Office of Research



RowanSOM Among Nation's Best for Geriatric Medical Education | more

Rowan students get set to style their 'staches and grow their goatees | more

WGLS-FM Drug Abuse Doc Wins a Gracie Award | more


Institutional Review Board
Frequently Asked Questions

Please click on the question below to go to the FAQ

1.  Who needs to submit an application to the Institutional Review Board?


2.  What does the Rowan University IRB consider to be research?


3.  When do I apply for IRB approval?


4.  How long should it take to get a response from the IRB?


5.  What if I need an answer more quickly?


6.  What kind of response should I get from the IRB?


7.  What is an exemption? Who can apply?


8.  Do I have to include the survey, questionnaire, or test that I plan to use?


9.  Do I need permission from my research participants?


10. Do I need permission from anyone else?


11. Do I have to complete the training in Human Participant Protections Education?


12. I am a student. Does my instructor need to sign anything?


13. Does the IRB form have to be typed?


14. Who can I contact for more information?

15. If I'm a student doing a class project, do I need IRB approval? If I'm a faculty member requiring a class research project, do I need IRB approval?


16. Who can be an investigator?


17. If I'm an emeritus, may I submit an application to Rowan University's IRB Committee?


18. If I'm an adjunct, may I submit an application to Rowan University's IRB Committee?


19. If I have no affiliations with Rowan University, but want to do research involving the Rowan population, can I?


20. If I submit an IRB application in the summer, when will it be reviewed?


21. Do I need certification from CITI if I have a NIH certificate?


22. What if I want to do resarch at the Cooper Medical School?


23. Do I need to complete and submit an IRB application for my class survey related to curriculum development?


24. Do I need to complete the Conflict of Interest Disclosure Form?


25. What is an " Interest" as referenced in the Conflict of Interest Disclosure Form?


26. Does the IRB review case studies?


27. My approved IRB application is coming to the end of the 12-month period to conduct the research. Is there anything that I need to do?

 


1. Who needs to submit an application to the Institutional Review Board?

All Rowan University faculty and staff are planning to conduct research with human subjects must submit an application for approval by the IRB.

Some (but not all) sudents who are planning to conduct research with human subjects must submit an application. Students conducting research related to their MASTER'S THESIS or DOCTORAL DISSERTATION must submit an application for IRB approval if their research involves the use of human subjects.

Student-conducted research that is conducted solely within the confines of the classroom or within a departmental research participant pool and:
     • is a general requirement of a course,
     • has the sole purpose of developing the student's research skills,
     • is not intended for presentation or publication outside the classroom, and
     • will be overseen by a faculty member;
may not be subject to IRB review. Check with your class instructor for guidance as to whether you must submit your research protocol for IRB review.

back to top

2. What does the Rowan University IRB consider to be research?

The Rowan University IRB defines "research" as a systematic investigation designed to develop or contribute to generalizable knowledge.

back to top

3. When do I apply for IRB approval?

You must apply prior to beginning your research. You must have the permission of the Rowan University IRB before identifying research subjects, beginning intervention, or collecting data. IRB applications are handled on a rolling basis, except for Full Board Reviews. Please refer to the IRB homepage to review the submission schedule for protocols and applications identified as requiring a Full Board Review.

back to top

4. How long should it take to get a response from the IRB?

You should receive a response within two weeks after the scheduled IRB meeting.

back to top

5. What if I need an answer more quickly?

Try to plan your research so you allow for the time it takes to receive an IRB approval. But, if you need a response before the usual approval dates, contact the IRB Chair. We will try to expedite the review. However, the IRB reserves the right to hold a full review of the proposal and/or request revisions prior to approval.

back to top

6. What kind of response should I expect from the IRB?

The IRB will give you one of three types of responses:
     • APPROVED - Exedited,
     • APPROVED - Exempted,
     • APPROVED - Full Board,
     • PENDING - Changes required to obtain approval
     • NOT APPROVED/DENIED (with explanation).

back to top

7. What is an exemption? Who can apply?

Federal law allows the IRB to exempt some research from a full review. This saves time and effort. The IRB application form describes the exemptions. If you think your research should be exempted, indicate this in a cover letter explaining which exemption you think applies to your research. Exemption for some protected classes, such as but not limited to children, prisoners, cognitively impaired, may not be granted an exemption due to the particular vulnerability of those subjects.

