Drexel University Office of Research

Frequently Asked Questions on IRB Submissions and Process

How can I enter the office of research website for human subjects studies and forms?
The URL for the Office is www.research.drexel.edu. Once you enter the website, place the cursor on research, scroll down to compliance and go to either medical or non-medical IRB which ever is appropriate for you. The definitions of medical and non-medical IRB are on questions 4 and 5.
What is the definition of human subjects research?
A systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
How and who will determine the proposed activity is human subjects research?
Simulations of human experiments (such as mock research projects, mock preparation of a posters with imaginary data, mock poster or formal presentations to educate students to learn to design, execute and present results of a mock study) and curricular-assigned data collection, quality control and workmans performance evaluations in using a technology or computers are generally not considered research. Since they are considered non-research, such activity need not be reviewed by the IRB.
If no publication or presentation will result from a project, does it still qualify as "research"?
Yes. Any activity that results in generalizable knowledge whether published or not is considered research since human subjects are involved and they are to be protected.
Do I need Human Subject Protection training?
All researchers engaged in human subjects research involving live subjects, records, database, tissue samples and surveys, are required to complete the training (www.research.ddrexel.edu) before their projects are reviewed by the IRB.
What are the levels at which IRB reviews research projects?
Three levels of reviews are applied. They are, exempt review, expedited review and full review by the IRB.
What is included under Exempt Research?
Although the category is called "exempt," this type of research does require review by the Office of Research, but NOT by the IRB. However, the Office of Research may determine that the research does not qualify for exemption and may advise the researcher to obtain expedited review or full committee review.
The exempt registration process is much less rigorous than an expedited or full-Committee review. To qualify, research must fall into six (6) federally defined exempt categories which are posted on our website www.research.drexel.edu under exempt review certification.
These categories present the lowest amount of risk to potential subjects because, generally speaking, they involve either collection of existing anonymous or publicly available data, analysis of existing anonymous tissue or conduct of the least potentially harmful research experiments. Some examples of Exempt research are: Anonymous surveys, research on educational strategies, educational tests, taste tests, retrospective chart reviews or research on existing data (must be existing on the day of the application) and analyses of discarded pathological specimens without patient identifiers. Note: Special conditions apply to inclusion of children to exempt research. Please see the full text version of exempt categories.
What are the regulations on using existing tissue and records for exempt research?
46.101(b)4. Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens. If these sources are publicly available or if the information is recorded by investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Example: An investigator wishes to screen blood samples or existing data at a clinic or a hospital (local or distant) or an agency for an unknown disease or for other research objectives. All of these activities are done without the use of subjects identifiable information. When identifiers are linked to individuals, such projects cannot be exempted.
What is included under Expedited Research?
To qualify for an expedited review, research must fall into nine (9) federally defined expedited categories. To review these categories and to use the expedited review forms, visit www.research.drexel.edu. Generally these categories involve collection of samples and data in a manner that is not anonymous and that involves more than minimal risk to subjects. Some examples of expedited research are: studies have to be minimal risk, studies are done using healthy volunteers, studies involving collection of hair, saliva or dental plaque samples, studies of blood samples from healthy volunteers; analyses of voice recordings, studies of existing pathological specimens with patient identifiers and survey of volunteers that are minimal risk and done with consent. One member of the IRB generally reviews Expedited review protocols. The reviewer may recommend the proposal to be reviewed by the full committee.
What comes under Full Committee Review?
Proposed human subject research, which does not fall into either the exempt or expedited review categories, must be submitted for full committee review. Visit our website www.research.drexel.edu to obtain information on how to submit projects for review, deadlines, meeting dates and committee actions. This is the most rigorous level of review and, accordingly, is reserved for research projects that present more than minimal risks to subjects. The committee may approve without changes (very rare), approve with pending conditions (since some of the IRB concerns are minimal and easily corrected); table (requires substantive changes) or disapprove (usually rare when IRB determines that the procedure is extremely invasive, puts subject population at increased risk that outweighs any benefit).
How do I know what form to use?
