What is human subject QA/QI monitoring?
QA/QI Monitoring is a thorough examination of key elements of an IRB approved protocol. The reviews are conducted to ensure human subjects are safe and used in compliance with the protocol.
What are the goals of the QA/QI process?
The primary goal of the QA/QI program is to ensure a human subject safety, to maintain regulatory and institutional compliance, and support the strive for research excellence. Associated with this, the process will facilitate the science by serving as a resource to the researchers. The QA/QI process is positioned to convey IRB policies, identify opportunities for improvement and make recommendations on how to achieve improvement. Ultimately, the QA/QI process will confirm that the manner in which research is conducted under an approved protocol is consistent with what the IRB approved.
What are the benefits that an Investigator may gain from the QA/QI process?
Reliable and meaningful research results depend on proper and consistent processes that support regulatory compliance and human subject safety. Compliance with these principles is mandatory. Some benefits that may be gained from a QA/QI review but are not limited to are:
- Increased understanding of the regulations that guide our research projects
- Increased communication concerning Federal regulations and University policies
- Access to an individual to clarify the Federal regulations and University policies
How does the QA/QI process protect my research?
The QA/QI process enables correction of protocol issues or procedural inconsistency, internally, so that regulatory agency inspectors are less likely to find problems. It is in the best interest of the DU, the IRB, and researchers to correct any issues in this way.
How are protocols selected for a QA/QI review?
The most common way is that protocols are selected from the pool of all approved protocols randomly based on risk criteria to some degree. Human subject risk criteria includes, but is not limited to complex interventional protocols, high enrolling protocols, researcher teams with high turnover rates, new PIs, or sponsored studies with the potential for FDA audits. If a protocol has been selected for QA/QI review, it does not necessarily mean that something is wrong. Protocols can be selected for cause from a complainant and/or unexpected outcomes reporting.
How long will a QA/QI review take?
If documentation is complete and organized, the QA/QI checklist review will take approximately an two hours or less (Checklist is available on website under study management tools). However, depending on the complexity of the protocol procedures and subject enrollment, subsequent appointments may be required to observe procedures to complete a comprehensive assessment of the level of protocol compliance.
What if the PI is unable to attend the scheduled QA/QI review meeting?
preferred option is to meet at a mutually agreeable time for both the QA/QI reviewer and the PI and research staff. If the PI is not able to attend, he/she may designate a representative for the QA/QI review.
Can I obtain informed consent over the telephone?
An oral approval over the telephone is not satisfactory. However, you can send the informed consent document to the legally authorized representative (LAR) of the subject and conduct the consent interview with the LAR by telephone when the LAR can read the consent as it is discussed over the telephone. If the LAR agrees, the LAR can sign the consent and return the signed consent document to the investigator. The consent document can be faxed before and after LAR signs the document.
Can the subject sign his own consent without a witness?
Yes. However, to be on the safer side, in general, many investigators obtain witness’s signature to make sure that the consent has been properly obtained.
Can we obtain consent with the use of electronic signatures?
Yes, but additional safeguards must be in place to validate the signature is authenticated.
Does the IRB ever waive consent?
Yes. It depends upon several circumstances such as:
· When the principle risks are those associated with a breach of confidentiality concerning the subject’s participation in the research (sensitive topics like drug abuse, sexual deviance)
· The consent document is the only document linking the subject with research
· Record or chart reviews
· If the IRB is satisfied that the information contained in the files is not particularly sensitive
· The research is no more than minimal risk
· The waiver or alteration would not adversely affect rights and welfare of subjects
· The results of study must be likely to bring social benefits of significant nature
· You have devised procedures to protect the confidentiality of information to be collected
· Your study could not be carried out if consent was required
During consent, should I discuss appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject?
To enable a rational choice to participate in the research study, you should discuss with the subject the range of alternate options that are available to them. Consent documents should briefly explain any pertinent alternatives to entering the study. But consent document need not contain an exhaustive list of options.
How do I close out a study?
Complete the “FORM: Continuing Review Progress Report (HRP-212 embedded in the COEUS Lite platform), and attach all requested supplements.
