the Sustainability and Ownership panel discussion at the International Symposium on Cohort and Longitudinal Studies in Developing Contexts, UNICEF Office of Research - Innocenti, Florence, Italy 13-15 October 2014
A presentation by Emla Fitzsimons as part of the Sustainability and Ownership panel discussion at the International Symposium on Cohort and Longitudinal Studies in Developing Contexts, UNICEF Office of Research - Innocenti, Florence, Italy 13-15 October 2014
What must be done?Capacity building for health systems research in low & mid...IDS
This presentation was given in plenary by Sara Bennett of the Future Health Systems Consortium at the Global Symposium on Health Systems Research, November 2010.
Presentation to National Institute for Health Research (NIHR) Public Involvem...Simon Denegri
This presentation includes slides detailing the initial findings from the NIHR Strategic Review of public involvement in research entitled 'Breaking Boundaries.'
The Nuffield Trust's Holly Holder presents on a project in partnership with the London School of Economics to evaluate a whole systems approach to integrated care in North West London.
A presentation by Jimmy Whitworth as part of the Sustainability and Ownership panel discussion at the International Symposium on Cohort and Longitudinal Studies in Developing Contexts, UNICEF Office of Research - Innocenti, Florence, Italy 13-15 October 2014
Professsor John Gladman - Caring for older people and stroke survivorsCLAHRC-NDL
Caring for older people and stroke survivors theme presentation by Professor John Gladman, delivered at the NIHR CLAHRC East Midlands launch event on 14 February 2014, Loughborough.
Professor Kamlesh Khunti - Prevention of Chronic DiseaseCLAHRC-NDL
Presentation by Professor Kamlesh Khunti on Prevention of Chronic Disease. Professor Khunti is Director of NIHR CLAHRC East Midlands and leads the Preventing Chronic Disease research theme.
Canadian Psychological Association For Cameron NormanCameron Norman
Presentation at the CPA convention on the work done by the CAN-ADAPTT project. Norman, C.D. & Selby, P. (2010, June). CAN-ADAPTT: Developing a Canadian Smoking Cessation Guideline. Presentation at the annual meeting of the Canadian Psychological Association, Winnipeg, MB, June 3, 2010.
A presentation by Rachel Hinton as part of the Cohort Research for Programme and Policy panel discussion at the International Symposium on Cohort and Longitudinal Studies in Developing Contexts, UNICEF Office of Research - Innocenti, Florence, Italy 13-15 October 2014
A presentation by Craig Bardsley as part of the Sustainability and Ownership panel discussion at the International Symposium on Cohort and Longitudinal Studies in Developing Contexts, UNICEF Office of Research - Innocenti, Florence, Italy 13-15 October 2014
Future Flight Fridays: Public trust - social science considerationsKTN
Slides from KTN's recent Future Flight Fridays session exploring some of the wider social concerns around Future flight and the priorities we need to consider in order to realise the 2030 vision for future flight in the UK.
A presentation by Nalini Takeshwar as part of the Cohort Research for Programme and Policy panel discussion at the International Symposium on Cohort and Longitudinal Studies in Developing Contexts, UNICEF Office of Research - Innocenti, Florence, Italy 13-15 October 2014
Academic success and promotion in medicine largely depends on the quality and quantity of received grants. Grant money brings prestige and notoriety to the writer and his institution. However, writing a grant proposal can be a challenging task especially for the inexperienced researcher. As research budgets are being reduced by many funding agencies and more researches are competing for it, it is becoming increasingly important to be able to write a grant proposal of high quality.
The purpose of this article is to give the reader guidance on how to organize a research proposal in order maximize chances to obtain the desired funding. Key aspects will be highlighted and practical tips emphasized. This article will primarily focus on writing a grant for a clinical study.
SECTION H ConsentAssentDescribe the following1) How will co.docxrtodd280
SECTION H: Consent/Assent
Describe the following:
1) How will consent/assent be obtained place. (e.g., signing a consent form in person, online consent form as front page for online survey, etc.)
2) If applicable, what procedures are in place to reduce coercion (e.g., if extra credit is offered, what non-research alternatives are available to students who do not wish to participate in research).
3) If participants are vulnerable populations, explain how you will follow research ethics guidelines for obtaining consent. (If applicable).
4) If a request for a waiver of consent or waiver of documentation of consent is being sought for this proposal, describe here how the request comports with Federal guidelines as outlined in 45CFR46-listed criteria for a waiver found at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116 .
1)
2)
3)
4)
SECTION I: Risks to Subjects
IRBs must evaluate the risk-benefit ratio of proposed human subject research. In approving a protocol, IRBs must determine that the benefits outweigh the risks and that risks to subjects are minimized.
Research risk is the probability of harm occurring as a result of participation in research. In non-technical language, address the following:
1) The types of risks (e.g., physical, psychological, social, economic, legal, etc.) the subject may reasonably encounter. Include any likelihood that questions may be sensitive or stressful to the participants.
2) Estimate the frequency/likelihood and magnitude of those risks (cite relevant literature, if available).
