MARYWOOD UNIVERSITY

Institutional Review Board

O’Neill Center for Healthy Families, Room 208, 2300 Adams Avenue, Scranton, PA18509(570) 961-4778

IRB ReviewerTemplate


This form is for reviewers’ reference only. After completing your review, please add your comments to the appropriate package in IRBNet at If your decision is to require modifications, be sure to specify if they will be minor or deferred. This determines which individuals will review the modifications once they are received.

Investigator(s):______Study Title:

MU IRB #: IRBNet #: Reviewer: Date of Review:

REVIEW COMPONENT / ACCEPTABLE / UNACCEPTABLE / COMMENTS
Complete and Accurate Application
Training of Investigator(s) / HRC RCR / HRC RCR
Training of Sponsor (if applicable) / HRC RCR / HRC RCR
Electronic Signature of Investigator(s)
Electronic Signature of Sponsor (if applicable)
Permission Letter(s) for Access to Participants or Data or Co-operative Letter
Must be signed and on letterhead.
Consent Form or Parental Consent Form
Should follow template & address purpose, how participants were selected, length of study time required of participants, location, procedures, risks/benefits, voluntariness of participation, how to withdraw what happens to data, confidentiality of data, data destruction and contact information (investigator, sponsor, research related injuries). Should be readable to the average person.
Note: While signature is required, a waiver of signed consent or an alteration/complete waiver of consent may be requested (i.e. online surveys; where harm would result from signed link). At MU,for online research with minors, parental consent is usually not waived. Requests must meet certain criteria (See Waiver request forms for details.).
Assent Form or Script (if applicable)
Data Collection Instruments
Must be included, if standardized, include reliability and validity (w/in last 10 yrs.); If researcher-developed, should reviewed by 1 professional (Master’s or higher), who must provide a statement of endorsement (via our template).
Research Design/Narrative
Should follow outline on application.
“[I]f a research study is so methodologically flawed that little or no reliable information will result, it is unethical to put participants at risk or even to inconvenience them through participation in such a study.” (ORHP, IRB Guidebook) / Acceptable / Unacceptable
What to look for: Objective, direct experiences, repeatability, systematic with clearly specified and controlled conditions; can be measured and evaluated; shows logic (re: inferences based on observations)
Does research involve the following?
= Requires or may require full review at a convened meeting.Others may or may not, but there may be special requirements, considerations or care concerning risks in the study.
  • Pregnant women, human fetuses or neonates? Yes
  • Prisoners, or those who will become prisoners Yes
    during the study?
  • Children/minors under the age of 18? Yes
  • Another possible vulnerable population? Yes
Cognitively Impaired Minorities Elderly Students
Trauma or Comatose Patients Terminally Ill Patients
Visually or Hearing Impaired Other
  • Non-English speaking participants? Yes
  • International research? Yes
  • Drugs, other controlled substances or biological Yes
    devices?
  • Internally taken (e.g., dietary supplements, herbs, Yes
    yogurt, etc.) or externally applied substances?
  • Removal of any fluids (e.g., blood, saliva) or Yes
    tissue from participants?
  • Payment to participants or other incentives? Yes
/
  • Procedures or activities that would place Yes
    participants atgreater than minimal risk
    (psychological, physical, social or financial)?
  • Sensitive aspects of a person’s own behavior or Yes
    experience, such as illegal conduct, abuse, alcohol
    or other drug use, sexual behavior, job loss binge
    eating, suicidal thoughts, etc.?
  • A student researcher performing greater than Yes
    minimal risk procedures (e.g., in HPL, blood draws,
    medical tests, etc.) that should require supervision?
  • Misleading or deceiving participants about any Yes
    aspect of the procedures or purpose of the research?
  • Data collection and/or analysis lasting longer than Yes
    12 months?
  • Receipt or recording of pre-existing data? Yes
  • Data collected with audio and/or visual recording Yes
    devices?

Recommendation:
Approved
Minor Modifications
(Expedited - Director of HPP reviews only; Full – Assigned to 2 reviewers plus Director & Asst. VP for Research)
Deferred (All original reviewers provide review.)
Not Approved(Not allowed for expedited reviews.)
Note: Reviews conducted via an Expedited procedure cannot be disapproved. In such cases, the study must be scheduled for review at a convened meeting.
If Expedited, Category or Categories #: / Missing:
Assent Form or Script
Consent Form /Participant Letter or Information Sheet
Parental Consent Form
Documentation of Professional Review or Pilot of Researcher-Developed Instrument
Permission Letter for Access to Participants or Data
Training Certificate(s)
Signature of Researcher(s) and/or Sponsor
Other:
Overall Assessment and Comments

Revised by IRB: 12/19/2012 1