Protecting Human Participantsin Research

http://orip.syr.edu/humanresearch.html

Office of Research Integrity and Protections (ORIP)

What Is the Institutional Review Board and what is

it’s role?

The IRB at Syracuse University is currently comprised of 10 members from relevant academic disciplines and includes one non-affiliated community member.

Composition of the IRB

Role of the IRBThe role of the IRB is to protect human subjects participating in research.Because Syracuse University receives federal funds. SU is obligated to review ALL projects involving human subjects for compliance with institutional, state, local and federal laws.

In the Federal Wide Assurance (FWA), SU pledges to follow certain ethical principles outlined in the Belmont Report and federal regulations 45 CFR 46-Part A.

Federal Wide Assurance

The Belmont ReportBasic Ethical Principles

1. Respect for Persons2. Beneficence-(1) do not harm and (2)

maximize possible benefits and minimize possible harms

3. Justice- fair procedures and outcomes in the selection of research subjects

Regulations for: The definition of research IRB membership IRB functions and operations IRB review of research Criteria for IRB approval of research IRB’s authority to suspend or terminate approval of

research IRB records General requirements for informed consent Documentation of informed consent

Federal Policy for the Protection of Human Subjects

Common Rule 45 CFR 46 (Part A)

Definition of Human Subjects Research as defined in 45 CFR 46

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains: (1) Data through intervention or interaction with

the individual, or (2) Identifiable private information.

Categories of IRB Review

ExemptExpedited Full Board

Exempt Review

Exempt Some studies meet the definition of human subjects research

but may qualify for exemption under one or more of the 6 categories defined by the Federal Regulations.

Examples include anonymous surveys, existing data that is publicly available, and research conducted in established or commonly accepted educational settings involving normal educational practices.

Exemption must be determined by the IRB, not the investigator (must submit and exempt application).

Exempt Review ProcessExempt applications are reviewed by the ORIP Director, Tracy Cromp.Turn around time for review is approximately 5-7 business days. There are no deadlines for exempt applications. Allow a minimum of 4 weeks for the review process.Exempt studies are authorized for a period of 5 years.

Expedited Review Expedited

Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the 9 categories defined by the Federal Regulations

May be reviewed by one member of the IRB, usually the IRB Chair unless additional expertise is needed

Expedited Review-con’t Common examples of expedited research include:

Research on individual or group characteristics or behavior

Research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies

Collection of data through noninvasive procedures routinely employed in clinical practice (moderate exercise, blood pressure screening, muscular strength and flexibility testing, and body composition assessment)

Expedited Review ProcessTurn around time for review is approximately 7-10 business days. There are no deadlines for expedited applications. Allow a minimum of 4 weeks for the review process.

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 The research involves greater than minimal risk:

Harm or discomfort > those encountered in daily life Potential illegal behavior

Under age drinking Child abuse or neglect

Sensitive topics that could be damaging to participants Disclosure of medical status Sexual Behavior

The research involves a population requiring FBR Legally restricted participants

Full Board Review ProcessFull 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.

Full Board Review Process-con’tAllow a minimum of 8 weeks for the full board review approval process.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.

Application Content Purpose of Research (Rationale or research question) Approach/Method –What are you going to do and what is

going to happen to the subject? Qualifications of the Researchers Characteristics of the Subject population to be Recruited Special Groups Involved in Research Type of Informed Consent to Be Obtained Precautions to Ensure Privacy and Confidentiality Risks to Subjects (physical, psychological, financial, etc.) and

how the risks will be managed. Benefits to Subjects and Society at Large - How Do the

Benefits Outweigh the Risks?

All applications should be completed under the guidance of the student’s faculty advisor and reviewed by the faculty advisor prior to submission.

The application must be signed by the faculty advisor and the student.

Application Content-con’t

Informed Consent

Required elements include (are not limited to): Statement – that the study involves “research” Purpose of Research Procedures involved in the Research Duration of Involvement in the Research Participation is Voluntary-Right to withdraw at anytime without

Penalty Right to confidentiality Risks and Benefits Who to Contact for More Information or Questions Who to Contact if a Participant is Harmed or Has Concerns

Informed Consent-con’t Use everyday language appropriate to potential

participant (readable and clear) On SU Letterhead Title of Research Signature lines Sample available at

http://orip.syr.edu/IRBInstructions.htm

Keep signed documents for at least 3 years after the study has closed

Outcomes of Review

Once your application has been submitted, the IRB can: Approve Request modification(s) or additional

information Disapprove Re-Categorize the research as Exempt,

Expedited or Full

Student Projects Student projects (including Capstone projects)

involving human participants that are conducted solely to fulfill course requirements do not require IRB review.

Master’s or doctoral theses involving human participants must be submitted for IRB review.

Student Projects con’tIRB review is not required for research projects conducted solely to fulfill course requirements and the results of the classroom assignment are only used and shared as follows: In the classroom; and/or, If the project involves gathering data from or about a company,

agency, or organization, the data/results are shared only with the company, agency, or organization; and/or

Project results are presented at departmental or interdepartmental seminars designed to exhibit coursework, or to continue the learning process related to presentations.

Student Projects con’t HOWEVER: If data will be shared beyond the

circumstances described above (e.g. for publication, presentation at academic conferences/workshops, in thesis/dissertation, etc.) then the project must receive IRB approval prior to initiation.

Even if the project stays within the class and IRB review is not required, the instructor of the class should be aware of the types of questions being asked and all ethical principles regarding teaching should be followed in addition to the ethical standards regarding privacy and confidentiality.

Training Requirements CITI Training is required for all Expedited and Full

Board Applications. All persons listed in the protocol application that will

have direct contact with participants and or identifiable human participant data are required to complete the CITI training appropriate to their role in the research.

No Expedited or Full Board studies will be approved until CITI training requirements are satisfied.

Amendments

Needed whenever anything changes in materials originally submitted (the “protocol”)

Cannot implement change to the protocol without prior IRB review/approval- Exception: if the change is essential to protect human

participants from harm

Reminders….

No human subjects research can be conducted without IRB approval or exemption.

Collaborative IRB Training Initiative (CITI) is required by all individuals actively engaged in the research (not required for exempt research).

Full board and expedited applications can be approved for up to 365 days (unless IRB determines more frequent review is necessary).

Allow enough time for your application to be approved, it can take up to two months if revisions are needed.

Where do I go for help? The Office of Research Integrity and Protections:

121 Bowne HallPhone Number: 443-3013Email: orip@syr.edu