3) Describe the procedures/process which will be used to reduce or minimize risks:
a. How the data will be safeguarded (e.g., data is anonymous, assigning pseudonyms, aggregate reporting, etc.).
b. How will subjects be explicitly informed if data will NOT be anonymous (Put “N/A” if using anonymous data)
c. What actions would you take if a participant gets hurt or upset?
1)
2)
3)
a.)
b.)
c.)
SECTION J: Deception/Incomplete Disclosure
If you cannot adequately state the true purpose of the study to the subject in the informed consent, deception/ incomplete disclosure is involved.
1) Describe the deception/incomplete disclosure of information to the subjects.
2) Explain why such deception/incomplete disclosure is necessary.
3) Explain the debriefing process, or explain why there will not be a debriefing process.
1)
2)
3)
SECTION K: Benefits
Describe any direct benefits participants could potentially receive (excluding compensation for participation). If there are no direct benefits, explain what other potential benefits are gained from the research (benefits to society). This cannot be left blank.
SECTION L: Subject Incentives/Compensations
L1. Does this study involve incentives or compensation to the subjects? For example cash, class extra credit, gift cards, or items. [__] Yes [__] No
L2. If yes, provide details about the nature of the payment (e.g. type, amount, when it will be provi.
This document applies to all students registered as a student at Anglia Ruskin University in the Ashcroft International Business School (AIBS), and all their Partner Institutions, regarding the ethical approval of Undergraduate, Taught Postgraduate Masters Dissertations, Research–based Management Research Reports, and Work-based projects. For those undertaking any research/project work outside the UK you are required to ensure that your research/study/project complies with UK legal and ethical requirements.
Presentation to National Institute for Health Research (NIHR) Public Involvem...Simon Denegri
This presentation includes slides detailing the initial findings from the NIHR Strategic Review of public involvement in research entitled 'Breaking Boundaries.'
The Nuffield Trust's Holly Holder presents on a project in partnership with the London School of Economics to evaluate a whole systems approach to integrated care in North West London.
A presentation by Jimmy Whitworth as part of the Sustainability and Ownership panel discussion at the International Symposium on Cohort and Longitudinal Studies in Developing Contexts, UNICEF Office of Research - Innocenti, Florence, Italy 13-15 October 2014
Professsor John Gladman - Caring for older people and stroke survivorsCLAHRC-NDL
Caring for older people and stroke survivors theme presentation by Professor John Gladman, delivered at the NIHR CLAHRC East Midlands launch event on 14 February 2014, Loughborough.
Professor Kamlesh Khunti - Prevention of Chronic DiseaseCLAHRC-NDL
Presentation by Professor Kamlesh Khunti on Prevention of Chronic Disease. Professor Khunti is Director of NIHR CLAHRC East Midlands and leads the Preventing Chronic Disease research theme.
Canadian Psychological Association For Cameron NormanCameron Norman
Presentation at the CPA convention on the work done by the CAN-ADAPTT project. Norman, C.D. & Selby, P. (2010, June). CAN-ADAPTT: Developing a Canadian Smoking Cessation Guideline. Presentation at the annual meeting of the Canadian Psychological Association, Winnipeg, MB, June 3, 2010.
A presentation by Rachel Hinton as part of the Cohort Research for Programme and Policy panel discussion at the International Symposium on Cohort and Longitudinal Studies in Developing Contexts, UNICEF Office of Research - Innocenti, Florence, Italy 13-15 October 2014
A presentation by Craig Bardsley as part of the Sustainability and Ownership panel discussion at the International Symposium on Cohort and Longitudinal Studies in Developing Contexts, UNICEF Office of Research - Innocenti, Florence, Italy 13-15 October 2014
Future Flight Fridays: Public trust - social science considerationsKTN
Slides from KTN's recent Future Flight Fridays session exploring some of the wider social concerns around Future flight and the priorities we need to consider in order to realise the 2030 vision for future flight in the UK.
A presentation by Nalini Takeshwar as part of the Cohort Research for Programme and Policy panel discussion at the International Symposium on Cohort and Longitudinal Studies in Developing Contexts, UNICEF Office of Research - Innocenti, Florence, Italy 13-15 October 2014
Academic success and promotion in medicine largely depends on the quality and quantity of received grants. Grant money brings prestige and notoriety to the writer and his institution. However, writing a grant proposal can be a challenging task especially for the inexperienced researcher. As research budgets are being reduced by many funding agencies and more researches are competing for it, it is becoming increasingly important to be able to write a grant proposal of high quality.
The purpose of this article is to give the reader guidance on how to organize a research proposal in order maximize chances to obtain the desired funding. Key aspects will be highlighted and practical tips emphasized. This article will primarily focus on writing a grant for a clinical study.
SECTION H ConsentAssentDescribe the following1) How will co.docxrtodd280
SECTION H: Consent/Assent
Describe the following:
1) How will consent/assent be obtained place. (e.g., signing a consent form in person, online consent form as front page for online survey, etc.)
