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Frequently Asked Questions
Research FAQs
  1. Why is it necessary for the federal government to require that institutions review research projects?
  2. What are the criteria for IRB review of a protocol?
  3. What are the different types of IRB review?
  4. How is minimal risk defined? 
  5. What is the deadline for submission?
  6. If the project will not be completed by the IRB expiration date, what is the procedure for requesting continuation?
  7. When it is necessary to change or add procedures on an approved protocol, what is the process for obtaining IRB approval of the change?
  8. What are the researcher's responsibilities?
  9. What kind of review is needed for class-related projects?
  10. Who needs to obtain IRB approval?
  11. To whom should I submit my IRB application?
Informed Consent FAQ's
  1. What is informed consent?
  2. What information should be included?
  3. Are sample consent forms available for review?
  4. What is assent?
  5. Under what conditions may documentation of informed consent be waived?
  6. Under what conditions may some or all of the elements of informed consent be waived?
Population Methodology FAQ's
  1. How do the regulations apply to Oral History projects?  
  2. What additional requirements apply to research with prisoners? 
  3. For collaborative research at outside facilities, is IRB approval required from both the Davenport IRB and that of the outside facility?
  4. When is a Certificate of Confidentiality required?
Certification Program FAQ's
  1. What is the Human Subjects Certification Program (HSCP)? 
  2. Obtaining certification for Human Subjects Certification Program (HSCP): 
  3. What is the process for securing a letter for NIH?

1) Why is it necessary for the federal government to require that institutions review proposed research projects? Don't all researchers take the appropriate steps to protect subjects on their own?

The vast majority of researchers plan and conduct their research in accordance with sound ethical principles. However, there is adequate documentation that some investigators do not take the necessary steps, either through conscious choice or as a result of ignorance, to protect the individuals who volunteer to participate in their research. When the researcher is affiliated with an academic institution, repercussions for failing to protect subjects affect not only the investigator, but the institution as well. For this reason, oversight by an institutional review board is necessary to ensure that projects include the appropriate safeguards to protect human subjects. The federal regulations found at 45 CFR 46 and 21 CFR describe those protections and form the basis for IRB policy.1) Why is it necessary for the federal government to require that institutions review proposed research projects? Don't all researchers take the appropriate steps to protect subjects on their own?

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2) What are the criteria for IRB review of a protocol?

When reviewing a protocol, the IRB must make the following determinations:

  1. Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
  2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
  3. Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disable persons, or economically or educationally disadvantaged persons.
  4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by §46.116.
  5. Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117.
  6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
  7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

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, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

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3) What are the different types of IRB review, and how do they differ from one another?

There are three levels of IRB review: exemption, expedited review, and full review.

Exemption: Protocols that present extremely low levels of risk to participants and include only procedures described in six specific categories of research may qualify for exemption. The investigator must complete a Human Subjects Review Form (HRS-1), attach a copy of the research protocol and all relevant documents, and submit the packet electronically to the IRB for review. After administrative review is completed, the investigator is notified of the outcome by email.

Expedited Review: Protocols that present no more than minimal risk to subjects and include only procedures described in nine specific categories of research may qualify for expedited review. The investigator must complete a Human Subjects Review Form (HRS-1), attach a copy of the research protocol and all relevant documents, and submit of the entire packet to the IRB for review. After review by the assigned IRB members, the investigator is advised of the outcome by email.

Full Review: Protocols that do not meet the criteria for either exemption or expedited review must be reviewed by the convened IRB. The investigator must complete a Human Subjects Review Form (HRS-1), attach a copy of the research protocol and all relevant documents, and submit the entire packet to the IRB for review. After preliminary review by two IRB members, the protocol is presented and discussed at a convened meeting of the full IRB. The investigator is notified of the outcome shortly after the meeting by email.

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4) How is minimal risk defined? 

A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed 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 [Federal Policy 45 CFR 46.102(i)]. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination.

The definition of minimal risk for research involving prisoners differs somewhat from that given for non-institutionalized adults. Per 45 CFR 46.303, when prisoners are subjects in research, "minimal risk" is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons. 

