Submission and Review
Why is IRB review required? test
IRB review is an important component of the commitment of the university community to conduct all human subject research activities within the bounds of the most rigorous ethical and methodological standards. The IRB links the researcher and the research participant via the use of appropriate procedures for obtaining the informed consent or agreement of participants before they participate in research. IRB review and approval of the research assures the participant that the researcher has adopted appropriate means for conducting the investigation and for protecting the participant’s rights and welfare. Also, IRB approval assures compliance with federal rules and regulations governing the treatment of research participants, as well as DePaul policies and procedures.
What type of research must be reviewed by the IRB?test
All research at the University that involves human subjects, as defined by the Federal regulations, requires IRB review. This is true regardless of its funding source or area of research. Research that requires IRB review includes any research on humans that:
- is conducted by DePaul faculty, staff, or students, regardless of the location of the research (e.g., DePaul, other institution, community, foriegn country) or engaged DePaul University or DePaul faculty, staff, or students in the condut of the research
- is performed with, or involves the use of, facilities or equipment belonging to the University
- is certified by a dean or department head to satisfy an obligation of a faculty/staff appointment at the University, including clinical or adjunct appointments
Examples of items that must receive IRB review include:
- All initial human subject research protocols
- Amendment or changes to already approved human subject research protocols
- Continuing Review Reports
- Final Reports
- Research conducted by affiliated faculty/staff
- Research conducted in courses (courses in research methods and class assignments involving research with human participants require IRB approval if the research project(s) will be contributing to generalizable knowledge. See FAQ 4.)
- Faculty-supervised student research (Faculty must take an active role in ensuring that research projects are conducted in accordance with the IRB's requirements)
- Research at a pilot or feasibility stage (pilot and feasibility studies, even those with only one human participant, require the same review as full-scale research projects. Applications to the IRB for pilot studies should be identified as such, and participants must be told during the consent process that the study is a pilot)
- Research involving secondary use of data (projects that use data from humans gathered in earlier projects and in which individual identifiers are present require IRB review. However, data gathered by someone who has legitimate access to the records and who gives the investigator only data that does not permit identification of the participants may not be human subject research.)
- Research using "waste" and "extra" material (i.e., human tissue or fluids) "Waste" material is material that is collected originally for clinical or diagnostic purposes but is no longer needed. "Extra" material is material that is collected above and beyond what is needed for a clinical or diagnostic procedure but for investigational purposes.
- Research projects in which the researcher is a consultant under contract with the University does not require IRB review if the researcher has a strict consulting relationship in which:
- the researcher is hired on his or her own time
- the researcher holds no rights in the work
- either the researcher nor the University retains any data
- Many oral history activities constitute human subject research and still require the review and approval of the IRB. For more information about whether a particular oral history project requires IRB review, please refer to the following guidance, provided by OHRP: Oral History Guidance.
Does oral history research require IRB review at DePaul?test
Late in 2003, the Oral History Association and the American Historical Association announced that the Office of Human Research Protections (OHRP) had concurred that most oral history projects are not research as defined by the HHS regulations governing human subjects research. In December 2003, OHRP’s Associate Director for Regulatory Affairs, Michael Carome, issued the following, more specific, guidance: OHRP Oral History Guidance.
In short, Carome’s guidance maintains that so long as oral history activities meet the federal definition of research according to 45 CFR 46.102(d), then they are still subject to IRB review. It is the IRB’s experience that most DePaul oral history activities are either (a) systematic investigations designed to draw conclusions/generalize findings or (b) designed to produce materials for permanent archiving in the Richardson Library. Carome’s guidance cites these two types of oral history activities as ones that continue to require IRB review and approval.
Accordingly, DePaul continues to assess the appropriateness of IRB review of oral history projects on a case by case basis.
What sort of review is needed for class-related projects?test
IRB review of classroom-related activities is not required at DePaul when the collection of information from people is exclusively for the purpose of class discussion or for the purpose of training in research or research methods. Instructors who believe that their students’ classroom-related activity does not require IRB review may choose to submit a summary of the classroom activities to the Office of Research Services (ORS) for confirmation that the activity does not involve research or human subjects.
