Preparing a New Study: The Review Process

Types of IRB review: How do I know which application to complete?

There are three categories for IRB review as defined in the federal regulations. They are Exempt, Expedited and Full Board. The category of research is determined by the level of risk to the participant.

Types of Review/Review Categories

Exemption

Exempt research studies present risks so benign, that the federal regulations
determine these types of study to be exempt from review. This determination must be
made by the SU IRB.

Research that qualifies for exemption involves no more than minimal risk and meets
criteria outlined in one of the six categories specified by federal regulations.

Categories for Exemption

Examples of exempt research might include anonymous surveys, complete data sets already in existence and publicly available, research conducted in commonly accepted educational settings involving normal educational practices.

Exempt applications are reviewed by the ORIP Director, Tracy Cromp.

There are no deadline dates for the submission of exempt applications. They can be submitted electronically as an attachment to an email (orip@syr.edu), via campus mail (IRB-214 Lyman Hall), via U.S. mail (IRB-Syracuse University, 214 Lyman Hall, Syracuse, NY 13244) or by hand delivery to our office located in Room 214 of Lyman Hall during regular business hours (Academic year hours are 8:30 am-5pm; summer hours are 8am-4:30 pm).

Turn-around time following initial review is generally 5-7 business days. Should modifications and/or clarifications be requested, additional review time will be required. On average the IRB advises you allow a minimum of 4 weeks for the IRB exempt review process. (This includes the investigators response time.)

All correspondence will flow through the Principal Investigator listed in the study protocol. Students/Research staff will be copied on all communications.

Exempt studies are authorized for a period of five years. They are not renewable. Two months before your research protocol expires you will be notified by the IRB. If you are still conducting the research, you will need to submit a new Exempt application for review and authorization.

If your research is complete prior to the expiration date, send an email to the IRB and request your study be closed. No further action is required.

Expedited

Expedited research activities present no more than minimal risks to participants– no greater than those encountered in daily life

Research that qualifies for expedited review must be listed in one or more the 9 categories defined by the federal regulations. Categories for Expedited Review:

Examples-research on individual or group characteristics or behaviors; research employing the use of surveys, interviews, focus groups, program evaluation and/or the collection of data through non-evasive procedures (moderate exercise, BP screening, muscular strength, flexibility testing, body composition assessment).

Expedited applications are reviewed by the IRB Chair or one of the two IRB Co-Chairs and, when deemed necessary, an expert consultant (e.g. disabilities expert).

There are no deadlines for the submission of expedited applications. They can be submitted electronically as an attachment to an email (orip@syr.edu), via campus mail (IRB-214 Lyman Hall), via U.S. mail (IRB-Syracuse University, 214 Lyman Hall, Syracuse, NY 13244) or by hand delivery to our office located in Room 214 of Lyman Hall during regular business hours (Academic year hours are 8:30 am-5pm; summer hours are 8am-4:30 pm).

Turn-around time for review is approximately 7-10 business days. Should modifications and/or clarifications be requested, additional review time will be required. On average the IRB advises you allow a minimum of 4-6 weeks for the IRB expedited review process. (This includes the investigators response time.)

All correspondence will flow through the Principal Investigator listed in the study protocol. Students/Research staff will be copied on all communications.

Expedited studies are approved for a period of one year (unless the IRB determines more frequent review is necessary) and are renewable for up to 7 years.

Full Board Review

Your research requires full board review when:

  • Involvement in the research exposes Human Subjects to discomfort or harassment beyond levels encountered in daily life.
  • Disclosure of the subject’s responses outside of the research could place them at risk of criminal/civil liability, be damaging to their social and/or financial standing, employability or reputation.
  • The research involves prisoners/legally restricted persons as participants.

Full board applications must be reviewed at a convened meeting of the IRB with a majority of IRB members in attendance.

There is a hard deadline for full board applications. Full board applications must be received two weeks prior to the scheduled IRB meeting.

The IRB meets monthly except during the month of July. The meeting schedule is posted on our website. Link to submission deadline schedule:

Full board applications cannot be submitted electronically.  The application packet must include one original plus 12 copies of the signed application, including all appendices.  The original copy should be single sided. The 12 copies can be double sided. The application packet can be submitted via campus mail (IRB-214 Lyman Hall), via U.S. mail (IRB-Syracuse University, 214 Lyman Hall, Syracuse, NY 13244) or by hand delivery to our office located in Room 214 of Lyman Hall during regular business hours (Academic year hours are 8:30 am-5pm; summer hours are 8am-4:30 pm).

The IRB advises you allow a minimum of eight weeks for the full board review approval process.

All correspondence will flow through the Principal Investigator listed in the study protocol. Students/Research staff will be copied on all communications.

Full board applications can be approved for up to 365 days from the date of review (unless the IRB determines more frequent review is necessary) and are renewable for up to 7 years.

