Frequently Asked Questions
The IRB maintains a variety of guidance and tools related to reportable events on our Forms page, under "Other Researcher Tools." For all events, investigators should be familiar with the following terms:
Serious Adverse Events (SAEs): Any death, life threatening adverse experience, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or congenital anomaly/birth defect.
Unanticipated Problem (UP): Any unexpected problem related to the Research that negatively affects the rights, safety or welfare of subjects and is not described as such in the materials describing risks associated with the study. This includes anticipated adverse events occurring with greater frequency or severity than had been expected. Unexpected problems that may significantly impact the integrity of the research data may also be considered UPs.
Non-Compliance (NC): Failure to comply with any of federal or local regulations and policies governing human subjects research, or a failure to follow the determinations of the IRB. Non-compliance may be considered serious and/or continuing, depending on the circumstances.
For general information about which sort of occurrences are reportable, and when, please consult the IRB's Reportable Event and Procotol Deviation assessment forms. Please note that substantive deviations from the protocol and all unanticipated problems should be reported to the IRB within 10 calendar days after the investigators becomes aware of the occurrence. A more detailed look at what may constitute unanticipated problems or noncompliance can be found in the NC/UP Guidance.
You may also use our Reportable Events Guidance Chart to aid in deciding what is reportable, and when. If you are still unsure, please contact our office at (404) 712-0720, or contact your protocol analyst directly.
What about External Events?
In general, the Emory IRB only needs to be informed of external adverse events that may unanticipated problems, with the same prompt reporting guideline applying to both external and internal UPs. Investigators unsure on whether an external event should be reported as an UP may consult the IRB's assessment forms linked above.
NOTE: Emory Sponsor-Investigators are still required to report external events, even if they do not constitute unanticipated problems.
How to report?
Reportable events should be submitted to the IRB through the eIRB system. Instructions on how to do this can be found here.
How do I submit an eIRB Amendment?
Please see Submit an Amendment guidance.
How do I make changes to a study that is already approved?
Please submit a modification/amendment request through eIRB. For a study previously deemed exempt whose study plan has since significantly changed, you may wish to consult with your IRB analyst for clarification as to whether the changes affect the exempt status.
What should be included in an Amendment?
Please describe the requested changes and all other documents or parts of the protocol that the change will affect. For example, if you request a change in enrollment from 10 to 20, you would include a change to your protocol in the amendment as well. If you listed on your consent forms that there were to be 10 subjects then you must include in your amendment that you are also requesting a change in your consent forms. All the documents that are affected must be changed and highlighted and non-highlighted versions must be uploaded in your amendment submission for review.
Why do FYI letters or upcoming change memos from the Sponsor need to be submitted with an amendment form?
An amendment form needs to be submitted so the IRB can consistently assess how these updates/changes impact the local research.
What is CITI?
The Collaborative IRB Training Initiative Program (CITI) is a leading online training program maintained by the University of Miami. It offers curricula in human subjects research, animal research, and the responsible conduct of research. If you are a first-time CITI user, you may wish to contact the IRB offices for help getting started.
Who has to take CITI?
The training requirement applies to anyone conducting human subjects research activities at Emory. This means anyone working directly with human subjects or with identifiable data or biological specimens for research purposes under Emory University auspices. Investigators, research nurses, coordinators, students, technicians working with identifiable data, and faculty advisors would all need to obtain CITI certification.
As each institution tailors the CITI program to meet their own needs and expectations, Emory can not accept CITI certifications from other institutions. All study personnel conducting research at Emory should take the appropriate Emory CITI course.
Which CITI course do I have to take?
You must take the course that is the most appropriate for your type of research. For example, clinical trial investigators should take the biomedical course. In addition, Veterans Administration-affiliated employees must take the VA course. Sociobehavioral researchers should take the sociobehavioral course. Researchers in the interdisciplinary field of public health may take either course and are encouraged to choose the one more closely aligned with their project’s activities. School of Medicine researchers and staff must take the biomedical course.
Additional courses are available, but are not required. The IRB recommends the Good Clinical Practice course, for instance, for all study personnel of Investigator rank who take part in clinical trials.
How long is my certification effective?
For IRB purposes, certification is good for three years for Emory and VA personnel. CITI offers refresher courses for recertification.
What if I have a CITI account through another institution, and want to certify for Emory (or vice-versa)?
To transfer your completed modules from another institution to the new institution, follow the instructions below:
- Log on to your CITI account and click on the "Affiliate with another institution" link.
- Choose the new institution from the drop-down menu. When prompted, answer "Yes" to "Do you need to take a required training course in human subjects protection at [new institution's name]?"
