Guidance Listing

Click on the following links for detailed information: (Back to Menu)

To view Rowan University Research Policies, please click on the following link: University Policies - Research

Impaired Consent/Surrogate Consent :

Surrogate Consent Guidelines and Forms

Note that prior IRB approval is necessary before utilizing a surrogate. If you have questions about the requirements or need help understanding the process, please contact your local IRB office for assistance.

Data and Safety Monitoring: Print View (PDF format)

Federal regulations require the IRB to determine that, “when applicable, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of subjects.” (45 CFR 46.111(a) (6))

The purpose of Data Safety Monitoring Plan (DSM) is to protect the safety of participants and ensure the integrity of the data. All studies involving human subjects require some level of data and safety monitoring.

Having a good DSMP helps insure the safety of study participants, the validity of data, and the appropriate termination of studies for which significant benefits or risks have been uncovered or when it appears that the investigation cannot be concluded successfully.

The following link to the National Institute of Health (NIH) Guide: Policy for Data and Safety Monitoring provides background, principals and different examples of Data Safety Monitoring information: http://grants.nih.gov/grants/guide/notice-files/not98-084.html

Click here for more information

Protocol Deviation - Print View (PDF format)

A protocol deviation is any change, divergence, or departure from the study design or procedures of a research protocol that is under the investigator's control and that has not been approved by the IRB. Upon discovery, the Principal Investigator is responsible for reporting protocol deviations via eIRB.

Examples:

  • A research subject is scheduled by study personnel for follow-up visits and/or treatment outside of the protocol defined window only if this does not adversely affect the well-being of the subject or the scientific validity of the study.
  • Enrollment of subjects beyond the number approved by the IRB.
  • Study schedule of events is not followed, i.e. study questionnaires are administered out of order.
  • Unapproved advertisements are utilized for recruitment

Protocol Violation

A protocol violation is a deviation from the IRB approved protocol that may affect the subject's rights, safety, or well being and/or the completeness, accuracy and reliability of the study data. Protocol Violations must be submitted for Full Board IRB review.

If the deviation meets any of the following criteria, it is considered a protocol violation.

The deviation has harmed or posed a significant or substantive risk of harm to the research subject.

Examples:

  • A research subject received the wrong treatment or incorrect dose
  • A research subject met withdrawal criteria during the study but was not withdrawn
  • A research subject received an excluded concomitant medication.

The deviation compromises the scientific integrity of the data collected for the study.

Examples:

  • A research subject was enrolled but does not meet the protocol's eligibility criteria.
  • Failure to treat research subjects per protocol procedures that specifically relate to primary efficacy outcomes. (if it involves patient safety it meets the first category above)
  • Changing the protocol without prior IRB approval.
  • Inadvertent loss of samples or data.

The deviation is a willful or knowing breach of human subject protection regulations, policies, or procedures on the part of the investigator(s).

Examples:

  • Failure to obtain informed consent prior to initiation of study-related procedures
  • Falsifying research or medical records.
  • Performing tests or procedures beyond the individual's professional scope or privilege status (credentialing)
The deviation involves a serious or continuing noncompliance with federal, state, local or institutional human subject protection regulations, policies, or procedures

Examples:

  • Working under an expired professional license or certification
  • Failure to follow federal and/or local regulations
  • Repeated deviations.
The deviation is inconsistent with RowanSOM research, medical, and ethical principles.

Examples:

  • A breach of confidentiality.
  • Improper destruction or removal of research records.
  • Inadequate or improper informed consent procedure.

Informed Consent

Content under revision

Investigational Drugs and Devices

Investigational Drug Studies (Click here for more detail)

Studies involving the use of an investigational drug will be conducted in compliance with 21 CFR 312 Subchapter D, Drugs for Human Use / Investigational New Drug Application (IND).

An IND is required for experimental drugs if the drugs are used for the purpose of developing information about their safety or efficacy. Approved, marketed drugs also require an IND if the proposed use in research is different from its previously FDA-approved use or administered by an unapproved route or method of delivery or an altered dosage.

Investigational Device Studies (Click here for more detail)

A medical device is defined, in part, as any health care product that does not achieve its primary intended purposes by chemical action or by being metabolized.

An investigational device is a medical device that is the object of a clinical study designed to evaluate the effectiveness and/or the safety of the device. All investigational device use must have prior IRB review and approval by the IRB in accordance with applicable laws and regulations [FDA 21 CFR 812 and 814 Subpart H].