Even when IRB review is not required, activities designed to collect information from people should protect the rights of these people and the confidentiality of hte information, especially if it might be deemed sensistive. In such cases, the instructor remains responsible for educating students about human subject research and why the current activity is not human subject research, and providing ethical guidance for all student projects. It is important that the students and instructors do not use the word research when contacting or talking to people and do not suggest that classroom projects or activities are IRB reviewed and approved. Both instructors and students are advised to review and adhere to DePaul’s Best Practices in Designing & Conducting Non-Reviewable, Classroom Based Activities.
*Note: Data collected for a class project may not be used for publication or presentation, unless the project was reviewed and approved by the IRB prior to recruitment and data collection. Should there be any possibility of or intent to publish, present, or otherwise disseminate research data or findings outside the course in the future (e.g., for a Senior Paper, a Master’s Thesis, by the instructor), thereby making the data generalizable and meeting the definition of research, an application must be submitted for review and approval by the IRB prior to the start of recruitment and data collection.
Who needs to obtain IRB approval?test
DePaul University is committed to the protection of the rights of human subjects in any and all research that in any sense is conducted by persons officially affiliated with the University. Thus, IRB review is required for all such research involving human subjects, most especially any that poses potential threats or injury of any sort to the subject. This specifically includes, but is not limited to:
- Principal Investigators who are seeking either external funds (from federal, state, or local governments, private foundations, etc.) or internal funds (from URC, LA&S Summer Research, etc.) for research projects that involve human participants
- Students collecting data from human subjects for honors or graduate theses
- Classroom instructors who have their students collect data from human subjects for course projects that are not exclusively for the purpose of class discussion or for the purpose of training in research or research methods.
How do I know whether I must submit an IRB application?test
The following decision questions should help you determine whether you need to submit an application to the IRB.
Is the proposed activity research?
- Research is a systematic investigation designed to develop or contribute to generalizable knowledge.
- Systematic investigation means that the information will be collected such that conclusions can be drawn and others can review those conclusions
- Generalizable knowledge means that the information derived from the investigation will be applicable to other cases or persons and the researcher plans to disseminate the research results and conclusions beyond an individual or internal group, usually via publication. (See the definition of generalizable knowledge on the definitions page.)
- NO: Stop, your investigation does not need IRB approval.
- YES: Go to the next question.
Does the research involve human subjects? This means that the person is alive and the information pertaining to that person will be obtained though:
- Intervention (e.g., taking a saliva sample, manipulating the participant’s environment or setting, medical or psychological therapy or treatment, educational intervention)
- Interaction (e.g., an interview, survey, or other interpersonal contact)
- A private/confidential source (e.g., medical, governmental, school, business records). Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. Also, private information is that which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record, school record). Private information must be individually identifiable (i.e., the identity of the participant is or may readily be ascertained by the investigator or associated with the information) in order for it to constitute research involving human participants.
Note: Use of data about deceased individuals does not need IRB approval. However, the HIPAA Privacy Rule may apply to the use of some information about deceased persons. In addition, some types of research with publicly available archival data does not require IRB review.
- NO: Stop, your investigation does not need IRB approval.
- YES: Go to the next question.
Does the research meet the criteria for exemption? There are six categories of exemption (see criteria for exemption). All follow the general rationale that the research is benign in that the risk posed by the research is no more than what people face in everyday life and that disclosure of the participants' identity would not place them at risk of criminal/civil liability or damage to their financial standing, employability, or reputation or the research activity itself will not cause physical or emotional harm.
- NO: Submit an Application for Expedited/Full Board Review.
- YES: Submit an Application for Exempt Review. Investigators do not have the authority to determine whether their research involving humans is exempt from IRB review. According to DePaul policy exempt research must be reviewed by an IRB member or a member of the ORS staff.
Does the research meet the criteria for expedited review, including involving minimal risk and meeting the criteria for one or more of the expedited categories? 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 daily life or during the performance of routine physical or psychological examinations or tests. Research that invovles minimal risk may be reviewed through the expedited review process.
- NO: Submit information for full IRB review.
