FAQs and Guidelines
The IRB is the Institutional Review Board. Every institution that carries out research involving human subjects has an IRB or equivalent body (for example, sometimes in other countries it is called an Ethical Review Board or a Research Ethics Committee). The purpose and function of an IRB is to ensure the protection of the rights and welfare of human subjects involved in research. The IRB carries out its function by reviewing all research protocols involving human subjects before such research is carried out to ensure that the research is conducted in an ethical manner.
If your project (1) involves living human subjects AND (2) is research according to federal guidelines, then, yes, your project needs IRB approval.
Principal investigators and/or faculty advisors must determine whether their project meets the federal definition of research and involves human subjects. If it is unclear whether the research will involve human subjects as defined in 45 CFR 46.102, please contact the current IRB Chair or the Office of the Provost, ext. 5375, for help.
As defined in the federal policy (45CFR46.102(f)), research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
A human subject is a living individual whom an investigator (whether professional or student) conducting research obtains (a) data through intervention or interaction with the individual, or (b) identifiable private information.
As defined in the federal policy (45CFR46.102(f)), a human subject is a living individual whom an investigator (whether professional or student) conducting research obtains (a) data through intervention or interaction with the individual, or (b) identifiable private information.
As defined in the federal policy (45CFR46.102(f)), research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
First determine whether your project is (1) research and (2) involves human subjects. If both of these conditions are not met, you do not need IRB approval.
If both conditions are met, then determine which category your project falls under: new research proposal, research approved at another institution, or a classroom project.
IRB applications are submitted through the Axiom Mentor portal. When you initiate a new protocol it will first administer a pre-diagnostic survey to help you determine which type of review your protocol requires.
If you submit an application for a Request for IRB Review of Research, please allow up to 30 days for an Expedited Review, or longer for research requiring a Full Review.
If the work will be done strictly as a classroom assignment, meaning that the intent of the project is solely academic learning and will not be disseminated beyond the scope of the course (presented or submitted only to the course instructor or other members of the class) or only disseminated in very limited manner (presented only to the wider Messiah community, including faculty, staff, students, parents, and local community members), then it likely does not fall under the federal definition of research and would not require review by the IRB.
It is the Messiah University IRB policy that these projects still be reported to the IRB to ensure that they meet the guidelines for Classroom projects. If the activity or project is being done strictly for a classroom project and does not fall under the federal definition of research, the project should be reported to the IRB as a "Classroom Project" using Axiom Mentor. Submission of a "Classroom Project" form should be completed by the course instructor and include the title of each project and the names of the students conducting the project.
Student Research Projects
If any part of the work, either on its own or as part of a larger faculty work, will be disseminated to a wider academic or professional audience, it likely falls under the federal definition of research and would require review by the IRB. Examples of dissemination to a wider academic or professional audience would include: publication in a peer-reviewed journal or presentation (oral, paper, or poster) at an academic or professional conference or venue.
Further, even if it does not fit under the federal definition of research, it is current IRB policy that the following types of projects should be submitted to the IRB for review using the Axiom system:
1) independent research for honors, senior capstone, or directed/independent study
2) international research
3) projects requiring subjects’ physical exertion or physical specimens (e.g., finger sticks)
4) projects involving deception, sensitive topics or protected populations
Note, some student research projects involve research-like activities but do not meet all the criteria of the federal definition of “research.” Researchers with questions or unusual circumstances should contact the IRB Chair.
One of the main principles of the regulations governing use of human subjects in research is that the subject is participating voluntarily after receiving complete and accurate information about the study. When the PI is also the research participant's teacher this relationship is inherently one that raises the issue of “voluntariness.” "No matter how well intentioned the instructor is, students may feel compelled to participate, believing that failure to do so will negatively affect their grades and the attitude of the instructor (and perhaps other students) toward them." (1) Therefore, the IRB generally discourages researchers from using their own students as subjects in their research if it can be avoided. This policy is similar to those at many other institutions.