- Select the same Learner Group (Biomedical Research or Social and Behavioral Research) for the coursework that you completed at the previous institution. Complete any modules the new institution requires, that your former institution did not.
The modules will automatically be listed as "complete" or "incomplete." To view your course completion history, follow the link to the CITI Course Completion Report.
What if I have inadvertently created two (or more) accounts in CITI? Which one should I use?
This can be an issue because when we check your CITI, we might check an out-of-date account and not notice that you are certified under a different account. It's best to have just one account of record.
In order to merge multiple accounts into just one CITI Program account, please send an e-mail to firstname.lastname@example.org and include the following information:
- Your first and last name.
- The name of your institution.
- The Member ID for the account to KEEP (in other words, the account with the most up-to-date information).
- The Member ID for the account to merge. It is IMPORTANT to make sure you have correctly identified which account you want to keep and which you want to merge.
For further assistance please contact the CITI Program help desk at (305) 243-7970 or e-mail them at email@example.com.
Does my study close if its approval expires?
No, but all human subjects research must STOP when the approval expires (unless you've let the IRB know that subjects in certain categories need to continue certain research activities in order to avoid harm; call or email your analyst or a Team Lead or Director for assistance with this).
When can a study be closed at Emory?
- Once all human subjects research is complete, at least at our local site. This includes analysis of individually-identifiable private information.
- When your data still retains identifiers, if required by Emory, Sponsor, VA, or other record retention policies, as long as you know you will not use the data any more for research purposes (i.e. it will be boxed up, or stored electronically in encrypted fashion, but no files opened up).
- For multisite studies where Emory is not the lead or coordinating site, FDA/OHRP guidance states that our local site can be closed out even if research activities are still ongoing with the Sponsor, and at other sites. Please check with the Sponsor, though, to be sure they agree our site can be closed out (they may want to leave the option of coming back to "clean" or collect more data from our site).
- When you are only preparing manuscripts, using aggregated data only
- Note - If an Emory investigator holds an IND or IDE:
- IDE: the study can be closed only after the final report is submitted to the FDA, and the IDE is closed
- IND: If the IND is not used in other protocols, the study can be closed only after the IND is closed and final report submitted to the FDA
- VA Studies: If your study took place at the VA, or used VA resources, then you need to submit the VA close out form with the eIRB submisison.
When should a study not be closed?
- Repositories or databases that will still be used by other research studies should not be closed out.
- If you wish to be able to continue to use data/specimens from your concluded study for other future research studies, best practice would be to set up a repository under a new IRB submission for that purpose. The IRB would assess whether the current study's consent form allows for storage and future use of the data/specimens.
- If you may need to go back and access individual-level data.
What if I need to reopen my study?
- If you close out your study then realize you would like to do more work on it, the IRB may permit this, but would require a continuing review application and potentially an amendment if any study aims or procedures are changing. Please inquire with your analyst from the closed study, or if they are unavailable, the IRB Team Lead.
Do I need to obtain informed consent?
If you are conducting "research" with "human subjects" (according to the definition in the DHHS regulations and Emory policy)-- even if it is exempt--you generally should get informed consent. Informed consent is a dialogue between the researcher and participant about the nature of the research, its risks and benefits, and the participant's rights. It is an ongoing process that may occur at several points during the research, and not just at the beginning. Informed consent is a basic right of research participants. The IRB may waive the requirement for informed consent in special circumstances involving minimal risk and planned emergency research. Please go to our Policies & Procedures chapters on waivers or alterations of consent.
Do I need a consent form?
The consent form is a record of the information communicated during an informed consent dialogue. A signature or thumbprint/sign further document a participant's informed consent. The consent form provides a record for the researcher and the participant. In some cases, the requirement for documentation of informed consent may be waived. Please refer to Policy & Procedures chapter on Informed Consent for more information on when documentation can be waived. In all cases, participants should still receive a written statement from the researcher that includes all the components of informed consent.
How do I do an assent form with children?
Individuals under the age of 18 cannot legally consent to participate in research. Therefore, a parent or legal guardian must give permission and the child should agree (assent) affirmatively. The child should be involved in the consent process to the extent that is appropriate for their age and maturity. At a minimum, children should be told that research is voluntary, and their verbal assent to participate should be obtained. Emory IRB policy contains guidelines for when assent should be obtained, when it should be verbal, and when it should involve a written document; see the first page of our Assent template. For more information, see the OHRP FAQ's on research with children: http://www.hhs.gov/ohrp/policy/faq/.