- YES: Submit a request for expedited review.
Who should I submit my materials to?test
You should submit your IRB application and all supporting materials via email to email@example.com. Hard copies of signed copies are no longer required for forms that have been converted to fillalbe PDF formats.
How long will it take for IRB review?test
Once you have submitted your application to the IRB, you should receive formal notification of the IRB evaluation within 7-10 business days. During certain time periods a response may take up to 15 business days. If the IRB requests revisions, then an additional time period may elapse, as the IRB awaits your response to the requested revisions, and then reviews your submitted revisions.
What research records does the IRB require me to keep?test
Researchers should maintain a file of all documents relevant to the IRB review of the research project in question. The principal investigator's records should be a mirror image of the IRB's records, meaning that all documents submitted by the researcher to the IRB and all correspondence between the IRB and the researcher should be kept on file by the researcher.
The documents that researchers should have on file include but are not limited to:
- a copy of the original application submitted to the IRB, including the consent form(s) (consent, parental permission assent) and the research protocol;
- a copy of the IRB's written response or request for additional information or revisions;
- a copy of your responses to the IRB’s requests for additional information or revisions;
- the original notice of final approval;
- a copy of the "Certification of Approval" sent by the researcher to any federal funding agencies (this document will be provided by Research Protections to the investigator with the approval letter);
- copies or originals of all other correspondence between the investigator and the IRB;
- copies of completed "Continuing Review" forms and attachments (if applicable);
- the original notice of coninuing approval and certification, where applicable;
- copies of completed “Amendment” forms and attachments (if applicable);
- the original notice of amendment approval (if applicable);
- original letters of collaboration from other institutions (forward only copies to the LRB and IRB),
- copies of any inspection or audit reports from internal or external entities.
Please note that in cases of exempt review, the researcher is responsible for retaining the only copy of some important documents including:
- Documents certifying that the researcher has met school district requirements when conducting research in educational settings (e.g., a letter of collaboration from the school principal; documentation from the school board).
Once my research has been approved, what are my ongoing responsibilities?test
Once your project has been approved, you must comply with any requirements included in your approval memo and with the following PI Responsibilities, which includes submitting timely continuing review reports and obtaining approval for changes via an amendment before changes are implemented.
A project will receive the same level of review at the time of continuing review as it received originally, unless: 1) the project was reviewed by the convened Board and the Board specifically determined the project to be eligible for expedited review at the time of renewal (determined to meet the criteria for category 9 expedited review); 2) a research protocol that was reviewed by the convened IRB is now eligible of expedited review under one of the category 8 continuing review categories; 3) new information or risks, or revisions to an research project originally reviewed under expedited review now indicate that the research should be reviewed by the convened IRB.
May I make changes to my materials or procedures once approved? test
Once the IRB has classified a project as exempt or approved a project, the project must be conducted as approved. For research projects reviewed under expedited review or convened review, changes in subject population or number, recruitment plans, research procedures, study instruments, study sites, or major research personnel must be approved by the IRB. For research projects granted an exemption determinations, all changes such as changes in the design or focus of the research project, revisions to the consent/information sheet for participants, addition of new measures or instruments, and any change to the research that might alter the exemption status (either add additional exemption categories or make the research no longer eligible for an exemption determination) would require submission to the IRB for approval prior to initiation in the research. If you have questions about whether an item requires submission to the IRB, please contact Research Protections staff.
Procedures for Submitting Amendments
NOTE: Proposed changes can not take place until approved by the IRB.
- Complete the amendment form. The amendment form can be found on the Forms & Templates page.
- Submit (electronically) the amendment form and any supporting materials directly to the IRB for review.
- If the IRB asks for revisions or additional information, prepare revised/additional materials and submit them to the IRB, along with a cover memo itemizing the changes/additions.
- Once you have appropriately addressed all of the IRBs concerns, the IRB will issue an approval memo, and you are authorized to implement your proposed revisions.