The Messiah IRB does recognize that there are some situations in which use of one’s own students is integral to the research. This may occur when the research involves teaching methods and/or the scholarship of teaching and learning. To fully comply with the principles of human subjects research, the IRB encourages researchers to utilize one of the following methods for collecting data from their students : 1) use of a third party to collect the data; 2) collection of online, anonymous surveys via Qualtrics or 3) collection of data after grades are entered for the course.
Please note: IRB approval is only needed for research. If the instructor will only be using their students’ data for internal evaluation purposes IRB approval is not needed.
Applications for review by the IRB can be submitted through the Axiom Mentor portal. Access to Axiom can be found through the Axiom Mentor tab in the menu to the left.
After you access the portal through the link at the left, utilize the single sign-on feature to sign-in with your Messiah credentials. An Axiom account will be created the first time a researcher/student signs in to the system. Further instructions on how to sign-in to Axiom can be found at the "Beginning a New Research Project" menu to the left.
If your research has already obtained approval by the IRB at another institution, you do not need to complete an application for new research. Please utilize Axiom to submit a Research Project Involving Human Subjects Approved by IRB at Other Institution form and appropriate accompanying documentation (copy of the IRB protocol, approval letter from the host institution, and certification for human subjects protection training for all researchers).
All research projects involving human subjects must undergo a review process for human subjects protection. If this project is being conducted under the auspices of another institution and has received approval from the IRB at that institution, then the Messiah University IRB must be provided with the appropriate information but may accept the approval of the other institution’s IRB and delegate responsibility and oversight to that institution. The Messiah IRB reserves the right to disapprove research that may have been approved at another institution if the research does not meet the guidelines established by the Messiah University IRB.
According to Messiah policy, all researchers must be certified to conduct research with human subjects. Certification indicates that appropriate training in human subjects protection has been received. Certification can be obtained through a tutorial offered online on the Messiah IRB website.
Yes. Any research that involves international work will require additional information, documentation, and review. All research involving international work must comply with both US regulations and with local policies and regulations for human subjects research, including whether there are local requirements for a research ethics committee approval is required. It is the responsibility of researchers to determine and document what, if any, such local regulations and policies are. It is recommended that researchers enlist the aid of a local collaborator to address these issues.
If approval by a local research ethics committee is required by the international site, documentation of such approval must be provided to the Messiah University IRB. If such local approval is not required, documentation of this should be provided to the Messiah University IRB.
Additionally, documentation of a Memo of Cultural Appropriateness should be provided to the Messiah University IRB.
A Memo of Cultural Appropriateness (MoCA) should be authored by an individual completely independent of your study who is highly familiar with the culture of the region where the research will be conducted and have the following required elements:
- Reference the title of the study displayed in the IRB application
- Describe the expertise of the individual preparing the letter to address the local cultural and social norms
- Confirm they understand the intent of the research and activities to be performed
- Confirm the planned study does not conflict with local and cultural norms
- Document is signed and dated
An example of a MoCA can be seen here from the UPitt IRB site.
If your study includes vulnerable populations, it will require a FULL review. The following categories of people are considered vulnerable populations here at Messiah University:
1.) individuals currently imprisoned
2.) individuals with reduced mental capacity or psychiatric disabilities
3.) economically disadvantaged individuals
4.) people who are pregnant
5.) individuals experiencing homelessness
6.) children (under the age of 18)
7.) individulas identifying as LGBTQIA+
8.) individuals who are terminally ill
9.) individuals who are undocumented
After you submit your application to the IRB, your submission will be processed and forwarded to the IRB chairs for review. For Expedited Reviews, one of the chairs or a designee will review your application and provide feedback and comments, typically within 2 weeks. Feedback and comments will usually ask for clarification or additional information. Typically, most applications will require at least one round of revisions and subsequent resubmission and review; some applications will require more than one round of revisions. Because of the time it takes for processing the applications, initial review, and subsequent rounds of revision and further review, please allow for at least 30 days from the initial submission date before obtaining approval and the anticipated start date for research. You may not start the research and data collection until IRB approval is obtained.
