Human Subjects - FAQs
- Where are the forms?
- What Should a Submission Include?
- Should I save a form, consent form template, or protocol template to my desktop?
- Is there a different e-formapplication for medical and social and behavioral research?
- Are there different forms for exempt studies, expedited studies, and full board studies?
- Do I have to use the informed consent template?
- Do I have to submit the consent form on department letterhead?
- There are two consent form templates. How do I know which consent template to use?
- What is "minimal risk"?
- What are some examples of minimal risk?
- Why isn't there an assent template?
- I want to enroll someone who does not speak English. What are the consent form requirements?
- Do I have to have a witness during the consent process and therefore a witness signature line in the consent form?
- How do I write a protocol?
- What is an Investigator Protocol?
- My study has both medical and social and behavioral aspects. How do I know whether the study is considered medical or social and behavioral?
- What happened to the electronic Adverse Events reporting system and what information do I need to report to the IRB?
- How does Temple define "practice runs", "dry runs", or "walk-throughs"?
- What types of activities are allowed as practice runs?
- What types of activities are prohibited under the official definition of a practice run?
- What if I am still unsure if my activity can meet the definition of a practice run?
Consent Form Questions
Adverse Events Questions
- How do I submit the forms?
- When will my item be reviewed?
- I'm teaching a class which involves a classroom project/activity. Do I have to submit an application to the IRB?
- How do I know if the classroom project activity is research?
- What are some examples?
- Where is the waiver of HIPAA authorization form?
- What if the protocol is designed and written by the sponsor (a for-profit entity/company) and the protocol is a Phase III or IV clinical trial?
- Should I use the checklists and worksheets?
- What if I'm not sure whether my activity is human subjects research?
- What if I want more information on the IRB?
- How do I know whether to submit a study to the Temple IRB or WIRB?
- Where can I find the WIRB forms?
- Do I submit a WIRB study to WIRB?
- If it's a WIRB study, do I need to submit everything on page 3 of Temple's Application for Human Research e-form?
- Can I modify the Temple University consent form template?
Questions Regarding Submitting the Forms
Questions Regarding the Review Process
Classroom Activities or Projects
Where are the forms?
New applications for new human research protocols must be filled out as e-forms with an eRA submission. The IRB no longer accepts the Word versions of the Application for Human Research or the Classroom Projects/Activities forms. Templates for all other documentation that should be included with an application can be found on the Forms and Templates page of our website.
What Should A Submission Include?E-forms are the electronic versions of the mandatory IRB forms that you would have previously downloaded from the IRB’s website and printed out to submit on paper. There are certain e-forms that are mandatory for each type of submission. They are as follows:
- Initial Submission (new application) – either the Application for Classroom Project OR the Application for Human Research e-form.
- Continuing Review – Continuing Review e-form.
- Modification – Modification of Approved Human Research e-form.
- Reportable New Information – Reportable New Information e-form.
- Close Protocol – Final Report e-form.
The mandatory e-forms will appear in bold type when you choose Add Institution Forms/Supporting Documents. All other supplemental documents (protocols, consent forms, HIPAA forms, etc.) are available as downloadable templates that can be modified and then uploaded as supplemental documents to the e-forms. Section III of the Application e-form lists the supplemental documents that may or may not be included with your initial application.
Please see the eRA Training Resources and User Guides section of our website for more information on making IRB submissions in eRA.
Should I save a form, consent form template, or protocol template to my desktop?
No. The reason is templates are often revised. Using only the current version found on the IRB website will minimize delays in the review process.
Is there a different application e-form for medical and social and behavioral research?
No. We have one Application e-form that covers medical and social and behavioral research and one Classroom Projects/Activities Application that covers medical and social and behavioral classes. These application e-forms must be filled out within eRA. All other supplemental documents to the application e-form (i.e. consent forms, protocols, etc.) can be found on the Forms and Templates page. These templates can be downloaded from the IRB’s website and included as supplemental documents with your eRA submission.