What authority does the IRB have?test
All research projects involving the use of human subjects or their data must be reviewed and approved before data collection or data analysis may begin. The IRB may:
- Approve, modify, or disapprove protocols based upon consideration of human subject protection
- Require progress reports from investigators and oversee the conduct of the research
- Place restrictions on the conduct of a study
- Suspend or terminate a project
The IRB seldom disapproves research activities. Instead, the IRB strives to work with the researcher to assure excellent research design with minimized risk and maximized benefits to the subjects or society.
I hear the term Local Review Board (LRB) used by my colleagues. Is this Board something I should worry about?test
The Local Review Baords were committees set up in departments, colleges, and schools, which most frequently submitted protocols to the IRB. The pupose of the LRB was to provide a scientific review of the field-specific methodology and research design. The LRB also conducted a pre-reiew for adherence to DePaul policy and templates. In August 2016, the IRB decided it was time to discontinue the LRB process at DePaul. You no longer need to submit your IRB protocol materials to the LRB first, but rather you submit all protocols materials directly to the IRB through ORS. Although the IRB has always had a mandate to review the scientific design of the research in order to ensure the risks to the subjects are minimized, the elimination of the LRB process means the IRB will be the sole scientific review process at DePaul.
What are the steps for making unanticipated problem or adverse event reports to the IRB?test
Unanticipated problems involving risks to subjects or others (UPIRSOs) whose nature, severity, and frequency were not described in the information provided to and approved by the IRB or provided to participants in the consent document must be reported to the IRB within 72 hours. Examples include unexpected complications in a participant, missteps in the consent documentation, or breaches of confidentiality. Sometimes a study must be suspended to ensure participants' safety. The report of the event should include:
- the facts of the case, including the date and a description of the participant(s)
- whether the event is related to the study's procedures or to the participant's condition
- the steps that have been taken to address the problem
- whether the event is likely to recur
- whether the event provides new information about the study's risks that should be conveyed to participants, in a revised consent form
These reports usually receive expedited review, but in some cases the full IRB is involved.
Why must women and minorities be included in research?test
Research benefits and burdens should be distributed fairly. If an individual or group is denied access to a clinical trial that might be beneficial or if some people are singled out to bear the burden of risks associated with a study, the requirement for fairness is not met. In accordance with the policies of the National Institutes of Health, the IRB requires researchers applying for federal funds to give breakdowns of their participant populations by gender and minority group. Studies with the potential to address issues relevant to both sexes must recruit both genders, and minority populations should be included in a study population wherever feasible. Researchers must justify the exclusion of women or minorities. The IRB makes exceptions only if there is adequate scientific justification for exclusion, such as when a disease predominates in one gender.
Can students or employees serve as research subjects?test
Yes. However, in addition to avoiding all obvious forms of coercion and undue influence, researchers must take precautions not to unintentionally or subliminally coerce anyone into studies. Subtle coercion often occurs when a potential research participant is also a student, employee, colleague, or subordinate. For this reason, researchers should avoid using their own students or employees as research participants. If there is a good scientific reason for including students, researchers should:
- Make sure students are confident that their participation will not influence class standing, grades, or other benefits under the control of the researcher (language regarding this issue should be contained in the consent document);
- Limit the use of extra credit points as a reward for participating (they should be used only when the research is closely tied to the course subject matter and they should not raise a student's grade by a whole step, e.g., from a B to an A)
- Keep financial rewards commensurate with the risks of participation. If possible, avoid using class time to recruit participants or complete study instruments. Inform students who might participate about the review process, the rationale for the study, the process of data collection, and the researcher's interest
- Researchers who include colleagues or subordinates as research participants, must be able to provide a rationale other than convenience for selecting them and must show that the recruitment method does not lead colleagues to think they will be compromised by not participating. Recruitment through bulletin board advertisements or by a third party is preferable to direct recruitment.
- Information about how students and colleagues will be recruited and rewarded should be included in the information submitted to the IRB.
Can children serve as research subjects? test
If research involves greater than minimal risk, children can be included in the study population only if the research projects meets specific criteria under the federal regulations [45 CFR 46 Sub Part D]. These regulations apply to research in both the health sciences and the social sciences. A research protocol in either field that involves anything more than minimal risk and that does not offer a direct benefit, the indirect benefit of offering knowledge to be gained about the child’s disease or condition, or the opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children cannot involve children.