To determine whether your research might be granted an exemption, consider your answers to the following questions:

a. Does your research involve deception of your subjects? Yes or No

If you answered yes to a, your research cannot be exempted from IRB review.

b. Will your research be conducted in an educational setting and involve the evaluation or comparison of normal educational practices?

c. Does your research involve the use of educational tests, surveys or interviews or observations, with no possibility of identification of the subjects and no possibility that the subjects might be placed at risk of criminal or civil liability, or of damage to their financial standing, employability or reputation? This exemption does not apply when children are used in the study, UNLESS the following are applicable to your study: 1) data is gathered anonymously and 2) researcher does not physically participate in the interaction with the children.

d. Are you surveying, testing, interviewing or observing public officials, and there is no identifying material of individual persons?

e. Does your research involve the collection or study of previously existing data, documents, records or specimens that are publicly available and/or cannot be linked to the individual contributors of the data?

f. Does your research involve study, evaluation or examination of public policies or procedures, and is your research subject to federal department or agency supervision?

g. Does your research involve food tasting of food without unsafe levels of additives?

If you answered yes to b-g, your research may be exempt. You can indicate exemption on your application, but a researcher cannot self-exempt. During the review of the application, the IRB will determine whether or not the research is exempt.

Please refer to more detailed explainations in the application itself or the Website of the U.S. Department of Health and Human Service Office for Human Research Protections (OHRP).

back to top

8. Do I have to include the survey, questionnaire, or test I plan to use?

If you have developed your own research instrument or made modifications to a published instrument, you must submit it with your application. If you are using a published instrument, include the complete citation for that instrument (author, publisher, date of publication) and a brief description of the instrument with your application.

back to top

9. Do I need permission from my research participants?

Yes. You may use the recommended consent form contained in Appendix B of the IRB Application Form (Click for Word version), or follow the guidelines presented in the application form to develop your own form.

If the only record linking the subject with your research would be the consent form, and the research presents no more than minimal risk of harm to subjects, you may not have to prepare a consent form. Instead you may state at the top of your research instrument or on an accompanying cover letter on department stationary:
     • a statement that all participation is voluntary,
     • a statement that you are conducting research and the reason for it (e.g.,
        master's thesis, publication, etc.),
     • purpose of the research-what you are investigating,
     • a statement that all responses will be kept anonymous and confidential,
     • a statement that participants need not respond to all questions,
     • if particpants are your own students, a statement that class standing will not
       be affected in any way based on participation, and
     • the name and telephone number of the Principal Investigator (PI) and faculty
       sponsor (if applicable).

back to top

10. Do I need permission from anyone else?

If your research is with children or with any other group who may not be able to provide informed consent, you must get signed permission from a parent or legal guardian.

If you are conducting research in an institution other than Rowan University (e.g., a school, hospital, community agency), you must have signed permission from an administrator from that institution on the institution's letterhead.

If you are collaborating on your research and/or conducting your research at an institution that has an Institutional Review Board, then an Inter-Institutional Authorization Agreement may have to be completed and signed. For more information, contact the Institutional Review Board Administration - Eric Gregory or Karen Heiser.

back to top

11. Do I have to complete the training in Human Participant Protections Education?

Yes. You must complete the training before the IRB can approve your application. Rowan University maintains a Federalwide Assurance (FWA) with the Office of Human Research Protection (OHRP), U.S. Department of Health & Human Services. This Assurance includes a requirement for all research staff working with human participants to receive training in ethical guidelines and regulations.

Click here to complete the CITI training program. You can work at your own pace, and you do not have to complete the training in one session. You can return at a later time and pick up where you left off! When you have successfully completed the training, an e-mail will be sent to the Research Office indicating that you completed the training.

