MARYWOOD UNIVERSITY

Office of Planning and Institutional Research

Immaculata Hall, Rm 104, 2300 Adams Avenue, Scranton, PA 18509

(570) 348-6211, x.2418 or

REQUEST FOR DETERMINING WHETHER A PROJECT INVOLVES RESEARCH WITH HUMAN PARTICIPANTS

Submit this form to the Institutional Review Board or Exempt Review Committee via IRBNetat you are unsure whether or not your project requires formal review. An administrator will communicate an official decision via letter indicating whether a formal application must be filed.

PROJECT
INFORMATION / Today’s Date:
/ Project Title:

APPLICANT INFORMATION

/ Name:
Degree:
University Status:
Doctoral Student (Ph.D.)
Doctoral Student (Psy.D.)
Faculty (FT) Faculty (PT/ADJ)
Graduate Student
Non-Affiliated Researcher
Other -Specify:
Staff
Undergraduate Student / Academic Department:
Mailing/Campus Address (room, building, street address):
Telephone: Extension:
E-mail:
NAMES OF PROJECT TEAM MEMBERS (if applicable) / SALUTATION/DEGREE
(e.g., MD, PhD, RN, etc.) / ROLE IN ACTIVITY
SECTION I: IS YOUR PROJECT RESEARCH?
“Research” is defined under 45 CFR 46.102 (d) as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
  1. Is the proposed activity a systematic investigation?
    A systematic investigation involves a prospective plan for examining a specific topic, answering a specific question(s), testing a specific hypothesis(es), or developing a theory. Some examples may include, but are not limited to, observation, interview techniques, distribution of surveys, group comparison, test development, etc.
/ Yes No
  1. Is the proposed activity designed to develop or contribute to generalizable knowledge?
    Such projects are designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program (e.g., presentations or publications). Results do not have to be published or presented to qualify the experiment or data gathering as research. The intent to contribute to scholarly knowledge makes an experiment or data collection research, regardless of publication.
/ Yes No
  1. Does your project involve journalism or documentary activities?
    Such projects are limited to investigations and interviews that focus on specific events, opinions, etc., and that lead to publication in any medium (including electronic), documentary production, or are part of training that is explicitly linked to journalism. There is no intent to test a hypothesis.
    Note: An application is required when journalists conduct activities normally considered to be scientific research intended to produce generalizable knowledge (e.g., systematic research, surveys and/or interviews that are intended to test theories or develop models).
/ Yes No
  1. Does your project involve oral history activities?
    Such projects are limited to oral history activities, such as open ended interviews, that only document a specific historical event or the experiences of individuals without the intent to draw conclusions or generalize findings.
    Note: An application is required when the oral history activities are intended to produce generalizable conclusions (e.g., that serve as data collection intended to test economic, sociological, or anthropological models or theories).
/ Yes No
  1. Does your project involve quality improvement or assurance activities?
    Such projects are limited to activities designed specifically to assess or improve performance within a department, hospital or classroom setting. The intention is not to reach conclusions that can be applied universally, outside of the immediate environment where the project occurred.
/ Yes No
  1. Does your project involve video or audio recording?
/ Yes No
SECTION II: DOES YOUR PROJECT INVOLVE HUMAN PARTICIPANTS (referred to as subjects in the regulations)?
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:
  1. Data through intervention or interaction with the individual, or
  2. Identifiable private information.
Interventionincludes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
  1. Does the project involve obtaining information about living individuals?
/ Yes No
  1. Does the project involve an intervention or interaction with individuals?
/ Yes No
  1. Does the study involve access to identifiable, private information about individuals?
/ Yes No
  1. If accessing existingdata or specimens, will the investigator or someone from the project team record information him/herself?
/ N/A
Yes No
  1. If yes, will the investigator record the information in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects?
/ Yes No
  1. If accessing existing data or specimens, will the information be received by the investigator with identifiable, private information intact?
/ N/A
Yes No
SECTION III: ARE YOU A STUDENT?
  1. Are you a student?
If yes, please answer all questions in this section. / Yes No
  1. Is this project part of an independent study, thesis, dissertation or honors project?
    If yes, the project must be submitted for formal review.
/ Yes No
  1. Is this project part of a class assignment?
    If yes, please answer the following questions.
/ Yes No
  1. Will you share the results outside of the classroom setting (e.g., publish, present at a conference, etc.)?
/ Yes No
  1. Is the risk involved no greater than minimal (no greater than risk encountered in everyday life or activities)?
/ Yes No
  1. Are any vulnerable populations involved (e.g., minors under the age of 18, prisoners, pregnant women, etc.)?
/ Yes No
SECTION IV: PROJECT DESCRIPTION
Please provide a summary of the planned activity.

C:\ Shared Documents\IRB\IRB FormsRevised 12/13/20161