1. Why is IRB review necessary?
2. What research must be reviewed?
3. What sort of review is needed for class-related projects?
4. Who needs to obtain IRB approval?
5. How do I know whether I must submit an IRB application?
6. How does someone apply for IRB approval?
7. Once my research has been approved, does it ever need re-review by the IRB?
8. What do I do if I want to make revisions to my IRB-approved protocol?
9. What are the steps for making incident or adverse events to the IRB?
10. What authority does the IRB have?
11. How long will it take for IRB review?
12. What research records does the IRB require me to keep?
13. Are there special considerations required in cross-cultural research?
14. Can students or employees serve as research participants?
15. Can children serve as research participants?
16. Can participants be paid?
17. Can advertisements or snowball recruitment be used to find potential participants?
18. Why must I specify the number of research participants in my protocol?
19. How can I ensure informed consent from non-English speaking participants?

1. Why is IRB review necessary?

IRB review is an important component of the commitment of the institute community to conduct all research activities within the bounds of the most rigorous ethical and methodological standards. The IRB links the researcher and the research participant via the use of appropriate procedures for obtaining the informed consent of participants. IRB review and approval of the research assures the participant that the researcher has adopted appropriate means for conducting the investigation and for protecting the participant�s rights and welfare. Also, IRB approval assures compliance with federal rules and regulations governing the treatment of research participants.

2. What research must be reviewed? All research at the Institute for Clinical Social Work that involves humans (or records gathered on humans) requires IRB review. This is true regardless of its funding source or area of research. Research that requires IRB review includes any research on humans that:

• is conducted by Institute faculty, staff, or students
• involves Institute students, staff, or faculty as participants
• is performed on the premises of the Institute
• is performed with, or involves the use of, facilities or equipment belonging to the Institute
• satisfies a requirement imposed by the Institute for the award of a degree or for the completion of a course of study
• is certified by a dean or department head to satisfy an obligation of a faculty/staff appointment at the Institute,
• including clinical or adjunct appointments

In addition, IRB review is required under the following circumstances:

• Research requiring "continuing review"
• Research conducted by affiliated faculty/staff
• Research conducted at another institution by ICSW affiliated persons
• Research in foreign countries conducted by ICSW affiliated persons
• Research conducted in courses (courses in research methods and class assignments involving research with human participants require IRB approval)
• Faculty-supervised student research (Faculty must take an active role in ensuring that research projects are conducted in accordance with the IRB's requirements)
• Research at a pilot or feasibility stage (pilot and feasibility studies, even those with only one human participant, require the same review as full-scale research projects. Applications to the IRB for pilot studies should be identified as such, and participants must be told during the consent process that the study is a pilot)
• Research involving secondary use of data (projects that use data on humans gathered in earlier projects and in which individual identifiers are present require IRB review. However, data gathered by someone who has legitimate access to the records and who gives the investigator only data that does not permit identification of the participants may qualify for exemption.)
• Research projects in which the researcher is a consultant under contract with the Institute does not require IRB review if the researcher has a strict consulting relationship in which:
• the researcher is hired on his or her own time
• the researcher holds no rights in the work
• either the researcher nor the Institute retains any data
• Despite the recent change in guidance provided by OHRP concerning the relevance of the federal regulations governing human research to oral history projects, many oral history activities constitute human subject research and still require the review and approval of the IRB. For more information about whether a particular oral history project requires IRB review, please refer to the following guidance, provided by OHRP: Oral History Guidance.

3. What sort of review is needed for class-related projects?

The Institute policy stresses that any sort of activity designed to collect information from human participants must protect the rights of these participants, even when IRB review is waived. The policy for classroom-related activities is that IRB review is waived only when the collection of information from participants is exclusively for the purpose of class discussion or for the purpose of training in research or research methods. In this situation, the instructors are responsible for educating students about the protection of human subjects and providing ethical guidance for all student projects. The course syllabus must include a component for training students about the ethics of collecting information from human participants (instructors may want to use an on-line training module such as http://cme.nci.nih.gov/ which provides the student with a hardcopy certificate certifying their training or http://www.research.umn.edu/consent/). Instructors who decide that their classroom related activity is waived from IRB review should submit their course syllabus to their IRB for confirmation of their decision. Instructors who are uncertain about whether their classroom activities need IRB review should submit their course syllabus to the IRB for evaluation. Note: any data collected for a class project should not be used for publication unless that class project had previously been approved by the IRB. Although classroom project data may be used as pilot data collected preliminary to the actual research project, it should not be used in publication or presentation outside of the classroom. Classroom data may be collected for dissemination within the institution for administrative and evaluative purposes without IRB review.

