Definitions of human subject and research
1. What is a human subject?
2. How do I know if I am conducting research with human subjects?

General Questions about the IRB
3. What is the Institutional Review Board?
4. Who serves on the IRB?
5. Where does the IRB get its authority?
6. What does the IRB have authority to do?
7. It is possible to know who reviewed my project?
8. What happens if I don't apply for IRB approval for my project before doing research?
9. What types of research must be submitted to the IRB?

Types of Submissions and Reviews
10. How can I get the fastest review possible?
11. What is a full review?
12. What is an expedited review?
13. What is an exempt review?
14. What are some examples of research that might be exempt?
15. What are some common items that may disqualify research as "Exempt" research?
16. What happens after the IRB reviews my project?
17. How can I find out about the status of my project?

Submission Procedures for New Projects
18. What are the procedures for IRB submission?
19. Where are the forms I need for submission?
20. What are the submission deadlines?
21. How long does the New Project review take?

Submission Procedures for Already Approved Projects
22. What procedures must I follow if I want to make changes to my study?
23. Do I need to notify the IRB if I add or change investigators on the project?
24. What if I decide, after my project is approved, that I want to post flyers or use a brochure to recruit people to participate into my study?
25. What is Periodic Review?
26. What is needed for a Periodic Review submission?
27. How will I know when my project needs to be periodically reviewed?
28. How long do submissions other than New Project submissions take?

Informed Consent
29. What is informed consent?
30. What elements should be included in a consent document?
31. Does the IRB really want me to follow the template? I have my own ways of expressing things.
32. Are sample consent forms available for review?
33. What is assent?
34. Under what conditions can some part of consent be waived?

1. What is a human subject?

A 'human subject' is a living individual about whom an investigator obtains either data through intervention or interaction with the individual or identifiable private information. Legal requirements to protect human subjects apply to a much broader range of research than many investigators realize including interviews with persons, observation of behavior, and medical chart review. The use of human subjects in research include the use of bodily materials, such as cells, blood or urine, tissues, organs, hair or nail clippings, even if you did not collect these materials, residual diagnostic specimens, including specimens obtained for routine patient care that would have been discarded if not used for research , and private information, such as medical information, that can be readily identified with individuals, even if the information was not specifically collected for the study in question. Research on cell lines or DNA samples that can be associated with individual's falls into this category. *(www.cancerdiagnosis.nci.nih.gov/specimens/brochure.html#conducting)

2. How do I know if I am conducting research with human subjects?

Research is defined as "a systematic investigation when human beings or their environment is manipulated; when information is sought from them directly (as through interview, examination, or questionnaire) or indirectly (as through observation), and when information concerning specific, individually identifiable human beings is asked for from third parties whether through access to files, data banks, or other depositories--or through direct inquiry.

3. What is the Institutional Review Board (IRB)?

The Institutional Review Board (IRB) is a standing university committee established under federal regulations to protect the rights and welfare of all human subjects who volunteer to participate in research studies conducted under the auspices of Northwestern University. It oversees institutional compliance with all federal, state, and University guidelines relating to research with human subjects. The IRB is responsible for reviewing all research involving human subjects, insuring the equitable selection of research subjects, ensuring that potential research-related risks are minimized, and that there is full disclosure so that volunteers can make an informed decision to participate.

4. Who serves on the IRB?

The committees are composed of persons who are sufficiently qualified, through experience and expertise, to review the research presented to them. In addition, they should be able to ascertain the acceptability of proposed research in terms of institutional policy, applicable law and standards of professional conduct and practice. Each committee includes at least one member whose primary concerns are in nonscientific areas and one member who is not affiliated with the institution, or part of the immediate family of a person who is affiliated with the institution. The members are appointed by the president of the university. Nominations are received from the chairs of university departments. A list of our committee members can be found on our board members page.