2) If applicable, what procedures are in place to reduce coercion (e.g., if extra credit is offered, what non-research alternatives are available to students who do not wish to participate in research).
3) If participants are vulnerable populations, explain how you will follow research ethics guidelines for obtaining consent. (If applicable).
4) If a request for a waiver of consent or waiver of documentation of consent is being sought for this proposal, describe here how the request comports with Federal guidelines as outlined in 45CFR46-listed criteria for a waiver found at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116 .
1)
2)
3)
4)
SECTION I: Risks to Subjects
IRBs must evaluate the risk-benefit ratio of proposed human subject research. In approving a protocol, IRBs must determine that the benefits outweigh the risks and that risks to subjects are minimized.
Research risk is the probability of harm occurring as a result of participation in research. In non-technical language, address the following:
1) The types of risks (e.g., physical, psychological, social, economic, legal, etc.) the subject may reasonably encounter. Include any likelihood that questions may be sensitive or stressful to the participants.
2) Estimate the frequency/likelihood and magnitude of those risks (cite relevant literature, if available).
3) Describe the procedures/process which will be used to reduce or minimize risks:
a. How the data will be safeguarded (e.g., data is anonymous, assigning pseudonyms, aggregate reporting, etc.).
b. How will subjects be explicitly informed if data will NOT be anonymous (Put “N/A” if using anonymous data)
c. What actions would you take if a participant gets hurt or upset?
1)
2)
3)
a.)
b.)
c.)
SECTION J: Deception/Incomplete Disclosure
If you cannot adequately state the true purpose of the study to the subject in the informed consent, deception/ incomplete disclosure is involved.
1) Describe the deception/incomplete disclosure of information to the subjects.
2) Explain why such deception/incomplete disclosure is necessary.
3) Explain the debriefing process, or explain why there will not be a debriefing process.
1)
2)
3)
SECTION K: Benefits
Describe any direct benefits participants could potentially receive (excluding compensation for participation). If there are no direct benefits, explain what other potential benefits are gained from the research (benefits to society). This cannot be left blank.
SECTION L: Subject Incentives/Compensations
L1. Does this study involve incentives or compensation to the subjects? For example cash, class extra credit, gift cards, or items. [__] Yes [__] No
L2. If yes, provide details about the nature of the payment (e.g. type, amount, when it will be provi.
This document applies to all students registered as a student at Anglia Ruskin University in the Ashcroft International Business School (AIBS), and all their Partner Institutions, regarding the ethical approval of Undergraduate, Taught Postgraduate Masters Dissertations, Research–based Management Research Reports, and Work-based projects. For those undertaking any research/project work outside the UK you are required to ensure that your research/study/project complies with UK legal and ethical requirements.
SCIENTIFIC MERIT ACTION RESEARCH TEMPLATE (SMART) FORMa..docxkenjordan97598
SCIENTIFIC MERIT ACTION RESEARCH TEMPLATE (SMART) FORM
a.k.a. “Research Plan”
School of Public Service LeadershipScientific Merit Process
Learners who are doing action research for their dissertation will use this form to go through the process of scientific merit review. The goals of this process are: (1) to facilitate the planning of the details of your action research project, (2) to ensure that the proposed project has rigor and allows for scientific merit review, and (3) to facilitate your progress through the dissertation. This is not an addition to your dissertation but rather a step to assist you in obtaining mentor, committee, school, and IRB approval more efficiently. You must obtain mentor, committee, and school approval of your Research Plan before submitting your IRB application.
Scientific Merit Criteria
The following criteria will be used to establish scientific merit. The purpose of the review will determine if the proposed project:
1. Contributes to society by improving a practice
2. Documents need for change by utilizing evidence-based needs assessment
3. Meets certain “Hallmarks” of a good action research project including:
a. Action research design
i. Practical
ii. Participatory
iii. Defined Action PlanScientific Merit ApprovalYour completed SMART form will be approved, not approved, or deferred for major or minor revisions. Your committee will use a checklist to determine if the study meets the criteria for scientific merit and the committee will provide specific feedback designed to identify any issues that need to be resolved related to the scientific merit. You will have up to three opportunities to submit this form for committee approval.
Obtaining scientific merit approval does not guarantee you will obtain IRB approval. The IRB review will focus on ethical issues. A detailed ethical review will be conducted during the process of IRB approval.Recommendations for How to Use This FormThe SMART form is intended to help you and your mentor plan the design and details of your dissertation. Once your mentor approves your SMART form, your entire committee will review the form for scientific merit. When the entire committee approves your SMART form, then it will be submitted for school approval. It is recommended that you use this form in a step-by-step way to help plan your design. Expect that you will go through a few revisions before your mentor and committee approve this form.
Tips for filling out the SMART form:
· Prepare your answers in a separate Word document, as editing and revising will be easier.
· Copy/paste items into the right-hand fields when they are ready.
· Don’t delete the descriptions in the left column!
· Don’t lock the form, as that will stop you from editing and revising within the form.
