irb.
what is it? IRB stands for Institutional Review Board. The primary responsibility of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating in research. The IRB functions according to the guidelines of the Office of Human Research Protection (OHRP) and other federal regulatory agencies.
how does it work? In order to perform your research involving the use of human research subjects, you must turn the following documents into the CMU Institutional Review Board (IRB). Be thorough and double check, and submit to irb-review@andrew.cmu.edu. This application The consent form that will be used in the research. Follow current CMU template. A copy of any questionaires, surveys, images, and debriefings used. A copy of all the training certificates for all involved individuals unless they are on file with CMU. Training can be completed at www.citiprogram.org
A Faculty Assurance Form (If the Principal Investigator is a student)
email all materials to: irb-review @andrew.cmu.edu need help? Call the CMU Office of Research Integrity and Compliance at 412-268-5460 or email at the above email address.
irb. table of contents 1
about principal investigator co-investigators
2
protocol : what? protocol : where? protocol : how? pt 1
3
protocol : how? pt 2 protocol : who?
4
consent
5
benefits risks
6
compensation co-operating institutions
7
conflict of interest confidentiality and data security
8
funding
9
assurance statement
about the principal investigator a. name
phone
dept
b.
if you are not the principal investigator (P.I.): name
phone
c.
if you are a student: faculty advisor
phone
email Make sure you have included your Faculty Advisor Assurance Form!
co-investigators a. name
name
name
name
name
name
b. training certificates Don’t forget to include Training Certificates for all those involved! If they are already on file, please name those individuals in the section below.
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protocol : what? a. title b.
c. your research question
if this is a previous study that has lapsed: previous IRB no.
d. a summary of your study
protocol : where? a. countries where research will be conducted
b.
if research is on CMU campus: specify which ones
U.S.A.
Pittsburgh
Qatar
Qatar
other (list below)
Silicon Valley
c.
if not: indicate the location Attach proof of permission to conduct research in a private, non-CMU space!
protocol : how? a. methods of participation recruitment flyers
participant pool
where?
describe
radio, tv
email solicitation
web based solicitation
other
how address obtained?
where?
specify
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protocol: how? (continued) a. describe participant recruitment c. reminder Don’t forget to attach all recruiting materials used, including emails and web based solicitations.
b.
if participants will undergo screening: describe process
protocol : who ? a. describe participant population
c.
specifically included participants:
d.
pregnant women or fetuses they will not be in or excluded
estimate percentage of minority groups
newborns age range how many participants male : female ratio
prisoners children people with compromised mental status if yes, explain
reflective of local population
b.
if your data represents a cross section of the region where the study is being conducted:
e.
if it does not: explain why is minority not considered
if you will target a certain population explain d. list inclusion/exclusion data
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consent if you plan to use consent forms: if you do not plan to use consent forms, please skip to question f. a. how will you obtain consent? paper b.
c. who will you obtain consent from?
d.
online
if participants are minors: will assent forms be used? yes
if you will obtain consent online:
no
You must request a Waiver of Written Documentation.
if no, explain
indicate which option applies the only record linking the participant and research is the consent document, and the only risk to the participant is breach of confidentiality. this is a minimal risk study
e.
explain why your selection applies
if you do not plan to use consent forms: Must request a Waiver of Informed Consent if your project fits the following requirements: -
-
if your formatting is different from the CMU model consent: explain
f. explain how your study fits these requirements
involve no more than minimal risk to subjects the waiver will not adversely affect the rights and welfare of the subject
g.
if the waiver does not apply to all study participants: specify who the waiver applies to
the research could not practicably be carried out without the waiver
if applicable, subjects may be provided with more information after participation.
h.
if the waiver does not apply to all study procedures: specify which the waiver applies to
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benefits a. describe direct benefits to participants
b. describe indirect benefits to participants
c. reminder Payment is not a benefit. Include tangible and intangible benefits.
risks a. please indicate the level of risk your research poses on subjects minimal risk: the magnitude of risk is not greater than those encountered in daily life, or during a routine physical or psychological exam.
c. discuss risks to subjects
d. discuss how risks are minimized
greater than minimal risk: the risk is greater than that experienced in daily life. e. b. explain how your study fits this risk level
if you will use deception: explain
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compensation a.
if you will compensate participants:
c.
amount
if any inducement will be offered to recruit participants:
e.