5. Where does the IRB get it authority?

Authority for the IRB is granted through the federal regulations that require any institution that receives federal money for research to establish Institutional Review Boards. Northwestern University's agreement with the federal government, through the Federalwide Assurance, stipulates that all research, regardless of funding, using human subjects, be submitted and reviewed by the IRB.

6. What does the IRB have authority to do?

The Institutional Review Boards have the authority to:

• approve, require modifications to, secure approval of, defer action on, or disapprove research protocols involving human subjects;
  
  
• require progress reports from the investigators;
  
  
• oversee the conduct of research;
  
  
• suspend or terminate approval of a study;
  
  
• place restrictions on a study;
  
  
• conduct reviews and inquiries regarding research activities as needed to obtain information necessary for the fulfillment of their responsibilities under the institutional assurances; and
  
  
• provide information as necessary to the Office of Research, the Office of the Dean of any of Northwestern's schools, and the appropriate administrative offices of those affiliates with whom there is a Memorandum of Understanding.

7. Is it possible to know who reviewed my project?

If an investigator would like to discuss concerns with an IRB reviewer, the request should be directed to OPRS staff and they will contact the reviewer. With the permission of the reviewer, the name may be released; however, reviewer confidentiality must be protected. Sometimes reviewers will call the Principal Investigator on their own and ask questions about the study prior to the IRB meeting.

8. What happens if I don't apply for IRB approval for my project before doing research?

Engaging in human subject research without IRB approval has serious ethical implications and violates university and federal policies. Students, faculty, and staff are required to submit IRB applications before embarking on any data collection. Even pilot studies must be approved by the IRB.

Any instances of non-compliance must be reported to the appropriate governing agencies. The UniversityÍs policy states that non-compliance may result in, among other things, suspension or termination of the study; and/or suspension of research privileges at the University.

Ramifications for Students

• Credit may be withheld: Schools at their discretion may refuse to grant students course credit for research conducted without IRB approval.
• Dissertation or thesis work will not be accepted: Graduate students must present to the Graduate School evidence of IRB approval for their projects involving human subjects. Thesis or dissertation work will not be accepted without it. Degrees will not be awarded for work based on non-IRB reviewed projects.
• Articles may not be published: Most professional journals require evidence of IRB approval when considering articles for publication.
• Funding may be withheld: IRB approval is required if you are a participant in a grant program. These programs will not release funds without IRB approval.

Ramifications for Faculty and Staff

• Funding may be withheld: Federal sponsors, and virtually all private sponsors, require IRB approval as a condition of funding. Sponsors may postpone review of proposals for which review is not complete or pending at the time of proposal submission.
• Many sponsors will not release funds to the University for the investigator's use without IRB approval. The Office of Sponsored Research may set up an account for billing the IRB fee but the account cannot be used by the investigator until IRB approval is in place.
• The Office of Sponsored Research will not set up accounts for projects lacking necessary IRB approval.
• Articles may not be published: Most professional journals require evidence of IRB approval when considering articles for publication.
• The University will not support unapproved research: Liability issues arising from unapproved research become the responsibility of the investigator. Persons conducting unapproved research are deemed to be acting outside the scope of authority granted them by the University. The University will not, therefore, provide an investigator of an unapproved project the resources to answer a liability complaint.
• Suspension of Research: The University can suspend all research activities for a specified time frame as a disciplinary measure.

9. What types of research must be submitted to the IRB?

All research involving the collection of data from human subjects must be submitted to the IRB for review. Some research activities are exempt from full IRB review but the IRB must confirm that an exemption is appropriate.

10. How can I get the fastest review possible?

"I want the fastest review possible as I am leaving town to conduct my research next week."
The type of review is determined by federal guidelines that include evaluating the risks of the research project, what is involved, whether information is collected anonymously or confidentially, and other factors. Depending on the type of review, some can only be carried out at scheduled meetings of the IRB. Investigators need to plan ahead when doing research and submit to the IRB so there is adequate time for review and approval before data collection is planned.