Upon initial review of your application by the chairs, it will be categorized as one of the following: EXEMPT, EXPEDITED REVIEW, or FULL REVIEW.
If your proposal is categorized as EXEMPT, then it is exempt from further IRB review. Upon receiving verification of the exemption, you may proceed with your project.
If your proposal is categorized as eligible for EXPEDITED review, then it will be reviewed by one of the chairs or a designee and will follow the procedures outlined above (initial review, feedback and comments, review of revisions). Once all criteria for approval have been met, the proposal will be approved and the research and data collection may begin.
If your proposal is categorized as requiring FULL review, then it needs to be reviewed by the full IRB committee. FULL REVIEWS generally take more time because the entire committee must review, deliberate, and vote on the proposal. FULL REVIEWS can take more than 30 days to complete. Once all criteria for approval have been met, the proposal will be approved and the research and data collection may begin. A schedule of monthly IRB meetings and deadlines for a submission to be considered at that meeting can be found on the IRB homepage.
According to 45 CFR 46.101(b):
(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; AND (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:
(i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
(5) Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:
(i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
According to 45 CFR 46.110, a protocol may be reviewed through an expedited process if the research activities (1) present no more than minimal risk to human subjects, and (2) involve only procedures listing on one or more of the categories listed below.
1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
(b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
(a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
(b) from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
3. Prospective collection of biological specimens for research purposes by noninvasive means.
Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)
Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject=s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
6. Collection of data from voice, video, digital, or image recordings made for research purposes.
7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
When a proposal involves more than minimal risk to human subjects or involves procedures not covered under the list of categories eligible for an expedited review, then it must undergo a full review by the IRB.
Included among the categories of proposals that will require a full review by the IRB are any proposals that involve deception or coercion, international work, or when some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
Applications for "Full Review" are only considered during regularly scheduled IRB meetings. A list of scheduled meetings and deadlines for submission can be found on the IRB website. Full reviews are not conducted after the conclusion of the spring term or before the start of the fall term as the IRB does not meet during the summer months.
Expedited and exempt applications are considered on a rolling basis throughout the entire year. There are no deadlines for expedited or exempt applications.
Please allow a minimum of 14 days to receive a verification of 'exempt' status.
For expedited reviews, you should allow for a minimum of 30 days to receive a decision from the IRB. This includes time to upload your documents to the IRB site so that members can access them, the time for initial review and to communicate initial feedback, time for you to make necessary revisions, and time for a second round of reviews. Sometimes second and third rounds of feedback and revisions are also necessary, or clarifying communication is required between the IRB and the researcher, before a decision can be issued. Each round of feedback and revisions takes time and so researchers should allow for a minimum of 30 days to receive a final decision from the IRB.
Applications that require a full review by the IRB may take longer to process.
Also, please note, some times of the year are particularly busy, either due to high volumes of applications submitted to the IRB or due to other factors (for example, during advising week or the ends of the semester) and during these times the turn-around times may be delayed.
See comment above regarding expected turn around times.
If the anticipated start date is less than 30 days from the submission date, then please contact the IRB prior to application submission to provide a rationale as to why an expedited turn around is necessary for the research and could not be processed according to the normal time frame. Note, insufficient advance planning and needing to meet class deadlines is not considered a valid rationale for needing expedited turn around.
Note, applications for which the start date is less than 30 days from the date of submission which have not obtained prior authorization from the IRB to be submitted for an expedited turn around will be returned without further review until the start date is revised in compliance with the 30 day rule.
Yes. The IRB is primarily comprised of educators who also have full time teaching responsibilities. As such, at certain times during the semester, there may be a delay to the normal turn around time for reviewing and processing applications, including during advising week and at the end of the semester when grades are due.
Most submitted applications have historically required at least one round of revisions, sometimes more, so it is advisable to anticipate this and to plan accordingly, especially with respect to anticipated start date expectations.
No. You must wait until you receive IRB approval before you start with any data collection or analysis. You may not start collecting data while your application is pending and just wait for IRB approval before presenting the results. Any data collected before IRB approval is obtained may not be used.