· Leave no blank spaces in the form. If an item does not apply to your study, type “NA” in its field.
· Read the item descriptions carefully. Items request very specific information. Be sure you understa.
THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS .docxjuliennehar
THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101.
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)
FORMCHECKBOX
Application Form with Signatures/ Confidentiality Agreements
FORMCHECKBOX
NIH Training Certificate(s)
FORMCHECKBOX
Protocol or Attached Research Proposal and/ or Contract/ Grant
FORMCHECKBOX
Solicitation Announcements/Recruitment Flyers
FORMCHECKBOX
Data Collection Instruments/Research Questions/Questionnaires/Surveys
FORMCHECKBOX
Informed Consent Documents
FORMCHECKBOX
Parental/Legal Guardian Permission Form (if applicable)
FORMCHECKBOX
Child Assent Form (if applicable)
FORMCHECKBOX
Approval from Study Sites (if applicable)
FORMCHECKBOX
Medical Screening Instrument (if applicable)
FORMCHECKBOX
Debriefing Plan (if applicable)
FORMCHECKBOX
Student as Principal Investigator Worksheet (if applicable)
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:
FORMCHECKBOX
Dr. FORMCHECKBOX
Mr. FORMCHECKBOX
Ms. FORMCHECKBOX
Professor
Highest Degree Completed:
Investigator Status:
FORMCHECKBOX
Faculty FORMCHECKBOX
Graduate Student FORMCHECKBOX
Staff
E-mail Address:
College/Department:
Campus Mailing Address:
Daytime Phone:
2) CO-INVESTIGATOR – 1 (if applicable)
Name:
FORMCHECKBOX
Dr. FORMCHECKBOX
Mr. FORMCHECKBOX
Ms. FORMCHECKBOX
Professor
Highest Degree Completed:
Investigator Status:
FORMCHECKBOX
Faculty FORMCHECKBOX
Graduate Student FORMCHECKBOX
Other
FORMCHECKBOX
Undergraduate FORMCHECKBOX
Staff
E-mail Address:
College/Department:
Campus Mailing Address:
Daytime Phone:
3) CO-INVESTIGATOR – 2 (if applicable)
Name:
FORMCHECKBOX
Dr. FORMCHECKBOX
Mr. FORMCHECKBOX
Ms. FORMCHECKBOX
Professor
Highest Degree Completed:
Investigator Status:
FORMCHECKBOX
Faculty FORMCHECKBOX
Graduate Student FORMCHECKBOX
Other
FORMCHECKBOX
Undergraduate FORMCHECKBOX
Staff
E-mail Address:
College/Department:
Campus Mailing Address:
Daytime Phone:
4) FACULTY SPONSOR (if applicable)
Name:
FORMCHECKBOX
Dr. FORMCHECKBOX
Mr. FORMCHECKBOX
Ms. FORMCHECKBOX
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 ...
THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS blossomblackbourne
THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101.
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)
FORMCHECKBOX
Application Form with Signatures/ Confidentiality Agreements
FORMCHECKBOX
NIH Training Certificate(s)
FORMCHECKBOX
Protocol or Attached Research Proposal and/ or Contract/ Grant
FORMCHECKBOX
Solicitation Announcements/Recruitment Flyers
FORMCHECKBOX
Data Collection Instruments/Research Questions/Questionnaires/Surveys
FORMCHECKBOX
Informed Consent Documents
FORMCHECKBOX
Parental/Legal Guardian Permission Form (if applicable)
FORMCHECKBOX
Child Assent Form (if applicable)
FORMCHECKBOX
Approval from Study Sites (if applicable)
FORMCHECKBOX
Medical Screening Instrument (if applicable)
FORMCHECKBOX
Debriefing Plan (if applicable)
FORMCHECKBOX
Student as Principal Investigator Worksheet (if applicable)
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:
FORMCHECKBOX
Dr. FORMCHECKBOX
Mr. FORMCHECKBOX
Ms. FORMCHECKBOX
Professor
Highest Degree Completed:
Investigator Status:
FORMCHECKBOX
Faculty FORMCHECKBOX
Graduate Student FORMCHECKBOX
Staff
E-mail Address:
College/Department:
Campus Mailing Address:
Daytime Phone:
2) CO-INVESTIGATOR – 1 (if applicable)
Name:
FORMCHECKBOX
Dr. FORMCHECKBOX
Mr. FORMCHECKBOX
Ms. FORMCHECKBOX
Professor
Highest Degree Completed:
Investigator Status:
FORMCHECKBOX
Faculty FORMCHECKBOX
Graduate Student FORMCHECKBOX
Other
FORMCHECKBOX
Undergraduate FORMCHECKBOX
Staff
E-mail Address:
College/Department:
Campus Mailing Address:
Daytime Phone:
3) CO-INVESTIGATOR – 2 (if applicable)
Name:
FORMCHECKBOX
Dr. FORMCHECKBOX
Mr. FORMCHECKBOX
Ms. FORMCHECKBOX
Professor
Highest Degree Completed:
Investigator Status:
FORMCHECKBOX
Faculty FORMCHECKBOX
Graduate Student FORMCHECKBOX
Other
FORMCHECKBOX
Undergraduate FORMCHECKBOX
Staff
E-mail Address:
College/Department:
Campus Mailing Address:
Daytime Phone:
4) FACULTY SPONSOR (if applicable)
Name:
FORMCHECKBOX
Dr. FORMCHECKBOX
Mr. FORMCHECKBOX
Ms. FORMCHECKBOX
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 ...
THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS .docxchristalgrieg
THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101.
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)
FORMCHECKBOX
Application Form with Signatures/ Confidentiality Agreements
FORMCHECKBOX
NIH Training Certificate(s)
FORMCHECKBOX
Protocol or Attached Research Proposal and/ or Contract/ Grant
FORMCHECKBOX
Solicitation Announcements/Recruitment Flyers
FORMCHECKBOX
Data Collection Instruments/Research Questions/Questionnaires/Surveys
FORMCHECKBOX
Informed Consent Documents
FORMCHECKBOX
Parental/Legal Guardian Permission Form (if applicable)
FORMCHECKBOX
Child Assent Form (if applicable)
FORMCHECKBOX
Approval from Study Sites (if applicable)
FORMCHECKBOX
Medical Screening Instrument (if applicable)
FORMCHECKBOX
Debriefing Plan (if applicable)
FORMCHECKBOX
Student as Principal Investigator Worksheet (if applicable)
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:
FORMCHECKBOX
Dr. FORMCHECKBOX
Mr. FORMCHECKBOX
Ms. FORMCHECKBOX
Professor
Highest Degree Completed:
Investigator Status:
FORMCHECKBOX
Faculty FORMCHECKBOX
Graduate Student FORMCHECKBOX
Staff
E-mail Address:
College/Department:
Campus Mailing Address:
Daytime Phone:
2) CO-INVESTIGATOR – 1 (if applicable)
Name:
FORMCHECKBOX
Dr. FORMCHECKBOX
Mr. FORMCHECKBOX
Ms. FORMCHECKBOX
Professor
Highest Degree Completed:
Investigator Status:
FORMCHECKBOX
Faculty FORMCHECKBOX
Graduate Student FORMCHECKBOX
Other
FORMCHECKBOX
Undergraduate FORMCHECKBOX
Staff
E-mail Address:
College/Department:
Campus Mailing Address:
Daytime Phone:
3) CO-INVESTIGATOR – 2 (if applicable)
Name:
FORMCHECKBOX
Dr. FORMCHECKBOX
Mr. FORMCHECKBOX
Ms. FORMCHECKBOX
Professor
Highest Degree Completed:
Investigator Status:
FORMCHECKBOX
Faculty FORMCHECKBOX
Graduate Student FORMCHECKBOX
Other
FORMCHECKBOX
Undergraduate FORMCHECKBOX
Staff
E-mail Address:
College/Department:
Campus Mailing Address:
Daytime Phone:
4) FACULTY SPONSOR (if applicable)
Name:
FORMCHECKBOX
Dr. FORMCHECKBOX
Mr. FORMCHECKBOX
Ms. FORMCHECKBOX
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 ...
THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS GrazynaBroyles24
THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101.
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)
FORMCHECKBOX
Application Form with Signatures/ Confidentiality Agreements
FORMCHECKBOX
NIH Training Certificate(s)
FORMCHECKBOX
Protocol or Attached Research Proposal and/ or Contract/ Grant
FORMCHECKBOX
Solicitation Announcements/Recruitment Flyers
FORMCHECKBOX
Data Collection Instruments/Research Questions/Questionnaires/Surveys
FORMCHECKBOX
Informed Consent Documents
FORMCHECKBOX
Parental/Legal Guardian Permission Form (if applicable)
FORMCHECKBOX
Child Assent Form (if applicable)
FORMCHECKBOX
Approval from Study Sites (if applicable)
FORMCHECKBOX
Medical Screening Instrument (if applicable)
FORMCHECKBOX
Debriefing Plan (if applicable)
FORMCHECKBOX
Student as Principal Investigator Worksheet (if applicable)
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:
FORMCHECKBOX
Dr. FORMCHECKBOX
Mr. FORMCHECKBOX
Ms. FORMCHECKBOX
Professor
Highest Degree Completed:
Investigator Status:
FORMCHECKBOX
Faculty FORMCHECKBOX
Graduate Student FORMCHECKBOX
Staff
E-mail Address:
College/Department:
Campus Mailing Address:
Daytime Phone:
2) CO-INVESTIGATOR – 1 (if applicable)
Name:
FORMCHECKBOX
Dr. FORMCHECKBOX
Mr. FORMCHECKBOX
Ms. FORMCHECKBOX
Professor
Highest Degree Completed:
Investigator Status:
FORMCHECKBOX
Faculty FORMCHECKBOX
Graduate Student FORMCHECKBOX
Other
FORMCHECKBOX
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Dr. FORMCHECKBOX
Mr. FORMCHECKBOX
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Highest Degree Completed:
Investigator Status:
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Other
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Name:
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Mr. FORMCHECKBOX
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Professor
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5) STUDENT INVESTIGATORS/RESEARCH ASSISTANTS (if applicable)
Name:
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THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS .docxkenth16
THIS IS AN EXAMPLE OF SOUTH UNIVERSITY’S IRB APPLICATION AND IS ONLY TO BE COMPLETED AND SUBMITTED AS AN ASSIGNMENT FOR NSG6101.