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5) What is the deadline for submission of protocols for IRB review or exemption? 

Investigators requesting full or expedited review of a protocol should submit the Human Subjects Review Form (HRS-1) and all relevant attachments to the IRB office no later than the 1st of the month preceding the IRB meeting at which it will be reviewed. For example, submit by May 1 for the May IRB meeting.

The IRB meets monthly.

Applications for Human Subjects Review Form (HRS-1) that meet the criteria for Exemption are accepted throughout the month, and reviewed on a rolling basis. There is no disruption of the exemption review process in the summer. 

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6) If the project will not be completed by the IRB expiration date, what is the procedure for requesting continuation?

Federal regulations require that all non-exempt protocols involving human subjects be reviewed by the IRB at least annually. If any project, including data analysis, will not be completed by the approved IRB expiration date, then the investigator must complete a Renewal Application and return it to the IRB not less than two months prior to the original expiration date so that there is no interruption in the approval period.

Enrollment of new subjects cannot occur on a project if it becomes inactive. In addition, research intervention or interaction with already enrolled subjects must stop if a project becomes inactive unless the IRB determines that it is in the best interest of individual subjects to continue. If a protocol becomes inactive, submission of a new Human Subjects Review Form(HRS-1) may be required.

Research designated as Exemptions do not have expiration dates; therefore, continuing review is not required. 

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7) Submitting an Amendment to an Existing Protocol (including Exempt): When it is necessary to change or add procedures on an approved protocol, what is the process for obtaining IRB approval of the change? 

Note that any deviation from the approved research protocol must be reviewed by the IRB prior to implementation of those changes. For example, any changes in the consent form or the questionnaires/interview guides must be submitted to the IRB prior to use.

To request an amendment (change) or addendum (addition) to an approved protocol, send an electronic copy of the amendment request to the chair of the IRB Committee.

Include the following information: description of the change or addition, rationale for the modification, unmarked copy of new documents (e.g., consent form, study instrument, advertisement), and the revised documents (noting all changes by bolding additions and deletions via strikethrough; or via the track-changes feature in MSWord).

After IRB review, a Notice of Approval or revised Notice of Exemption will be emailed to the investigator. Changes to approved protocols may not be implemented until the change is approved by the IRB. Amendments to non-exempt protocols must be submitted by the 1st of the month for review at that month's IRB meeting.  

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8) What are the researcher's responsibilities if an adverse or unexpected event occurs on an approved protocol?

An Adverse/Unexpected Event is defined as: (1) any medical, psychological or behavioral event that is undesirable and unintended, although not necessarily unexpected; (2) an event in which the outcome is fatal or life threatening, causes permanent disability, causes hospitalization or prolongation of hospitalization; (3) an overdose; or (4) a complaint by a research subject or family member of a research subject concerning the research or the protocol.

If an adverse or unexpected event occurs on an approved protocol, the investigator is required to submit an Adverse/Unexpected Event Report to the IRB. The form and specific instructions may be downloaded from the IRB website. The investigators must notify the IRB in a timely manner (within 48 hours of the event).

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9) What kind of review is needed for class-related projects?

For research done within an undergraduate class as a class project, the instructor should submit a  Human Subjects Review Form (HRS-1) with Department Chair approval for a course in which research is students commonly do research (rather than students submitting independently for approval). The  instructor takes on full responsibility for monitoring the protection of human subjects, student training and keeping the project within the bounds of the IRB guidelines.

Undergraduate students doing independent senior theses, undergraduate research studies/projects, graduate students doing a master's research studies, and similar exercises must independently submit a Human Subjects Review Form (HRS-1) to the IRB as a student-researcher. A  supervising faculty member ultimately is responsible for the protection of the subjects, even if the student is the primary researcher and actually directs the project. During the design of a project, the supervising faculty member should instruct students on the ethical conduct of research, help the student prepare the application for IRB approval, and review the application prior to submission. In particular, students should:

  • understand the elements of informed consent, 
  • develop a readable consent form following the sample, 
  • plan appropriate recruitment strategies for identifying subjects, 
  • establish and maintain strict guidelines for protecting anonymity and confidentiality, and 
  • allow sufficient time for IRB review and completion of the project.