Researchers proposing projects that include Chicago Public School District (CPS) students or their school records should consult the CPS Guidelines for research and Research Protections Guidance for Conducting Research with School Children:
CPS Research Guidelines
Can research subjects be paid? test
Researchers may pay research subjects for their participation, but payment arrangements must be disclosed to the IRB and are subject to a stringent review. Payment arrangements affect the fairness of recruitment plans, the balance of risks and benefits, and the adequacy of informed consent. Although there are no fixed formulas for determining whether payment plans are acceptable, the IRB prohibits payment arrangements that appear to be coercive. Payment should not encourage subjects to participate or continue to participate against their better judgment.
The amount paid to subjects must correspond to the burdens of participation. For example, payment might defray parking charges or transportation costs. Payments may also be scaled to the time that participants spend in a study or to the biological materials they donate. The minimum wage provides a ready baseline for hourly rates for participation, and the Blood Bank's payment scale for plasma and other blood products offers a guideline for compensating participants for biological materials.
Departmental or college policy may not allow researchers to pay cash so researchers may offer gift certificates or cards or grocery vouchers. When children and adolescents are the subjects, researchers sometimes reimburse parents for parking or transportation and give a token payment or gift certificate to the subject. Lotteries and raffles are subject to the laws and regulations governing games of chance and are generally discouraged.
Subjects should generally receive at least partial payment if they withdraw from a study early. This is called proration of payment. Withholding all payment until participation is complete is coercive, so if possible payments should be prorated and made after each research visit or group of visits for long-term research projects. A modest lump sum can be paid after the subjects's participation is complete if the arrangement is thoroughly documented in the consent form.
Are there special considerations required in cross-cultural research? test
Yes. Researchers engaged in cross-cultural research should give particular attention to the use of culturally appropriate assessment instruments and procedures, the language(s) used in the conduct of the research and consent process, and the language preference and language variability of the research participants. Researchers developing studies involving members of an unfamiliar racial, ethnic, cultural, linguistic, gender or sexuality group should develop a reasonable level of familiarity with, but would not be limited to, the language, behavior, social mores, customs and traditions of that group. A researcher should consider consulting social and behavioral scientists and others who are more knowledgeable of, and experienced with, the intended study group before constructing a protocol.
Why must I specify the number of research subjects in my protocol?test
The application must specify the number of study subjects to be recruited and tested, grouped by age, gender, and population diversity. This assures a representative research sample, statistically adequate results, and prevents aggressive over recruitment. Additionally, the IRB can assess the scientific validity of the data that may reasonably result from the reearch protocol.Exceeding the recruitment limits agreed to by the IRB is a protocol violation or non-compliance unless the IRB gives written permission (approval of an amendment increasing the subject number).
If it is difficult to predict how many subjects will be eligible or be attracted to a study, the optimum number should be specified, for example if you plan to send out 200 emails then 200 should be specified. Responses such as "don't know" or "as many as we can recruit" to questions about the number of subjects are not acceptable. A discussion of the problems faced in recruiting subjects should be included.
Multicenter studies, in which data will be pooled and recruitment may vary, present a special problem for investigators. The application should provide information about the total picture, including both the number of subjects to be studied at the University or by University researchers and information on overall recruiting at all sites (expectations for local recruitment and study-wide recruitment).
Can snowball recruitment be used to find potential participants?test
Advertisements are part of the informed consent and participant selection process. Samples of all advertisements, such as flyers, newspaper ads, radio and television announcements, bulletin board tear-offs, and posters, along with an explanation of other methods of recruiting participants, must be submitted to the IRB.
Advertisements should be submitted with the application or as soon as the principal investigator decides to use them. The content of advertisements should be limited to:
- names of the investigators conducting the research, identification of the university by name as the location of the research or the researchers main affiliation, and contact information for the researchers;
- purpose of the research;
- general eligibility criteria;
- straightforward and truthful descriptions of benefits (e.g. research procedures are free of charge) and risks.
