Human Participants Institutional Review Board (IRB)

The IRB approves all Moravian University student, faculty, staff, and administration research proposals that involve human participants (including fetuses and human biospecimens).

2022-2023 members of the Moravian IRB:

Dr. Rebecca Bawayan, School of Rehabilitation Sciences
Dr. Sara Benham, School of Rehabilitation Sciences
Dr. Elise Colancecco, School of Nursing & Public Health
Dr. Paulette Dorney, School of Nursing & Public Health
Dr. Aleena Hay, Department of Psychology, College of Arts & Sciences
Dr. Louise Keegan, School of Rehabilitation Sciences
Dr. Kathleen Madara, School of Rehabilitation Sciences
Dr. Rebecca Malinski, Department of Sociology, College of Arts & Sciences
Dr. Daniel O’Connor, School of Business & Economics
Dr. Jennifer Ostrowski, School of Rehabilitation Sciences
Dr. Ann Marie Potter, School of Rehabilitation Sciences
Dr. Mary Anne Riopel, School of Rehabilitation Sciences
Dr. Michael Steimling, School of Rehabilitation Sciences
Dr. Bess Van Asselt, Department of Education, College of Arts & Sciences
Dr. Kimberly Wynarczuk, School of Rehabilitation Sciences

Executive board:

Dr. Sarah Johnson, Department of Psychology, College of Arts & Sciences
Dr. Debra Wetcher-Hendricks, Department of Sociology, College of Arts & Sciences
Dr. David Wilkenfeld, School of Rehabilitation Sciences

Forms and information for proposers:

Moravian University Human Subjects Policy
CITI Certification The following individuals must complete CITI training and submit the certificate of completion before their proposals will be considered.
- faculty who are principal investigators or co-principal investigators
- staff who are principal investigators or co-principal investigators
- students who are principal investigators or co-principal investigators
- faculty advisors to student research
Detailed information regarding this requirement as well as the CITI courses, themselves, can be accessed by clicking on the CITI certification link.
HSIRB Proposal Form: This is the primary form completed by the researcher which provides details about the research project. Those proposing projects that do not meet the criteria for exemption (as identified on the Exemption Request Form) must complete and submit this form. Each Monday at 9:00 a.m., all proposals received since the previous Monday are distributed to HSIRB members for review.
HSIRB Exemption Request Form: This form is available for researchers who believe they qualify as exempt from IRB review. Standard exemption categories are listed in this form. All research with human participants that is considered exempt from IRB review should still be submitted to the IRB via this form to confirm exemption status.
HSIRB Informed Consent Template: This form is intended to help proposer draft their informed consent form/letter. This template outlines all of the information that proposers must provide in order to assure informed consent.
HSIRB Consent Form Instructions: This form provides some additional information on drafting the informed consent document.
HSIRB Tips: Other helpful tips as proposers draft their proposals.
HSIRB Guidelines for Student Proposers: This document provides guidelines to students who may be navigating the research proposal process for the first time.
Ethical Issues in Research on Illegal Activities

Complete proposals include:

A completed HSIRB proposal form submitted as a Word or pdf document (we will not review Google Drive documents or other kinds of documents that can be changed during the review process).
Informed consent document(s)
Copies or links to all research instruments, and copyright clearance if using copyrighted instruments
Copies of debriefing materials if and only if the proposal involves deception.

Incomplete proposals will be returned to the proposer before review and this will delay the review process. Poorly constructed, error-ridden proposals will also be returned so please be sure to proofread your proposal before submission.

Submit all of your forms electronically to:

hsirb@moravian.edu

Please make sure that ALL of your proposal materials are sent collectively in one email submission, otherwise the review process will be delayed.

Timing of the review process:

During the standard academic calendar, the HSIRB committee reviews proposals on a rolling basis. Given the large volume of proposals we receive from faculty, Honors students, other undergraduate students and graduate students, it typically takes us 2-3 weeks to complete an initial review of a completed proposal. Please note that the proposal may not be sent out for review the day it is received. Many proposals often require some edits/modifications before we can grant full approval and the revision process often adds an additional week+ to the review process, for a total turn-around time of 3-4 weeks. The majority of proposals will be fully reviewed within 1 month, but proposals that are submitted incomplete, with many editing errors, or with substantial clarity problems may take longer. The time-frame for completing the review depends substantially on how quickly the proposal author responds with any requested revisions.

Proposers should keep this time frame in mind as they plan their research projects. Students who are completing a research project for a class must pay close attention and submit their research proposals in the first few weeks of the semester to assure adequate time for review and revision. Honors students should make sure their proposals are submitted well ahead of the time when they plan to conduct their research. Proposals can be submitted over winter break and summer, but the review time-frame may be extended as IRB members are not always available at those times to review immediately.

Some Helpful Websites:

Protecting Human Research Participants

NIH Institute for Extramural Research
Link to PHRP Online Course
http://phrp.nihtraining.com/users/login.php

This online course is designed to prepare investigators involved in the design and/or conduct of research involving human subjects to understand their obligations to protect the rights and welfare of subjects in research. The course material presents basic concepts, principles, and issues related to the protection of research participants. At the end of the course, participants can obtain a certificate that verifies that they have reviewed all of the course material.

Upon completion of this course, you should be able to:

Describe the history and importance of human subjects protections
Identify research activities that involve human subjects
Discover the risks a research project might pose to participants
Understand how to minimize the risks posed by a research project
Describe additional protections needed for vulnerable populations
Understand additional issues that should be considered for international research
Describe appropriate procedures for recruiting research participants and obtaining informed consent
Identify the different committees that monitor human subjects protections
Understand the importance of study design in the protection of research participants
The first module examines significant historical events that have contributed to the way we view the protections for participants in clinical research today.

The Belmont Report: Office of the Secretary

Ethical Principles and Guidelines for the Protection of Human
Subjects of Research, The National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

What is Ethics in Research & Why is it Important?

by David B. Resnik, J.D., Ph.D.

http://www.niehs.nih.gov/research/resources/bioethics/whatis/index.cfm

Questions?

Contact the IRB Executive Board at hsirb@moravian.edu