Helpful Tools & Guides

Academic Affairs Office

Helpful Tools and Guidance

Submission Checklist

Checklist of What to Submit
Helpful Tutorials

Tutorial Videos
IRBNet Guide

Written Instructions

Decision Charts

OHRP has issued two sets of decision charts: one set is dated February 16, 2016 and titled, “Human Subject Regulations Decision Charts: Pre-2018 Requirements,” and is consistent with the Pre-2018 Requirements. The second set of decision charts is dated June 23, 2020 and titled, “Human Subject Regulations Decision Charts: 2018 Requirements,” and is consistent with the 2018 Requirements.

View Decision Charts

Guidance/Guidelines

Guidance on Data Collection via Online Survey

Guidance for Research Advisors

Guidelines for Classroom Projects

Class assignments or exercises involving human participants may or may not require review by the Institutional Review Board (IRB) or Exempt Review Committee (ERC), depending on whether they meet the federal definition of “research”, which is defined as, “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

Independent Studies / Theses / Dissertations / Honors Projects

According to the federal definition, all students completing theses (undergraduate honors or graduate), independent studies, or doctoral dissertations must apply through the IRB or ERC. Such research requires a full-time Marywood University faculty advisor (sponsor).

Classroom Assignments / Educational Inquiry / Practice

Research activities that are designed as part of a course requirement and involve human participants may not require IRB/ERC review and approval. Eligible assignments or learning exercises are those that do not involve a systematic investigation designed to contribute to generalizable knowledge and meet the conditions below. Such activities may engage students in interaction with individuals in order to teach research methods or to help students comprehend topics covered by the course. In most instances, such activities are not intended to create new knowledge or to lead to scholarly publication or presentation.

Classroom activities may not require IRB/ERC review if all of the following conditions are true:

The activity is a class assignment designed for learning purposes only and is not designed to develop or contribute to generalizable knowledge. However, individuals who wish to gather data from human participants for classroom assignments, educational inquiry or practice AND intend to use the data as research data for the purpose of publishing or sharing with a research community or the public at large (e.g., research or professional forum), must obtain IRB or ERC approval prior to conducting the activity.
Results of the project are viewed only by the course instructor for teaching purposes and discussed within the classroom for teaching and learning purposes. In the case that data is gathered at an internship or practicum, it is acceptable to share the de-identified data with the collaborating agency.
Results of the research are not made public through presentation (outside of the classroom) and are not published in paper or electronic format.
Risk to participants is no more than minimal - no greater risk than would ordinarily be encountered in daily life or activities.
Participants are not a vulnerable population (under 18 years of age, prisoners, individuals court-ordered to treatment, etc.).
Participants or data collected is not identifiable.
When an investigator obtains data through an intervention or interaction (survey, interview, observation, etc.) with living individuals, a participant letter must be provided to fully inform the individuals about the nature and expectations of their participation in the class assignment.

Please note: Students conducting class assignments/exercises/projects may not recruit participants via the Marywood University email list serves. In order to recruit via the list serves, IRB/ERC review and approval is required.

Responsibilities of the Course Instructor

The course instructor is responsible for informing students about the ethical considerations of using human subjects in research. Procedures for course assignments should include proper instruction regarding: informed consent, appropriate recruitment of subjects, minimizing risk to subjects, and protecting confidentiality. Completion of the CITI online training courses is not required to be submitted to the IRB/ERC for student projects that do not require IRB/ERC review. IRB/ERC staff are available to speak to classes about human subjects protections and/or ethical research practices.

It is important to note that IRB approval cannot be provided retroactively. If a classroom assignment produces interesting results, the data MAY NOT be used nor may the results be disseminated if IRB/ERC approval was not obtained prior to the implementation of the study. If a student believes that data collected may be useful for research purposes, then IRB or ERC approval must be sought at the outset, before any research activity has begun.

In making a determination of whether or not a class research project requires IRB/ERC review, the instructor is asked to complete the “Request for Determining Whether a Project Involves Research with Human Participants” form and submit it via IRBNet. The instructor may also contact the Director of Human Participants Protection and Research Compliance to discuss any questionable cases.

Permission Chart

For the purposes of research, investigators planning to recruit Marywood University students, faculty,staff, or community members, or access their private data, must first obtain a permission letter from an appropriate MU official prior to applying to the Institutional Review Board (IRB) or Exempt Review Committee (ERC).

Investigators must:

Review the Recruitment of Human Subjects Policy.
Download and customize the Permission Letter Template. Log in at IRBNet, click Forms and Templates on the left menu, and then select the IRB or ERC’s library.
Ensure that the letter (1) is placed on the department or unit’s letterhead, (2) is hand-signed by the MU official (no signature fonts), (3) includes the official’s typed name and contact information, (4) includes a statement about the official’s awareness of the research and agreement to subject or data access, (5) states exactly how recruitment or data access will take place (e.g., that the department will forward an email to a particular LISTSERV), and (6) if using a large email LISTSERV, states the number of times it will be posted (IT limits posts to 3x per study per semester).
Ensure that the official sends the letter directly to the investigator, who must then upload it to the IRBNet package as a scanned PDF or photographic image.

When planning multiple populations, more than one permission letter may be necessary.