Advertisements should not claim, explicitly or implicitly, that the research is treatment or is superior to any current practice. Extravagant attention-getting devices such as extremely large, bold typefaces and dollar signs for payment information are prohibited. Advertisements should not pressure readers into participating.
Snowball recruitment – often times researchers have an initial pool of contacts and they hope those people will "nominate" other qualified potential participants. This kind of sampling is commonplace in case study and qualitative psychological, sociological, and anthropological research. However, it may be used also in genetic studies where it is necessary to recruit relatives of the initial participant for direct interviews and/or tissue sampling, etc. This recruitment procedure is sometimes inappropriately labeled "cold calling". The following excerpt from the Belmont Report regarding voluntariness compels IRBs to pay close attention to snowball recruitment procedures:
"Unjustifiable pressures usually occur when persons in positions of authority or commanding influence---especially where possible sanctions are involved--- urge a course of action for a subject. A continuum of such influencing factors exists, however, and it is impossible to state precisely where justifiable persuasion ends and undue influence begins."
For example, what if a highly respected individual in the community (say a local elected official, teacher, member of the clergy, or tribal elder) provided the name of a potential contact. When the nominee is contacted, the person might be unduly influenced to participate in the project because of the stature of the nominator. Consideration of minimal risk is likely to play an important role in IRB review of snowball recruitment procedures. For example, it would make a big difference whether the research involved extramarital affairs or substance use as opposed to family meal time routines or leisure activities. To "cold call" someone on sensitive topic issues places him or her in a potentially embarrassing situation, which should be avoided. Moreover, the original subject is being placed in the position of being asked to disclose information about a third party without that party's consent.
Snowball recruitment where the researcher obtains names and contact information from one individual for another one, particularly for research involving sensitive topics, is generally not considered appropriate by the DePaul IRB. Using such a method could result in the researcher obtaining information about an individual that is sensitive and private without their permission. Alternatively, the researcher should ask other subjects to pass along flyers, emails, information sheets, etc. that contain contact information for the researcher to prevent a breach in confidentiality or an invasion of privacy. In instances where the research subject is not sensitive (i.e. opinions on politics, consumer opinions), a snowball recruitment method where one person provides the name and contact information may be acceptable.
One means of reducing the risks in snowball recruitment is for the researcher to gently ask subjects whether they would be willing to pass some information about the study they just completed to other potential subjects. The researcher may give the original subject an information sheet or flyer that they can give to people they think might be interested and qualified. Then these potential participants can contact the researcher if they are interested. The researcher must provide the IRB with a copy of the recruitment item (which must include all of the same information that is in the initial recruitment script) he/she will give to the initial contact to distribute. If the potential subject were interested in study participation, they would be free to contact the researcher.
There are some reasons why snowball recruitment could be approved for minimal risk projects, including:
- People cannot always be depended upon to make phone calls and contacts. Even with good intentions, they forget, become busy, etc.;
- If participants have to contact others, they may have to use their time to make at least two phone calls (one to other potential subjects and one to the investigator). Participants shouldn't be required to do extra work if there is no practical risk involved;
- Participants might not accurately describe the research and its purposes or they might prep other participants to provide particular responses.
The IRB recommends the following safeguard procedures if snowball recruitment is to be used:
- Let subjects know that they will be asked to provide the names of other potential recruits, but that they have the right to decline to provide this information.
- Obtain the nominating subject's written permission to reveal their identity to subsequent contacts on the consent form via an initialed check list item. That is, if the subject agrees to provide names of other possible contacts, they could initial a check box on the consent form that they agree to allow their identity to be revealed to the subsequent contacts. Not initialing the box would be interpreted as meaning the subject was unwilling to permit his/her name to be used when making the additional contacts, even if he/she supplied the names and contact information.
- Provide the IRB with a script detailing how the researcher will be obtaining the information for the snowball recruitment.
Are there any rules or requirements for recruitment materials?test
Yes. In general, it is important to remember that the recruitment process is an extension of the consent process. The IRB must review and approve all recruitment materials and processes to ensure that the information provided to subjects is accurate and not coercive. The language in recruitment materials should be targeted to the subject population and be at a similar reading level as the consent process, usually the 6th -8th grade reading level for adults.