Please plan in advance and submit your application at least 30 days in advance of your anticipated start date.
Yes! Working closely with faculty supervisors, students can and do submit applications to the IRB.
If you are carrying out a research project that is beyond the scope of a classroom project, that you intend to disseminate to a wider professional or academic audience (e.g. publication or presentation at an external professional conference) you and your faculty supervisor will need to submit a Request for IRB Review (Form 20) and obtain IRB approval before you commence research and data collection.
However, it is critical that students work closely with their faculty supervisor(s) to complete the application before submitting it to the IRB. This will make the process more efficient, make for a more timely turn around, and hopefully ensure a more streamlined experience. Faculty supervisors should provide oversight and guidance to the proper completion of all parts of the application. Submissions to the IRB are expected to be of professional quality and are expected to have gone through multiple rounds of rigorous feedback and revision with the faculty supervisor prior to submission on Axiom. Submitted applications should be the equivalent of the final version of an “A” level quality work.
Successful completion of the application can involve a significant amount of work and be a time consuming process, both for the applicant as well as the IRB committee. As such, students and faculty supervisors should “count the cost” before embarking on this endeavor and only submit an application for review if there is a clear intention of publication or professional presentation. A realistic assessment should be made of whether the work will result in potentially publishable data. An application should not be submitted if the work does not have reasonable potential to yield potentially publishable quality data, or based on a “just in case” approach.
Students who are carrying out research projects should work closely with their faculty supervisor to complete and submit a Form 20.
Students who are carrying out a classroom project that will not be disseminated widely beyond the Messiah community do not need to submit a Form 20. The faculty supervisor, not the student, will submit a Form 55, a Faculty Report of Classroom Projects.
For clarification on which category your project may fall into, please consult the Decision Tree found on the IRB website.
All applications, including student applications, are expected to be completed at a professional level of quality. If applications are completed as part of a course, the application submitted to the IRB should represent the “final” version of an “A” level paper that has undergone at least one round of review and critique by the supervising faculty mentor and revisions.
Applications should not be in “draft” form. Applications that are incomplete or show indications that they have not undergone a sufficient review and revision process with the faculty mentor will be returned without review.
Thank you for your commitment in supervising a student research experience!
If you and your student researcher(s) are planning a project with the clear intention of and reasonable possibility of publication, then you need to submit an IRB.
If this is the case, then the expectation of the IRB of faculty supervisors are that:
Faculty supervisors will work closely with student researchers during the entire process.
Faculty supervisors will work closely with student researchers in ensuring that the design and methodology of the research meets professional standards and expectations so that the work will have a reasonable potential to meet the standards required of publication or professional dissemination in the field.
Faculty supervisors will work closely with student researchers to properly and completely prepare the Form 20, including multiple rounds of rigorous feedback and revision. Background sections should be properly researched and cited, methodology should be appropriate for the field, all sections of the application should be properly completed. The submitted application should represent the final version of an “A” quality paper of a major, upper level course assignment. It should not be the equivalent of a “draft” version.
Though undergraduate research can be an invaluable educational experience for students, it is likely that not every student project in an undergraduate research course will be of publishable quality. Only those student projects that have a reasonable and realistic potential for publication should submit an IRB proposal to the IRB for review. It is anticipated that in most fields such student projects will be relatively few.
In addition to the research itself, the process of completing and receiving feedback on an IRB proposal can be a valuable pre-professional experience for students. However, for student projects that are likely not going to be published, the completion and review of the IRB Form 20 should be done in the context of the course. Review should be done and feedback given by the course instructor as part of an educational exercise and not submitted to the IRB for review. Only proposals for research with a clear and reasonable expectation of publication in a professional venue should be submitted to the IRB for review.
When a Form 20 is prepared as part of a course but is also submitted to the IRB for review, the timeline for course requirements should conform to the IRB guidelines, including guidelines for the time frame for obtaining approval (30 days for Expedited approvals). If there are course deadlines that need to be met, proper planning should be taken to ensure enough time has been allotted based on the guidelines provided here.
