Human Subjects Research
Federal law requires institutional review of protocols that involve the use of human subjects for “systematic investigations, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” The Code of Federal Regulations Subpart A of 45 CFR 46 established the “Common Rule,” where fourteen agencies of the federal government came together to require that: 1) agencies establish institutional review boards; 2) delineate levels and criteria for protocol review; and 3) ensure in most cases that investigators secure the informed consent of participants before embarking on their projects. The Office of Research Integrity in the Department of Health and Human Services (DHHS) has responsibility for oversight of federally-funded human subjects’ research.
ASU Institutional Review Board
Consistent with the law, Arkansas State University’ maintains an Institutional Review Board (IRB) that has oversight responsibility for campus-wide human subjects’ research, with the primary purpose of ensuring that the rights and welfare of participants are protected. IRB Committee Roster 2012-2013 >>
Human subjects research is categorized in one of three classifications including full board review, expedited review, exempt status, and student protocols.
Full Board Review
Full Board review is required for all research involving greater than minimal risk to subjects and for research involving any protected subject populations including pregnant women and their fetuses, prisoners, children, elderly, and psychiatric patients. Only the full board can reject an application to conduct projects using human subjects.
Expedited review is appropriate for research that involves no more than minimal risk or for review of minor changes to previously-approved research projects. An expedited review may include the IRB chairperson alone, or one or more experienced reviewers. Protocols eligible for expedited review include:
- Collection of hair and nail clippings in a non-disfiguring manner;
- Collection of excreta and external secretions;
- Collection of data from subjects 18 years of age or older using non-invasive procedures that are routinely employed in clinical practice;
- Collection of blood samples from subjects who are 18 years of age or older, in good health, and are not pregnant, such collection not to exceed twice weekly venipuncture and a maximum of 450 milliliters in an eight-week period;
- Anonymous voice recordings made for research purposes, such as investigations of speech defects;
- Moderate exercise by healthy volunteers;
- Study of existing data, documents, records, pathological specimens or diagnostic specimens;
- Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate the subject's behavior and the research will not involve stress to subjects;
- Research involving manipulation of the subject's behavior which does not involve stress or risk;
Expedited review may also be appropriate for minor changes or requests for extensions in previously-approved research during the period (one year or less) for which approval is authorized.
"Exempt" protocols are administratively reviewed, but must meet the following conditions:
- The research must be conducted in established or commonly accepted educational settings, involving normal educational practices, such as research on regular and special education instructional strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods;
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless the subjects can be identified and any data disclosure could reasonably place the subjects at risk;
- 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;
- Research and demonstration projects which are conducted by or subject to the approval of governmental department or agency heads to study public benefit or service programs;
- Taste and food quality evaluation and consumer acceptance studies if the food is at or below the level found to be safe, by the Food and Drug Administration or approved by the and/or the Inspection Service of the U.S. Department of Agriculture.
Research and clinical practica (usually in the form of research methods classes, evaluation projects and/or directed studies) are designed to allow students to the conduct of research and are typically limited in scope and do not lead to general knowledge. Rather than bypass the IRB process, however, faculty who teach research methods classes are requested to submit blanket protocols to the IRB for its review. Note, however, that if the intent of research conducted by graduate and undergraduate students is to contribution to general knowledge, their protocols must be classified and reviewed by the IRB including, but not limited to, all independent research projects, master’s theses, and doctoral dissertations.
ASU investigators must seek IRB review for human subjects’ research (including oral histories) before conducting their projects. Steps in the process include:
- Participation in mandatory training, available at Citiprogram.org.
- Please login to IRBNet.
- If you are a new user, please click new user registration on the upper right corner and begin registration process.
- Once registered, make sure you check your email and confirm by clicking the link provided in the email.
- After confirming your registration, login and you can begin preparing your protocol.
- All of the forms required to build your protocol are located under "Forms and Templates" and you must select a library "Arkansas State University IRB - Documents for Researchers"
- Prepare an application form, and a consent form for non-medically related research or a consent form for a medically-related research;
- Development of surveys, interview instruments, or other documents that pertain to the proposed research;
- Once you have completed the forms, you will click "Create New Project" and begin to fill out the fields
- Next, you will upload all those documents including a copy of your CITI Training completion report under the "Designer" tab located on the left box under "Project Administration."
- After uploading your documents, you will electronically sign your protocol by clicking on "Sign this Package."
- Finally, you will submit your protocol by clicking on "Submit this Package" and follow the instructions.
- After your submission, wait for institutional review and feedback.
Key questions to ask as you prepare your applications include the following:
- Does the value of the project outweigh risk to participants?