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)
FORMCHECKBOX
Application Form with Signatures/ Confidentiality Agreements
FORMCHECKBOX
NIH Training Certificate(s)
FORMCHECKBOX
Protocol or Attached Research Proposal and/ or Contract/ Grant
FORMCHECKBOX
Solicitation Announcements/Recruitment Flyers
FORMCHECKBOX
Data Collection Instruments/Research Questions/Questionnaires/Surveys
FORMCHECKBOX
Informed Consent Documents
FORMCHECKBOX
Parental/Legal Guardian Permission Form (if applicable)
FORMCHECKBOX
Child Assent Form (if applicable)
FORMCHECKBOX
Approval from Study Sites (if applicable)
FORMCHECKBOX
Medical Screening Instrument (if applicable)
FORMCHECKBOX
Debriefing Plan (if applicable)
FORMCHECKBOX
Student as Principal Investigator Worksheet (if applicable)
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:
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Ms. FORMCHECKBOX
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Graduate Student FORMCHECKBOX
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Dr. FORMCHECKBOX
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Mr. FORMCHECKBOX
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Dr. FORMCHECKBOX
Mr. FORMCHECKBOX
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5) STUDENT INVESTIGATORS/RESEARCH ASSISTANTS (if applicable)
Name:
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Structure for writing a scientific research proposal in biotechnology - pubricaPubrica
• The intention of writing a research proposal in biotechnology is to get approval for research work from a committee irrespective of what you are applying.
• The researcher aims to clearly describe the research in a way that a non-specialist can understand.
• The research proposal in biotechnology must not only define how the research will be carried out but also need to providedetail description about the required timeline.
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RESEARCH ETHICS FAQS FOR DOCTORAL STUDENTS IN THE CLINICALINT.docxronak56
RESEARCH ETHICS FAQS FOR
DOCTORAL STUDENTS IN THE CLINICAL/INTERVENTION FIELDS:
PRACTICAL TIPS FOR AVOIDING DELAYS AND PROBLEMS
IN THE RESEARCH APPROVAL PROCESS
This guide is designed to help students consider the ethical issues relevant to doctoral research occurring in clinical and intervention settings. These tips will be most helpful to students early in the research planning process, when they are considering potential research designs, sites, and samples. In this guide, the term, “intervention” refers to any form of therapeutic program, clinical treatment, psychotherapy, support groups, psychoeducational programs, training, or professional practice designed to promote change or development in individuals.
1. WHAT IS IRB APPROVAL?
All doctoral students are required to obtain ethical approval from the university’s Institutional Review Board (IRB) before recruiting research participants or collecting data. The IRB’s ethical approval can only be given when the researcher demonstrates that potential benefits of the study are likely to outweigh the risks and burdens placed on participants, in accordance with the university's ethical standards as well as U.S. federal regulations.
2. WHEN DOES IRB APPROVAL HAPPEN?
The IRB’s ethical review occurs after the defended proposal has been approved by the full committee. However, research ethics questions may be posed to the IRB at any time by emailing [email protected].
3. WHAT KINDS OF DATA MAY I ANALYZE FROM MY OWN CLIENTS/PATIENTS VIA SECONDARY ANALYSIS?
Service providers may analyze data from their own clients when it is either
(A) Collected anonymously via surveys (such that the provider doesn’t know who volunteered and who declined, and doesn’t know which responses belong to which participant), or
(B) A secondary analysis of data that meets all of the following criteria: (i) generated as a byproduct of normal intervention practices, (ii) no client names/identifiers are recorded in the research documents, and (iii) the IRB determines that the study is eligible for a HIPAA-compliant waiver of authorization to use protected health information for research purposes. This approach is sometimes called chart review, archival analysis, or secondary data analysis. It can also be used to analyze other providers’ records. Secondary data analysis can be approved for the following:
-intake assessments
-ongoing assessments that document progress
-worksheets or journals that primarily serve therapeutic purposes (as opposed to research purposes)
-clinical records
-any other data that is generated as a result of regular intervention activities
While it would not be ethical for a service provider student to leverage his/her authority in the organization to coerce patients/clients into providing data in order to achieve the personal goal of completing a doctoral degree, there are many situations in which it is ethically appropriate for a researcher’s doctoral study to consist of a secondary analysi ...
Ethnobotany and Ethnopharmacology:
Ethnobotany in herbal drug evaluation,
Impact of Ethnobotany in traditional medicine,
New development in herbals,
Bio-prospecting tools for drug discovery,
Role of Ethnopharmacology in drug evaluation,
Reverse Pharmacology.