11. What is a full review?

All research activities involving greater than minimal risk (physical, social, psychological, and financial risks) to the subjects must be considered through Full Board Review.

New Project Submissions:

As defined by the Northwestern IRB a full review for a new project requires two board members serving as reviewers. They receive a complete packet of all materials in the submission and present it at a convened IRB panel meeting. They assess that subjects are not exposed to undue risks by the research; that the nature of procedures of the research are ethical; and that the prospective subject can participate voluntarily as evidenced by the consent form.

Full Board Review for Other types of Submissions

Full Board review for other types of submissions only requires one reviewer.

12. What is an expedited review?

A research project eligible for an expedited review is any research project in which the involvement of human subjects is considered low risk. An expedited review requires only one reviewer. Normally expedited reviews of New Projects go to the IRB panels meetings and may be discussed.

A list of procedures in certain categories helps to guide what type of review should be chosen and therefore what type of submission should be prepared. The activities listed on the expedited review form should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

The expedited review form has the categories as described by federal regulations. www.research.northwestern.edu/oprs/irb/templates/

This list includes the following types of studies and methodologies:

1. Clinical studies of drugs or devices in which an IND or IDE application is not required.
2. Collection of blood samples by venipuncture in amounts not exceeding 450 mls
3. Noninvasive collection of biological specimens such as hair and nail clippings, deciduous teeth, sweat, saliva, placenta removed at delivery, dental plaque and calculus, etc.
4. Collection of data through noninvasive, routinely employed clinical procedures (not x-rays)
5. Research involving materials that have been/will be collected for nonresearch purposes
6. Voice recordings for research purposes,.(i.e. to investigate speech defects)
7. Research on individual or group behavior via surveys, interviews, observations

13. What is an exempt review?

According to Federal Guidelines (45 CFR 46), research that presents little or no risk to human subjects (non-vulnerable subjects) does not require review by a convened Institutional Review Board. Although the project does not require full board approval, OPRS staff, in consultation with an IRB chair, must certify the exemption before the research study may commence. If the risks to human subjects appear questionable or the project does not fit into the federally defined categories for exemption, OPRS will notify the investigator that he/she must submit the study as a new project, for either full or expedited review. If you have doubts about the type of review, discuss your study with an OPRS staff member prior to submission.

14. What are some examples of research that might be exempt?

• An observational study of the public behavior of persons at a tennis club, as long as you are not video taping or photographing the people you are observing.
• An anonymous survey or interview (e.g., no names are collected or can be linked to the participants), as long as the survey does not cover sensitive or psychologically distressing topics
• A study analyzing secondary data sets (e.g., Census Data or Medicare Data)
• Any study using archival documents that are publicly available, such as library archives or legal cases.

15. What are some common items that may disqualify research as "Exempt" research?

• Use of personal/individual identifiers;
• Use of minors where interaction with researchers is involved (e.g., school settings that go beyond observations or where the researcher has contact with the children);
• The subject of research relates to sensitive information where the identities of the subjects may be capable of being recognized;
• Audio taping or videotaping the subjects because then the subjects are not anonymous;
• Use of vulnerable populations including minors, pregnant women, prisoners, and cognitively impaired persons. Other groups may be considered vulnerable populations based on the study design.

16. What happens after the IRB reviews my project?

After the IRB meeting, the OPRS staff prepares letters advising investigators about the status of their projects. Investigators with projects receiving full approval at the meeting receive approval letters within a week following the meeting. Investigators with projects requiring additional work receive letters outlining what needs to be done to prepare an approvable submission. Sometimes projects are tabled because there was insufficient information or inappropriate information so that the IRB could not make a decision on approval. When a project is tabled, it must be re-considered by the IRB panel that tabled it.

17. How can I find out about the status of my project?

Submit your question to irb@northwestern.edu including PI name, IRB Project # (if you know what it is) and project title, plus a description of what information you are looking for. Status requests are usually processed within 24 hours.