- Have you adequately protected participant confidentiality either by masking identifying information and physically separating the key from the data or by not collecting identifying information during data collection?
- Have you established adequate safeguards for vulnerable populations (i.e., children, prisoners, mentally disabled individuals, and pregnant women and their fetuses)?
- Have you clearly identified your inclusion and exclusion criteria for subject participation?
- Do you have an adequate data protection and disposal plan?
- Does your consent form meet federal guidelines, providing potential participants with information about the study, their ability to opt in or out at any time, how the study may be helpful to them or to society, how confidentiality will be maintained, who to contact with questions about the study, who to contact with questions about the IRB?
- Do you clearly articulate how the consent process will be administered?
Frequently Asked Questions
What is the ASU policy regarding the use of human participants in research?
All research involving human participants conducted by faculty, staff, or students of Arkansas State University (ASU) must be reviewed and approved by the ASU Institutional Review Board (IRB). The ASU IRB operates according to the guidelines in the Code of Federal Regulations (45CFR46) and other state and institutional guidelines.
What does the IRB do?
It is the responsibility of the IRB to review research protocols involving human participants to ensure that the rights of the participants are protected, that they are not subject to unreasonable harm (physical and emotional), and that information about them is kept confidential.
What is research?
Research means a systematic investigation, including pilot research, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy.
What is a human participant?
Human participant means a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or through identifiable private information.
How do I know if I should submit a research protocol to the IRB?
If your research project (including observation, interviews and surveys) involves human participants, you must submit an IRB Review request form.
When should I submit my review request to the IRB?
You may submit your request at any time, but you must receive IRB approval before you begin recruiting participants or collecting data. For a full board review, please submit your request 2 weeks prior to the next scheduled IRB meeting date.
What do I submit?
You should submit an IRB request that includes the appropriate request form, an informed consent form or survey cover letter, training certifications for all researchers involved, and any tests, surveys, or interview questions you will be using in your study.
There are several types of IRB review and specific request forms for each type of review. Details regarding the types of review and the required request forms can be found here.
What is informed consent?
Both written consent and verbal consent for participation in research must involve an informed consent process. Informed consent involves an education and information exchange that takes place between the researcher and the potential subject.
Sometimes the information to be imparted to potential subjects is complex or possibly distressful and may require some time for it to be absorbed and appreciated. In these circumstances, the researcher should present the information and discuss the issues with potential subjects on more than one occasion, or allow a period of time to elapse between imparting the information and requesting a signature on the consent form. During this waiting period, potential subjects should be encouraged to discuss their possible participation with family members, close friends, or trusted advisors. With IRB approval, other approaches to communicating complex information can be used, including the use of audio-visual materials and brochures.
Informed consent is not merely a document to be signed or handed to the research subject. It is an ongoing process meant to keep your subject informed of the risks and expectations of your research.
To whom do I submit my request?
IIRB review requests must be submitted via IRBNet.org. The IRB Administrator has created detailed instructions for both registering with IRBNet and submitting a study for review. These instructions can be found by clicking the links above.
What happens after I submit my IRB Review Request?
Once your study has been submitted by you via IRBNet it routes automatically to the IRB Administrator (Kimberly Marshall). At that point, it will be given an internal routing number and reviewed for completeness. If there are documents missing you will be informed via email and your study will be unlocked so that you may revise and upload the necessary documents. Once it is deemed complete, it will be reviewed for compliance with Federal regulations and a determination made. You will receive an email with either suggestions for further revision, or a determination (exempt, approved, not approved, etc.) Once a determination is reached, a letter will be created and filed within your study on IRBNet. You will have access to the letter within 1 day of receiving the email at which time you can log in and print a copy for your records.
The type of IRB review dictates the length of time necessary for a decision. If your study is eligible for an 'Exemption From Full Board Review' submission, you will receive a decision within five business days from the 'official receipt date.' An 'Expedited Review' submission decision is made within 3 weeks after submission, and a 'Full Board Review' submission decision is made within one month after submission.
How will I be notified of the status of my request?
You will receive an email from the IRB Administrator either asking for revisions, or explaining the determination (exempt, approved, not approved, etc.). Once a determination is reached, a letter will be created and filed within your study on IRBNet. You will have access to the letter within 1 day of receiving the email at which time you can log in and print a copy for your records.
What is the best way to prepare my IRB Review request?
You should work closely with your faculty advisor (if you are a student) well in advance of beginning the actual research. It will be important for all researchers to apply what you learned in the CITI online training course when you complete your IRB proposal.