Research Ethics Committee (REC) Proposal submission form

Please be sure to click save before exiting the site OR clicking on any of the hyperlinks within this form as doing so will take you out of the form and progress will be lost.
Please indicate if this is your initial or revised submission. Note, if this is a revision, please be sure all revisions have been made in all necessary attachments and all revisions highlighted throughout.

Click here if this is your initial submissionClick here if you are making revisions per conditional approvalClick here if you are the PI and need to sign or confirm submissionClick here if you are the REC reviewer

Research Ethics Committee (REC) Cover Page
Training Requirement:

All individuals involved in human subjects research are required to complete training in the protection of human research participants.
Completion of training must occur prior to the final approval of this research project proposal. A web-based training program through the Collaborative Institutional Training Initiative (CITI) can be accessed at https://about.citiprogram.org/en/homepage/

All investigators must submit a certificate of completion with this research project proposal.

Note: CITI training must be renewed every three (3) years.

Click here to upload CITI training certificates of completion. Note, if you have already submitted your CITI certificate you do not need to resubmit here. By clicking to upload your certificate here, you will be redirected to a different form and will need to use the back button in your browser to get back to the first page of this form.
By Checking YES, you verify that ALL listed investigators have completed CITI training and submitted certification of completion.*

YESNO
RESEARCH PROJECT TITLE:*
Please include your abstract here. Briefly describe the purpose, rationale, major procedures and methodology of your research project.
Some projects involve multiple components. Please select all that apply to the proposed research.*

records reviewprogram evaluationother data collectionuse of publicly available data (institutional data or data with no individual identifiers)
If you will be doing records / chart review as any part of your research, you will also need to complete the application to conduct records-based research https://form.jotform.com/223033741588053

If you are doing only records review then you only need to fill out the records-based research application and do not need to proceed with this form.

If you are doing records review in addition to other data collection then you will need to complete this form and the records-based application form.

INVESTIGATOR(S) INFORMATION:
Name of Faculty Advisor / Primary Investigator*

First NameLast Name
Investigator Role*
Degree Attained:*
Department:*
Title:*
PI / Faculty Advisor Email*
example@example.com
Does the PI / Faculty advisor have a conflict of interest (COI) to disclose?*

YesNo
If you selected Yes, please explain your COI below.
Campus Address*

Street Address

Street Address Line 2

CityState / Province

Postal / Zip Code
Primary Phone Number*
Please enter a valid phone number.
Secondary Phone Number
Please enter a valid phone number.
Name of Student / Co-investigator

First NameLast Name
Investigator Role
Degree Attained:
Department:
Title:
Student / Co-Investigator Email
example@example.com
Does this investigator have a conflict of interest (COI) to disclose?

YesNo
If you selected Yes, please explain your COI below.
Campus Address

Street Address

Street Address Line 2

CityState / Province

Postal / Zip Code
Primary Phone Number
Please enter a valid phone number.
Secondary Phone Number
Please enter a valid phone number.
Click here if you have additional investigators to add

add more investigators
Do any (other) investigators have a conflict of interest (COI) to disclose?

YesNo
If you selected Yes, please explain the COI below.

Click here to enter additional investigator information
Name

First NameLast Name
Investigator Role
Degree Attained:
Department:
Title:
Email
example@example.com
Campus Address

Street Address

Street Address Line 2

CityState / Province

Postal / Zip Code
Primary Phone Number
Please enter a valid phone number.
Secondary Phone Number
Please enter a valid phone number.
Name

First NameLast Name
Investigator Role
Degree Attained:
Department:
Title:
Email
example@example.com
Campus Address

Street Address

Street Address Line 2

CityState / Province

Postal / Zip Code
Primary Phone Number
Please enter a valid phone number.
Secondary Phone Number
Please enter a valid phone number.
Collaborating Investigator(s) and Affiliation(s):

Please use the spaces below to enter the names and affiliations of any collaborating investigators.
Name

First NameLast Name
Affiliation:
Email
example@example.com
If there are additional investigators, please complete the ‘Additional Investigators’ form and upload it here. The form can be found at https://rec.spalding.edu/rec-forms/

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This section will help determine the appropriate level of review needed for this proposal.
REC review is required whenever you are conducting research (a systematic investigation designed to contribute generalizeable knowledge) involving human subjects. The questions below will help deterime if your project qualifies as human subjects research and whether or not it meets criterion for exempt status.
Is the purpose of your research solely to improve processes internally at a specific organization?*

YESNO
Is the activity a systematic investigation designed to develop or contribute to generalizable knowledge (I.e. is it research)?*

YESNO
Does the research involve a LIVING individual about whom you will (select ALL that apply): [Note, use of an anonymous survey IS an interaction and environmental modification IS an intervention]-the first option applies to most*

obtain information via interaction or interventionobtain biospecimens via interaction or interventionobtain or generate identifiable private information or biospecimensNone of the above apply to my researchobtain information via records review
Please choose from the following options regarding EXEMPT categories. Note, that selection of any of these does not guarantee approval of exempt status.
According to your selection above, your research may qualify for exempt status, if certain conditions are met. Please be sure to review the decision charts linked on page 7 of this form prior to selecting the level of review needed for this proposal.

Click here to review exempt categories on the REC website.