18. What are the procedures for IRB submission?

Projects should be submitted to OPRS by the posted deadlines (www.research.northwestern.edu/oprs/irb/meetings/) for the next available IRB Panel meeting. A complete project submission, with appropriate attachments, signatures, and the appropriate number of copies are needed to process your application.

There are forms for almost any type of submission that are easy to use and can be opened in Microsoft Word and filled out using the computer. Unfortunately, at this time most submissions cannot be sent electronically.

Submission packets should include the following items:
NEW PROJECTS - Submit the original and two copies

• Completed and signed New Project Submission Form
• Final version of the study protocol
• All consent/assent forms
• Investigator's Brochure (if available)
• Questionnaires
• Recruitment materials including advertisements, scripts, flyers, letters
• Any additional information that may help the review process (journal articles, news reports, etc.)
• Be sure that you have obtained the correct endorsements if your project is to be conducted at NMH, RIC, VA-Lakeside, or the Cancer Center
• All studies require a HIPAA response form (to indicate that HIPAA does or does not apply) and if appropriate, the correct HIPAA authorization form, request for waiver or exception forms.

NEW PROJECTS/EXPEDITED - Submit the original and one copy

• Completed and signed New Project Submission Form with Expedited Review Application completed and attached
• Final version of the study protocol
• All consent/assent forms
• Questionnaires
• Recruitment materials including advertisements, scripts, flyers, letters
• Any additional information that may help the review process (journal articles, news reports, etc.)

NEW PROJECTS/EXEMPT - Submit only the original

• Completed and signed Exemption Certification Form
• Final version of the study protocol
• Data collection sheets (if applicable)
• All consent/assent forms
• Questionnaires
• Recruitment materials
• Any additional information that may help the review process (journal articles, news reports, etc.)

NEW PROJECTS/MEDICAL RECORD REVIEW - Submit only the original

• Completed and signed Medical Records Review form
• Final version of the study protocol
• Data collection sheets
• All consent/assent forms
• Any additional information that may help the review process (journal articles, news reports, etc.)

19. Where are the forms I need for submission?

Forms are available on the OPRS website at www.research.northwestern.edu/oprs/irb/templates/

They should be filled out using a computer, printed and the appropriate number of photocopies made. Investigators should always keep a copy of whatever submissions are made to the IRB.

20. What are the submission deadlines?

Submission deadlines and the meeting schedule are located on the OPRS website at: www.research.northwestern.edu/oprs/irb/templates/

21. How long does the New Project review take?

Generally speaking it takes four to six weeks for an IRB project to be approved. Though this may seem like a long time, the materials must be processed by the OPRS staff, distributed to the IRB panels a week before the meeting, and then they are considered at an IRB meeting. Most projects require revisions. Sometimes they are minor. An application that is complete, with all attachments, and proofread with no typos can be reviewed more quickly than a project submission that is incomplete or poorly prepared.

22. What procedures must I follow if I want to make changes to my study?

All changes to an approved study must be submitted for review and receive IRB approval before the changes can be implemented. A revision form found at: www.research.northwestern.edu/oprs/irb/templates/ should be completed and signed by the principal investigator.

If you are revising your consent form(s), attach the new form(s) and answer 'yes' to the revised consent form question. Also attach any other revised documents (i.e. new questionnaires, recruitment materials) for IRB review.

The protocol may be changed without prior IRB approval only when there is an apparent immediate hazard to a patient, however, the IRB must be notified by letter as soon as possible of such a change and review is required immediately. The submission of a revision does not change the expiration date of a project. The expiration date is always one year from the time of the initial review or periodic review.

23. Do I need to notify the IRB if I add or change investigators on the project?

Submit a revision form noting any changes in study personnel. This requested change must be reviewed and approved by the IRB before new personnel begin their participation in the study. Revisions to personnel on a study may affect HIPAA documentation. Be sure to check your Authorization Form if you are adding or deleting personnel.

24. What if I decide, after my project is approved, that I want to post flyers or use a brochure to recruit people to participate into my study?