When should a participant be routinely re-consented to determine continued willingness to participate?
At times it may be appropriate for researchers to formally check with subjects to ensure that they want to continue participation. This is called re-consenting. The IRB may require that the investigator re-consent subjects after taking into account the study's anticipated length and the condition of the individuals to be included (e.g., participants with progressive neurological disorders, participants who may become incarcerated, an altered risk/benefit ratio, etc.). In addition, the IRB will consider whether and when to require a reassessment of decision-making capacity.
What is required for the consent process?
The most important thing to remember that in general, presenting the consent form itself is not sufficient for informing subjects about a study. The consent discussion is the most important part of the process.
Consent is the process of informing the participant about a study and allowing him or her to think about it and come to a voluntary decision. Consents can be in oral (spoken, without signature) or documented in a signed format. Specific elements need to be included unless a waiver to leave out parts is requested. A waiver of written consent can be requested which relieves the researcher from documenting/getting a signed consent form but does not relieve him/her from conducting the consent process. The required elements include the following (underlined items are required in all consents unless a waiver is requested):
- Identification Information - Study Title, PI(s) Name, Sponsor(s) Name if any
- Purpose of the study - statement that this is research you're asking them to participate in, why you're doing it, who will be involved, # of Participants
- Procedures - What will you do, What will participants be asked to do
- Risk - describe are any risks, discomforts or inconveniences
- Benefits - describe what if any positive impact a participant, or society or a class of persons may receive as a result of the study
- Alternatives (if applicable/ if any exist)
- Compensation (if applicable)
- Costs (if applicable)
- Contacts - contact person for study questions and contact person(s) for rights as a research participant/IRB
- New Findings (if applicable)
- Voluntary Participation and Withdrawal - must include statement that this is voluntary and that participants can withdraw at anytime, and what the withdrawal procedure entails.
For more information see the Consent Toolkit.
What else is required for Informed Consent materials?
- Stamping Template in the Header
- Page X of X and a Version Date in the footer
- Scripts and/or Information Sheets for oral consent
For more information see IRB website and samples
What is a waiver of consent?
The IRB may permit the researchers not to obtain informed consent from research participants under certain circumstances outlined in the federal regulations. If you are conducting a chart review of 2000 records, you might request a waiver of consent because it would be impracticable to conduct the study if you had to try and contact the 2000 patients to ask if they would like to participate, and because risk is minimal and the research unlikely to adversely affect the subjects' rights or welfare. The IRB makes the final determination as to whether those criteria are met, for non-exempt research.
When would the IRB waive consent based on "impracticability"?
We start by remembering the Belmont Principle of respect for persons. While a chart review, for example, seems routine and harmless to most researchers, many patients may not realize that their records are accessed without their knowledge, and those patients may have a spectrum of opinions about that. Waiving the requirement to tell people what is being done with their private information is a responsibility that the IRB does not take lightly. So please bear with us if we question your plans in ways that you may not have expected.
All waivers are on a case-by-case basis. However, some guidelines:
- The IRB cannot consider cost alone when looking at whether obtaining consent is practicable. Research studies need to be adequately resourced in order to be conducted ethically and in compliance with applicable regulations. The IRB can help you look at all ethical and compliant options for doing research within your budget.
- Studies that require gathering data on 100% of a population may qualify for a waiver, if the risk/benefit ratio is acceptable, and the justification is robust. Examples: epidemiological studies/surveillance of infectious disease; development of quality improvement initiatives that require baseline data from institutions as to their current practices
- Purely retrospective chart reviews usually qualify for a waiver - in these, you will be looking solely at data that already exists prior to initial IRB approval. If you wish to continue looking at new data generated after that point, a waiver is not as clear-cut. You will be asked to provide the IRB with a robust justification for why you cannot obtain consent from patients going into the future, beyond basic inconvenience.
- The argument that 100% participation is needed to maximize the validity of your data is not justification for a waiver, even for minimal risk studies. All research analyses would benefit from 100% participation; therefore if this argument were valid, one should waive consent in all studies, instead of using sampling and statistical methods.
What are Data Transfer Agreements?
Data Transfer Agreements (DTAs) are used to transfer human subject data from one institution to another for research purposes. A DTA is a contract between the providing and recipient institutions that governs the legal obligations and restrictions, as well as compliance with applicable laws and regulations, related to the transfer of such data between the parties.