Clinical investigations of medical devices will comply with regulation 21 CFR 812 unless otherwise exempt, as noted below.

Genetic Research

What is genetic research?

RowanSOM defines genetic research as research that involves the analysis of DNA, RNA, chromosomes, proteins, or certain metabolites which might act as or identify markers associated with a known or suspected predisposition to disease or behavior. Usually genetic research involves the collection of human biological material such as blood, skin or other tissues, nail clippings or hair. Genetic research also may include the construction of pedigrees (maps of the distribution of a particular trait or condition among related individuals or family medical histories). Although gene transfer is another form of genetic research, this guidance document does not apply to gene transfer research.

Investigator Responsibilities

Protecting the Rights, Safety, and Welfare of Study Subjects.

Good Clinical Practice - GCP - Print View

Good Clinical Practice (GCP) is an international quality standard. GCP Guidelines include standards on how clinical trials should be conducted; define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. Adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critical requirement to the conduct of research involving human subjects. Many countries have adopted GCP principles as laws and/or regulations.

The links below will provide you with the specific GCP requirements of the Food and Drug Administration(FDA) and the International Conference on Harmonisation (ICH)

FDA: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm

ICH: http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html

Non-English speaking subjects

The purpose of this guidance document is to ensure that Non-English speaking persons (or their legally
authorized representative or surrogate) are provided information about proposed research in a language
they understand in order to exercise autonomy to participate in research offered by and at RowanSOM.

 

HIPAA - Personal Identifiers and PHI

The HIPAA Privacy Rule regulates the use and disclosure of certain information held by "covered entities" (generally, health care clearinghouses, employer sponsored health plans, health insurers, and medical service providers that engage in certain transactions.) It establishes regulations for the use and disclosure of Protected Health Information (PHI). PHI is any information held by a covered entity which concerns health status, provision of health care, or payment for health care that can be linked to an individual.

non human subjects research

Content under revision

Protocol Contents

Every IRB application must be accompanied by a protocol for research. The protocol must be a summary of the research plan outlined according to factors which the IRB considers essential for its review.

- Protocol Template

Unanticipated Problems/Adverse Events

- Print version

- Policy

Under 45 CFR 46 "unanticipated problems" involving risk to subjects or others must be reported to the IRB, institutional officials, study sponsor and OHRP. In addition, under 21 CFR parts 56, 312 and 812, adverse drug events and unanticipated adverse device effects that are 'unanticipated problems" must be reported to the IRB, study sponsor, and FDA.

All deaths in interventional studies that occur within 30 days of the intervention must be reported to the IRB within 24 hours of discovery whether or not considered study-related when RowanSOM is the IRB of record.

Incidents, experiences, outcomes and adverse events which meet all the criteria below also must be reported to the RowanSOM IRB:

  • unexpected in terms of nature, severity or frequency, given the research protocol, investigator's brochure, IRB-approved informed consent document, product labeling and other sources of information, and given the characteristics of the subject population being studied (expected natural progression of subjects' disease, disorder or condition or predisposing risk factor profiles)?
  • related or possibly related to participation in the research, i.e., is there a definite or reasonable possibility that the incident, experience or outcome may have been caused by the research drug/device or research procedures?
  • potentially place the research subjects or others at a greater risk of harm (including physical, psychological, economic or social harm) than was previously known or recognized?


Unanticipated problems which are serious adverse events must be reported within one week of discovery. All other unanticipated problems must be reported to the IRB within two weeks of discovery.

The following must be included in the submission of an Unanticipated Problems / Adverse Events in Human Subjects Research Report:

Please log into someirb.umdnj.edu to complete a New Reportable Event:
•Your 1st step is to open your study in eIRB:
click on "New Reportable Event" for unanticipated problems, adverse events,

Following review, the Unanticipated Problem/Serious Adverse Event will receive one of the following status determinations: Accepted or Not Accepted. This determination will be provided to the principal investigator, outlining follow-up steps as deemed necessary by the committee.

Advertising/Recruitment - Print View (PDF format)

Any advertisement that will be seen or heard by prospective subjects to solicit their participation in a study is considered Direct Advertisement for Research Subjects.

This includes, but is not necessarily limited to: e-mail announcements, online advertisements, newspaper, radio, TV, bulletin boards, posters, and flyers that are intended for prospective subjects.

