Institutional Review Board Application

Framingham State University Institutional Review Board (IRB)

Application for the Conduct of Research Involving Human Subjects

All research involving human subjects conducted by members of Framingham State University must be approved by the FSU IRB. The investigator should provide complete information regarding procedures and the informed consent process. Student researchers must submit applications that include a faculty sponsor’s signature. For Part Three, an electronic or hard copy of the project description should be submitted to Patricia Bossange. For ease and speed of review, electronic copies are preferred. Applicants will be notified of the IRB’s decision.

Part One

Project information: 











If the answer is 'yes' to either of these, please complete the following information:






If yes, please submit one complete copy of the proposal with this application and indicate agency or sponsor and deadline.
Part Two







Part Three

Project Description
Please provide a description for each of the following items in a separate document. Please use the headings indicated below; number your responses as below; and limit the document to ten or fewer pages.

Submit the document by email or in hard copy to Patricia Bossange, IRB administrator (pbossange@framingham.edu). For ease and speed of review, electronic copies are preferred.

A. Summary of the project
This should be no more than one page in length. It should include pertinent points of the research, highlight potential risks and benefits, and describe risk management procedures.
B. The Protocol
1. Purpose and Background
This should contain information about the relation of the proposed research to previous scientific investigations and/or theory in the field of the proposed research. Include aims and/or hypotheses of the research; the contribution the research is expected to make; and the relevance of the hypotheses. If the research constitutes a pilot or exploratory study, indicate how the information obtained will be used in future studies.

Researchers should use lay language explanations to enable IRB members to understand objectives, methods, potential results, and conditions and risks to which subjects will be exposed. There should be clear justification for the participation of human subjects.
2. Describe the informed consent process to be used
Justification must be included for the inclusion of members of populations whose capability to provide informed consent is absent or limited. This includes children;persons with diminished mental capacity; the senile confined to institutions; and the unborn child or fetus. 
Attach a copy of all consent and/or assent and/or disclosure documents.1 Ensure the consent form uses language that is understandable to the subject or the subject's representative and that it includes the following:
a. Statement that study involves research (including explanation of purposes of research, duration of subject's participation, procedures to be followed, and experimental procedures)
b. Statement of whether the results will be published
c. Statement of foreseeable risks or discomforts to the subject
d. Statements of benefits to the subject and/or society that may reasonably be expected from the research
e. Statement of extent, if any, to which anonymity or confidentiality of records will be maintained
f. Statement that participation is voluntary and refusal to participate or decision to withdraw from the study at any time will incur no penalty or loss of benefits to which the subject would otherwise be entitled
g. Information about whom to contact for answers to questions about research, whom to contact for answers to questions about subjects' rights and whom to contact in event of a research-related injury to the subject (should include the researched, faculty advisor (where appropriate), administrator for the IRB)
3. Subjects
Identify how subjects will be selected, enlisted, or recruited. Include an advertising flyer, if appropriate. Describe the sampling procedures to be employed. The concern of the FSU IRB is that subject selection is equitable and that burdens and benefits of research are fairly distributed. Discuss any potential problems involving the subject groups.
4. Methodology
Provide a step-by-step description of the methodology to be employed, particularly all procedures to be performed on human subjects.
a. Indicate the type of contacts and interactions with subjects and the means of observation when observational or interview studies are used.
b. Identify standard psychological tests to be used.
c. Describe devices or activities, and/or applications of devices or activities, not customarily encountered by subjects in their daily lives.
d. Explain special procedures or devices (such as electrical devices or new drugs) to be used.2
e. Include a copy of tests, questionnaires, or other materials to be used which indicate types of personal data to be collected. 
f. Report any reasons for not informing subjects of procedures.
g. Include a tentative time schedule for procedures, including how long each aspect of the study will take, frequency and timing of ancillary procedures, nature and duration of human discomfort, and location in which the study is to be conducted.
5. Describe methods for ensuring privacy and confidentiality
This pertains both to the methods used to collect data and to the storage of data. If personally identifiable records are to be used, indicate what steps will be taken to ensure privacy and confidentiality of those records. If covert observation or participant observation are to be used, explain how privacy and confidentiality will be maintained. Indicate that study records will be retained for a minimum of 3 years post-research. For studies involving Protected Health Information (PHI) - such as those with HIPAA authorizations or those receiving HIPAA waivers, indicate instead that records will be retained for 6 years post-research.
6. Describe all known and anticipated risks to subjects
Include any known or anticipated violations of normal expectations. Identify possible physical, psychological, or legal risks, as well as social risks to individuals and/or social groups.3 Explain why these risks are justifiable. Identify intended procedures for protecting against or minimizing risks and provide an assessment of their likely effectiveness.
7. Describe anticipated benefits to subjects and/or society
Identify the significance of new knowledge being sought.
8. Letters of agreement
Such letters, from participating organizations/institutions, should be signed by a person with authority to sign such agreements.

1A sample copy of an informed consent form is included in the document, Information, Application Instructions, and Deadlines for Application Submissions. This can be found at https://www.framingham.edu/Assets/uploads/academics/academic-affairs/grants-and-sponsored-programs/_documents/irb-sample-consent-form.pdf.
2Such procedures or devices must be granted approval by appropriate agencies before FSU IRB approval can be granted. Electrical devices must receive Occupational Health and Safety approval. Radioisotopes or research involving any source of radiation must receive Environmental Health and Occupational Safety approval. New drugs must be approved by the Federal Drug Administration.
3See the FSU IRB Policy Regarding Use of Human Subjects for detailed information on risks to subjects.
Part Four

Signatures

I certify that, to the best of my knowledge, the information presented in this application is an accurate reflection of the proposed research project. I agree to report any legal, ethical or moral violations that I see or that may arise, and to report any changes in the research plan that may affect subjects. I agree to file for an extension with the FSU IRB if data collection will extend beyond the project end date indicated above.



For projects involving a faculty sponsor:
I confirm the accuracy of this application, and accept responsibility for supervision of the conduct of this research, supervision of treatment of human subjects, and maintenance of informed consent documentation as required by the FSU IRB.


Data collection may not begin until IRB approval/exemption has been granted.