Outgoing DTA - School of Medicine
For the provision of human subject data by Emory investigators to a researcher at another not-for-profit institution for research purposes, Emory has developed outgoing DTA templates to govern such transfers, depending on the level of identity of the data (de-identified, limited data-set, or full PHI).The Emory unit (SOM or EHC) from which the data is sourced must approve the transfer. To initiate routing and initiation of the appropriate DTA, Emory investigators should complete an Outgoing DTA Questionnaire (provided at http://www.med.emory.edu/research/resources/index.html or http://www.ott.emory.edu/forms/index.html) and email the questionnaire to firstname.lastname@example.org.
Outgoing DTA - Other Schools
Please consult your Department Administrator for information.
OTT manages all DTAs covering receipt by an Emory investigator of human subject data to be used for research purposes not involving a clinical trial or human subject interaction/intervention by the Emory investigator. All OTT-managed incoming DTAs should be forwarded to OTT for approval, along with a completed Incoming DTA Questionnaire (see “Incoming DTA Questionnaire” on the OTT website at http://www.ott.emory.edu/forms/index.html). Faculty members should forward these documents via email to email@example.com.
OSP may manage DTA terms that are part of an Emory clinical trial agreement, sponsored research agreement, or contract specifically governing human subject interaction/intervention by the Emory investigator. Please consult with your OSP analyst before reaching out to SOM or OTT. Such requests should be sent to OSP for review at firstname.lastname@example.org.
The requirement to complete an appropriate DTA for a transfer of human subject data is in addition to, and not a substitute for, obtaining appropriate applicable informed consent, HIPAA authorization, or IRB approval for any research activity.
Only those individuals authorized to sign on behalf of Emory University may sign agreements that legally bind the University. Anyone else who does so, whether inadvertently or not, is subjecting themselves to substantial personal legal liability. Since most, if not all, DTAs contain terms obligating Emory University, as a matter of policy, all DTAs must be forwarded to the appropriate department for review and approval.
Departmental Approval is required for all new study submissions. This review helps to inform the IRB about the adequacy of the facilities, the qualifications of the investigators, and the scientific merit of the study.
Currently only Departments that start with an ASTERISK (*) are associated with approvers. The Department is selected in the "Required Reviews" page of the eIRB Smartform.
- If you are a faculty member conducting research:
- Item 1 in this section should auto-populate with the PeopleSoft department with which the PI is affiliated. If the department that has auto-populated the smartform is incorrect or does not start with an ASTERISK (*), please see the Departmental Approvers list to determine the most accurate department to provide the required review.
- Please select only ONE department in the “Required Reviews” section unless your department has instructed you otherwise. If you select more than one department, your study will be delayed. If two departments have auto-populated in the smartform, remove the unnecessary department (usually the higher-level department), ensuring the one remaining starts with an ASTERISK (*) (revising if necessary).
- Conflicted Departmental Approvers: If you see on the Departmental Approvers list that all of your departmental approvers are also members of your study team, then you must remove that department and select the department one level up (indicated on the top line of the Departmental Approvers list for your area).
- If you are a student conducting research:
- You will not be required to complete Item 1 in this section. Instead, you should indicate who your faculty advisor is in Item 2.
- If you are not able to find your faculty advisor’s name in the drop-down menu for Item 2, s/he probably does not have the role of faculty advisor assigned to her/his account.
- Follow this link: http://www.irb.emory.edu/eirb/eirb_access_request.html to request that the role of faculty advisor be added to your faculty advisor’s eIRB account.
For Active Studies:
Researchers are expected to retain all original, signed informed consent forms filed in a secure location. The original, signed consent forms should not be destroyed, even if they are scanned into an electronic system. Other documents should be retained in either electronic or physical form: these include formal correspondence letters from the IRB, approved versions of the protocol, and IRB approved versions of the informed consent form. If retaining these documents in electronic form, they should be saved to a secure folder outside of the eIRB system.
After Study Completion:
Retention of documents after study completion is directed by the University Records and Information Management Policy of Emory Libraries. Included in this policy is the requirement to retain original, signed informed consent forms for a minimum of 10 years after closure of the study. This time period is longer for particular studies, such as those involving minors. Please refer to the Record Retention Schedule for Research to determine how long you must retain these documents.
The IRB will retain its own records for at least three years after the completion of the research (five years for VA research), as per the IRB Policies and Procedures chapter on Documentation and Record Retention. Contractual provisions, study particularities, or other factors may result in longer retention periods.
What are the IRB Committees?
The Emory University IRB consists of three committees. Committee C, for sociobevioral research, meets once a month. Committees A and B, for biomedical research, each meet three times a month. Technically, "IRB Committee" is redundant, since the "B" stands for Board, which is synonymous with "Committee."
When do the Committees Meet?