As assurance that the University's guidelines will be followed, the supervising faculty member is required to sign the student's application for IRB approval and obtain the Chair’s signature prior to submission.

After IRB approval, the supervising faculty member should take an active role in ensuring that projects are conducted in accordance with the IRB's requirements. Meeting periodically with students to review their progress is one way to meet this responsibility.

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10) Who needs to obtain IRB approval?

The scope of the Institutional Review Board's (IRB) charge is broad. Generally, any University research that uses humans, human tissue, surveys of human subjects, or human subjects' records requires IRB review. The IRB's charge extends to research in the social and behavioral sciences as well as research in the health and biological sciences.

IRB review and approval is required for any research involving human subjects that:

  • is conducted by University faculty, staff, students 
  • is performed on the premises of the University,
  • is performed with or involves the use of facilities or equipment belonging to the University; 
  • involves University students, staff, or faculty;
  • involves Davenport University data
  • satisfies a requirement imposed by the University for a degree program or for completion of a course of study; or
  • is certified by an institutional official to satisfy an obligation of a faculty appointment at the University, including clinical or adjunct appointments. 
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11) To whom should I submit my IRB application? 

Submit the completed Human Subjects Review (HRS-1) with  certificate(s) of completion of  Human Subjects training to irb@davenport.edu.

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 Informed Consent FAQ's

1) What is informed consent?

Informed consent is one of the primary ethical requirements underpinning research with human subjects; it reflects the basic principle of respect for persons. It is too often forgotten that informed consent is an ongoing process, not a piece of paper or a discrete moment in time. Informed consent assures that prospective human subjects will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate. The prospective subject should be presented with the information, then given an opportunity to ask questions and have them answered, prior to signing the consent document.

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2) What information should be included in a consent document?

(a) Basic elements of informed consent:

  1. a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
  2. a description of any reasonably foreseeable risks or discomforts to the subject;
  3. a description of any benefits to the subject or to others which may reasonably be expected from the research;
  4. a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
  5. a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
  6. for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
  7. an explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject
  8. a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

(b) additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:

  1. a statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
  2. anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
  3. any additional costs to the subject that may result from participation in the research;
  4. the consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
  5. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
  6. the approximate number of subjects involved in the study.
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3) Are sample consent forms available for review?

Yes. Sample consent forms may be found within the Informed Consent guidance material that is available online on the Institutional Review Board website. Sample forms are presented to provide guidance to researchers from various disciplines. Additional forms may be added periodically.

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4) What is assent?

Assent is defined as, "A child's affirmative agreement to participate in research. Mere failure to object should not be construed as assent [45 CFR 46.402(b)]". While children may be legally incapable of giving informed consent, they nevertheless may possess the ability to assent to or dissent from participation. Out of respect for children as developing persons, children should be asked whether or not they wish to participate in the research, particularly if the research: (1) does not involve interventions likely to be of benefit to the subjects; and (2) the children can comprehend and appreciate what it means to be a volunteer for the benefit of others. The IRB must determine for each protocol - depending on such factors as the nature of the research and the age, status, and condition of the proposed subjects - whether all or some of the children are capable of assenting to participation. Where appropriate, IRB’s may choose to review on a case-by-case basis whether assent should be sought from given individual subjects.

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5) Under what conditions may documentation of informed consent be waived?

The IRB may waive the requirement for written documentation of informed consent, if it finds and documents either of the following:

a. Signed consent is the only record linking the subject to the research and the greatest risk of the research is a breach of confidentiality; b. The research presents no more than minimal risk and involves procedures for which consent wouldn't normally be obtained outside of the research context.

In situations in which signed consent will not be obtained, it is often advisable to present subjects with an information sheet or letter that contains the elements of informed consent, for their future reference.

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6) Under what conditions may some or all of the elements of informed consent be waived?

