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IRB Human Studies Application
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Welcome to the IRB Human Studies Application website.

Purpose: The purpose for this website is to submit the application for research activities involving human subjects to the IRB for review and approval. The Hanover College IRB is responsible for approving, requiring modifications in (to secure approval), or disapproving all research activities involving human subjects conducted by representatives of Hanover College [45 CFR 46.109].

Overview: The application is comprised of five main sections: Details, Participants, Classification, Documents and Status. The first four sections each contain required fields that must be completed before you can submit the application for review. The Status section provides information about field requirements, submission and review statuses and comments. Once the application has been completed is must be reviewed and approved by any assigned sponsors and then submitted to the IRB for final review and approval. Once approved by the IRB, research activities involving human subjects may begin.

Access: This website primarily intended for current Hanover College students and faculty. If you are not a Hanover College student or faculty, and you have been designated as a co-author for a study, please check for an email invitation from the study application author who assigned you as the co-author. If you do not have the email or need it re-sent, please contact the student or faculty that originally invited you to co-author their study.

Study Applications:
Academic Year:
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#IDTitleCreatedAuthorTypeStatus
Study Application #:
Details:
Title:
Authors:
No Co-Authors listed.
Sponsor:
Faculty sponsor required.
Description:
Describe the purpose of your research and your procedures and measures in lay terms. Consider what will the typical participant in your project experience or, if your study involves naturalistic observation or archival research, how and where will you collect data? Be as brief as possible, but provide enough information for a non-specialist to understand your research.

Course/Program:
If your study is affiliated with a course or program, please provide the name of the course or program:
Sample Size and Duration:
Anticipated number of subjects your study will have:
The duration that the subjects will be involved with the study:
(minutes)
Conflicts of Interest:
Do you have any conflicts of interest, if so, please explain:
Participants:
1. Will participants be completing the study in more than one session?
Please describe the multiple sessions:
2. Will you be obtaining informed consent from participants before the study begins?
Please provide the text of your informed consent form:
2.1 Will you be obtaining participants' written signatures on an informed consent form?
2.1.1. Could those signatures pose a risk to participants?

If people knew that a particular person was in your study, would that information pose any risk to that person's reputation, liability to prosecution, employability, financial standing, or insurability?

For example, if all your participants were selected because they reported illegal drug use, their signature on an informed consent form could pose a risk and you should answer "Yes" to this question.

Please explain what steps will you take to ensure that the informed consent forms are not publicly disclosed?
Please explain how will you be obtaining informed consent, if not through a signed informed consent form?
2.2. Why will you not be obtaining informed consent?
If consent cannot be obtained without jeopardizing the study (e.g., field study, naturalistic observation), please explain why:
If there is another reason, please clarify:
3. Will you be debriefing your participants at the end of your study?
Please provide the text of your debriefing message:
Please explain why you will not debrief participants?
4. Will you be recording participants' personal or other uniquely identifying information?

For example, their full names, email address, phone numbers, voices, faces, etc.

a) What personally idendifiable information will you be collecting?
b) Who will have access to this information (e.g., just you, faculty supervisor, whole class, etc.)?
c) By what date will the personally identifiable information will be destroyed?
d) If you are providing an informed consent form, explain how will the information for the questions above be addressed on the form? If you are not providing an informed consent form, please explain how you intend to inform participants?
4.1 Will the personally identifiable information be linked to any other information about the participant?

For example answers to interviews or survey questions.

4.1.1. Would public disclosure of a participant's responses pose a risk to the participant's reputation?

Including liability to prosecution, employability, financial standing, or insurability?

Describe what precautions you will take to minimize the risk of public disclosure. For example, will your data be stored in a location only accessible by you? Will you be securely destroying the data at some specified future date?
5. Does the study involve a risk of harm or discomfort?

Any harm or discomfort that is beyond what is encountered in daily life or during the performance of routine physical or psychological tests.

Describe the risks in your study:

Warning! Studies that exceed minimal risk must be reviewed by the full Institutional Review Board, a process that may take 2-3 weeks. Consider modifying your procedures so that they do not exceed minimal risk.

6. Will your data be obtained in a private setting; could participants reasonably expect that they are not being observed?

For example in a restroom or a bedroom. Answer No if your only data collection method is a questionnaire.

Explain why this is necessary and how you will address participants' concerns about privacy.
7. Will you be deliberately misleading participants, either about the topic of your study or about the procedures they will be performing?

This includes the use of actors posing as participants.

Describe the deception, explain why it is necessary, and describe how you will address participants' concerns about the deception.
8. Will participants be exposed to material that they might find offensive, threatening, or degrading?