Only individuals who have previously completed and received a certification in Human Subjects Protection (of which the certificate is set to expire), can access and complete the Refresher Course in the CITI training program. For all individuals, who have never completed human subjects research training, the Refresher course is not an option, and those individuals will be required to complete the initial/basic training.

back to top

12. I am a student. Does my instructor need to sign anything?

Yes. You need to input the name and contact information of your faculty advisor on the first page of the application, and your instructor needs to sign the assurance on the last page (as do you). As a student, the faculty advisor is considered the Principal Investigator, but that does not mean that a student cannot plan, conduct, and report on the research. The ultimate responsibility of the research lies with the faculty advisor.

A faculty advisor has to be a full-time, permanent faculty or staff of Rowan University.

back to top

13. Does the IRB Application form have to be typed?

Yes. You can complete the form online or copy the form to your computer and complete it offline. The IRB will not accept handwritten applications.

back to top

14. Who can I contact for more information?

Check out the Compliance Website, or e-mail the Research Office or IRB Chair if you have any questions regarding the IRB or the use and rights of human participants in research. Additionally, an investigator can contact Eric Gregory for any questions and concerns.

15. If I'm a student doing a class project, do I need IRB approval?

For Master and Doctoral students performing human subject research to use in their thesis or dissertation, IRB approval is required. For undergraduates who are participating in an assigned class project/exercise that is related to or has a component of human subjects research, then the professor or instructor should be certified in the protections of human subjects. The professor or instructor will need to assist students when determining a research project is not considered human subjects research requiring IRB review. The professor should instruct the students on IRB policies and/or require the student to complete Students - Class Projects training in CITI. To determine if a classroom exercise is subject to IRB review, go to IRB homepage and review the Classroom Exercise Section of the webpage.

back to top

16. Who can be an investigator?

Any externally funded project requires the Principal Investigator must be a permanent employee (faculty member or staff member) of Rowan University at the time of sponsored program award acceptance and project excution. If a faculty member or staff member does not meet the PI eligibility requirements above, then please contact the Research Office or Office of Sponsored Programs for more information.

Office of Human Research Protections and code of federal regulations define researcher as such:

Who are “investigators”?

The HHS regulations at 45 CFR part 46 use the term “investigator” to refer to an individual performing various tasks related to the conduct of human subjects research activities, such as obtaining informed consent from subjects, interacting with subjects, and communicating with the IRB. For the purposes of the HHS regulations, OHRP interprets an “investigator” to be any individual who is involved in conducting human subjects research studies. Such involvement would include:

  • obtaining information about living individuals by intervening or interacting with them for research purposes;
  • obtaining identifiable private information about living individuals for research purposes;
  • obtaining the voluntary informed consent of individuals to be subjects in research; and
  • studying, interpreting, or analyzing identifiable private information or data for research purposes.


Investigators can include physicians, scientists, nurses, administrative staff, teachers, and students, among others. Some research studies are conducted by more than one investigator, and usually one investigator is designated the “principal investigator” with overall responsibilities for the study. In every human subjects research study, investigators have certain responsibilities regarding the ethical treatment of human subjects.

Students submitting an IRB application must identify and record a faculty advisor on their IRB application, and the faculty advisor is also required to sign the attestation and confirmation statement on the IRB application. The faculty advisor must be a full-time, permanent faculty or staff member of Rowan University.

back to top

17. If I'm an emeritus, may I submit an IRB application for approval?

Yes. Emeritus needing IRB approval may submit an IRB application to the IRB Committee.

back to top

18. If I'm an adjunct, may I submit an IRB application for approval?

Yes. Adjuncts needing IRB approval may submit an IRB application to the IRB Committee; however, they must provide their off-campus contact information.

back to top

19. If I have no affiliations with Rowan University, but want to do research involving the Rowan population, can I?

No. A full-time, permanent faculty or staff member employed at Rowan University needs to be involved and identified in the IRB Application submitted for review.

back to top

20. If I submit an IRB application in the summer, when will it be reviewed?

Summer applications are reviewed within two weeks after submission. There is no deadline for applications, and these applications are handled on a rolling basis.

back to top

21. Do I need certification from CITI if I have a NIH certificate?

No, a current NIH certificate is satisfactory and acceptable. However, when the NIH training certificate expires (NIH certificates expire in 3 years), then CITI Human Subject training in your field of expertise or study must be completed. CITI training webpage - https://www.citiprogram.org/ There may be additional training requirements for faculty, students, administrators, and staff who are doing research through an externally funded grant, of which the Research Office will inform you.