Not included are:

  1. communications intended to be seen or heard by health professionals, such as "dear doctor" letters and doctor-to-doctor letters (even when soliciting for study subjects)
  2. news stories
  3. publicity intended for other audiences, such as financial page advertisements directed toward prospective investors.

FDA considers direct advertising for study subjects to be the start of the informed consent and subject selection process. Advertisements should be reviewed and approved by the IRB as part of the package for initial review. However, when the clinical investigator decides at a later date to advertise for subjects, the advertising may be considered a modification to the ongoing study.

When direct advertising is to be used, the IRB must review the information contained in the advertisement and the mode of its communication, to determine that the procedure for recruiting subjects is not coercive and does not state or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and the protocol.

Generally, FDA believes that any advertisement to recruit subjects should be limited to the information the prospective subjects need to determine their eligibility and interest. When appropriately worded, the following items must be included in advertisements.

  1. the name and address of the clinical investigator and/or research facility;
  2. the condition under study and/or the purpose of the research;
  3. in summary form, the criteria that will be used to determine eligibility for the study;
  4. a brief list of participation benefits, if any (e.g., a no-cost health examination);
  5. the time or other commitment required of the subjects; and
  6. the location of the research and the person or office to contact for further information.

FDA Inspection readiness

Successful FDA Inspections at Investigative Sites for Clinical Trials of Drugs and Biologics - Print View (PDF - Format)

Certificate of Confidentiality - Print View (PDF- format)

Certificates of Confidentiality are an important tool to protect the privacy of research study participants

Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. By protecting researchers and institutions from being compelled to disclose information that would identify research subjects, Certificates of Confidentiality help achieve the research objectives and promote participation in studies by helping assure confidentiality and privacy to participants.

Information about how to apply for a Certificate of Confidentiality can be found at: http://grants.nih.gov/grants/policy/coc/

CITI - Human Subjects Training

All RowanSOM faculty, students, and other individuals involved in human subjects research are required to complete the Collaborative Institutional Training Initiative (CITI) Basic Course prior to IRB approval. This requirement also extends to all RowanSOM IRB members and Office of Institutional Review Board staff. RowanSOM IRB will not issue final approval of any IRB submissions until it is verified that listed study personnel have completed the current requirements for human subjects research education.

For more information click here.

Clinical Trials Registration

All clinical trials must be registered with Rowan University Clinical Trials and Resarch Office Administration.

The FDA Amendments Act of 2007 requires all clinical trials be registered in a public database. The Act of 2007 contains trial registration requirements at ClinicalTrials.gov. Consequences of not registering can include monetary and civil penalties. Additionally, many journals require that the trials have been registered before papers will be considered for publication. RowanSOM requires investigators to register all Investigator-initiated and National Institute of Health (NIH) trials into the University’s profile at www.clinicaltrials.gov. Industry sponsored studies are registered by the Sponsor.


Contact Information:
RowanSOM – Office of Clinical Trials Management; Phone: (856) 566-2305 – Jillian Stanley, Research Coordinator
Glassboro/CMSRU – Office of Research Compliance

The following links provide detail:

The law:
http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf

NIH Guidance:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-014.html
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-147.html
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-007.html

OHRP Guidance:
http://www.hhs.gov/ohrp/international/clinical-trial-registries/
http://www.hhs.gov/ohrp/international/compilation-human-research-standards/

Closure of studies

The RowanSOM IRB administrative office must be notified when a study is completed. This notification should be sent when enrollment of participants and data collection is complete and data analysis is to the point that participants' records will no longer be required. Please complete a Final Study Report and submit it to the IRB within 30 days of closure of the study. Notification of the closure of exempt studies is also recommended.

Please access your study via eIRB.Rowan.edu, click on the create Final Report option in your study workspace. 

 

Conflict of interest

On August 25, 2011, the U.S. Department of Health and Human Services, Public Health Service  adopted a revised regulation for managing potential or real conflicts of interest in “Responsibility of Applicants for Promoting Objectivity in Research” (42 C.F.R. Part 50, Subpart F).  The link to the notice is: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-109.html

RowanSOM has revised its Investigator Conflict of Interest Policy to be consistent with these amended PHS regulations which are intended to provide the reasonable expectation that the design, conduct, and reporting of the research will be free from bias resulting from Investigator financial conflicts of interest.  All Institutions receiving PHS funding are required to implement the new rules prior to August 24, 2012.  After August 7, 2012, you will be able to find a copy of the revised policy at:http://www.umdnj.edu/oppmweb/university_policies/research/PDF/00-01-05-10_05.pdf