Faculty supervisors and their students should not expect or do the following:
Students and faculty supervisors should not submit “draft” or incomplete versions of the Form 20.
Faculty supervisors should not expect the student to prepare and complete the Form 20 independently with minimal supervision or feedback from the faculty mentor. The submitted Form 20 should have been rigorously reviewed and critiqued by the faculty supervisor. If the completion of the Form 20 is an assignment for a course for which the student is receiving a grade and so must largely be done independently without faculty collaboration to asses the quality of the student’s work, then the independent student work should be submitted to and evaluated by the faculty supervisor for a grade first, and then once the grade has already been assigned, then the faculty supervisor and student should work together to further revise the document for submission to the IRB.
Students and faculty supervisors should not expect an accelerated turn around time on proposals, especially during times of high volume (for example, if multiple students from the same course all submit their proposals at the same time), in order to satisfy course timelines.
In general, no.
The process for obtaining IRB approval for a research project generally takes time. The estimated time frame to obtain approval for an Expedited proposal is 30 days. This includes the time required for initial processing of the application in our system, initial review feedback by the chairs or designee, revisions by the authors, and subsequent review of the revisions. Sometimes more than one round of revisions is required.
In rare circumstances, requests to expedite the turn around time can be evaluated on a case by case basis. However, such requests for expedited reviews must provide justification for the request of why the application could not have been submitted earlier or the research carried out later that is not based on the restrictions of the course time lines. In general, it is expected that the entire process of designing a project, completing and submitting a Form 20, obtaining IRB approval, and conducting and analyzing the research will not easily fit within the confines of a single semester.
Some of the most common issues that come up with applications that require revisions are:
-Incompletely filling out any part of the application, including the checklist in Section B (it’s there for a reason, so that you don’t forget to fill anything out!)
-Having an unrealistic anticipated starting date. If your anticipated starting date is the day after, the day before (yes, we have seen them!), in the same week as, etc… the date the application was submitted, and not at least 30 days out, at best the starting date you entered will be ignored, or at worst, your application may be returned to you without further review until you revise the anticipated starting date to the prescribed time frame, further adding time to the processing of your application.
-Improperly or incompletely filling out the background section, with appropriate references.
-Not properly or completely identifying the target population, including clearly specifying the inclusion and exclusion criteria.
-Not properly or completely describing the recruitment process, including not providing the recruitment language to be used.
-Not providing the study instruments to be used and their proper citations (or indicating that they are researcher developed).
-Not providing sufficient or adequate details of the study procedures.
-Not providing sufficient or adequate details on how risk (if any) will be minimized.
-Issues arising from providing remuneration, compensation, or incentives to participation.
-Confusion about the distinction between anonymity and confidentiality.
-Not providing sufficient or adequate details on how data will be stored, especially with regards to specifying how data will be stored securely (double lock standard).
-Not providing sufficient or adequate details on how data will be destroyed.
-Issues arising from when participants decide to withdraw from a study, especially if compensation or an incentive was offered.
-Issues related to Informed Consent (a very common source of issues)
-Don’t have one (you probably need one, or an online consent!)
-Readability too high (check this before you submit!)
-Doesn’t contain all the elements (use the template!)
You can greatly improve the turn around time of obtaining IRB approval if you carefully review and follow the guidelines and FAQs presented here, including carefully following any guidelines to completing the various sections of the Form 20 provided below.
Most of the time in processing an IRB application is spent in reviewing the proposal and identifying issues, waiting while revisions are made by the applicant, and then further reviewing the revisions to ensure the original concerns were adequately addressed.
The guidelines below provide information about what the committee is looking for in various sections and what the most common mistakes we come across. By carefully following the them, you will minimize the number and scope of issues that may come up and thus the time required to address them.
The readability index is a quantitative measure of the difficulty of the reading level of a selection of text. Informed consent documents for adults must be at the 8th grade reading level or below to obtain IRB approval.