Submit the flyers, advertisements, radio scripts, brochures, etc. on an OPRS form found at: www.research.northwestern.edu/oprs/irb/templates/
Flyers that are posted should have the IRB approval stamp on them. Do not post flyers until they are reviewed and approved by the IRB.

25. What is periodic review?

A Periodic Review is a reevaluation of an approved project conducted at least once a year, as mandated by federal regulations. This review allows the IRB to monitor the progress of the project. If you plan to continue conducting research beyond your current expiration date, you must complete a Periodic Review Form and submit it to OPRS at least 45 days prior to the expiration date of last yearÍs approval.

If you are still in the stage of data analysis the study should remain open. Research protocols must have continuing approval until all data analysis has been completed and termination reports are submitted. After the project has expired, no further research can be done. It is very important if you donÍt want your project closed that you remain in compliance by submitting your application for renewal in adequate time for review. If your project is not reviewed and approved prior to the expiration date, no further research can be done. All research must stop.

If you are uncertain about the expiration date of your project, consult the initial approval letter. The expiration date does not change despite other submissions about the project during the year.

26. What is needed for a Periodic Review submission?

PERIODIC REVIEW - Submit one copy Periodic Review Form

• Submit one copy
• One set of previously stamped and one set of clean (no date stamp) and updated consent forms (see consent form template on OPRS Web site for any new required changes)
• Investigator's Brochure (if updated from original submission)
• Any additional information or findings that may help the review process

27. How will I know when my project needs to be periodically reviewed?

OPRS staff attempts to send an electronic (e-mail) Periodic Review reminder to the principal investigator eight weeks prior to the deadline for submission. Investigators should also track their periodic review due dates themselves. The periodic review should be submitted at 45 days before it is scheduled to expire.

28. How long do submissions other than New Project submissions take?

Within a week following the meeting, investigators should receive either a pending letter explaining what more needs to be done or an approval letter. If after 5-7 business days you have not received a response, call OPRS for assistance.

29. What is informed consent?

Informed consent is the process by which a fully informed research subject can determine whether they wish to enroll in a research study. It is based on the legal and ethical rights of humans to make voluntary and autonomous decisions about whether they wish to be a research subject.

Informed consent is required for all research studies unless specifically waived by the IRB. In order to participate in a research study, human subjects must understand that they are part of a research project, that participation is voluntary, and that they may withdraw at any time without penalty. They must also understand the procedures involved, time commitment, benefits and risks, and the extent to which confidentiality is maintained. This information is presented to prospective subjects in consent forms.

30. What elements should be included in a consent document?

Federal regulations prescribe the basic elements required in a consent form.

Since Institutional Review Boards are organized locally, the Northwestern IRB has a consent form template that provides standard language and is approved for use at Northwestern University and its affiliates. www.research.northwestern.edu/oprs/irb/templates/

31. Does the IRB really want me to follow the template? I have my own ways of expressing things.

The template makes it easier for investigators to prepare consent forms and for IRB panels to review submissions. Because the board members know the template and the required elements of consent are included, the review process can go faster. Furthermore, OPRS staff can help with the review by pre-review and editing to point out to Board members where the template is not followed.

32. Are sample consent forms available for review?

Sample consent forms are on the web and available for review. If investigators have a particular problem that needs to be considered in a consent form, they may contact OPRS staff for assistance in writing a consent form that will address the unique problem.

33. What is assent?

Assent is basically the same as consent yet involves minor children (under age 18) who are not authorized to give legally valid informed consent because of their age. Assent is written in child friendly language and describes the research participation, risks, benefits, and other elements of consent.

34. Under what conditions can some part of consent be waived?

The decision to waive some part of consent (written and/or verbal) is a decision made by the IRB when your project is considered. Investigators should consult the guidelines for waiver of consent and prepare the appropriate materials. Guidelines are available at: www.research.northwestern.edu/oprs/irb/templates/