Please view Meeting Schedules to see when the IRBs meet.
What is the deadline for submitting a study to be reviewed at a committee meeting?
There is no guarantee that a study will be seen at a given meeting date. Most biomedical studies have a waiting list for Full Board review and will depend on the total number of studies awaiting committee review by the full board. Currently there isn't a waiting list for Social Behavioral Studies. Most Social Behavioral studies that are submitted two weeks prior to the next meeting date usually make it on the agenda for that month.
What is a Designated Reviewer?
A Designated Reviewer is an IRB member who is authorized to review a study under the expedited review process. These studies don't have to wait for the full committee to meet.
My study sponsor wants a copy of the IRB membership list. Why does the IRB want us to provide them with a standard letter instead?
The sponsor needs to make sure an investigator is using an IRB that complies with the requirements from 21 CFR 56 [see 21 CFR 312.23(a)(1)(iv)]. The sponsor views a membership list as one marker of compliance. The FDA information sheets (see "Sponsor-Investigator-IRB relationship" in the 1998 update) state:
FDA regulations [21 CFR 312.23(a)(1)(iv)] require that a sponsor assure the FDA that a study will be conducted in compliance with the informed consent and IRB regulations [21 CFR parts 50 and 56]. This requirement has been misinterpreted to mean that it is a sponsor's obligation to determine IRB compliance with the regulations. This is not the case. Sponsors should rely on the clinical investigator, who assures the sponsor on form FDA-1572 for drugs and biologics or the investigator agreement for devices that the study will be reviewed by an IRB. Because clinical investigators work directly with IRBs, it is appropriate that they assure the sponsor that the IRB is functioning in compliance with the regulations.
Some sponsors operate outside of the United States and have asked for a written statement that the IRB is in compliance with the ICH guidelines. They commonly refer to 5.11 ("Confirmation of Review by IRB/IEC"). These are guidelines only and are not regulations.
The Emory IRB membership often changes (especially during the course of the study which can be several years). Therefore, in response to these requests, the IRB provides a standard letter (Compliance Letter) to address the sponsor's concerns related to IRB compliance.
As a courtesy, we also post a list of our members the Staff and Members page of this website, which we update frequently, though not always immediately when members change.
All studies using investigational drugs, biologics, or devices are FDA-regulated; additional requirements apply for studies for which the FDA has granted an investigational new drug (IND) or investigational device exemption (IDE). FDA-regulations also apply to research using non-significant risk devices, and studies will be considered under an abbreviated IDE.
The FDA regulations apply to FDA-approved drugs and devices a little differently. For drugs, FDA regulations apply when there is any use of an FDA-approved drug in the course of the study, except if the use is of a marketed drug as part of routine medical practice (i.e., if a drug is part of the of the study conduct and protocol, then it is FDA-regulated). Device studies are FDA-regulated if the purpose of the study is to determine the safety or efficacy of a device (i.e., use of the device is part of the research question).
How does the FDA define drug?
- A substance recognized by an official pharmacopoeia or formulary;
- A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease;
- A substance (other than food) intended to affect the structure or any function of the body; or
- A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device.
- Biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process.)
How does the FDA define device?
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them;
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes
Note: as of September 2016, the Office of Quality EHC Nursing Checklist and Exemption/Attestation forms were incorporated into eIRB, replacing the prior paper-form-based Office of Quality process. In eIRB, the new form is called “Clinical Research Key Points.” The form is also uploaded by the Office of Clinical Research into the EHC medical records, as a safety measure.
If I filled out the new Clinical Research Key Points form in the eIRB submission, do I still have to submit signatures on paper forms to the Office of Quality?
- If the study was originally submitted to the IRB with the new Clinical Research Key Points form, then no, you would not also need to fill out the old paper form.
- If your eIRB study was originally submitted prior to the new Clinical Research Key Points form going “live,” you may still have been required to fill it out later, if we sent the study back to you for changes. However, the Office of Quality will not automatically be alerted to it in that case. Submit the old version of the checklists to the Office of Quality, or check with them to see what they prefer.
What are you referring to when asking for version dates on the Clinical Research Key Points Summary form? Should I use today's date? Are you referring to the protocol version?
You can input the date you are filling out the form. This information is useful for cases where there are later updates to the form, to determine which version is the most current.
I was told that with the new system we get our Office of Quality checklist approval after seven days. Why are my informed consent forms not released by the IRB yet?
Any status inquiries about the checklist should be directed to the Office of Quality. While the goal for certain sign-offs is now seven days, the IRB must wait for the Office of Quality to issue its approval in eIRB.