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IRB Training Requirements

As federally mandated and required by the Rensselaer IRB, all investigators must complete a self-study course in human subject protection via the CITI Training Program. Each investigator on a research project involving human subjects is required to certify that they have completed the required course(s) before engaging in the research.

Basic IRB Review and Approval Procedure

  • The principal investigator* must complete the application form to submit proposed research protocols for review to the committee Chair.
  • The proposed protocols are reviewed to ensure that the science is appropriate and ethical according to accepted guidelines and that all personnel who will work on the project have received IRB training.
  • The approval period is for one year and may be renewed annually, subject to board review and approval.
  • All modifications to the approved protocol must be submitted using the Renewal/Closure form and re-approved in writing by the IRB prior to implementation.
  • When the research is finished, the PI must submit a Closure form to the IRB.

* The investigator who is primarily responsible for the conduct of the research. Students who are principal investigators must submit a letter of support from their faculty adviser.

To submit your protocol, click on My Protocols to the left, and be sure to include

  • IRB Proposal Summary form (available in Resources, left)

  • Consent forms or consent scripts

  • Survey or example of questionnaire, if applicable

  • Completion report for your CITI training in Social/Behavioral Research OR Biomedical Research. (Do not complete the training course for IRB Members.) This should be uploaded under PI Documentation. Until training has been completed,your proposal will not be approved

 

 

Date of future meetings:

Meeting Date Submission Deadline
08/06/2014 12:00 PM EDT 07/30/2014
09/03/2014 12:00 PM - 1:30 PM EDT 08/27/2014
10/01/2014 12:00 PM - 1:30 PM EDT 09/24/2014
11/05/2014 12:00 PM - 1:30 PM EST 10/29/2014

 

Institutional Review Board

Rensselaer Polytechnic Institute

 

Title of Proposal:         

 

Researcher:                          

 

Objective: 

 

Methods:

 

Effects on Subjects:

 

Measures to Minimize Risk:

 

Likelihood of Harm:

 

Documentation of Risks:

 

Benefits to Participants:

 

Alternate Method Not Using Human Subjects:

Qualifications of Researcher:

Recruiting of Subjects: 

 

Confidentiality:

 

 

Attach a copy of any questionnaires you plan to use.

Attach appropriate Informed Consent form for subjects 18 and over. For subjects under 18, attach the Child Assent form and Parental Permission form.

 

Required Elements for Informed Consent Forms (45 CFR 46.116)
The following information shall be provided to each subject:
1. A statement that the study involves research, and an explanation of the purposes of the research; the
expected duration of the subject's participation; a description of procedures to be followed, and
identification of any procedures which are experimental;
2. A description of any foreseeable risks or discomforts to the subject;
3. A description of any benefits to subjects or to others which may reasonably be expected from the
research;
4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be
advantageous to the subject;
5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will
be maintained;
6. For research involving greater than minimal risk,
• an explanation as to whether any compensation will be made
• an explanation as to whether any medical treatments are available if injury occurs
• and, if so, what they consist of and where further information may be obtained;
7. An explanation of whom to contact for answers to pertinent questions about the research and research
subjects' rights, and whom to contact in the event of a research-related injury to the subjects (student
researchers are also to include contact information for their advisor); and
8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of
benefits to which the subject is otherwise entitled and the subject may discontinue participation at any
time without penalty or loss of benefits to which the subject is otherwise entitled.
When appropriate, one or more of the following elements of information shall also be
provided to each subject:
1. A statement that the particular treatment or procedure may involve risks to the subject (or to the
embryo or fetus if the subject is or may become pregnant) which are currently unforeseeable;
2. Anticipated circumstances in which the subject's participation may be terminated by the investigator
without regard to the subject's consent;
3. Any additional costs to the subject that may result from participation in research;

4. The consequences of the subject's decision to withdraw from the research and procedures for orderly
termination of participation by the subject; (biomedical)
5. A statement that significant new findings developed during the course of the research which may relate
to the subject's willingness to continue participation will be provided to the subject; and
6. The approximate number of subjects involved in the study.
Additional statements may be appropriate when doing ethnographic research. These
examples below may be edited to suit the circumstances of the study.
I am under no obligation to be interviewed if I do not wish to do so.
I am not obligated to answer any of the questions. I may decline to answer any or all of the
questions, and I may terminate the interview at any point.
If there is anything that I do not wish to have quoted, I may say at any point during or after the
interview say what I wish to have kept “off the record,” and it will not be quoted.
I understand that if [name of researcher] decides to use any portions of this interview in subsequent
publications, that s/he will send me a copy of the portions of the interview, including any quotations
and paraphrases that [name of researcher] decides to use, for my editing and written approval. I will
have the right to edit the material and I will receive a copy of the final publication. [Name of
researcher] will only use the material that I have approved.
I understand that I may choose to remain anonymous or have my name revealed. I may also change
my mind at any point up to and including the review of any quotations and paraphrases that might
be used (check one):
_____ I choose to remain anonymous.
_____ I choose to reveal my name.
Based on reading this form (check one):
_____ I agree to be interviewed (photographed, audiotaped, videotaped).
_____ I do not agree to be interviewed.
When you write the informed consent document for your study, ask yourself at least the
following four questions:
1. Does it contain the general requirements for informed consent?
2. Is it written at a reading level that my intended research subjects can understand (i.e., taking into
account the abilities and limitations of the study participants)?
3. Is the document formatted well? Is the text broken into short sections with headings that make the
document easier to read?

4. Can the document be shortened without compromising other requirements?
Please note that when some or all of the subjects are likely to be vulnerable* to coercion or undue
influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or
educationally disadvantaged persons, researchers may need to include additional safeguards in the
study to protect the rights and welfare of these subjects." (45 CFR 46.111(d)).
*Vulnerable research subjects are persons who are relatively or absolutely incapable of protecting their
own interests. "They have insufficient power, prowess, intelligence, resources, strength or other needed
attributes to protect their own interests through negotiations for informed consent." (Robert J. Levine,
"Ethics and Regulation of Clinical Research", Yale University Press, 1988, P.72)
Contact Information is to be included as follows:
For further information contact:
Name, address, phone, and email of researcher (and if researcher is a student, faculty advisor)
For more information about your rights as a research participant, please contact the Chair, Institutional
Review Board, Rensselaer Polytechnic Institute, CII 9015, 110 8th Street, Troy, New York, 12180;
(518) 276-4863; irb@rpi.edu.
Waiver of Elements of Informed Consent
An IRB may waive or alter some or all of the requirements for written informed consent if the IRB
determines that the research meets the following criteria (see 45 CFR 46.116(d)):
1. The research involves no more than minimal risk* to subjects;
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 (e.g., as for
distribution of anonymous surveys) and;
4. Whenever appropriate, the subjects will be provided with additional pertinent information.
* Minimal risk means "that the probability and magnitude of harm or discomfort anticipated in the
research are not greater in and of themselves than those ordinarily encountered in daily life or the
performance of routine physical, psychological examinations or tests" (45 CFR 46.102(i)).

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