Study Managment Tools: Print View - Table of Contents

The Study Management Tools are intended to be used as an aid to help the researcher and research team. This template attempts to provide a general format applicable to all types of research. After choosing the appropriate template, it should be modified to reflect the unique attributes of the study

  • Study Staff Delegation Log: Use this log to document study staff signatures/initials and their research related responsibilities as delegated by the Principal Investigator. Update as responsibilities change
  • Study Staff Training Log: Use this log to document any education or training completed by study staff (eg. CITI, GCP, Sponsor protocol Training, Certificate Programs completed)
  • Subject Enrollment Log: Use this log to document to keep track of participant screening, eligibility, enrollment or reasons for exclusion.
  • Monitoring Log: Use this log to document date of monitoring visits, name of monitor and type of monitoring visit taking place.
  • Drug Accountability Log: Use this log to manage study drug compliance. Document Subject ID, date received, Kit #, dispensing amounts, who dispensed drug, dates, return dates, amount returned, etc.
  • Device Log: Use this log to manage study device compliance. Document Subject ID, Model #, Serial #, Lot #, date device used, date destroyed and/or returned.
  • Unanticipated or Adverse Event Log: Use this log to document to keep track of participant unanticipated or adverse events. Document Subject ID, date event occurred, date staff learned of event, describe event, date reported to IRB and/or Sponsor.
  • Protocol Deviation Log: Use this log to document to keep track of deviations from the IRB approved protocol. Document Subject ID, date deviation occurred, type of deviation (code), date protocol deviation form was completed and submitted to IRB.

Glossary

The following glossary is not intended to be a complete biomedical and social behavioral research glossary, but the intent of this glossary is to cover concepts that are important in the completion of IRB applications. This glossary does not include terms specific to any one research project.

Prisoner Research

Frequently Asked Questions (FAQs): PDF Format

Who may be a Principal Investigator (PI) for Human Subjects Research

Definition of Principal Investigator: A principal investigator is the individual who assumes full responsibility for a research project, including the supervision of any co-investigators, research assistants, house staff and students. The Institutional Review Board only recognizes one principal investigator per human subjects research study, no matter how many research sites may be involved. Other individuals may be named co-investigators. The principal investigator must possess the expertise, time and commitment to conduct and provide the necessary oversight for all aspects of the study, and must be willing to accept full responsibility for the study. In multi-site studies for which RowanSOM is the coordinating institution, the principal investigator assumes the responsibility for the conduct of the study at each performance site and by each site-specific principal investigator.

Human Subjects Research Policy: Word Version

Expired Studies:

STANDARD OPERATING PROCEDURES: (Click here to view)

GUIDANCE: Print View

Federal regulations and University policy mandate:

  • If approval for continuation is not granted prior to the expiration date of the protocol, all recruitment, subject enrollment, and other research related activities (e.g. study visits, chart reviews, data analysis using subject identifiable data, manuscript development, and etc.) must stop.
  • Currently enrolled subjects should continue to receive treatment and follow‐up that is in their best interest.
  • Failure to submit timely requests for continuing review demonstrates non‐compliance with federal regulations and institutional policy and is reportable to the FDA, OHRP, and the study sponsor (when applicable).
  • Continued non‐compliance affects the investigators standing with the IRB and may prohibit the investigator from conducting future research at the University.

IRB Office Requirements:

  • In order to prevent non‐compliance due to an expired protocol, an investigator must submit his/her Continuing Review Application or Final Study Report to the IRB office
    • At least 4 weeks in advance of the expiration date of IRB approval for minimal risk (expedited) protocols
    • At least 8 weeks in advance of the expiration date of IRB approval for greater than minimal risk (full board) protocols
  • If non‐compliance occurs due to an expired protocol, then the investigator must submit the Expired Study Report Form with his/her Continuing Review Application or the Closure Form with his/her Final Study Report. Both forms require the investigator to provide a detailed corrective action plan.

Corrective Action Plan for Expired Protocols:

A corrective action plan describes how a delayed submission resulting in an expired protocol will be prevented from occurring in the future and what changes in procedure are being implemented to prevent protocol approvals from expiring in the future. Below are three examples of acceptable corrective action plans:

Example #1

1. My system/procedure to track deadlines will be by placing the dates in my calendar and in the calendar of the co‐investigators and other study personnel.
2. The visual tool, with an available alarm, is the Outlook calendar that we will be using.
3. My plan for maintaining calendar notifications for expiring protocols will be to set an alarm in the calendar which will notify us of expiration dates. The calendar will be backed up on the departmental server in case the local drive fails.