For example pornography, intense scenes of violence or horror, or racist statements.

Describe the objectionable material and what steps you will take to minimize harm to participants.
9. Will you be asking sensitive questions?

Questions are considered "sensitive" if participants are likely to feel some discomfort in disclosing the information in a face-to-face setting.

Example topics include the participants' own (1) criminal actions, (2) diseases or disorders, or (3) sexual behavior.

Describe the nature of the sensitive questions and how you will minimize participants' discomfort.
10. Is your sample likely to include women?
10.1 Would any of your procedures pose more than minimal risk to either a pregnant woman or fetus?

For example consumption of alcohol or tobacco, or exposure to chemicals like pesticides.

Describe these risks and how you will minimize them:
11. Indicate your participant recruiting methods or proceedures:

How will you be recruiting participants? Check all that apply:

  • If none of the above and/or you intend to use any other recruitment methods, please explain:
12. Indicate the types of participants involved with your study:

Check all that apply:

  • If none of the above, and/or if there are any other groups for whom informed consent is unclear or special protection is necessary, please explain:
Classification:
1. Is your research "classified"?

In other words, is knowledge of either the procedures or results of your research restricted to individuals with United States government security clearances?

This study is not eligible for expedited review and would need to be reviewed by the full Institutional Review Board, a process which can take 2-3 weeks. To avoid this delay, you may consider revising your procedure.

2. Does the study involve the use of drugs that you provide to research participants?
2.1 Do you intend to report the results of your study to the FDA?

As a well-controlled study in support of a new indication for use.

This study is not eligible for expedited review and would need to be reviewed by the full Institutional Review Board, a process which can take 2-3 weeks. To avoid this delay, you may consider revising your procedure.

2.2 Do you intend for your results to be used to support any other significant change in the labeling for the drug?

This study is not eligible for expedited review and would need to be reviewed by the full Institutional Review Board, a process which can take 2-3 weeks. To avoid this delay, you may consider revising your procedure.

2.3 Do you intend for your results to support a significant change in the advertising for a drug?

Such as one that is lawfully marketed as a prescription drug product?

This study is not eligible for expedited review and would need to be reviewed by the full Institutional Review Board, a process which can take 2-3 weeks. To avoid this delay, you may consider revising your procedure.

2.4 Does your procedure involve a route of administration of the drug product?

Or use in a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product?

This study is not eligible for expedited review and would need to be reviewed by the full Institutional Review Board, a process which can take 2-3 weeks. To avoid this delay, you may consider revising your procedure.

2.5 Is your procedure in compliance with the requirements for informed consent?

This study is not eligible for expedited review and would need to be reviewed by the full Institutional Review Board, a process which can take 2-3 weeks. To avoid this delay, you may consider revising your procedure.

2.6 Do you promise not to promote the drug under investigation as safe or effective?

This study is not eligible for expedited review and would need to be reviewed by the full Institutional Review Board, a process which can take 2-3 weeks. To avoid this delay, you may consider revising your procedure.

2.7 Do you promise not to commercially distribute or test market an investigational new drug?

This study is not eligible for expedited review and would need to be reviewed by the full Institutional Review Board, a process which can take 2-3 weeks. To avoid this delay, you may consider revising your procedure.

2.8 Do you promise not to unduly prolong an investigation?

Prolong the investifation after finding that the results of the investigation appear to establish sufficient data to support a marketing application?

This study is not eligible for expedited review and would need to be reviewed by the full Institutional Review Board, a process which can take 2-3 weeks. To avoid this delay, you may consider revising your procedure.

3. Does the study involve medical devices?
3.1 Does the device present a potential for serious risk to the health, safety, or welfare of a subject?

You will need to submit an "Investigational Device Exemption" application to the FDA [21 CFR 812.20] and receive approval prior to beginning research.

This study is not eligible for expedited review and would need to be reviewed by the full Institutional Review Board, a process which can take 2-3 weeks. To avoid this delay, you may consider revising your procedure.

3.2 Has the device been approved for marketing and used in accordance with its cleared/approved labeling?
3.2.1 Do you promise to ensure that all shipments or deliveries of the device are prominently labeled?

In the case of devices in the laboratory research phase, the label should read : "For Research Use Only. Not for use in diagnostic procedures."

In the case of devices being product-tested prior to full commercial marketing, the label should read : "For Investigational Use Only. The performance characteristics of this product have not been established."

3.3 Is the device intended for use in the collection of specimens taken from the human body?

Including the collection, preparation, and examination of specimens taken from the human body for the purpose of diagnosing disease or other conditions (i.e., is it an "in vitro diagnostic")?