Consent is required from any human subject in research unless informed consent has been specifically waived by the IRB. The IRB may waive consent under two sets of circumstances:

a. if the project involves no more than minimal risk; the waiver doesn't adversely affect subjects; the research couldn't practicably carried out without the waiver; and, where appropriate, subjects are given information about the project afterwards.

b. the research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is 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; and the research could not practicably be carried out without the waiver or alteration.

Otherwise, written informed consent must be obtained. For additional information, review the applicable federal regulation online at  45 CFR 46.116.

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Population Methodology FAQ's

1) How do the regulations apply to Oral History projects? 

If the archived data will be made publicly available then the research must be prospectively reviewed and approved by the IRB before the research project begins. The IRB requires that the researcher make provisions for obtaining informed consent from all participants and document the process. Participants in oral history projects should be allowed to review the material prior to public archive and decide if they wish any or all of the oral history archived.

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2) What additional requirements apply to research with prisoners? 

Under the terms of 45 CFR 46, Subpart C, prisoners are considered to be members of a vulnerable population and therefore entitled to special protections if they participate in research activities. Subpart C defines both the types of permissible research with prisoners, and the safeguards that must be followed. For additional information, review the regulations.

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3) For collaborative research at outside facilities, is IRB approval from both the Davenport and the IRB of the outside facility required?

Yes. As a result, investigators who propose to conduct research at an outside facility need to submit documentation to both Davenport IRB and the IRB for the outside facility.

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4) When is a Certificate of Confidentiality required?

A Certificate of Confidentiality is issued by a federal agency when protection against compelled disclosure of identifying information about subjects of biomedical, behavioral, clinical, and other research is necessary. For additional information, review the information posted by the federal Department of Health and Human Services (DHHS).

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Investigators who are considering submitting an application for a Certificate of Confidentiality are advised to plan well in advance, as the process can be very lengthy. If participation in research is likely to place an individual at risk of criminal liability, the IRB may require that a Certificate be obtained.

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 Certification Program FAQ's

1) What is the Human Subjects Certification Program (HSCP)? 

HSCP is a web-based education program for all principal investigators, other key personnel and Department Chairs who are named on protocols that involve human subjects. As a requirement for an assurance of compliance, which allows an institution to receive federal funding for research involving human subjects, the federal Office for Human Research Protections (OHRP) has mandated that principal investigators and other key personnel involved in human subject protocols participate in education designed to increase understanding of the regulations, policies, and ethical standards governing the protection of human subjects.

The education program provides the means to satisfy the education requirement of the National Institutes of Health (NIH). All principal investigators and key personnel who are involved in human subject research for which funding by NIH is requested or has been awarded must participate in education on the protection of human subjects in research. Certification of successful completion of the education program is required before NIH funds will be awarded for competing applications or contract proposals involving human subjects. Investigators submitting non-competing renewal applications for grants or annual reports for contracts that involve human subject research must also include the certification in their annual progress reports.

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2) Obtaining certification for Human Subjects Certification Program (HSCP): 

All researchers, key personnel and Department Chairs signing an IRB application ARE REQUIRED to complete a Human Subjects Certification Program (HSCP). Any NIH or NIH approved training program that provides a certificate upon completion will meet this requirement.  The DU IRB recommends the NIH site found at http://phrp.nihtraining.com/users/login.php.  Once registered, please select the Basic Research training.  Please print the certificate once the training is completed and submit with your IRB applications.  Certification is good for one year from the date of completion.

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3) What is the process for securing a letter for NIH, certifying successful completion of education in the protection of human subjects for all key personnel?

IRB staff will generate the letter of education certification upon request by the investigator, or in response to a request by NIH. Certification of all individuals named as key personnel in the grant application or contract proposal who are affiliated with DU will be verified internally. Key personnel who are not affiliated with DU may satisfy the education requirement by either of two methods: a) successfully complete the DU online education program; or b) provide written certification from their institution that they have successfully completed a comparable program. Key personnel who have no contact with human subjects, or with confidential data about human subjects are exempt from the education requirement; however, the principal investigator must provide this information to IRB in writing.

For more information, email the Chair of the IRB at irb@davenport.edu Return to top