Are there different forms for exempt studies, expedited studies, and full board studies?
No. You only need an initial application via eRA, and include all supplemental documents required in addition to your e-form application. The IRB will decide whether the study can be classified as exempt, expedited, or full board. As a reminder only the IRB can make the termination of exempt status. Consequently, even if you believe that your study falls under the exempt review status, you still must submit an initial application for review.
Consent Form Questions
Do I have to use the informed consent template?
We encourage you to use the informed consent form template. Since it's a template, you can modify it according to your study's needs. For example, many sections may be irrelevant or inapplicable; delete those sections from the template. Note that substantial variations regarding subject injury or confidentiality may result in a delay of the review process.
If your subject injury language needs to be revised from the template language and the study is an industry-funded/outside sponsor study, please contact the Office of Clinical Research Administration at (215) 707-9639 for the appropriate language.
Do I have to submit the consent form on department letterhead?
There are two consent form templates. How do I know which consent form template to use?
Use the minimal risk social and behavioral consent form template if the study is a social and behavioral study and the study has minimal risk. If the study is a medical study or a social and behavioral study that has more than minimal risk, use the other consent form template.
What is "minimal risk"?
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in the daily life of normal persons or during the performance of routine physical or psychological examinations or tests in normal persons.
What are some examples of minimal risk?
Examples of procedures that are minimal risk can be found in the CHECKLIST: Eligibility for review using the expedited procedure.
Why isn't there an assent template?
The assent form should be an explanation of the proposed research procedures in a language that is appropriate to the child's age, experience, maturity, and condition. The explanation should include a discussion of any discomforts and inconveniences, in non-technical terms, the child may experience if she or he agrees to participate. Due to these variables, the investigator is in a better position to draft the assent form.
I want to enroll someone who does not speak English. What are the consent form requirements?
See our SOP Informed Consent Process for Research.
Do I have to have a witness during the consent process and therefore a witness signature line in the consent form?
The IRB does not routinely require a witness to be present when consent is obtained and therefore does not routinely require a witness signature in the consent form. However, the IRB requires a witness signature in the following circumstances:
- The subject is illiterate
- The subject is non-English speaking
- It is also possible that the IRB may require a witness signature for select studies.
For those situations where the IRB requires a witness, the witness signature section should be marked as "Required" on the consent form to ensure that a witness signature is obtained.
If the IRB does not require a witness signature, the absence of a witness signature does not violate IRB policy.
The investigator has the option to include a witness signature line on the consent form. The investigator might elect this option in the following situations:
- The study's risk profile is particularly large
- The investigator feels more comfortable obtaining a witness signature in this subject population or with a specific subject
When a witness signature is obtained, investigators should include, in the medical record, the reason why a witness signature was obtained.
For detailed information on witness signatures, refer to the Standard Operating Policy Informed Consent Process for Research.
How do I write a protocol?
Please refer to the Protocol Templates section of the Forms Page. Since it's a template, you can modify it according to your study's needs. For example, many sections may be irrelevant or inapplicable; delete those sections from the template.
What is an Investigator Protocol?
If the study is not sponsored, the Investigator Protocol is simply the protocol that you will follow at Temple.
However, if the study is sponsored, the Investigator Protocol describes how the study will be operationalized or done at Temple University. These operational issues include: information regarding the study facilities; patient population; the expected number of local subjects; recruitment methods; who will recruit the subjects; and how much time will be devoted to recruitment. The Investigator Protocol is therefore distinct from the sponsor protocol.
My study has both medical and social and behavioral aspects. How do I know whether the study is considered medical or social and behavioral?
If the principal investigator's department is on the Health Sciences Campus, use the Investigator Protocol Template for Medical Studies. If the principal investigator's department is on the main campus, use the Investigator Protocol Template for Social and Behavioral Studies.
Adverse Events Questions
What happened to the electronic Adverse Events reporting system and what information do I need to report to the IRB?