if there is a cost to participate: describe
describe
source type (gift card, cash)
b.
if class credit will be offered:
d.
class
if you will compensate participants for injuries: describe
instructor email
co-operating institutions if your research is being done in co-operation with any institutions, individuals, or orgs not affiliated with CMU: a. list and describe their roles
b.
if you have/plan to receive IRB approval from another IRB:
c.
if multiple institutions are involved:
d. reminder attach documentation of approval if applicable!
indicate who is responsible for oversight of the entire study
Provide names and contact info for all officials approving your use of human subjects at non-CMU institutes:
I have applied elsewhere but it is pending I have received approval elsewhere attach a copy of approval
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conflict of interest a.
what is conflict of interest?
b.
It can occur when members are in a position to influence a decision where they might directly or indirectly receive financial benefit or give improper advantage to associates. They arise when members’ involvements in outside activities substantially interfere with their primary commitments to the university: to teach, to conduct research and to meet related obligations to students, colleagues and the university.
if conflict of interest may occur in your research project: please attach detailed information to help the IRB to determine if such involvement should be disclosed to potential subjects
questions? visit http://www.cmu.edu/policies/ documents/IntConflict.html
confidentiality and data security a.
if personal identifiers will be collected: list them
if you will not be translating identifiers into code: explain why
b.
if audio recordings will be made: describe
c.
if video recordings will be made:
f. describe how you will monitor data to ensure that study goals are met
describe
eg frequency of meetings to review data, who will come to meetings, how recruitment will be monitored, etc
d. identify who will have access to private data eg surveys, recordings, interview records, etc
e. describe how you will protect secure records and subject confidentiality eg secure computer, locked cabinet, etc
g.
my information is so sensitive that I will obtain a certificate of confidentiality from the NIH
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funding if your research is funded: a. indicate type
d.
Internal Funding
if multiple institutions are involved: is this application consistent with
External Funding
the grant?
b. indicate the sponsor
yes
National Science Foundation
no
National Institutes of Health Other specify
e.
if CMU is a recipient of the funding: indicate the level
c. grant title
Prime recipient Sub-recipient SPEX proposal # SPEX award #
assurance statement for using human subjects in research I certify that the information provided in this IRB application is complete and accurate. I understand that as Principal Investigator, I have ultimate responsibility for the conduct of IRB approved study I understand that it is my responsibility to ensure that the human participants’ involvement as describied in the funding proposals is consitent in principle, to that contained in the IRB application. I will submit modifications and or changes to the IRB as necessary I agree to comply with all Carnegie Mellon University policies and procedures as well as with all applicable federal state and local laws, regarding the protection of human participants in research including, but not limited to: Ensuring all investigators and study personnel have completed human subjects training program; Ensuring protocols are conducted by qualified personnel following the approved IRB application; Implementing no changes in approved IRB applications or informed consent documents without prior IRB approval in accordance with CMU IRB policy (except in an emergency, if necessary to safeguard the well being of a human participant, and will report to the IRB within 1 day of such change.;
continued on next page
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Obtaining the legally effective informed consent from human participants or their representative, using only the currently approved date stamped consent forms, and providing a copy to the participant.; Ensuring that only IRB approved investigators for this study obtain informed consent from potential subjects; Informing participants of any relevant new information regarding their participation to the research that becomes available; Promptly reporting to the IRB any new information involving risks to research participants, including reporting to the IRB, Data Safety and Monitoring Boards, sponsors, and appropriate federal agencies any adverse experiences and all unanticipated problems involving risks to human subjects or others that occur in the course of the research; If unavailable to conduct research personally, as when on sabbatical leave or vacation, arrangements for another investigator to assume direct responsibility for studies will be made through modification requests to the IRB; Promptly providing the IRB with any information requested relative to protocols; Promptly and completely complying with IRB decisions to suspend or withdraw approval for projects; Obtaining Continuing Review approval prior to the date the approval for the study expires (approval for the study will automatically expire); Maintaining accurate and complete research records, including but not limited to, all informed consent documents for three years from the date of study completion; Informing the CMU IRB of all locations in which human participants will be recruited for protocols and being responsible for obtaining and maintaining current IRB approvals/letters of cooperation when applicable; Complying with federal, state and local laws and regulations and sponsor terms and conditions; And Complying with CMU policies on the responsible conduct of research.
principal investigator name and signature
you’re done.
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