The Art Pastor's Guide to Sabbath | Steve ThomasonSteve Thomason
What is the purpose of the Sabbath Law in the Torah. It is interesting to compare how the context of the law shifts from Exodus to Deuteronomy. Who gets to rest, and why?
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
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Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
This is a presentation by Dada Robert in a Your Skill Boost masterclass organised by the Excellence Foundation for South Sudan (EFSS) on Saturday, the 25th and Sunday, the 26th of May 2024.
He discussed the concept of quality improvement, emphasizing its applicability to various aspects of life, including personal, project, and program improvements. He defined quality as doing the right thing at the right time in the right way to achieve the best possible results and discussed the concept of the "gap" between what we know and what we do, and how this gap represents the areas we need to improve. He explained the scientific approach to quality improvement, which involves systematic performance analysis, testing and learning, and implementing change ideas. He also highlighted the importance of client focus and a team approach to quality improvement.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
1. IRB Application Guidelines
The Intuitional Review Board Application is an interactive pdf form. Information can be entered
directly into the form. Once it is saved, it can be email it back to irb@hccs.edu. The information
in the Guidelines is designed to clarify what it to be included in the Application. If there are
additional questions, please email them to irb@hccs.edu and include a contact number.
Section I General Information
Section I covers general information about the researcher and the proposed project.
The date of submission is the date on which it is emailed to irb@hccs.edu
HU
U
Check New if this is the first submission of the proposed research proposal; Continuing if the project has
been approved but changes are being requested; and Modification if this is a revision from the initial
submission as requested by the IRB.
Principal Researcher (PR)
Name of individual who will be doing the research.
Institutional Affiliation
Name of the institution for which the individual is doing the research. This could be the institution
where the PR is a student or faculty member.
Researcher Title
Title of individual who will be doing the research
Researcher E-Mail Address
Email address where all correspondence should be sent.
Researcher Phone Number
List the primary phone number that can be used to contact the PR if there are questions about
the proposal.
Researcher Alternate Number
Optional. Complete if there is an additional phone number that can be used to contact the PR.
Researcher Mailing Address
Mailing address where correspondence can be sent.
Co researcher
Provide information on other researchers who will be directly involved in the proposed project.
These may include dissertation chairs who will have access to any individually identifiable
information that is collected.
Project Title
Provide a reference name for the project. This can be the title of the dissertation.
Reason for research
List the reason the research is being proposed. This could include dissertation, course
requirement, HCC vendor research, HCC study, or grant project.
Proposed Start Date
Date on which it is proposed that research begin.
Proposed End Date
Date on which it is proposed that research end, typically less than 12 months
HCC Locations
List the HCC campuses or facilities that have been identified where the research will occur.
HCC Sponsor
List any HCC employees the PR will be working with to assist with logistics, including recruiting
participants. While PRs are responsible for coordinating the project, it is recommended that PRs
who are not affiliated with HCC identify a liaison to assist them. This is often some one at the
location where the research will occur.
Source of Funding
August 2011 Page 1
2. If appropriate, indicate sources of funding for the research project. This is optional for non-HCC
Applications. Those affiliated with HCC must list funding sources.
External
If the funding sources or sponsors are external to HCC, list them here. These might include NSF,
THECB, private foundations, universities etc.
Internal
If the funding sources or sponsors relate to HCC initiatives like Chancellor’s Innovation Grants
and internal projects, list them here.
Other
List funding sources that are not grant-related, including personally funded.
Human Subjects Training
All researchers involved in research projects involving human subjects must complete training
that has been approved by a federal agency. Provide information on the date the training was
completed and the type of training taken. HCC recommends the on-line training provided by the
NIH, but evidence of other training programs is also accepted. The free NIH training can be
access at this url: http://phrp.nihtraining.com/users/login.php
HU
U
Section II Overview Questions
Section II is a list of questions that will assist the IRB members in making a determination (1) if the project
is considered to be research according to the Federal guidelines and (2) the level complexity of the
review process.
Please check either Yes or No for each question.
Section III Description of the Research Study
Section III focuses on the project itself and will assist the IRB members in understanding the proposed
research project and in determining how the Principle Researcher will address key issues related to the
protection of human subjects.
1.
PURPOSE OF THE STUDY
In one or two paragraphs, summarize the objectives of the research. Use language appropriate for people
outside of your field of study. Do not cut and paste from long, complex sources, including dissertation or
grant proposals.
2.
RESEARCH QUESTION
The proposed project must meet the federal definition of research. Briefly state the hypotheses and
research questions to be studied. Explain any technical terminology that is specific to the field of study.
3.
RECRUITMENT OF SUBJECTS
Explain who the subjects will be and how will they be recruited. Include as attachments samples of
recruitment flyers or similar documents that will be used. Define any assistance from HCC faculty or staff
that will be needed.
4.