Maintain electronic copies of all information submitted to the IRB in case revisions are required. If you fail to submit a continuing review form to close out Human Research, you will be restricted from submitting new Human Research until the completed application has been received. If the continuing review application for closing out a Human Research study is not received by the date requested in the approval letter, you will be restricted from submitting new Human Research until the completed application is received.
How do I get additional information and answers to questions?
This document and the policies and procedures for the Human Research Protection Program are available on the IRB Web Site at www.research.drexel.edu/compliance. If you have any questions or concerns, about the Human Research Protection Program, contact the Office of Regulatory Research Compliance at:
Office of Regulatory Research Compliance
1505 Race Street
Bellet Building 7th Floor
If you have questions, concerns, complaints, allegations of undue influence, allegations or findings of non-compliance, or input regarding the Human Research Protection Program that cannot be addressed by contact the Office of Regulatory Research Compliance, follow the directions in the “HUMAN RESEARCH PROTECTION PROGRAM PLAN (HRP-101)” under “Reporting and Management of Concerns.”
How do I submit a Reportable New Information?
Complete the HRP 214 Reportable New Information form located on the website. Be sure to include the corrective action plan to prevent future recurrence of the event. Submit via the COEUS platform as an "FYI" and attach the HRP 214 form as well as any other relevant documents.
How do I submit continuing review?
Complete the “FORM: Continuing Review Progress Report (HRP-212) (embedded in the COEUS Lite platform and ,” attach all requested supplements.
If the continuing review application is not received by the date requested in the approval letter, you will be restricted from submitting new Human Research until the completed application has been received. If the approval of Human Research expires all Human Research procedures related to the protocol under review must cease, including recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection or analysis of private identifiable information. Continuing Human Research procedures is a violation of federal regulations. If current subjects will be harmed by stopping Human Research procedures that are available outside the Human Research context, provide these on a clinical basis as needed to protect current subjects. If current subjects will be harmed by stopping Human Research procedures that are not available outside the Human Research context, immediately contact the IRB chair and provide a written list of the currently enrolled subjects and why they will be harmed by stopping Human Research procedures.
How do I submit new Human Research to the IRB?
All IRB submissions are ONLY accepted via the COEUS Lite platform.
HRP-211 Application for Initial Review
HRP-212 Continuing Review Progress Report Form
HRP-213 Modification of Approved Research Form
Letter of Determination Application
Case Reports and Case Studies Application
Forms are now embedded in the COEUS lite platform and do NOT need to be completed or attached EXCEPT for researchers st St Christopher’s Hospital for Children.
The HRP 503 protocol , HRP 502 Consent and all other forms when applicable are attached into COEUS submission.
How do we consent if the subject does not speak English?
If you anticipate subjects who primary language is not English, you will need to submit the consent in both English and the identified language. A letter of attestation noting the translation is accurate must accompany the submission to IRB.
If you do not anticipate a non-English speaking population as subject and one subject does not speak English, the short form consent may be used.
Short Form Consent Guidance [DOCX]
I know most new drugs and new investigational devices will have some risk or induce some discomfort. How should I describe those risks to the subjects?
The risks associated with each research protocol has been reviewed and approved by the IRB and is clearly outlined on the consent form. Use the informed consent as your guide. Explain those risks to each subject. Do not minimize the risk(s). If there is any information available on the morbidity/mortality whether it was related to humans or animals, describe those findings so that they can make a decision on whether or not to participate in such a study. Please always inform each subject that their participation is entirely voluntary. Assure them that if they refuse to participate in the study, it will not affect the quality of care they are receiving.
If I have a sponsor-prepared informed consent document, can I use that?
Generally, most sponsors provide a sample or draft consent document. They are useful in preparing the consent document. Drexel does have mandatory language which must be inserted into the sponsor's template. This language is posted on the website with the consent templates.
Once I have obtained consent, should I always give a signed copy of the consent to the subject?