There are different algorithms that can be used to compute a readability measure, but the IRB at Messiah uses the Flesch-Kincaid index in determining readability.
Instructions on how to compute readability scores using the Flesch-Kincaid index as well as others can be found in the document “Tips on Adjusting Readability” on the IRB website. This document also provides guidance on how to adjust readability scores downwards (often, initial drafts of informed consent documents have readability scores that are too high and need to be adjusted downwards to reach the 8th grade level).
Please use the guidelines provided to check the readability score of your informed consent documents before submitting your application to the IRB. If you determine that the readability score is too high (a Flesch-Kincaid score of 9.0 or more), then you should follow the guidelines to make adjustments to the language until the readability is <9.0.
The committee always checks the readability of the informed consent. If you do not do this and the readability score of your informed consent is too high, the committee will require that your revise your informed consent language until it falls within the appropriate range.
Readability scores that are too high are one of the most common mistakes that are made and that need to be revised on new applications. If you check to make sure that the readability on your informed consent is in the correct range before submission you will likely greatly improve the turn around time for processing your application.
Incomplete applications or applications that show evidence of being inadequately prepared will be return without further review pending proper completion and resubmission. The Form 20 is a professional document and is expected to be completed to a professional standard.
Social media can be an excellent tool for the recruitment of human subjects for research. The Messiah IRB will consider the use of social media recruitment methods that include a clear justification and meet the guidelines outlined below. Since the online environment is constantly changing, these guidelines may not address all possible scenarios. Each IRB submission utilizing social media for recruitment will be reviewed individually to ensure adherence to University standards and HHS regulations.
- Justification – It is important for researchers to carefully consider the use of social media and explain to the IRB how this method of recruitment will be an appropriate and effective means for reaching the target study population. Recruitment, including social media recruitment, must adhere to the principles of justice, respect for persons and beneficence. When deciding to use social media for recruitment, researchers should consider whether online recruitment may create a biased sample. It is also important to consider which social media platform will most effectively reach the target audience.
- Description – The IRB submission should include a complete description of how social media platforms will be used during recruitment. The description should include a list of all social media platforms that will be utilized and an explanation for how the research team will interact with users on the platform. (Examples: Will comments be disabled? Will the researchers answer questions on the platform? Will potential participants be re-routed to another website for more information?)
- Recruitment Language – All recruitment materials, including social media recruitment, should meet the requirements outlined in the recruitment section of the IRB website. In short, all recruitment materials should include the following information: indication that this is a research study, a brief description of the purpose of the study, a brief description of the procedures involved including the time commitment for research subjects, inclusion and exclusion criteria, a statement on voluntariness of participation, the location of the study, the institutional sponsor of the study, risks, compensation, contact information for the researcher and a statement as to whether the participants’ identity will be confidential or anonymous. The exact recruitment post should be included in the IRB submission. It is also important to ensure that the text of the recruitment post will fit within the social media platform’s text restrictions. For some platforms it may be necessary to include a link to a different site with more complete information about the study. If different recruitment materials will be created for different social media platforms, each one must be submitted to the IRB for review.
- Privacy – Researchers should not use personal social media accounts to post recruitment materials for research studies. Research is official business of the University and should be kept separate from personal accounts. Researchers may choose to create a social media account specifically for the research study.
- Accessibility – Recruitment materials should be accessible to all individuals in compliance with Messiah’s commitment to inclusive excellence and the Americans with Disabilities Act. When possible, recruitment materials should be text based. If images must be used, those images should include alt-text for e-readers.
- Permissions – If researchers will be asking groups/pages/organizations to share the recruitment post on their social media sites, the IRB submission should include evidence that permission was received from those entities.
- Security – Recruiting human research participants using social media platforms increases the possibility of invalid research results due to ‘bad faith’ or bot submissions. Researchers may consider the use of screening questions to determine eligibility, collection of IP addresses to screen out repeat responders, and/or the structuring of survey questions to help identify unusual, repetitive, or inconsistent responses.