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I. STUDY TITLE

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II. FUNDING

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Type of Funding:
Please select funding and include requested information.

Do you plan to apply for funding in the future?

* Wait until you have been notified that your project will be funded before seeking IRB approval unless otherwise instructed by funding source. Submit documentation of funding status with application and a complete copy of the grant with your IRB application.

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III. GENERAL STUDY INFORMATION

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A. Participant Recruitment Numbers:

B. Participant Ages

C. Estimated Project Duration

D. Why is this Project being conducted?

E. Special Study Populations (check if applicable)

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IV. RESEARCH RISK

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*Research must present no more than a minimal risk to human participants in order to qualify for expedited review. Minimal risk means that the “probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or test.” (45 CFR 46.102).

A. Does the research propose greater than a minimal risk to participants?
(If 'Yes' skip to part C of this section)

B. Does the research include prisoners?
(If research includes prisoners, the application must be reviewed by the full board)

C. Check all procedures that apply to the research:

D. Does this study involve any of the following? (Check all that apply)

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V. RESEARCH SUMMARY

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Please attach a brief research summary using the topic headers A-I below. Please use simple language, avoid technical jargon and bold headers.

Note: , thesis, dissertation or course work proposals may not be submitted in lieu of the Research Summary because traditional proposals do not include specific information on risks, benefits and detailed informed consent procedures. Grant, thesis or Dissertation proposals should be attached as an addendum to the IRB application. Some of the information in a traditional proposal may be cut and pasted into the Research Summary such as the introduction, methods, materials and analysis.

A. Introduction and Background:
1. State the problem and hypothesis
2. Provide the scientific or scholarly reason for this study and background on the topic

B. Specific Aims/Study Objectives:
1. List the purpose(s) of the study (what are you hoping to learn as a result of the study)

C. Materials, Methods and Analysis (quantitative and qualitative):
1. Describe data collection methods (Procedures) be specific
2. Describe the specific materials or tools that will be used to collect the data – be specific

D. Research Population & Recruitment Methods:
Describe:
1. Inclusion and Exclusion Criteria (what participant traits are needed to be included, what traits exclude participants?)
2. What is the scientific or scholarly justification for the number, gender, age, or race of the population you intend to recruit?
3. How did you choose the source of participants or data? (census records, ND students, other records, etc)
4. Recruitment procedure (if applicable) including who will recruit participants
5. Tools that will be used to recruit (payment, advertisements and flyers attach copies to this application)

(Note: participant payment beyond $600 must be reported to the IRS, and this requirement must be added to the consent form)

E. Informed Consent Procedures:
Describe:
1. Who will perform the informed consent procedure?
2. How will that person be trained? (previous related coursework, previous experience, one-on one training with PI or faculty, etc.)
3. How will the prospective participant’s competence or understanding of the procedures be assessed; will participants be asked questions about the procedures, or encouraged to ask questions?

F. Confidentiality:
Describe the Provisions for participant and data confidentiality:
1. Where the data will be stored, and who will have access to the data and the area?
2. How will the data be stored, and in what format (hard or electronic copy, identifiable or de-identified)
3. Will the participant’s identity be coded? Will the codes to identify participants be stored with the data?
(Note: If you are working with a Hospital or Clinic, please see information on HIPAA and Research )

G. Potential research risks or discomforts to participants:
1. Indicate the type of risk that may result from participation. Consider psychological or emotional risks, social stigma, change in status or employment, physical risks or harms, information risks-breech of confidentiality and any effect loss of confidentiality may have on status, employment, or insurability. If the protocol involves treatment, what are the risks compared to other treatments in terms of “standard of care”?
2. Consider the likelihood and magnitude of the risks or discomforts occurring? Are they unlikely, or likely to occur and what effect would the discomforts or risks have on the individual should they occur?
3. How will you minimize risks? Some examples include informed consent, adequate staff training and experience, debriefing , and monitoring adverse effects on participants.