The person who signed the consent form must be given a copy as a reference and reminder of the information conveyed in the consent document.. Please remember that by giving this form the subject is now aware of not only the contents of consent document he/she signed, but also will have the written information on when to schedule an appointment to see the study doctor or for a study-related test.
What appropriate procedures should I use to consent a research subject?
To obtain informed consent, use your consent document as a guide for the verbal explanation of the study. The consent document contained regulatory required elements for all human subject research Give adequate opportunity for the subject to exchange information with you. Open the discussion with a concise summary of key information- the prospective subject or legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.
All of the information contained in the consent is critical since subjects need to understand what is being done to them. Describe to them how this research project distinguishes itself from routine care they receive from their doctor.
What are some of the applicable laws and regulations pertinent to Informed Consent?
For studies that meet DHHS (e.g., NIH) policy, Federal regulation 45 CFR part 46.116 states that “no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or his representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence”. Basic elements of informed consent are also described under this regulation.
For studies that are subject to FDA regulations (clinical trials of drugs or devices), the informed consent documents should meet the requirements of 21 CFR 50.20 and contain information required by each of the eight basic elements of 21 CFR 50.25(a) and each of the six elements of 21 CFR 50.25(b) that is appropriate for the study.
There are some differences in DHHS and FDA applicable laws and regulations.
What is a Clinical Trial?
"Clinical trial" is "a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
What is the purpose behind obtaining informed consent?
The Nuremberg Code developed by International Military Tribunal that tried Nazi physicians for the “experiments” they performed on un-consented inmates of concentration camps, was the first widely recognized document to explicitly deal with the issue of informed consent and experimentation on human subjects.
Informed consent is the primary ethical requirement underlying research with human subjects. It emphasizes the basic principle rights of individuals and respects for persons. Informed consent is an ongoing process. It assures that prospective human subjects will understand the nature of research and individuals can voluntarily and knowledgeably decide whether or not to participate in a study.This voluntary consent is absolutely essential. This assurance protects all parties, the research subject whose autonomy is respected, the investigator(s), the sponsor and the institution where the proposed research is being conducted.
What training does my staff and I need to conduct Human Research?
Investigators and staff conducting human subject research must complete the Relevant Group Specific online Collaborative Institutional Training Initiative (CITI) human subjects”. Access the site at CITI Program . Please note that all members of the research team involved in the design, conduct, or reporting of the research are required to complete training. IRB approval will not be granted for proposed research in which members of the research team have not completed human research protections training.
Where can I get help to write the informed consent for my study in our university?
The DU IRB website has a template of informed consent that contains standard language/or a standard format that must be used in consent documents. They are developed for those elements that deal with confidentiality, compensation, voluntary nature of participation, pregnancy/pregnancy waiver, statement on no apparent benefit, who is responsible for costs in case of injury, contact information for questions on research project, in case of injury and adverse reactions. Please be aware that these are some standard statements that may or may not directly apply to your study, but may help organize your study information.
Who can sign the consent if a research subject is unable to give consent because he/she has diminished mental or medical capacity to consent?
If an adult research subject is unable to consent on his/her own behalf due to medical or mental incapacity, only the subject’s legally authorized representative (a court appointed conservator or guardian, an attorney-in-fact pursuant to a durable power of attorney) may consent on his/her behalf.
Family members (also called "next-of-kin") who do not meet the definition of legally-authorized representative may not provide consent for a related adult to be enrolled in research.
If there is no legally-authorized representative, and the adult patient cannot consent, the patient may not become a human subject in a medical experiment unless the federal requirements for waiver of consent have been met.
Minors cannot give consent, but sign an assent if they are seven years or older. If a minor (emancipated?) is unable to consent on his/her own behalf due to medical or mental incapacity, a parent or legal guardian may provide consent for research. (Note: under normal circumstances, enrollment of minors as subjects requires permission by the parent or legal guardian and assent by the minor).
Who has the ultimate authority for assuring the adequacy of informed consent document?
It is your IRB that has the final authority to ensure that the informed consent contains appropriate and adequate information in the informed consent that will safeguard the subject, the investigator, the sponsor and the institution where the research being conducted.