4. Who needs to obtain IRB approval?

The Institute is committed to the protection of the rights of human participants in any and all research that in any sense is conducted by persons officially affiliated with the Institute. Thus, IRB review is required of all such research involving human participants, most especially any that poses potential threats or injury of any sort to the participants. This specifically includes, but is not limited to:

• Principal Investigators who are seeking either external funds (from federal, state, or local governments, private foundations, etc.) or internal funds for research projects that involve human participants
• Students collecting data from human participants for dissertations


• Classroom instructors who have their students collect data from human participants for course projects.

5. How do I know whether I must submit an IRB application?

   1.    Is the proposed activity research?

Research is a systematic investigation designed to develop or contribute to generalizable knowledge. Generalizable knowledge means that the information derived from the investigation will be applicable to other cases Systematic investigation means that the information will be arranged such that conclusions can be drawn and others can review those conclusions Answer:     NO: Stop, your investigation does not need IRB approval.                YES: Go to the next question.

   2.    Does the research involve human participants?

This means that the person is alive and the information pertaining to that person will be obtained though:
• Intervention (e.g., manipulating the participant�s environment or setting)
• Interaction (e.g., an interview, survey, or other interpersonal contact)
• A private/confidential source (e.g., medical, governmental, school, business records). Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. Also, private information is that which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the participant is or may readily be ascertained by the investigator or associated with the information) in order for it to constitute research involving human participants.
Note: Information collected about deceased individuals or from commercial or public repositories or registries does not need IRB approval. Answer:     NO: Stop, your investigation does not need IRB approval.                YES: Go to the next question.

   3.    Does the research meet the criteria for exemption?

There are six categories of exemption (see criteria for exemption). All follow the general rationale that the research exposes participants only to the same small physical, social, and psychological risks that they take in living every day. Answer:     NO: Go to next question.                YES: Submit a claim of exemption. Investigators do not have the authority to determine whether their research involving humans is exempt from full review. Although research that involves only minimal risk is sometimes exempt from full review, it is never exempt from peer review.

   4.    Does the research meet the criteria of minimal risk?

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the 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. Answer:     NO: Submit information for full IRB review.                YES: Submit a request for expedited review.

6. How does someone apply for IRB approval of a new project?

1. Fill out a protocol application form and attach any supporting documents, as appropriate: research/grant proposal as submitted to external agencies; recruitment materials, flyers, emails, advertisements; informed assent, consent, and parental permission forms; questionnaires, surveys, and interview guides; debriefing/informational material for participants; documentation of approval or notice of application with another committee or cooperating agency must review the study.
2. Once the appropriate IRB Application form is completed and signed by appropriate individuals, it should be delivered to the Registrar at the ICSW, 200 N. Michigan Ave., Suite 407, Chicago, IL 60601-7202. Students have the option of submitting the application electronically (one copy) with seven copies in print of all attachments (one for the office and one for each IRB Committee member). Or students can submit seven packets in print format, each with a copy of the application and the relevant attachments.

7.  Once my research has been approved, does it ever need to be re-reviewed by the IRB?

Research that has been approved by the IRB via exempt, expedited, or full Board review must undergo continuing review as determined by the Board (at least annually).

The goals of continuing review are to ensure that the risk/benefit ratio is still acceptable; that the measures taken to safeguard participants are adequate; that the approved protocol is followed; and that the project reflects any changes that have been made in the regulations for human research since the last approval. The IRB may require changes in protocol or revisions in the consent form if the study's risk were originally underestimated, but the converse can also occur: the investigators and the IRB may have underestimated the benefit to research participants.

Note: Transcriptions that meet the above criteria may be retained, so long as the actual audio/videotapes have been destroyed. Tapes, even if unlabelled, are considered identifiable.

In order to seek a renewal on a previously approved protocol, answer all questions on the continuing review application form, attach all required documents, and submit the materials to the IRB at least 3 weeks prior to the protocol�s expiration date.

What information is required for a continuing review?

Continuing review requires you to disclose the number of participants enrolled since the last review and the total number of participants enrolled to date, breakdowns of the participant population by gender and other demographics, and a summary of the results of the research to date, including:

• any unanticipated risks or adverse outcome
• any early indication that one of the treatments under study is significantly better or worse than others
• any difficulties recruiting or retaining participants with an explanation
• the number of participants who withdrew from the study
• any proposed changes to the research protocol, including proposed changes in research staff, or a copy of the consent form currently in use (as approved by the IRB)

What is the process for continuing review?

A project usually merits the same level of review in continuing review as it received originally. As in the initial review,the IRB may require revisions in the protocol or the consent documents.

8.  What do I do if I want to make revisions to my IRB-approved protocol?

Once the IRB has approved a project, it must be carried out as planned. Any changes in participant population or number, recruitment plans, research procedures, study instruments, study sites, or major research personnel must be approved by the IRB.