Federal guidance clarified that only a small subset of adverse events occurring in human research subjects are unanticipated problems that must be reported under 45 CFR part 46. The guidance helps ensure that the review and reporting of unanticipated problems occur in a timely, meaningful way so that the human subjects can be better protected from avoidable harms, while reducing unnecessary burden on IRB members. The vast majority of adverse events occurring in human subjects are not unanticipated problems, or alternatively put, are anticipated problems; a small proportion of adverse events are unanticipated problems; and unanticipated problems can include other incidents, experiences, and outcomes that are not adverse events. Investigators are obligated to report the following information items to the IRB within 5 business days of learning of the information.
Any information that meets all of the following three criteria:
- Unanticipated or unexpected, in terms of nature, severity, or frequency, given the research procedures that are described in the protocol-related documents (e.g., the IRB-approved research protocol and informed consent document) and the characteristics of the subject population.
- Related or possibly related to participation in the research (there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research).
- And suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
Information that indicates a new or increased risk, or a safety issue. For example:
- New information (e.g., an interim analysis, safety monitoring report, publication in the literature, sponsor report, or investigator finding) that indicates an increase in the frequency or magnitude of a previously known risk, or uncovers a new risk.
- Withdrawal, restriction, or modification of a marketed approval of a drug, device, or biologic used in a research protocol.
- Protocol violation that harmed subjects or others or that indicates subjects or others might be at increased risk of harm.
- Complaint of a subject that indicates subjects or others might be at increased risk of harm or at risk of a new harm.
- Any changes significantly affecting the conduct of the research.
- Non-compliance with the federal regulations governing human research or with the requirements or determinations of the IRB, or an allegation of such non-compliance.
- Audit, inspection, or inquiry by a federal agency.
- Written reports of study monitors to the investigator; data safety monitoring board reports; changes to the investigator brochure, package insert, or device labeling; or written reports of sponsors to investigators (excluding Medwatch reports sent to the FDA).
- Failure to follow the protocol due to the action or inaction of the investigator or research staff.
- Breach of confidentiality.
- Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a subject.
- Incarceration of a subject in a study not approved by the IRB to involve prisoners.
- Complaint of a subject that cannot be resolved by the research team.
- Premature suspension or termination of the research by the sponsor, investigator, this institution, or another institution.
- Unanticipated adverse device effect (any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.)
How does Temple define "practice runs", "dry runs", or "walk-throughs"?
The Temple University IRB formally defines "practice runs" (also known as dry runs or walk-throughs) in its Standard Operating Procedure (SOP) 01: Definitions, Section 3.18: "Investigators or study staff practice a study or conduct a 'dry run' to ensure its feasibility. Certain activities the investigator intends to evaluate during a practice run or walk through may be prohibited by this policy."
What types of activities are allowed as practice runs?
Research interactions can be practiced among research personnel to test feasibility prior to implementation with actual study subjects. For example, study personnel can practice interactions, such as reading through the informed consent script, with another member of the research team acting as the subject. Other examples of activities allowed as practice runs include:
- Peer review of surveys
- Research personnel practicing completing a survey prior to using the survey for data collection
- Practicing the use of consent forms among research personnel
What types of activities are prohibited under the official definition of a practice run?
Blood draws, MRIs, the use of radiation, or the use of an FDA-regulated drug or and FDA-regulated device are all activities that are prohibited under the official definition of a practice run.
What if I am still unsure if my activity can meet the definition of a practice run?
If you are still unsure about your activity after reviewing the Temple IRB's definition of a practice run, you are required to submit a ~1 page synopsis of your activity to the IRB. The IRB will review your activity, and advise you as to whether you can proceed as a practice run.
Questions Regarding Submitting the Forms
How do I submit the forms?
All submissions must be made in eRA. Please see the eRA Training Resources and User Guides section of our website for complete instructions on making IRB submissions through eRA.