3.3.1 Is the device testing noninvasive?

Noninvasive means that the device does not, by design or intention, penetrate or pierce the skin or mucous membranes of the body, the ocular cavity, or the urethra; or enter the ear beyond the external auditory canal, the nose beyond the nares, the mouth beyond the pharynx, the anal canal beyond the rectum, or the vagina beyond the cervical os.

For purposes of this part, blood sampling that involves simple venipuncture is considered noninvasive, and the use of surplus samples of body fluids or tissues that are left over from samples taken for noninvestigational purposes is also considered noninvasive.

3.3.2 Does the device testing, by design or intention, introduce energy into a subject?
3.3.3 Will device testing be used as a diagnostic procedure exclusively?
3.3.4 Will device testing be used as a diagnostic procedure without confirmation?

Without the confirmation of the diagnosis by another, medically established diagnostic product or procedure?

3.4 Is the device undergoing consumer preference testing?

Testing of a modification, or testing of a combination of two or more devices in commercial distribution?

3.5 Is the device a "custom device"?

According to [21 CF R812.3(b)], a custom device is a device that:

  • Necessarily deviates from devices generally available or from an applicable performance standard or premarket approval requirement in order to comply with the order of an individual physician or dentist;
  • Is not generally available to, or generally used by, other physicians or dentists;
  • Is not generally available in finished form for purchase or for dispensing upon prescription;
  • Is not offered for commercial distribution through labeling or advertising;
  • Is intended for use by an individual patient named in the order of a physician or dentist, and is to be made in a specific form for that patient, or is intended to meet the special needs of the physician or dentist in the course of professional practice.
3.5.1 Is the device being used to determine the safety or effectiveness of the device for commercial distribution?
4. Does your study involve the collection of blood samples by finger stick, heel stick, ear stick, or venipuncture?
4.1 Has the person performing the collection met all state and federal training and licensing requirements?

And specifically for the type of blood collection they will perform?

4.2 Will all of your participants be healthy, nonpregnant adults who weigh at least 110 pounds?
4.3 Will the amount of blood drawn be less than 550ml in an 8 week period?

And collected no more frequently than 2 times per week?

4.3.1 Will the the amount of blood drawn be less than 3 ml per kg of body weight in an 8 week period?
4.3.2 Will blood collection occur less frequently than 2 times per week?
5. Does your study involve the collection of biological specimens other than blood?

For example saliva, sweat, or skin swab.

Please describe your collection procedure:

To qualify for expedited review and thus avoid a 2-3 week delay for full IRB review, your procedure must conform to the following description:

Prospective collection of biological specimens for research purposes by noninvasive means (from Category 3 in OHRP Expedited Review Categories (1998) guidance document.)

Examples:

  • hair and nail clippings in a nondisfiguring manner;
  • deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
  • permanent teeth if routine patient care indicates a need for extraction;
  • excreta and external secretions (including sweat);
  • 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;
  • placenta removed at delivery;
  • amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
  • 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;
  • mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
  • sputum collected after saline mist nebulization.
Documents & Links:
Collaborative Institutional Training Initiative Certificate:

Each author of the study, and sponsor if one is designated, must provide a completed certificate of the Collaborative Institutional Training Initiative (CITI Program) Social-Behavioral-Educational (SBE) Basic course.

Note: Uploading a file will replace any existing file.

(Study Applicant and Lead Author)
CITI certificate file reqiured.
(Study Co-Author)
CITI certificate file required.
Supporting Documents:

Please upload any supporting study documents. Examples include Health Information Privacy (HIPPA), surveys, flow charts and protocols.

Uploaded Files:
No supporting files uploaded.
Status:

For each section of the application, if any reqiured fields are still incomplete, they will be listed below.

Once all sections are complete, you can submit the application.

Details:

Complete!

Incomplete fields:

    Participants:

    Complete!

    Incomplete fields:

      Classification:

      Complete!

      Incomplete fields:

        Documents & Links:

        Complete!

        Incomplete fields:

          Study Application # Review:
          Application Status:
          Application Submitted:
          Approve - Sponsor
          Pending
          Approve - IRB
          Pending
          Application Amendment Files:
          No amendment files uploaded.
          Study Details:
          Study Title:
          Applicant/Lead Author:
          Co-Authors:
          Sponsor:
          Course:
          Conflicts of Interest:
          Anticipated number of subjects participating in study:
          Duration that subjects will be involved with the study:
          Description:
          Study Participants:
          Study Classification:
          Study Documents & Links:
          CITI Certificates:
          Supportive Files:
          Supplemental Links:
          IRB Members:
          Name Title Department Options