back to top

22. What if I want to do research at Cooper Medical School (CMS)?

All research done at Cooper Medical School must be approved by its IRB Committee. Click here for directions, template, and application form. If your project does not fit the template, please click here for the Investigator-Initiated Protocol Template.

back to top

23. Do I need to complete and submit an IRB application for my class survey related to curriculum development?

Internal curriculum development does not require a review by the IRB, and therefore, does not require the completion and submission of an IRB application. However, if a classroom survey related to curriculum development is associated with a sponsored project and will contribute to generalizable knowledge/publication/reporting to the public, then the curriculum development survey may be subject to IRB review. Please contact the Glassboro Campus - Social, Behavioral and Educational Review Board Administration (Eric Gregory or Karen Heiser) for more information.

24. Do I need to complete the Significant Interest Disclosure Form?

Yes, EACH "investigator," as defined below, on a research or training project must complete his/her section of the Disclosure Form which must then be submitted with the proposal to the Social, Behavioral and Educational Institution Review Board. This requirement pertains to both funded and unfunded research or training activity. If the project is to be funded, please attach this disclosure form to your Proposal Planning Form submitted to the Office of Sponsored Programs.

The term "investigator" means:

  • the principal investigator,
  • co-principal investigators, co-investigators, and
  • any other University personnel who, in the course of their association with the University are or will be responsible for the design, conduct, administration, collaboration, analysis and/or reporting of either research or training activities funded or proposed for funding by any sponsor, or of unsponsored research or training activities. These persons may include faculty, non-faculty employees, research associates, technicians, consultants, postdoctoral fellows, graduate and other students.

(NOTE: If one or more such individuals had not been named at the time of proposal submission, a form or forms must be subsequently completed by the(se) individual(s) and submitted by the principal investigator to the Rowan University Social, Behavioral and Educational Institutional Review Board when submitting an IRB Application Revision Request).

25. What is an "Interest" as referenced in the Conflict of Interest Disclosure Form?

The term "interest" means any financial or other personal involvement of the investigator, his or her spouse, domestic partner, children, parent, or siblings who reside in the same household including, but not limited to:

  • income; honoraria or other payment for services;
  • reimbursed or sponsored travel for services
  • equity such as stock, stock options or other ownership rights, excluding interests of any amount in publicly traded, diversified mutual funds, pension funds, or other institutional investment funds over which the faculty member does not exercise control;
  • patents and copyrights;
  • contracts, licensing and other agreements;
  • royalties (including those royalties distributed by the University);
  • employment; and services, relationships or positions, even if uncompensated.

If there is a financial or other personal interest requiring disclosure, then Part 2 of Attachment A in the application needs to be completed and submitted with the IRB application. Be sure to include in Part 2 all relevant details about the relationship of the interest to the Investigator’s Institutional responsibilities, and sufficient information for the Disclosure Review Committee to determine if a conflict of interest exists, and how such a conflict of interest might be managed, reduced or eliminated. Use additional pages if needed, and we recommend to be as specific as possible.

26. Does the IRB review case studies?

Case studies are handled on a case-by-case basis. Please contact Harriet Hartman to discuss the case study prior to submitting an IRB application.

27. My approved IRB application is coming to the end of the 12-month period to conduct the research. Is there anything I need to do?

If your study was approved under the exemption review procedures, then you are not required to do anything at the end of the 12-month period to conduct the research. If you study was approved under the expedited and full board review procedures, then you must submit a Continuing Review/Final Report Form.

 

 

back to top

Shreekanth Mandayam
Associate Provost for Research
Rowan University
856-256-5150
shreek@rowan.edu

Harriet Hartman, Ph.D.

IRB Chair

Rowan University

856-256-4500, ext. 3787

hartman@rowan.edu

Dr. Sreekant Murthy
Chief Research Compliance Officer
Rowan University
murthy@rowan.edu

Eric Gregory

Compliance & Contracts Specialist

Rowan University

856-256-4500, ext. 4058

gregorye@rowan.edu

Karen Heiser
Secretary to the Associate Provost
Rowan University
856-256-4167
heiser@rowan.edu

back to top