ESTIMATED PROJECT DURATION:

Please be sure your start date reflects time needed for review and revision of the proposal.
Estimated Start Date (please allow ample time for REC review)*

MonthDayYear
Date
End Date*

MonthDayYear
Date
Total duration (days):
FUNDING INFORMATION (If Applicable):
RESEARCH PROJECT SITE(S) Note, if data collection is online please indicate that in lieu of site along with the survey platform used. For any fields that do not apply enter NA:*
Upload site permission letter(s) here.

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LEVEL OF REVIEW

Please use the following section to indicate the appropriate level of review.
EXEMPT: This research project is eligible for exempt review because it meets at least one of the following criteria:
1. Research conducted in established or commonly accepted educational settings, involving normal educational practices.
2. Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior, EXCEPT when participants can be identified and such disclosure results in risk.
3. Research involving benign behavioral interventions (i.e., brief in duration, harmless, painless, not physically invasive, no significant adverse lasting impact, and not offensive or embarrassing to participant) in combination with the collection of information, EXCEPT when participants can be identified and such disclosure results in risk.
4. Secondary research for which consent is not required (e.g., participants identity cannot be readily ascertained, identifiable information is publically available, identifiable information was originally collected for non-research purposes, or collection and analysis of identifiable information are for the purposes of “health care operations,” “research,” or “public health activities and purposes).Taste and food quality evaluation and consumer acceptance studies.
5. Research and demonstration projects conducted or supported by a federal department or agency that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs.
6. Taste and food quality evaluation of consumer acceptance studies.
7. Storage or maintenance for secondary research for which broad consent is required.
8. Secondary research for which broad consent is required.
EXPEDITED: This research project is eligible for expedited review because the research activities present no more than minimal risk to human subjects and it meets at least one of the following criteria:
1. Clinical study of drug and medical devices only when an investigational new drug or device exemption application is not required and when the medical device is approved for marketing and being used in according to the approved labeling.
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture that follows approved practice guidelines.
3. Prospective collection of biological specimens for research purposes by noninvasive means.
4. Collection of data through noninvasive procedures routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.
5. Research inolving materials that have been or will be collected solely for non-research purposes.
6. Collection of data from voice, video, digital, or image recordings made for research purposes.
7. Research on individual or group characteristics or behavior, or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
8. Continuing review of research previously approved by the REC or IRB where the research is permanently closed to the enrollment of new subjects, all subjects have completed all research-related interventions, and the research remains active only for long-term follow-up of subjects; or where no subjects have been enrolled and no additional risks have been identified; or where the remaining research activities are limited to data analysis.
9. Continuing review of research involving no greater than minimal risk and no additional risks have been identified.
FULL: This research project requires a full board review because it is not eligible for an exempt or expedited review (based on the criteria listed above) and/or it meets at least one of the following criteria:
1. Research activities involves greater than minimal risk to participants.
2. Involvement of intentional deception, such that misleading or untruthful information will be provided to participants.
3. Inclusion of participants of special consideration (e.g., vulnerable populations).
4. Use of procedures that are considered intrusive, stressful, or potentially traumatic.
Please refer to these ORHP decision charts as needed for more information regarding potential exemptions. These can also be found on the REC website, www.rec.spalding.edu
Select the level of review needed.*
Use the text box to indicate why your proposal qualifies for the level of review indicated. For example, if you chose expedited because it meets criteria number 7 then write "Expedited 7" in the box below. Visit the REC website for more information regarding the specific categories to be sure your proposed research meets all of the requirements for any of the selected exempt or expedited categories. *

CERTIFICATION / SIGNATURE PAGE

Proposals will NOT be reviewed without ALL necessary signatures. Faculty advisors must review student proposals PRIOR to submitting this form.
Please read each statement before checking:*

I certify that the information contained in this Research Ethics Committee (REC) Application for Project Review and all attachments is true and correct.I certify that I have received approval to conduct this research from all persons named as collaborators and from officials of the project sites.If the REC approves this proposal, I agree to conduct the research according to the approved protocol.I agree not to implement any changes in the protocol until such changes have been approved by the REC.If at any time unanticipated risks or harm to participants are discovered, I will report them to REC right away.
Name of Individual submitting proposal:*

First NameLast Name
Email of individual submitting proposal*
example@example.com
Role of individual submitting the proposal:*

Study Title
This following section is for signatures of any additional investigators.

Note that all investigators must sign the proposal.
Name

First NameLast Name
Signature

Clear
Name

First NameLast Name
Signature

Clear
Name

First NameLast Name
Signature

Clear

For REC Use Only. DO NOT FILL BELOW THIS LINE
Study Title
Type of review conducted:

Full BoardExpeditedExempt / Limited Review
Approval recommended?

YESNOConditional per requested revisions
Is additional Spalding administration approval needed?

YesNoNot sure
Reviewer comments / conditions to be met for final approval (if conditional approval is recommended).
Upload Reviewer Guidelines Here

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Date

MonthDayYear
Date
Reviewer Signature

Clear
Should be Empty:

Research Ethics Committee (REC) Cover Page

Training Requirement:

INVESTIGATOR(S) INFORMATION:

Collaborating Investigator(s) and Affiliation(s):

This section will help determine the appropriate level of review needed for this proposal.

ESTIMATED PROJECT DURATION:

LEVEL OF REVIEW

RESEARCH PROJECT PROPOSAL OUTLINE:

CERTIFICATION / SIGNATURE PAGE

This following section is for signatures of any additional investigators.