Recruitment

The Institutional Review Board is responsible for reviewing study recruitment procedures and materials to ensure protection of the rights and welfare of human subjects and equitable subject selection. All methods of recruitment must be approved by the IRB prior to implementation. Recruitment materials might include but are not limited to: oral scripts-for direct/in-person/telephone recruitment; posters/flyers/brochures; advertisements-newspaper/radio/television/SU Today/departmental research boards; postings-Internet websites/social media/twitter/Facebook, etc.

All recruitment materials should:

  • Clearly state the purpose for the research
  • Indicate that solicitation is for research purposes
  • List the eligibility requirements for participation
  • Specify the time commitment for participation
  • Specify the location of the research
  • Only when appropriate-include incentive/compensation information that is not emphasized in any manner such as larger or bolder type

If an agency/organization/institution/school/college will aid with recruitment by providing private contact information- listserv, phone numbers, email/home addresses, names, etc.-a letter of cooperation on official letterhead signed by the person who has the authority to share that information must be provided. In such instances, investigators are permitted to contact these sources in order to obtain the required permission.

If you ask the agency/organization/institution/school/college to simply share information regarding participation in your research by forwarding recruitment information, letters are not required.

No recruitment of participants may be initiated prior to formal notification from the IRB of Approval or Exemption of the research.

Informed Consent-Required Elements and Templates

Click here for complete list.

Privacy and Confidentiality

What is the difference between Privacy and Confidentiality?

The IRB is responsible for systematically evaluating proposed research for adequate provisions which protect the privacy interests of participants and to maintain the confidentiality of identifiable data.

The federal regulations differentiate between privacy and confidentiality, and it is important to understand the difference in order to determine whether these regulatory criteria for approval  of human subject research are appropriately met.

Privacy refers to a person’s desire to control the access of others to themselves. For example, persons may not want to be seen entering a place that might stigmatize them, such as a pregnancy counseling center that is clearly identified as such by signs on the front of the building. Privacy concerns people, whereas confidentiality concerns data. The research proposal should outline strategies to protect privacy including how the investigator will access information from or about participants.

In developing strategies for the protection of subjects’ privacy, consideration should be given to:

  • The methods used to identify and contact potential
  • The settings in which an individual will be interacting with an
  • The appropriateness of all personnel present for research
  • The methods used to obtain information about
  • The nature of the requested
  • Information that is obtained about individuals other than the “target participants,” and whether such individuals meet the regulatory definition of “human participant” (e.g., a subject provides information about a family member for a survey)
  • Privacy guidelines developed by relevant professional associations and scholarly disciplines (e.g., oral history, anthropology, psychology)
  • How to access the minimum amount of information necessary to complete the study

Confidentiality refers to the researcher’s agreement with the participant about how the participant’s identifiable private information will be handled, managed, and disseminated. The research proposal should outline strategies to maintain confidentiality of identifiable data, including controls on storage, handling, and sharing of data. When appropriate, certificates of confidentiality can be used to maintain the confidentiality of identifiable data.

When the IRB evaluates research proposals for strategies for maintaining confidentiality, where appropriate, consideration will be given as to whether:

  • Methods to shield participants’ identity adequately protect participant
  • There is a long-range plan for protecting the confidentiality of research data, including a schedule for destruction of identifiers associated with the
  • The consent form and other information presented to potential research participants adequately and clearly describe confidentiality
  • The informed consent process and the informed consent document, and if applicable the Authorization Form, clearly delineates who will have access to the subject’s information and under what circumstances data may be shared (i.e., government agencies, sponsors).
  • Tips for Application Submission
    • Answer each question in the application completely. If a questions is not applicable, it is better to state this than to leave sections of the application blank.
    • Ensure all applicable attachments are included with the application including:
    • All research instruments such as surveys/questionnaires/interview guide questions/focus group guide questions, etc. (The level of risk to the participant cannot be determined by the IRB without this information.)
    • Copies of all consent and/or assent forms as applicable.
    • Copies of all recruitment tools you plan to use to inform potential participants about your research such as oral recruitment scripts for direct (in-person) and/or telephone recruitment, letters, emails, newspaper/radio/television advertisements, flyers, brochures, posters, and information posted on departmental research boards, the Internet, Social Media, etc.
    • When applicable:
  • Letters of cooperation
  • IRB approval from other institutions
  • A list of references citing relevant background information (required for Expedited and Full Board only)
  • CITI training certificates if training has been completed through an affiliation other than Syracuse University (required for Expedited and Full Board only).
  • Vulnerable Populations Forms if the research involves Children/Minors, Cognitively Impaired Individuals, Prisoners, and/or Pregnant Women.
  • A copy of the International Research Form if the research will be physically conducted internationally. Research conducted by a researcher in the U.S. via Skype with persons internationally, is not considered international research and does not require the submission of the International Form.
  • If research will be conducted in a school or is funded by the U.S. Department of Education, an additional form s required
    • The application must be signed by the Principal Investigator and when appropriate, the student/research staff listed on the first page of the Exempt application and in Section 1 of the Expedited/Full Board application.

Full Committee Review Dates and Deadlines

Learn more here.