Protocol Number (IRB Office Use Only):______IRB Form A
Farmingdale State College
Institutional Review Board (IRB)
Application for Approval of Research Involving Human Subjects
Instructions and Information: Form Aand Form Bare required for all protocols. If the research has been approved by another institution’s IRB, the researcher may submit those forms, with approval letter, to the Farmingdale IRB. IRB protocols should be submitted at least one month prior to the researcher’s planned data collection for Exempt and Expedited protocols and three months prior for protocolsthat do not meet the requirements for Exempt or Expedited review. Protocols that do not meet these requirements are reviewed by the Full Board. This is a protected MS Word Document. Save this document to your computer before completion. Check boxes can be activated with a mouse click and text boxes will expand as you input data. Handwritten forms will not be accepted.
SECTION I. GENERAL PROTOCOL INFORMATION
Section I.A.- Date of Submission:
- Study Title:
- Proposed Start Date:
- Proposed End Date:
Section I.B. Investigator Information
Note: All study personnel must complete an FSC approved human research participants training program such as CITI () or NIH (). Certificates of completion for all study personnel must be submitted with this protocol.
- Principal Investigator:
- Department:
- Campus Address:
- Office Telephone:
- E-Mail:
- Additional Study Personnel (Co-Investigators including Student Research Assistants)
Co-Investigator Name:
If additional space is needed, list personnel in Form B. / Affiliated Institution: / Research Category
(0,1,2,3 or 4)*: / Student Assistant (Check if applicable):
A.Click here to enter text. / Click here to enter text. / Click here to enter text. / ☐
B.Click here to enter text. / Click here to enter text. / Click here to enter text. / ☐ /
C.Click here to enter text. / Click here to enter text. / Click here to enter text. / ☐ /
* Categories:
0. No interaction with human subjects, human data, or human tissue. Specify role in Form B.12 (i.e. Technician).
- Interacts directly with human subjects in research that does not involve drugs, biologics, or devices.
- Interacts directly with human subjects in research that involves drugs, biologics, or devices.
- Only interacts with human data or human tissue in this research activity.
- Institutional Research Personnel- No interaction with human subjects or human tissue. No access to human data beyond normal job duties and access.
Section I.C. Site of The Research
Note: If any part of the proposed research will be conducted at another site or by a co-investigator from another institution, that location’s IRB approval, an Institutional Authorization Agreement (IAA), or other documentation may be required. Please contact FSC’s IRB Office for more information.
- Site(s) of the Research:
Section I.D. Research Funding
- Funding Sources (check all that apply):
☐Applied for Funding
☐Obtained Internal (SUNY/FSC/Department)
☐Obtained External (Grant)
SECTION II: SUBJECT / DATA RESEARCH
Section II.A. Type of Study- Will this study involve ANY interaction with human subjects?
*If No, select the category of research:
☐Review of data that exists at the time of application (e.g. school databases, medical records).
☐Review of data that does not already exist at the time of application submission.
☐Analysis of existing biological specimens (i.e. specimen already on lab shelf at time of application).
☐Analysis/review of data collected at a collaborating institution/site.
☐Prospective collection of anonymous/discarded clinical samples.
☐Other (please specify):Click here to enter text.
- Will this study involve the use of any drugs or medical devices?
*If Yes, complete IRB FormF:Drug/Device Research.
- Does this protocol involve deception?
*If Yes, describe deception and debriefing process in Form B.
Section II.B. Human Subjects Information
Note: Human subject is defined as any individual about whom an investigator conducting research obtains data a) directly through intervention or interaction with the individual or b) indirectly through study of the individual’s existing data and /or biological specimens.
- What method(s) will you use to recruit subjects?
*If using classroom announcement to recruit subjects, list the faculty members and courses involved in Form B. Note that IRB approval does not obligate faculty to participate in recruitment. Approval must be granted by each faculty member, the Department Chair, and Dean (if applicable). / ☐Psychology/ Business Participant Pool
☐Word of Mouth
☐Classroom Announcement*
☐Posters/Flyers
☐Direct Contact
☐Letters / Email
☐Internet
☐Printed Ads / Radio / TV
☐Other (Please Specify):Click here to enter text.
- Total expected number of subjects:
- For multi-sitestudies, provide a breakdown of total expected number of subjects from all sites:
Site: / Click here to enter text. / Total expected subjects: / Click here to enter text. /
Site: / Click here to enter text. / Total expected subjects: / Click here to enter text. /
Site: / Click here to enter text. / Total expected subjects: / Click here to enter text. /
- Justification for total number of subjects:
☐Power Analysis
☐Other (Please specify):Click here to enter text.