Example #2

The study’s coordinator is going to construct a well‐organized e‐file system for every study under the PI’s name. The folder will be located on the PI’s shared drive and will be organized by protocol. There will be subfolders within each protocol’s folder, organized in chronological order, for each of the continuing reviews, amendments, and etc. This system will provide anyone new to the study, such as new research fellows, with easy access to the status of all studies under this PI and the most current IRB documents. Additionally, the coordinator is going to develop a spreadsheet for all protocols under the PI. The spreadsheet will be updated as needed and will serve as a quick reference for when continuing reviews need to be compiled and submitted.

Example #3

Upon receiving approval from the IRB:

1. I will complete corrections to the final chapter of the project. At the time of suspending the project all of the research was completed. My faculty advisor had only reviewed the data that I compiled and only made recommendations for corrections to the written report.
2. I will complete those corrections to the written report and then give my faculty advisor a weekly progress update on Fridays.
3. My faculty advisor and co‐investigator will review my final written report.
4. I will schedule a weekly meeting in person with my faculty advisor to review her recommendations to the final document.
5. I plan to present the findings and submit the paper for publication. The results of this study will provide evidence based information to the ongoing discussion among stakeholders as they attempt to provide enhanced healthcare for foster children in the State of New Jersey.
6. I will submit a Final Study Report/Study Closure Form to the IRB at least 4 weeks before my IRB approval expires after my paper has been accepted for publication or presentation and no additional analysis of the data will be done. If further data analysis is needed before my paper is accepted, then I will submit a Continuing Review Application to the IRB at least 4 weeks before my IRB approval expires.

Please note that exact duplication of these examples in place of an original corrective action plan will not be accepted by the IRB and will be returned to the investigator to be revised and then resubmitted to the IRB.

Research Tissue or Data Bank

These guidance documents may be used as a resource for investigators who wish to develop: (a) standard operating procedures to establish a research tissue bank or a research data bank; (b) a consent document to collect tissue for future research; and (c) an addendum consent document to collect tissue for future research secondary to a main study. This guidance applies to activities that include the collection and storage of blood, tissue or other biological materials (excluding embryos* or embryonic stem cells*) and/or health data that will be used by a single investigator or shared with multiple investigators for future research not yet defined, including genetic (but not stem cell*) research. This guidance does not apply to the collection and storage of specimens or data as part of a single IRB-approved protocol for defined research purposes. *Contact your IRB Office for guidance on embryo or stem cell research.

Guidance for the development of standard operating procedures for a research tissue bank or a research data bank: SOP Guidance

Guidance for the development of a consent form for a research tissue bank or research data bank: RowanSOM Tissue or Data Bank Consent Template (existing link)

Guidance for the development of a consent forms appended to a main study to collect tissue for future research secondary to a main study: Guidance for Addendum to Main Study

 

National Institutes of Health (NIH) Guidance

NIH on August 2, 2012 issued a notice that provides detailed guidance on the types of changes in human subjects research awards that require prior NIH approval. It also provided information on the process for the submission of such requests. A separate notice "clarifies NIH requirements related to prior NIH approval of human subjects research plans for awards which were submitted with the intent to conduct human subjects research during the period of support, but for which definitive plans could not be described in the grant application."

Guidance on Changes That Involve Human Subjects in Active Award

Prior NIH Approval of Human Subjects Research in Active Award

Research Noncompliance

Research noncompliance refers to a failure (intentional or unintentional) to follow the regulations, institutional policies governing human subject research, or requirements of or determinations by the IRB by the investigators or research staff, including the RowanSOM IRB or IRB administrative staff. Noncompliance can result from action or omission. Noncompliance may be non-serious (minor) or serious, and may also be continuing:

Click Here for Details

Research Misconduct

Research Misconduct means any fabrication, falsification, plagiarism, or other practice that seriously deviates from those that are commonly accepted with the scientific community in proposing, performing, or reviewing research, or in reporting research results. Research misconduct does not include honest error, conflicting data, differences of opinion, or differences in interpretations or judgments about data or experimental design. :

Click Here for Details

Quality Assurance/Quality Improvement (QA/QI) Projects

Quality Assurance (QA) and Quality Improvement (QI) consist of activities that are undertaken to measure the effectiveness of standard accepted processes, programs, or services, the results of which are intended to be shared only with individuals associated with the process, program or service being evaluated. QA/QI projects cannot expose individuals to any additional risks.

