Human Subjects in Research

PLEASE NOTE THE FOLLOWING IRB POLICY REVISION:

 

Please be advised that University at Albany’s Institutional Review Board (IRB) has changed the document-stamping procedure for informed consent forms (ICFs) and subject recruitment materials. Effective October 24, 2012, all materials approved by the IRB will be stamped with the following:

UA
IRB

This new procedure will eliminate the need for annual submission of clean ICFs and recruitment materials to be re-stamped each year, if no modifications or changes have been made.

Continuing review (if you currently have stamped materials):
Principal investigators (PIs) should submit clean copies of all materials which were stamped using the former IRB date stamp at the time a request for continuation is submitted. When the continuation of the protocol is approved, materials will receive the new UA IRB stamp.

Modifications:
If ICFs and/or recruitment materials will be changed, clean copies of the revised materials must be submitted to the IRB for review and approval. When approved, materials will receive the new UA IRB stamp.

Approval period for UA IRB-stamped materials:
The approval for ICFs and/or recruitment materials remains in effect for the remainder of the protocol approval period (five years for expedited or full review, or one year for exempt review) or until a modification is requested – whichever occurs first.

As always, PIs are responsible for ensuring the most current stamped version of the ICFs and/or recruitment materials are used for subject enrollment.

If you have questions or concerns, you may contact ORRC at 518/442-9050 or at orrc@albany.edu.

Submission to the IRB

Protocol Submission Requirements

Protocols must be deemed “complete” before they are considered as received by ORRC.

Do not use jargon, terms of art, or technical language when completing the protocol. The project description must be written in a style suitable for presentation to a freshman class. If the narratives are not provided in layperson’s terms, the protocol will be returned to the investigator.

A complete protocol includes the following:

- The most current version of submission and supplemental forms (as found on the website);
- Original signatures (investigator, faculty advisor, department chair, etc.);
- CITI training report for each person engaged in research;
- All related supplemental forms;
- Complete grant application (no excerpts), including cover page(s);
- Financial Conflict of Interest Form (for protocols that are, or are expected to be, grant-funded).

Institutional Review Board (IRB) protocols must also include (if applicable):
- Recruitment scripts and flyers;
- Data-collection tools.

Modification and continuation requests must include:
- The revised protocol;
- Revised support materials.

IRB Protocol Submission

The principal investigator (PI) will submit the original IRB Protocol Submission Form and related documents/forms with all required signatures, including:

PI and co-investigator (if applicable);
faculty advisor (if student)

The Form and related documents/forms should be sent to:

The Office of Regulatory Research Compliance
Attn: Institutional Review Board
LCSB 28

ORRC Administrative Review

ORRC staff will triage the protocol to ensure that the protocol submission is complete; i.e., that all required elements (e.g., training certificates, grant application, etc.) have been submitted. The protocol will then be referred to a research compliance administrator (RCA) for administrative review. The RCA will notify the PI when the protocol is accepted for IRB review.

The purpose of the administrative review is to identify issues that are either incomplete or unclear, thereby preventing or delaying approval by the IRB. Once issues are identified, the PI must respond to and/or revise the protocol before it can be referred on for IRB review. Protocols that require extensive revision or are missing a significant amount of information will take longer to review.

Although the administrative review process will materially improve the probability that the protocol will be approved, it does not guarantee approval. It is to the PI's advantage to follow this submission format to avoid delaying the review process.

A protocol wil be considered complete and accepted for review if it meets ALL the following criteria:

- the protocol form and all related documents/forms, signed by the appropriate parties, are received by ORRC. E-mail submissions will not be accepted. The protocol will be returned to the PI if it is incomplete;
- an administrative review by an RCA has determined that the PI has submitted all information necessary for the IRB to adequately review the protocol;
- a grant review has determined that the information presented in the proposed protocol is congruent with the research proposed in the grant application;
- training requirements for the PI and all research personnel have been met.

 

Exempt and Expedited Reviews

Applications are accepted and reviewed as they are received.

Submissions Requiring Full Board Review

Protocols accepted for review which require full committee review are placed on the agenda of the next scheduled meeting.

The PI will receive an email from the RCA indicating the date of the meeting at which their protocol will be reviewed. PIs are invited to the meeting to address any IRB questions or concerns.

 

IRB – Human Subjects in Research Required Training

 

PLEASE NOTE: Training completed on or after September 1, 2009 remains effective for five (5) years. This applies to all Basic and Refresher courses. Training completed on or before August 31, 2009 remains effective for three (3) years. It is in the principal investigator’s responsibility to ensure that all those involved in human subjects research have current training.

Human Research Subjects Course

The University at Albany requires that ALL investigators and research personnel proposing to conduct research involving human subject complete training on the ethical principles and guidelines for the protection of human research subjects. Research personnel are defined as anyone who has contact with human participants and/or access to research data.

The University offers an on-line training program through the University of Miami’s CITI Course in The Protection of Human Research Subjects. There are several groups from which to choose as outlined below. Please contact ORRC if you need assistance in determining which group is appropriate for your type of research.

Group 1: Biomedical – This group is intended for professors, research personnel, faculty advisors and key personnel who engage in the study of specific diseases and conditions (includes research which involve any physiologically invasive procedure, e.g., blood draws, carbon dioxide inhalation, saliva swabs, etc.).