- What is the expected duration of participation?
- Will subjects be paid for their participationin the research?
*If Yes, provide details of remuneration (i.e. total amount, prorated scheduling, and funding source):
Click here to enter text. /
- Subject gender for this study:
☐Other (Please specify): Click here to enter text.
- Will those recruited for this study be limited to specific ethnic or social group(s)?
*If Yes, describe:
Click here to enter text. /
- Federal mandates require that you include minorities in your research unless you can justify their exclusion. Are you including minorities?
*If No, justify the exclusion of minority groups:
Click here to enter text. /
- Federal mandates require that you include non-pregnant women (age 18+) in your research unless you can justify their exclusion. Are you including this population?
*If No, justify the exclusion of women:
Click here to enter text. /
- Federal mandates require that you include minors (18) in your research unless you can justify their exclusion. Are you including minors?
*If No, justify the exclusion of minors:
Click here to enter text. /
Section II.C. Vulnerable Populations
- Indicate which of the following populations will be included in the research.
Depending on which populations are included in your research protocol, you may need to complete questions 28-35. Only complete the questions that correspond to the populations you have selected below. If none, skip to Section III.
☐None (Skip to Section III)
☐Students
☐Employees
☐Women of Childbearing Potential
☐Minors (<18 years)
☐Pregnant Women/Fetuses
☐Individuals Unable to Consent for Themselves / ☐Non-English Speakers
☐Nonviable/ Questionably Viable Neonates
☐Prisoners
☐Educationally/ Economically Challenged
☐Institutionalized Persons
☐Abortuses
☐Minors who are Wards of the State
- Research Involving Students
- Will participation in research be offered to students as a way to fulfill course requirements?
- Will an option be given for those who choose to not to participate in the research?
*If Yes, describe alternative option(s):
Click here to enter text. /
- What protections are in place to ensure students are not coerced into participating in research out of concern for their student status and/or grades:
Click here to enter text.
- ResearchInvolvingEmployees
a. What protections are in place to ensure employees are not coerced into participating in research?
Click here to enter text. /
b. What protections are in place to maintain the confidentiality of employee data?
Click here to enter text. /
- Research Involving Women of Childbearing Potential
- Does the research pose any potential risk to an unborn fetus?
*If Yes, explain:
Click here to enter text. /
- *If Yes, how will you ensure that pregnancy does not occur during the course of this study? (Select all that apply)
☐Pregnancy test during study
☐Pregnancy test prior to initiation of the study
☐Not Applicable
- Research Involving Minors (<18 years of age)
- What is your assessment of the risk/benefit
☐Greater than minimal risk with possible direct benefit
☐Minor increase over minimal risk without the possibility of direct benefit, but likely to yield information about the subject’s disease or condition (both parents must give permission)
☐Other (Please explain) Click here to enter text.
b. Will you obtain parental permission? / ☐Yes☐No*
*If No, justify why you will not obtain parental permission:
Click here to enter text. /
- Will you obtain minor assent?
*If No, justify why you will not obtain assent:
Click here to enter text. /
- Research Involving Pregnant Women/Fetuses
- Where scientifically appropriate, have preclinical (animal) studies and clinical studies been done on non-pregnant women to assess potential risks to women and fetuses?
- Risks to fetus are:
☐Caused by procedures holding out the prospect of direct benefit for the woman or fetus.
☐Minimal and no direct benefit but the purpose of the research is to yield important biomedical
knowledge which cannot be obtained by any other means.
- Explain the risk/benefit to the fetus and/or mother:
Click here to enter text. /
- Research Involving Subjects who are Unable to Consent for Themselves
- Will the study involve either minimal risk or more than minimal risk with the possibility of direct benefit?
- If your subject population will include adults who will not or may not have the capacity to give informed consent, provide justification for inclusion of these subjects, discuss how surrogate consent will be sought, and provide detailed steps to be taken to ensure additional protection of the rights and welfare of this subject population.
Click here to enter text. /
- Research Involving Non-English Speakers
- How will you ensure that the information you provide will be understandable to the subjects?
☐The IRB-approved English version of the consent form(s) will be translated into a foreign language.
☐I will use the short form consent method (used only for minimal risk studies).
- Research Involving Non-Viable/Questionably Viable Neonates
- Which category is applicable to your research?