Questions Regarding the Review Process
When will my item be reviewed?
We place items requiring full board review on the next available Board. Note that "next available Board" means the next Board's agenda that is not already full. Exempt and expedited items are assigned to the Chairperson or a designated reviewer.
Classroom Activities or Projects
I'm teaching a class which involves a classroom project/activity. Do I have to submit an application to IRB?
You must submit an application using the "Classroom Project/Activity" e-form if the classroom project/activity is human subjects research. Please refer to the human research determination worksheet.
The analysis is based upon the behavior and actions of the classroom activity. Publication, presentation, and dissemination of the results are irrelevant to the analysis. For example, if students in a class are creating survey questions and testing the questions, this activity is research methods, rather than research, and IRB review is not required. On the other hand, if students in a class develop a hypothesis, write a plan, implement the plan, and analyze the results of the plan, the activity is research and IRB review is required, even if the professor's intent was to teach research methods.
How do I know if the classroom project activity is research?
Classroom activities or projects can be human subjects research. If the professor did the same project outside the class, would IRB review be required? If yes, the classroom activity is human subjects research; if not, the classroom activity may not be human subjects research.
The analysis is based upon the behavior and actions of the classroom activity, not the publication, presentation, or dissemination of the results.
What are some examples?
Examples of classroom projects/activities that are not human subjects research:
If a professor teaches research methods by "blackboard instruction" i.e., discussing different research methods and designs with the students.
If students in a class create survey questions and test the questions on themselves.
If students in a class create a questionnaire and use the questions to promote classroom discussion.
Example of a classroom project/activity that is human subjects research:
If students in a class develop a hypothesis, write a plan, implement the plan, and analyze the results of the plan, even if the professor's intent was solely to teach research methods.
Where is the waiver of HIPAA authorization form?
The criteria for requesting a waiver of HIPAA authorization should be reflected in your protocol. Please refer to the protocol template for instructions on requesting a waiver of HIPAA authorization.
What if the protocol is designed and written by the sponsor (a for-profit entity/company) and the protocol is a Phase III or IV clinical trial?
Submit the new study application to the Temple IRB with the Temple-specific attachments (e.g., consent form and HIPAA authorization form) and contact WIRB for the WIRB forms.
Should I use the checklists and worksheets?
If a form refers you to a checklist or worksheet, please use it. However, you do not need to submit checklists or worksheets.
What if I'm not sure whether my activity is human subjects research?
Email a synopsis of the activity to email@example.com and the IRB will respond with a written determination.
What if I want more information on the IRB?
"The Human Research Protection Program Plan" provides more information and the "Investigator Manual" provides even more detailed information. They can be accessed on our website. If you still have a question, please contact us at (215) 707-3390 or firstname.lastname@example.org.
How do I know whether to submit a study to the Temple IRB or WIRB?
If the protocol is a phase III or IV clinical research study sponsored by a pharmaceutical company, use the WIRB forms. However, all WIRB studies are submitted to the Temple IRB. See the WIRB Information Sheet for more details.
All device studies are reviewed by the Temple IRB.
Where can I find the WIRB forms?
The link to the WIRB forms can be found in the WIRB Information Sheet.
Do I submit a WIRB study to WIRB?
No. Submit the WIRB study to the Temple IRB. See the WIRB Information Sheet for more details.
If it's a WIRB study, do I need to submit everything listed in Section 3 of Temple's Application for Human Research e-form?
No. See the WIRB Information Sheet for the Temple forms that should be submitted with WIRB studies.
Can I modify the Temple University consent form template?
Yes, but note that deviations to the "confidentiality" or "subject injury" sections of the consent form template require approval from Temple legal counsel before WIRB approval. This approval from Temple legal counsel may delay the study approval. Consequently, we strongly recommend that you use the "confidentiality" and "subject injury" sections of the consent form template. See the WIRB Information Sheet for more details.
If you have suggestions for other questions for the FAQ page, please email email@example.com