Required content includes:
- The names of the investigators conducting the research, identification of DePaul university by name as the location of the research or the researchers main affiliation (Department or School), and contact information for the researchers (name and contact information e.g. email, phone number);
- The purpose of the research;
- A statement that the volunteers are being recruited for “research” purposes (not just ‘a survey’ or ‘a study’);
- The general eligibility requirements;
- A brief description of what would be involved in participation, including the anticipated amount of time for participation (i.e. number of visits, how long it takes to complete the survey or questionnaire);
- A brief description of the risks and benefits of the research, if any. Do not promise a direct benefit when there is none. Differentiate between direct and indirect benefits to the subjects. If benefits are discussed they must be balanced by a discussion of the anticipated risks of the research;
- A description of any compensation or reimbursement that may be provided. Statements regarding compensation or payment must not be bolded, enlarged, or use other methods of emphasizing payment (i.e. dollar signs, pictures of gift cards) and should not be the header or lead sentence in the recruitment item;
- The IRB protocol# and version date of the document, preferably in a footer.
Please refer to our guidance document on recruitment materials and consent for additional information.
How can I ensure informed consent of non-English-speaking subjects? test
Department of Health and Human Services regulations for the protection of human subjects require that informed consent information be presented "in language understandable to the subject" and, in most situations, that informed consent be documented in writing. The written consent document should embody, in language understandable to the subject, all the elements necessary for legally effective informed consent. Whenever possible, subjects who do not speak English should be presented with a fully translated consent document written in a language understandable to them. In addition, someone who speaks the language of the subject must be present to answer any questions that the subject might have at the time of consent and during the course of the research. This person could be the researcher, a certified translator, etc.
A second method of obtaining consent for persons who are non-English speaking involves the use of a “short form” consent document and process. When using the “short form” process, informed consent information is presented entirely verbally in the language of the subject using an information sheet or research summary (which can be the approved English consent document) and a verbal translation process. Then a “short form” that has been translated into the subject’s language is reviewed with the subject. The “short form” is a document stating that the elements of consent have been verbally presented to the subject or their legally authorized representative. There should be a witness to the entire consent process (presentation of the information sheet/research summary and the “short form”). The subject (or their legally authorized representative) and the witness must sign the short form. The person conducting the consent process and the witness to the consent process must sign the information sheet or summary of the research. The subject must be given copies of the information sheet or research summary and the signed “short form”.
The IRB must receive all foreign language versions of the consent document as a condition of approval. It is important to have the translated documents independently back-translated into English to assure that the translation has not distorted the intention of the English version. If using the short form process, the IRB must specifically approve the short form consent process (must be explained in the application), the information sheet/research summary, and the translated short form that will be used in the research. If more than one group of non-English speaking persons will be recruited, then all potential versions of the short form must be approved for use by the IRB.
Example: The approved consent form is in English and needs to be translated into Spanish.
- The approved English version (document 1) is converted to a Spanish version (document 2) by translator 1.
- The Spanish version (document 2) is converted back to an English version (document 3) by translator 2.
- The original approved English version (document 1) is compared to the re-converted English version (document 3) for content and language. If it compares sufficiently to ensure to the IRB that the translated version (document 2) is comparable to the original approved version (document 1), the translation is then approved.
What additional review requirements exist if my research involves recombinant or synthetic nucleic acid molecules, potentially pathogenic substances, toxins, or other biohazardous agents? test
Additional federal regulations may apply to your research if your research involves recombinant or synthetic nucleic acid molecules, potentially pathogenic substances, toxins, or other biohazardous agents. In order to access the risks related to research involving these materials and to ensure that the proper safety precautions and procedures are in place, protocols utilizing these materials must be reviewed and approved by the DePaul University Institutional Biosafety Committee (IBC). Research projects may be submitted to the IRB and the IBC simultaneously. However, the IRB review and final approval for the research project cannot occur until final IBC approval has been received. The most common type of protocol at DePaul University requiring IBC review and approval is one drawing blood and utilizing the blood for the research, such laboratory testing or manipulations.