☐Neonates of Uncertain Viability
- Does your research satisfy the criteria outlined in Policy 11 of the IRB Policy and Procedure Manual?
*If No,provide a justification:
Click here to enter text. /
SECTION III. INFORMED CONSENT
Note: A subject may not be involved in research (including collection/ study of their tissue or data) unless informed consent has been obtained or a waiver is granted by the IRB (under limited conditions).- Will informed consent information be provided prior to the initiation of any study procedures?
- List the names of all individuals who will obtaininformed consent fromsubjects:
Click here to enter text. /
- Informed Consent will be obtained from:
☐Legally Authorized Representative
- Do you anticipate that any subjects will be decisionally impaired due to:
☐Mental Illness ☐Emotional Distress
☐Unconsciousness ☐Learning Disability
- Indicate whether you plan to obtain written consent or are requesting a waiver of consent, documentation of consent, or elements of informed consent (select one).
☐Written Consent / Written consent requires that participants, or representative, provide a legal signature on a consent form. Note that electronic consent is not considered written consent and requires a waiver of documentation of consent. A copy of the consent form must be submitted with this protocol.
☐Waiver of Documentation ofConsent
To qualify for a waiver of documentation of consent, one of the following options must be met (select one): / A waiver of documentation only waives the requirement that study participants must provide a legal signature on a consent form. Informed consent information must still be provided to participants. A copy of consent information must be submitted with this protocol and a justification for the waiver must be included in Form B.
a. ☐The only record linking the subject and the research would be the consent document and the
principal risk would be potential harm resulting from a breach of confidentiality.
OR
b. ☐The research presents no more than minimal risk of harm to subjects and involves no procedures
for which written consent is normally required outside the research context.
☐Waiver of Consent
To qualify for a waiver of consent, one of the following options must be met (select one): / A waiver of consent is granted in limited circumstances. A justification for the waiver must be included in Form B.
a. ☐The research or demonstration project is to be conducted by or is subject to the approval of state
or local government officials and is designed to study, evaluate or otherwise examine (i) public
benefit or service programs; (ii) procedures for obtaining benefits or services under those
programs; (iii) possible changes in methods or levels of payment for benefits or services under
those programs and the research could not practicably be carried out without the waiver or
alternation.
OR
b. ☐All of the following must be met (1) The research involves no more than minimal risk to the
subject; (2) the waiver or alteration will not adversely affect the rights and welfare of the subjects
(3) the research could not practicably be carried out without the waiver or alteration; (4) when
appropriate,the subjects will be provided with additional pertinent information after participation.
☐Waiver of Elements of Consent / If it can be justified, the IRB may approve a consent procedure which does not include or which alters some of the required elements of informed consent. A description of the elements to be waived or altered, and a justification, must be included in Form B.
SECTION IV. SUBJECT DATA / BIOLOGICAL SPECIMENS
Section IV.A. Privacy / Confidentiality- Information about research participants will be obtained through (check all that apply):
☐Interviews / Focus Groups
☐Direct Observation
☐Performance of Tests and Procedures
☐Other (Please Specify):Click here to enter text.
- Data collected for this study will be obtained:
☐Anonymously / No identifiable information is collected; there is no way to link participant data to their identity.
☐In a Coded Manner / A link to the subject is retained (e.g., ID number); it is possible to link participant data to their identity. A description of coding procedures (and de-identification procedures, if applicable) must be included in Form B.
☐In a Fully Identifiable Manner / Identifiable information is collected and stored with participant data.
- What precautions will be used to maintain the confidentiality of identifiable information in data collection, maintenance/storage of data, and the dissemination of findings?
Click here to enter text. /
- Is banking of data (e.g. registry) proposed for future, as yet unspecified, research?
- Will this research use any third party information such as family history or sexual contacts?
*If Yes, describe protections for consent and/or privacy of the third party:
Click here to enter text. /
Section IV.B. Biological Specimens
- Does this study involve the collection of biological specimens?
- How will Biological Specimens be obtained?
☐Specimens will be obtained from future, discarded clinical specimens.
☐Specimens will be obtained from procedures performed specifically for research.
☐Retrospective collection (specimens have already been obtained, i.e., already “on the shelf”)
- Will the analysis of the specimens be able to provide information that has known clinical significance for diagnosis or prediction of a disease state for either the subject or the subject’s family members?
- Is banking of biological specimens proposed for future, as yet unspecified, research?
SECTION V. DETERMINATION OF RESEARCH STATUS