All the forms and when to use them are listed under (www.research.drexel.edu). There are two separate lists for the Medical and Non-Medical IRB, respectively. Select one that is most appropriate for your research.
What is considered medical research?
Clinical research in healthy and unhealthy subjects, clinical study in healthy and unhealthy subjects, clinical investigation of a drug or device in healthy and unhealthy subjects, social and psychological experimentation or observation in unhealthy subjects is considered medical research.
What is considered non-medical research?
Examples of non-medical research include the following: 1. An historian engaged in gathering oral histories 2. A psychologist studying interpersonal behaviors in a group of individuals with mental disorders 3. Computer scientists or an engineer engaged in collecting information about various human performance characteristics and or limitations or studying the human factors aspects of a newly designed artifact 4. An instructor evaluating classroom techniques or activities with the intent to publish the findings 5. A nurse surveying volunteers about their attitude toward organ donation 6. Any other project that involves a survey or a data collection through consent
How do I fill out the IRB Application forms?
These are MS Word or MS Excel documents that can be downloaded from www.research.drexel.edu. and filled on your computer. All forms must be filled completely before the IRB office will accept the proposal.
What are the IRB meeting dates?
We currently have four IRBs: IRB # 1 meets the 1st and 3rd Wednesday of each month; IRB # 2 meets the 1st and 3rd Friday of each month; IRB # 3 meets at least once on the last Thursday of the month and IRB # 4 meets the last Wednesday of each month. IRB meeting dates and locations are posted on (www.research.drexel.edu). Occasionally, meeting locations may change. If you have submitted a research project for review, you will receive an e-mail from the office informing you of the location and an approximate time when your project may be used. The time of review is approximate because certain research projects may consume more time to review.
When do I have to turn in my review materials?
Exempt and Expedited review materials can be submitted at any time. For exempt and expedited review, you will need to submit one (1) original and three (3) copies. For Full Committee Review, you will need to turn in one (1) original and six (6) complete sets of information to the Office of Research Compliance located at Drexel University College of Medicine, 245 N. 15th Street, Suite 2105, New College Building (NCB), Philadelphia, PA 19102-1192 to start the review process. The deadlines for submissions are posted on the website (www.research.drexel.edu).
How do I write an Informed Consent?
A template for an informed consent is available on the website (www.research.drexel.edu). Use this format including the paragraph numbers as the basis for your consent and fill in the study specific information. Any other format will probably confuse the reviewer leading to better clarifications, modifications, etc. Use directions on the template to make sure that you have specified the entity name (Drexel University, Drexel University College of Medicine, etc.) on the top and throughout the consent form.
How do I write a Child or Adolescent Assent?
A template for your Child Assent is available to download (www.research.drexel.edu). A Childs Assent is generally used for children age 7 and above depending upon the level of comprehension of the child. Use appropriate judgment to use the Childs Assent, but be sure to use the assent template for formatting your projects childs assent.
What happens after I submit my IRB Forms?
After administrative review, your submissions are sent to the IRB for review. When your submission is sent to the IRB, you will be notified that your study has been assigned one of the IRBs. Once the IRB has reviewed your submission, you will receive a communication from the IRB, generally within the five working days, the status of approval (conditional or tabled or disapproval) and any questions that the IRB may have to give full approval. Do not start a research project until you receive a full approval and a stamped consent form from the Office of Research Compliance (ORC). Only stamped consent forms must be used for consenting subjects. An approval letter from the ORC is required for research projects before such projects are started. The approval letter contains a blank Research Activation Form. This form must be completed and sent to the ORC as soon as the project is activated or the first subject enrolled into the specific study.
Do I have to come to the IRB meeting?
It is our policy to invite the Principal Investigator (PI) to be present at the IRB meeting to provide responses to substantive or controversial issues involved. The PI may choose not to attend. However, in certain circumstance, IRBs have the right to request for the PI to attend.
Is there an IRB fee for all studies reviewed?
There is a $1,500 fee for IRB review for all industry-sponsored contracts. This is a onetime fee for now. NIH grant applications, investigator-initiated research proposals, research projects submitted by students and some foundation grants are exempt from IRB fees.