After IRB/ERC approval, contact the appropriate individual for access. Provide them with:

1. The IRB or ERC’s approval letter

2. The signed recruitment permission letter

3. The approved content to be forwarded or posted (e.g., email, flyer, social media post)

POPULATION SCENARIO	MU OFFICIAL GRANTING PERMISSION LETTER
Students in These Scenarios Large Email LISTSERVS: UG, Grad, Resident, and Commuter Residence Halls During Events (e.g., when a large group of student attendees is targeted) Campus-Wide Flyers Posted for or Distributed to Students Main, Official Marywood Social Media Accounts (not department level)	Mr. Ross Novak, Dean of Students rnovak@marywood.edu or 570-348-6211, x. 6246 After IRB or ERC Approval – Contacts for Access: LISTSERVS: Adrienne Mullikin at ajmullikin@marywood.edu Main Social Media: Christa Ann Vinciguerra at cavinciguerra@marywood.edu or 570-340-6019 NOTE: The Office of Information Technology now limits posts to the large email LISTSERVS to THREE posts per study.
Student Military or Veterans	Mr. Robert C. Piurowski, Vice-President for Enrollment Management rcpiurowski@marywood.edu or 570-961-4728
Students on Athletic Teams	Mr. Andrew Smith, Director of Athletics and Recreation aesmith@marywood.edu or 570-348-6211, x. 2348 While each coach must agree to recruitment within his/her practice or meeting time, no formal letters are required from coaches. After IRB or ERC Approval – Contacts for Access Email: Coaches may need to be contacted if they maintain email lists for student athletes.
Students During a Class Meeting Time	Department Head for an Individual Department or Dean for Entire College (if accessing multiple departments in one college) While each professor agree to recruitment within his/her classroom, no formal letters are required from professors.
Students via SONA System (Psychology Participant Pool)	No Letter Required
Entire College (including Students)	Appropriate Dean
An Entire Department (including Students)	Department Head
Entire Faculty or All Employees (e.g., large faculty LISTSERV, MWAdmin LISTSERV, HR) Visitors to Campus (e.g., flyers in mutiple buildings - does NOT cover students) Institutional Records	Ms. Leslie Christianson, Assistant Provost lchristianson@marywood.edu or 570-348-6211, x. 6232 Planning and IR Data Request Policy After IRB or ERC Approval – Contacts for Access: LISTSERVS: Adrienne Mullikin at ajmullikin@marywood.edu Main Social Media: Christa Ann Vinciguerra at cavinciguerra@marywood.edu or 570-340-6019 NOTE: The Office of Information Technology now limits posts to the large email LISTSERVS to THREE posts per study.

Tips

Tips on SCANNING IMAGES

TIPS ON tracking CHANGES

Tips to Writing a Readable Form

According to the Common Rule's general requirements for informed consent under 45 CFR 46.116, "The information that is given to the subject or the representative shall be in language understandable to the subject or the representative."

While most Institutional Review Boards require reabability scores between grades six and eight, Marywood University's IRB understands that readability may be skewed by formal names, definitions, or even the analysis program itself. As a result, it should be at or below a tenth grade reading level for the general public. However, it may need to be decreased depending on the population under study. For children or those with impaired decision-making capacity, assent or consent forms also need to be developmentally appropriate.

To improve informed consent form readability:

Avoid use of acronyms or abbreviations.
Use familiar words instead of jargon.
If you must use terminology, briefly define it.
Be consistent with any words or terminology.
Change passive voice to active voice (i.e. sentence's subject is doer of act).
Make sentences short, simple and direct.
Use words with no more than 3 syllables.
Break all compound sentences (and, but, because) into two short sentences.
Create short paragraphs. Support one idea per paragraph.
Use bullets, tables or charts to make ideas clear.

Limit line length to 30-50 characters and spaces.
List procedures in chronological order.
Use an easy to read font and type size, suitable for subjects, such as 12 pt. Times New Roman or 10 pt. Arial.
Restrict procedures to those the subject will experience and understand (i.e. tell them you will give survey rather than naming an unfamiliar instrument, or that you are testing blood for a particular reason rather than providing the technical name).

Examples and Further Reference

Instead of stating, "An survey will be administered online", you should state, "You will take a survey online." Instead of stating that "You must consume additional fluids while in this study in order to maintain hydration", you should state, "The drug can cause you to become dehydrated. You must drink plenty of water while you are in this study."

Hemingway Editor - Use this to make your writing bold and clear, and highlight lengthy complex sentences and common errors.
Federal Plain Language Guidelines - Use this for guidance on how to make communication simple and clear.

How to Check Readability - Microsoft Word 2016, 2013 or 2010

If the below instructions do not work for you, check your word processing software's help menu with the term readability. It is often found where there's a question mark or lightbulb icon in the top menu. After you enable readability, you must run and complete a spell check for the readability statistics to appear.

If readability does not currently show when you run a spell check, you must first set it.

At the top, click the File tab.
On the left panel, click Options.
On the left, click Proofing.
Under When correcting spelling and grammar in Word, make sure the check grammar with spelling check box is selected.
Select the box next to show readability statistics.
Click OK.

When Microsoft Word finishes its spelling and grammar check, it displays the Flesch Reading Ease and Flesch-Kinkaid grade level readability statistics.