H. Potential research benefits to participants:
1. Indicate the type of benefit that may result from participation. Consider psychological or emotional benefits, learning benefits, learning benefits, physical benefits and discuss if participant will benefit directly or if the benefit is largely to gather generalizable knowledge or provide scientific or social information on a topic that may benefit society. DO NOT OVERSTATE the benefit.
2. Consider the likelihood of the benefits. Will all or some participants benefit? (Note: Monetary compensation is not a benefit of participation, it is a recruitment tool)

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VI. INFORMED CONSENT AND WAIVER OF ELEMENTS
OF INFORMED CONSENT OR DOCUMENTATION

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A. The informed consent document should include all required elements of consent (See ND Consent Guide for informed consent samples. Confirm that each element is included in your consent form (unless you are requesting a waiver or partial wavier of consent skip question VII. B):

- A statement that the study involves research

- The purpose of the research in lay terms (language understandable tot the participant)

- A statement that they are being asked to participate in research, and how they were selected to participate

- The expected duration of the participant’s participation “You will be asked to complete a survey every month for 1 year”

- The total time commitment of participation in the procedures “the survey will take 20 minutes to complete”

- A brief but complete description of all procedures to be followed (if research includes treatment describe which procedures are experimental and alternatives to those procedures)

- The risks or discomforts that are reasonably expected from the research, and a statement that “There may be unknown risks”

- The benefits to the participant or others that are reasonably expected from the research

- A statement of confidentiality that provides the participant a contact at the institution who may be reached if injury occurs or confidentiality is breached (this should be someone other than the researcher)

- A statement that participation is entirely voluntary and may be discontinued at any time

- A statement that withdrawal from participation will not result in denial of entitled benefits

- Invasive biological, clinical or behavioral interventions require specific descriptions of the procedure

- The consent form must be signed and dated, or oral consent must be witnessed and signed and dated by the witness

- A statement and check box that includes the participants have a copy of the informed consent Document

Note: Individuals with added protections require both permission of a legal representative and assent of the individual.

B. In some instances the IRB may consider altering the informed consent requirements. To be considered for an alteration or waiver of the required elements of informed consent, one of the following must apply in accordance with (45 CFR 46.116 (d)) or 45 CFR 46.117 (c)

Are you requesting an alteration or waiver?
If 'Yes', you must complete the ND Consent Waiver/Alteration Form.

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VII. RESEARCH STAFF

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(e.g., PI. Co-PI, Research Assistant, etc) Please list and CITI training certificates for all personnel who will interact or collect data. If ORC has your certificate on file please list the date of training.

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VIII. PERFORMANCE SITES

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(e.g., University of Notre Dame, Hospital, Public Schools, etc) If the institution has an IRB, please provide that documentation to the ND IRB. If the institution does not have an IRB, the Institution must authorize or provide permission for the research activities (please email, fax or attach a site permission letter from an Institutional Official). If you are collecting data at a Hospital with an IRB, seek Hospital approval prior to submitting the ND IRB Review Application.

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IX. ACKNOWLEDGEMENT

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SUBMISSION OF A PROPOSAL TO THE ND IRB REQUIRES THAT THE PRINCIPAL INVESTIGATOR (AND MENTOR IF THE PI IS A STUDENT OR FELLOW) SIGN THIS PAGE AND READ COMPLETLEY THE DEFINITION OF “SCIENTIFIC MISCONDUCT” AND ANSWER ALL “CONFLICT OF INTEREST” QUESTIONS GIVEN BELOW.

A. “Scientific Misconduct” shall be considered to include:

1. Fabrication, falsification, plagiarism or other unaccepted practices in proposing, carrying out or reporting results from research;
2. Material failure to comply with Federal requirements for the protection of human participants, researchers and/or the Public;
3. Failure to meet other material legal requirements governing research;
4. Failure to comply with established standards regarding author names on publications;
5. Failure to adhere to issues of confidentiality as provided in the participant consent form, the study protocol, and as outlined in the Code of Federal Regulations (45 CFR 46).

B. Conflict of Interest

1. Are you or any member of your immediate family (spouse or dependent children) an officer, director, partner, trustee, employee, advisory board member, or agent of any of the following (check all that apply):

2. Are you or any immediate family member the actual or beneficial owner of more than five percent (5%) of the voting stock or controlling interest of (a) the external organization funding this project or (b) any external organization from which goods and services will be obtained under this project (including those to which you may be subcontracting a portion of the project work), (c) any external organization whose financial condition could benefit from the results of this project, or (d) any external organization having business dealing in an area related to the work under this project?

3. Have you or any member of your immediate family derived income within the past year, or do you or any member of your immediate family anticipate deriving income, exceeding $10,000 per year from (Check all that apply):

4. For those projects funded by any external entities, do you have a current, up-to-date Conflict of Interest Disclosure on file with the Office of Research that describes this financial relationship?
(if 'No' you must submit an updated COI disclosure before IRB approval)