Group 2: Social and Behavioral – This group is intended for professors, research personnel, faculty advisors and key personnel who engage in research with a focus on the understanding of behavioral or social processes that does not involve biomedical procedures.

Group 3: Graduate Student – This group is designed for masters- and doctoral-level students engaged in research or research practica. Graduate students who engage in biomedical research must also complete the Group 1 Module.

Group 4: Undergraduate Student – This group is designed for undergraduate students who may be engaged in research, research practica or a research-methods class.

Group 5: IRB Members and Staff – This group is designed to meet one of the requirements that IRB members and staff receive comprehensive continuing education. It provides an overview of IRB responsibilities, elements of protocol review, and research involving vulnerable populations.

Group 6: IRB Reference Resource – This group does NOT satisfy the educational requirement. It provides an overview and reference information.

Group 7: Research Involving Human Tissues/Samples ONLY – This group is designed for researchers and key personnel who engage solely in human subjects research of secondary analysis of human tissues and/or samples.

Group 8: Basic (Restricted use only; requires ORRC permission) – This group is designed for non-researchers and non-key personnel who minimal engagement with human subjects or human subjects’ data (e.g. transcribers, etc.). Only ORRC may designate this learner group to individual(s) in order to satisfy an educational requirement.

Investigators and research personnel new to University at Albany are required to take one of the BASIC courses. If investigators and research personnel wish to continue human subjects research upon the expiration of the five-year certification period, they will be required to re-certify by taking the REFRESHER course.

Click on the link below and follow the registration instructions on the CITI site. Once you have completed the required modules, a Completion Report will be generated for you by CITI. Please print a copy of the Report for your records and have it available upon request. A copy of the Report must also be submitted with the protocol to the Office of Regulatory Research Compliance.

Click below to go to the CITI training website:

Collaborative Institutional Training Initiative (CITI)

PLEASE NOTE: When choosing an institution to affiliate with, you must pick SUNY - University at Albany. DO NOT CHOOSE Albany State University.

Instructions for CITI (for assistance with registration)

ORRC strongly encourages researchers to call or visit the office for answers to specific questions. Additionally, ORRC staff are available for classroom lectures. Please contact the office to schedule an appointment to speak with a staff member.

 

 

 

IRB Review Forms

IRB Screening Form

Use this form ONLY if you are unsure if your research project requires IRB review (this form will be evaluated to determine if you research project requires IRB review) | Word or RTF

IRB New Submission Forms

Initial/New Submission Primary Protocol (Use for Expedited or Full review categories ONLY) | Word or RTF
Application for IRB Exemption | Word or RTF (You may refer to this guidance for explanation of exempt categories)

Additional Key Personnel for Initial or De Novo Submissionl | Word or RTF

Other IRB Forms

Request for Continuing Review | Word or RTF
Request for Modification to Change, Modify, or Revise Approved Research | Word or RTF

Request to Add or Delete Key Personnel Word or RTF

Request to Change or Replace Principal Investigator Word or RTF

IRB Protocol Closure | Word or RTF

Supplemental Forms That May Be Required

1 - Research Involving Minors (Children Under the Age of 18) | Word or RTF
2 - Biomedical Research (Involving Invasive Procedures) |Word or RTF
3 - Research Involving the Use of Focus Groups | Word or RTF
4 - Research Involving Human Tissue Samples | Word or RTF
5 - Research Involving Deception | Word or RTF
6 - Research Conducted on UAlbany Campus or in a UAlbany Classroom | Word or RTF
8 - International Research | Word or RTF
9 - Research Involving Sensitive Topics such as Sexual Behavior, Illegal Conduct, HIV/AIDS Status,Genetic Information, Alcohol Use or Other Sensitive Topics | Word or RTF
10 - Research Involving the Use of Secondary/Existing Data | Word or RTF
11 - Oral History or Ethnographic/Naturalistic Research | Word or RTF
12 - Research Involving the Use of Experimental Equipment with Subjects (not audio/video tapes or discs) | Word or RTF
13 - Research Involving the Use of Psychology 101 Participants | Word or RTF
14 - Research Involving Collaborating External Investigator* | Word or RTF
15 - Research Involving Collaborating External Organization* | Word or RTF
16 - Research Involving Electronic/On-line Data Collection| Word or RTF
(Please refer to this guidance)
16A -Server Compliant Checklist for Electronic/On-line Data Collection | Word or RTF

* : Includes Collaborating External Investigator Agreement Template

Adverse/Unanticipated Event Report

Use this form to report ANY study-related adverse or unanticipated problem (e.g. breach of confidentiality, subject complaint, protocol deviation, etc.) that occurs during the protocol approval period. All study-related adverse or unanticipated events must be submitted within 10 days of their occurrence. | Word or RTF

Guidelines for Informed Consent

Informed Consent for Non-Exempt Research (Consent form should be prepared in language that is "user-friendly" for your research population) | Word or RTF

Informed Consent for Exempt Research

For use when conducting an exempt research projects with adults. (You should evaluate the applicability of this template to your research proposal. This form will not fit all exempt research studies) | Word or RTF

 

Coming Soon.