Rowan Users (Internal)

Appendix A - Prospective Participation of Children as Subjects 
Appendix B - Elements of Consent 
Appendix C - Waiver of Consent for Research 
Appendix D - Elements of Review
Appendix E - Stem Cell Research 
Appendix F - Categories of Research for an Expedited Review Procedure 
Appendix G - Categories of Research for an Exempt Review Procedure 
Appendix H - Intentionally Left Blank
Appendix I  - Electronic Consenting
Appendix J  - Certificate of Confidentiality Update

* Click here for surrogate consent guidelines and forms

The study protocol templates below are required when submitting an IRB application via CIRB. All researchers and investigators are encouraged to use one of these templates as a guide to develop your research protocol.

• CLINICAL/CLINICAL TRIAL Protocol Template (Word)
• MEDICAL CHART REVIEW Protocol Template (Word)
• NJDOH USERS Protocol Template (Word)
• SOCIAL BEHAVIORAL EDUCATION RESEARCH Protocol Template (Word)
• SECONDARY USE OF BIOSPECIMENS Protocol Template (Word)

 FDA Issues Guidance on New Informed Consent Requirements (click here for details)

Subject recruitment is an important part of most human subject research studies. All human subject recruitment must also be reviewed and approved by the IRB prior to implementation. All appropriate recruitment documents, tools, and methods should include the following: 

• Name of study
• Indication of "Research Study" and statement of voluntariness  
• Time commitment and study location
• Subject enrollment requirements (i.e. 18 and older, students, subjects with "x" condition etc.) 
• Primary Investigator contact information
• Statement that study has been approved by Rowan's IRB

The above bulleted items should be included in advertisements and other recruitment instruments.

Below are some templates to use for flyers, listservs or letters/emails:

• Recruitment Flyer Template
• Recruitment Rowan Daily Mail or Listserve Template
• Recruitment Email and Letter Template
• Recruitment Verbal Script Template

Social Media Advertisements with Limited Character Space

For research that only utilizes an electronic, anonymous survey and researchers will not access, use, or collect subject identifiable information, the template below can be used. For research studies that include research procedures other than or in addition to electronic, anonymous survey, but will use social media advertisements should include the advertisement content requirements listed above.

•  Electronic, Anonymous Survey Recruitment Template

When conducting research at a non-Rowan study site, permission from a representative at the site is required prior to the recruitment of subjects. The permission letter should include the following: 

• Name of study
• Study site letterhead
• Principal Investigator and/or student's full name
• Purpose of study
• What resources/sites/rooms will be provided to the researchers
• Statement and understanding that human subjects will be recruited at the site, and human subjects will undergo research experimental procedures
• Signature, title, and contact information of the individual providing approval

Please use the Non-Rowan Study Site Permission Letter Template as guidance. The above bulleted items should be included in the study site permission letter and uploaded in the Cayuse IRB application.

HIPAA 

HIPAA and Medical Research

Health Insurance Portability and Accountability Act (HIPAA) Data / Protected Health Information (PHI)

HIPAA Training Requirements Guidance – Rowan University

Who Needs HIPAA Training?

• Interact with patients for research purposes (e.g., consent, intervention, manipulation of environment)
• Access or use Protected Health Information (PHI)
• Analyze identifiable data
• Perform IRB-approved procedures

Training Requirements Summary

Module Descriptions

Faculty and Staff Training

1. HIPAA Research
2. Law Enforcement Uses and Disclosures
3. Patient Rights
4. Privacy Rule
5. Security Rule
6. Violations and Penalties

• HIPAA Privacy Rule
• HIPAA Security Rule
• HIPAA Patient Rights
• HIPAA Violations and Penalties
• HIPAA Law Enforcement Uses and Disclosures

• HIPAA Privacy Rule
• HIPAA Security Rule
• Safeguards for PHI
• Breach notification requirements
• Data handling and protection protocols

Student Training

Requesting Access to HIPAA Training Modules

• Rowan NetID username
• Banner ID number
• Rowan email address
• Contact phone number

External Collaborators & Affiliated Entities

• External (non-Rowan) collaborators may submit their institution’s HIPAA/PHI training certificate
• If their institution does not offer training, Rowan’s HIPAA/PHI training may be used. Researchers will need to contact the Rowan Office of Compliance and Corporate Integrity (OCCI)
• Rowan HIPAA/PHI training is required for access to RowanSOM patient charts prior to June 6, 2023
• Affiliated entities (Virtua, Cooper, Inspira): Rowan IRB accepts their HIPAA/PHI training for researchers listed on submissions

Important Notes

• Before releasing such data, Rowan-VirtuaSOM requires Rowan HIPAA/PHI training
• Researchers must clearly identify their roles in IRB submissions (e.g., recruitment, consent, intervention, data analysis)

Links for information and access to training applications 

• Click here to go to the RowanSOM Compliance Training Webpage

• HIPAA 101 Compliance Module FAQ

• HIPAA Research 109 Compliance Module FAQ

• Login for Faculty & Staff - OCCI Training Portal
• Login for Students - KnowBe4

Upcoming IRB Workshops

Training Videos

Cayuse IRB Student Submission Training Video

Request an IRB Training/Workshop

856-256-4078

cirb@rowan.edu

Presentation & Training Material Library

Ethics & Informed Consent in Practice and Protocol & Human Subjects Research Project Management -Powerpoint

OHRP Training Videos

The Office for Human Research Protections (OHRP) offers educational videos on a variety of topics including IRB membership, general informed consent requirements, IRB records, and complex issues with research involving vulnerable populations.

Additional information on OHRP's educational videos pertaining to OHRP guidances for various aspects of human subjects research and IRB regulatory requirements can be found at: http://www.hhs.gov/ohrp/education/#materials.

OHRP Luminaries Lecture Series

Click the above link to view the OHRP Luminaries lecture series webpage to view recorded lectures by esteemed researchers. The videos listed on the webpage link are also available on the YouTube Playlist.

Clinical investigators play a pivotal role in medical product development by providing FDA with the clinical data for regulatory decisions. Yet, the clinical trial industry faces a chronic shortage of well-trained, experienced clinical investigators committed to performing clinical trials over the long haul.

The resultant need to continually recruit new investigators drains valuable resources and may compromise the quality of clinical research, since new investigators may be less equipped to recognize emerging safety issues, ethical problems, and pitfalls in study design. They may also not fully apprehend FDA's regulatory and monitoring requirements.

To help develop a cadre of well-trained investigators, FDA's Critical Path Initiative has launched a Clinical Investigator Training Course targeted at medical professionals (experts who sign FDA Form 1572 before participating in an investigation). The 3-day course includes lectures given by senior FDA experts and guest lecturers from industry and academia, providing FDA's perspectives on new safety concerns, adverse event monitoring, compliance with legal and ethical obligations of clinical research, and acceptable scientific and analytic standards in clinical study design and conduct.

To access FDA course materials, please follow the link below: 
FDA's Clinical Investigator Training Course