Daniel Webster College
 

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DANIEL wEBSTER College

iNSTITUTIONAL Review Board (IRB)

 

APPLICATION FOR REVIEW OF RESEARCH INVOLVING HUMAN PARTICIPANTS

 

Action Taken:

(do not write in this box)

 

____ Disapproved                    ____ Approved

                                                         from_______________ to __________________

 

Chair:_______________________

 

 

New:  Project # __________________

(do not write in above space)

 

 

(One copy must include the original signature)

 

 

 

Continuation: Project # _____________

(write in prior approval number)

 

    ___ No modifications

 

    ___ Modified (provide explanation)

 

(Only two continuations will be granted, then a new application must be submitted)

 

Please type, or print legibly, with blue ink. Do not write in shaded areas.

 

PROJECT TITLE:

 

 

 

 

 INVESTIGATOR:

(name, division, telephone):

 

 

 

If student investigator, provide faculty supervisor’s name, division, telephone:

 

____ check here if student investigator

 

 

 

DATES APPROVAL REQUESTED

(maximum of one year; must be reviewed annually)

 

If used in GCS for multiple semesters and multiple sets of participants:

 

 

From: __________________ to _______________

 

 

 

Semesters Involved (GCS) ___________________________

 

 

SIGNATURE OF INVESTIGATOR:

 

 

 

 

Date _____

 

 

SIGNATURE OF ADVISOR

(IF STUDENT INVESTIGATOR):

 

 

 

Date____

 

Application Components

 

Expedited and Full Reviews

(See policy for full description of components)

1. The Abstract should be a brief summary of the proposed study which will include all the pertinent points of the research and will highlight the potential risks, the potential benefits, and risk management procedures.

 

2. Purpose and Background.  This section should state the relation of the proposed research to previous scientific investigations in the field including relevant laboratory and animal studies. 

 

3. Methods Section. A detailed description of all procedures to be performed on human subjects for the purposes of research must be included.  Observational or interview studies should indicate the type of contacts and interactions with subjects and the means of observation to be used.

 

4. Subjects.  A description of the participants and how they are selected must be included.

 

5. Potential Benefits.  This section must present a justification for the proposed study.  The discussion should focus on the significance of the new knowledge that is being sought and an evaluation of the benefits to individuals and/or society with respect to the risks involved in the study.

 

6. Potential Risks. A discussion of the risks, if any, to the subject is required.  Such deleterious effects may be physical, psychological or social.  Some research involves neither risks nor discomfort, but rather violations of normal expectations.  Such violations, if any, should be specified.

 

7. Management of Risk.  A discussion of the management of risk is required.  Procedures for protecting against or minimizing potential risks should be described (including confidentiality safeguards).  An assessment of their likely effectiveness should be discussed. 

 

8. Subject Compensation and Course "Extra Credit".  If subjects are to be compensated, the nature of the compensation and its influence on subject participation must be discussed. 

 

9. Personnel.  Identify all personnel who will participate in or assist in the conduct of this research.  Identify each individual by name, title and responsibility in this research project.  Briefly outline each individual's qualifications. 

 

10. Informed Consent.  Informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative.  A COPY SHALL BE GIVEN TO THE PERSON SIGNING THE FORM.

 

SPECIAL CONSIDERATIONS

 

Check if any of the following apply. If any are checked you will have a full or expedited review.  

 

 

 a)      use of participants under 18 years of age, OR who might otherwise have limitations on ability to give consent (e.g., mentally ill, mentally retarded or other cognitive impairment, infirm, aged)

 

b)      asking participants to reveal illegal behavior on their own or another’s part

c)      request for any information of a sensitive nature or which is potentially embarrassing

d)      use of any materials or procedures which may be offensive or embarrassing

 

e)      recording of physiological responses (e.g., BP, EEG), weighing, or testing for sensory acuity or performance

f)        participants taking internally any drug, food, liquid, or other substance, OR having any substance applied externally to any part of the body

 

g)      removal or collection of any tissue or fluids from the participant by invasive or noninvasive means

h)      use of manipulated variables

i)        obtaining any information which would identify participants’ responses

 

j)        use of deception which misleads participants as to the purpose or nature of the study

k)      exposure to stressful conditions (physical or psychological) which exceed what can reasonably be considered the level occurring in their normal, everyday activities

l)        any procedure which would place the participant at other risk (physical, psychological, or social) which exceeds what can reasonably be considered the level occurring in normal, everyday activities

m)    other potential ethical problems not covered in the above list?