Students or researchers planning a change should:

• write to the IRB office citing the title and code number of the approved study
• describe the proposed change in lay language
• explain why the change is needed
• describe the implications for the participants
• provide revised consent documents, if the change will affect the participants

How does one change the principal investigator of a project?

9.  What are the steps for making incident or adverse event reports to the IRB?

Unexpected problems whose nature, severity, and frequency were not described in the information provided to the IRB or to participants must be reported to the IRB within 10 working days. Examples include unexpected complications in a participant, missteps in the consent documentation, or breaches of confidentiality. Sometimes a study must be suspended to ensure participants' safety. The report of the event should include:

• the facts of the case, including the date and a description of the participant(s)
• whether the event is related to the study's procedures or to the participant's condition
• the steps that have been taken to address the problem
• whether the event is likely to recur
• whether the event provides new information about the study's risks that should be conveyed to participants, in a revised consent form

These reports usually receive expedited review, but in some cases the full IRB is involved.

10.  What authority does the IRB have?

All research projects involving the use of human subjects or their data must be reviewed and approved before data collection may begin. The IRB must:

• Approve, modify, or disapprove protocols based upon consideration of human participant protection
• Require annual progress reports from investigators and oversee the conduct of the research
• Place restrictions on the conduct of a study
• Review incident reports and suspend or terminate a project as needed to protect subjects.

The IRB seldom disapproves research activities. Instead, the IRB strives to work with the researcher to assure excellent research design with minimized risk and maximized benefits to participants.

11.  How long will it take for IRB review?

Once your application has submitted to the IRB, you should receive formal notification of the IRB evaluation within six weeks. In many cases, principal investigators receive an initial response and/or review decision within 4 weeks.

12.  What research records does the IRB require me to keep?

Researchers should maintain a file of all documents concerning the use of humans in research, including original paperwork whenever possible and a copy of everything else. The principal investigator's records should be a mirror image of the IRB's records: where the IRB holds an original, the principal investigator should hold a copy, and vice versa.

The documents that researchers should have on file include:

• a copy of the original application submitted to the IRB, including the consent form and the research protocol
• an original of the IRB's response
• a copy of responses to IRB stipulations or requests for additional information
• the original notice of full approval
• copies or originals of all other correspondence with the IRB
• copies of completed "Continuing Review" forms and attachments
• the original notice of renewal of approval and certification, where applicable

13.  Are there special considerations required in cross-cultural research?

Yes. Researchers engaged in cross-cultural research should give particular attention to the use of culturally appropriate assessment instruments and procedures, the language(s) used in the conduct of the research, and the language preference and language variability of the research participants. Researchers developing studies involving members of an unfamiliar racial, ethnic, cultural, linguistic, gender or sexuality group should develop a reasonable level of familiarity with, but would not be limited to, the language, behavior, social mores, customs and traditions of that group. A researcher should consider consulting social and behavioral scientists and others who are more knowledgeable of, and experienced with, the intended study group before constructing a protocol.

14.  Can fellow students, ICSW faculty or employees of the ICSW serve as research subjects?

No.

15.  Can children serve as research participants?

If research involves greater than minimal risk, children can be included in the study population only if there is direct personal benefit to the child. A research protocol that involves anything more than minimal risk and that offers no demonstrated benefit to the participant cannot involve children.

16.  Can participants be paid?

Researchers may pay research participants for their participation, but payment arrangements must be disclosed to the IRB and are subject to a stringent review. Payment arrangements affect the fairness of recruitment plans, the balance of risks and benefits, and the adequacy of informed consent. Although there are no fixed formulas for determining whether payment plans are acceptable, the IRB prohibits payment arrangements that appear to be coercive. Payment should not encourage participants to participate or continue to participate against their better judgment.

The amount paid to participants must correspond to the burdens of participation. For example, payment might defray parking charges or transportation costs. Payments may also be scaled to the time that participants spend in a study. Researchers who are reluctant to pay cash may offer gift certificates or vouchers. When children and adolescents are the participants, researchers sometimes reimburse parents for parking or transportation and give a token payment or gift certificate to the participant.

If participants are being paid, if participants withdraw from a study they should receive at least partial payment. A modest lump sum can be paid after the participant's participation is complete if the arrangement is thoroughly documented in the consent form.