What do I have to report to the IRB?
You must report all adverse events using a form posted on our website (www.research.drexel.edu). all changes to the protocol to ongoing research protocols, any apparent protocol violations and any emergency use of an Investigational Drug.
How do I renew my study approval?
The ORC sends out two letters of notification (60 days and 30 days before the expiration date) when a study approval period is nearing its end. The second 30 days letter will also include an e-mail communication. This letter will include a Periodic Report for Continuing Review or Final Summary Form (this is an official form from the ORC) and an Abstract Summary form to report ongoing activities of the specified project. To download these forms go to our website (www.research.drexel.edu). These forms must be submitted at least 21 days before the expiration date. If the IRB has not approved continuing review past the expiration date, new subjects should not be enrolled until the IRB approves the project for another year. Periodic reports that have expired during the review process are considered active and the review is continuing. Studies that have expired due to submissions past the expiration date are subject to full review with a new application to the IRB.
What if my study has expired?
The continuation of research after the expiration date is a violation of the regulations [21 CFR 56.103(a)]. Therefore, all research activities pertinent to the study should stop and no new enrollment should occur. You may submit a new application for the continuation of the project, which will go through full IRB review. The ORC will be pleased to provide necessary assistance to secure approval for this project with minimum delays. The ORC sends three notices before a protocol expires. If you were actively pursuing renewal with the IRB at the time of expiration, and the IRB believed that there was an overriding safety or ethical concern, the IRB would have permitted continuation of the study for a brief time to complete the review process. All IRB protocols are approved for one year or less depending upon the level of risk. Continuing reviews are required at a frequency determined by the IRB at the time of approval to ensure the rights and welfare of research subjects.
How can I close my study when I am done?
You do not have to wait for the end of your study approval period to close out your study if you have completed the research. You do need to provide the ORC with a letter informing that the study has been closed. The ORC will then send you a Periodic Report for Continuing Review or Final Summary Form. Complete and submit this form and the Abstract Summary Form for IRB review. You MAY NOT CLOSE a study if ANY human subjects are still active, even for only one more visit or for any type of follow-up or information gathering or statistical analysis. If a study was closed because of sponsors decision, please inform the ORC right away. If a study is going to be closed because of, for example, an investigator leaving the institution, you are then required to inform the sponsor, the IRB and the Contracts Office.
What happens if there are problems with my study?
The ORC and the IRB must be notified of any problems with your study. The most common problems are protocol violations, communications from the sponsor or the funding agency, forgetting to renew your study and adverse events. For other types of problems with your study, please contact the ORC.
Where can I get a copy of the IRB rosters?
They are posted on the website (www.research.drexel.edu) and they can be printed.
What procedure should I use to consent subjects?
Procedures to consent subject is clearly described in the guidelines book. Follow the exact procedure. Make sure that the subject had the opportunity to read and understand the consent form. Explain clearly the research procedures and responsibility to cost and procedures on how you will maintain confidentiality. Once you consented a subject, please provide an original copy of the signed consent form to the subject and retain another signed (not a xexrox copy) copy in your file.
How long should I keep research records?
Research records are confidential records and they are university property. Records must be stored safely in your university office or your department, but not at your house or apartment. All research records must be kept for three years. If records involve children, it must be kept until seven (7) years after the child reaches the age of 18 years. Example: if a child participated in your study when he/she was three (3) years old, his/her records must be kept for 22 years. Researchers engaged in clinical trials are required to keep all records as specified by the sponsor. Generally, records clinical trials records are kept until two years after the drug has reached the market.
What should I do with the audio and video tapes?
When committee reviews your research project it will provide you information on when those tapes have to be destroyed. In the event that you like to use the video tapes for demonstration, apart from the consent, you must also obtain a separate authorization from the subject for the use of the tape. To store tapes, you must follow the same directions as storing research records.
This FAQ has not completely helpful. Can I get additional help from the Office of Research?
The Office of research will provide assistance when help is needed. You can contact the office at 215 762 3453.