AUDIO/VIDEO/PHOTOGRAPHIC RECORDING OF HUMAN SUBJECTS

This guidance applies to all human research studies that involve the audio, video, photographic, or any other recording (hereafter referred to as recording) of research subjects

Individual Investigator Agreement (Form)

The Individual Investigator Agreement form establishes guidelines and mechanisms for when the use of an Individual Investigator Agreement (IIA) is appropriate to submit for a collaborating investigator, from an institution other than Rowan University and its Affiliates, "engaged" in human research activities. Rowan University and its Affiliates are assured institutions that may extend, for one or more protocols, their Federalwide Assurance (FWA) to cover collaborating independent or institutional investigators. This agreement will ensure that collaborating investigators outside of Rowan University and its Affiliates are appropriately acknowledged under the Rowan's FWA and that the Individual Investigator Agreement is utilized accordingly. All collaborating Investigators outside of the jurisdiction of Rowan University or its Affiliates, that qualify as "independent" or "institutional" investigator should submit this agreement for review with the corresponding protocol.

Reviews Preparatory to Research (Form)

In accordance with the HIPAA Privacy Rule, Rowan University School of Osteopathic Medicine (RowanSOM) may use or disclose Protected Health Information (PHI) for the purpose of ‘Reviews Preparatory to Research’ (RPR), wherein a researcher uses/reviews PHI for the purpose of developing a research protocol; formulating a research hypothesis; or to screen for study eligibility.
Under the ‘Reviews Preparatory to Research’ (RPR) mechanism, the RowanSOM may release PHI to a Researcher without an individual’s HIPAA Authorization or a Waiver of HIPAA Authorization granted by the Privacy Board. However, the law requires that the RowanSOM obtain from the Researcher the attached RPR Form to ensure privacy and confidentiality of the PHI being released.

Procedures
1. Researchers who are members of the RowanSOM may utilize PHI of the RowanSOM obtained through the RPR to contact patients for recruitment activities.


2. At no time during the review will the information be removed from the RowanSOM premises.


3. Special Note on Reviewing PHI for Recruitment Purposes. Researchers may use PHI obtained pursuant to this Review Preparatory to Research procedure to contact potential study subjects subsequent to receiving the RowanSOM-IRB approval for the study protocol. At no time you nor your staff will contact patients about the proposed study or conduct any research until you submit and receive the approval for the human subject protocol from RowanSOM, but only after IRB approval of the study has been obtained.


4. Researchers who are not members of the RowanSOM may utilize the PHI of the RowanSOM obtained through the RPR for recruitment only upon obtaining IRB approval of the study and obtaining a HIPAA Partial Waiver of Authorization from the IRB/ Privacy Board.


5. At Rowan SOM, the IRB serves as both HIPAA Privacy Board and the IRB.


6. The HIPAA Privacy Officer at RowanSOM verifies that the completed RPR Form is in compliance with the Standard Operating Procedure. If changes are required, the HIPAA Privacy Officer advises the Researcher of the changes needed. If no changes are required, the HIPAA Privacy Officer signs and dates concurrence and returns the RPR Form to the Researcher and retains a copy in the office. Signed RPRs will be reported to the Privacy Board.


7. The review of PHI will commence on the date of approval of the RPR Form and will expire on the date specified in the Certification Form. After the expiration date, you will no longer access the PHI for research preparation and will retain the PHI in accordance with the policies on human subject research, only if needed as part of an approved research protocol from the RowanSOM IRB.

Note: In the case where the PHI is being derived from another Covered Entity (CE) and the Rowan IRB is establishing a protocol for such study, the RPR must be completed and noted that the information is being obtained from another site and all documents from the site necessary to conduct research must be made available and part of the RPR process.

For additional Information, please contact the HIPAA Privacy Office at:
Ray Braeunig, CHC, CHPC, CHRC
Chief Compliance & Privacy Officer
Office of Compliance & Corporate Integrity
Rowan Medicine-1300
Stratford, NJ 08084
856-566-6136

Reference: 45CFR 164.512(i)(1)(ii)