PROCEDURES AND DATA COLLECTION
Describe the research procedures to be used, especially any experimental and interventional procedures
(interviews, surveys, focus groups, observation, review of existing records, etc.). Provide copies of any
survey instruments, including questions that may be asked as part of an interview process. If applicable,
a copy of the questions as approved by the PR’s home institution must be included as part of this
application.
August 2011 Page 2
3. All data collection and analysis are subject to the legal and procedural requirements of Houston
Community College and other local, state and federal regulations. For certain types of data, it may be
necessary to request approval from the HCC General Counsel’s Office. This is the responsibility of the
Principal Researcher.
5.
USE OF DECEPTION
If deception is to be used, explain clearly how it will be used. Explain why it is integral to the proposed
research; how it will be conducted; and how participants will be debriefed.
6.
USE OF HCC RECORDS
Explain any need for paper or electronic data, documents, or records belonging to HCC be used. These
might include data from HCC’s PeopleSoft system, curriculum materials that have been developed by HC
faculty, student participation information that is part of on-line courses, student service records and the
like.
For certain types of data, it may be necessary to request approval from the HCC General Counsel’s
Office. This is the responsibility of the Principal Researcher.
7.
RISK ASSESMENT
Describe your assessment of possible risks to the subjects involved in the proposed research that may be
presented by the procedures stated in the Procedure and Data Collection section, including any physical,
psychological, social, economic, legal, or confidentiality risks. Explain and assess the levels of risks.
8.
RISK MANAGEMENT
For each possible risk presented, explain what will be done to minimize such risks or to respond to any
adverse events, should they occur. Define the possible worst-case scenarios, and how they will be
minimized. Explain how will any adverse effects on subjects be handled or remedied. Explain how the
subjects will be informed of the risks to which they will be subjected, including informed consent
procedures.
9.
COSTS ASSOCIATED WITH PARTICIPATION
List any costs to the subjects by related to participation in this research. These costs may include
transportation, time, parking, etc.
10.
COMPENSATION/REIMBURSEMENT
If any compensation or reimbursement to subjects in this research will be given, explain in detail what
these may be. Compensation may include monetary items like gift cards and non-monetary benefits like
course credit or extra credit.
11.
BENEFITS
Explain the likely benefits of this research to the participants, other than any compensation described
above. Explain how the study will benefit others or contribute to the field of research.
12.
CONFIDENTIALITY
a.
Describe the procedures to be used to maintain the confidentiality of any individually identifiable
data (including any social media, videotapes and/or audiotapes of the participants). This may include
storage and coding of records.
August 2011 Page 3
4. b.
Security of any personally identifiable information is essential to maintaining confidentially.
Explain where the research records will be maintained, who will have access to them, any coding or other
steps that will be taken to separate participants’ names from research data, and how long individually
identifiable data will be retained.
c.
If anyone other than those listed in the application will have access to individually identifiable
data, describe who they are and the purpose of such disclosures. These may include, but are not limited
to presentations at workshops, conferences, dissertation committee, committee meetings etc. If none,
state so.
13.
DISSEMINATION OF DATA/RESULTS
Identify all methods of publicly dissemination of the results of the research, including but not limited to,
meetings, journals, academic conference, thesis or dissertation, etc.
14.
USE OF OUTCOMES/RESULTS
Explain how the research findings will be used. Examples might include in publications, presentations,
grant reports, HCC decision-making, and discussion in that are part of committees.
15.
OTHER DOCUMENTATION AND APPROVALS
If the proposed research study has been reviewed and approved by another institution, explain where,
why and the outcomes of the review. Provide as attachments copies of any documents that demonstrate
approval of the proposed research.
16.
INFORMED CONSENT
Informed Consent is required for most IRB projects. Explain how informed consent will be obtained.
Provide as an attachment a copy of an Informed Consent Form to be signed by the participants.
Section IV Checklist
To be considered complete, the applicable items below must be included as attachments to the proposal.
All attachments must be sent electronically as part of the Application. Check only those items that are
related to and included in this proposal.
1.
An Informed Consent Form will be used and is provided with this protocol.
If the Informed Consent been reviewed by a committee at another institution, attach a copy of the
approved documents.
2.
All Researchers (Principal Researcher and Co-PRs) have completed computer based training on
the protection of human subjects and a copy is provided.
This is the certificate that is issued at the completion of training.
3.
This protocol uses questionnaires/surveys/instruments and the final format is attached.
If these have been reviewed by a committee at another institution, attach copies of the approved
documents.
4.
Résumé or Curriculum Vitae (CV) of Principal Researcher is attached.
August 2011 Page 4
5. Include a copy of the most recent résumé or Curriculum Vitae (CV).
5.
Copies of recruitment flyers/letters are attached.
If any flyers are to be used, to assist with recruiting subjects, include drafts.
6.
If this protocol has already been approved by another institution, their IRB approval letter is
attached.
If the proposed research been reviewed by an IRB at another institution, attach a copy of the
approval document.
7.
Government issued photo ID of Principal Researcher included.
This may be a copy of a driver’s license or passport.
August 2011 Page 5