17.  Can advertisements or snowball recruitment be used to find potential participants?

Advertisements are part of the informed consent and participant selection process. Samples of all advertisements, such as flyers, newspaper ads, radio and television announcements, bulletin board tear-offs, and posters, along with an explanation of other methods of recruiting participants, must be submitted to the IRB with the application or as soon as the principal investigator decides to use them. The content of advertisements should be limited to:

• names of the investigators of the school identified by name and contact information
• purpose of the research
• general eligibility criteria
• straightforward and truthful descriptions of benefits (e.g. free treatment) and risks

Advertisements should not claim, explicitly or implicitly, that the research is treatment or is superior to any current practice. Extravagant attention-getting devices such as extremely large, bold typefaces and dollar signs are prohibited. Advertisements should not pressure readers into participating.

Snowball recruitment � often times researchers have an initial pool of contacts and they hope those people will "nominate" other qualified potential participants. This kind of sampling is commonplace in case study and qualitative research. The following excerpt from the Belmont Report regarding voluntariness compels IRBs to pay close attention to snowball recruitment procedures:

"Unjustifiable pressures usually occur when persons in positions of authority or commanding influence---especially where possible sanctions are involved--- urge a course of action for a subject. A continuum of such influencing factors exists, however, and it is impossible to state precisely where justifiable persuasion ends and undue influence begins."

For example, if a highly respected individual in the community such as a local elected official, teacher, member of the clergy, or therapist provides the name of a potential contact when the nominee is contacted, the person might be unduly influenced to participate in the project because of the stature of the nominator. Consideration of minimal risk is likely to play an important role in IRB review of snowball recruitment procedures. For example, it would make a big difference whether the research involved extramarital affairs or substance use as opposed to family meal time routines or leisure activities. To "cold call" someone on sensitive topic issues places him or her in a potentially embarrassing situation, which should be avoided. Moreover, the original subject is being placed in the position of being asked to disclose information about a third party without that party's consent.

One means of reducing the risks in snowball recruitment is for the researcher to gently ask subjects whether they would be willing to pass some information about the study they just completed to other potential subjects. The researcher may give the original subject an information sheet that they can give to people they think might be interested and qualified. Then these potential participants can contact the researcher if they are interested. The researcher must provide the IRB with a copy of the information sheet (which must include all of the same information that is in the initial recruitment script) he/she will give to the initial contact to distribute. If the potential subject were interested in study participation, they would be free to contact the researcher.

There are some reasons why snowball recruitment could be approved for minimal risk projects, including:

• People cannot always be depended upon to make phone calls and contacts. Even with good intentions, they forget, become busy, etc.
• If participants have to contact others, they may have to use their time to make at least two phone calls (one to other potential subjects and one to the investigator). Participants shouldn't be required to do extra work if there is no practical risk involved
• Participants might not accurately describe the research and its purposes or they might prep other participants to provide particular responses

The IRB recommends the following safeguard procedures if snowball recruitment is to be used:

• Let subjects know that they will be asked to provide the names of other potential recruits, but that they have the right to decline to provide this information
• Obtain the nominating subject's written permission to reveal their identity to subsequent contacts on the consent form via an initialed check list item. That is, if the subject agrees to provide names of other possible contacts, they could initial a check box on the consent form that they agree to allow their identity to be revealed to the subsequent contacts. Not initialing the box would be interpreted as meaning the subject was unwilling to permit his/her name to be used when making the additional contacts, even if he/she supplied the names and contact information.
• Provide the IRB with a script detailing how the researcher will be obtaining the information for the snowball recruitment.

18.  Why must I specify the number of research participants in my protocol?

The application must specify the number of study participants to be recruited and tested, grouped by age, gender, and population diversity. This assures a representative research sample and prevents aggressive over recruitment. Exceeding the recruitment limits agreed to by the IRB is a protocol violation unless the IRB gives written permission.

If it is difficult to predict how many participants will be eligible or be attracted to a study, the optimum number should be specified. Responses such as "don't know" or "as many as we can recruit" to questions about the number of participants are not acceptable. A discussion of the problems faced in recruiting participants should be included.

19.  How can I ensure informed consent of non-English-speaking participants?

Department of Health and Human Services regulations for the protection of human participants require that informed consent information be presented "in language understandable to the participant" and, in most situations, that informed consent be documented in writing. The written consent document should embody, in language understandable to the participant, all the elements necessary for legally effective informed consent. Participants who do not speak English should be presented with a consent document written in a language understandable to them. In addition, someone who speaks the language of the participant must be present to answer any questions that the participant might have. This person could be the researcher, a certified translator, etc.

If informed consent information is present entirely orally, then a consent document written in the language of the participant (stating that the elements of consent have been presented orally) must be signed by both the participant and the individual who did the oral presentation. The participant must be given copies of the consent document. At the time of consent, the consent document should be signed by the participant (or the participant's legally authorized representative).

The IRB must receive all foreign language versions of the consent document as a condition of approval. It is important to have the translated documents independently back-translated into English to assure that the translation has not distorted the intention of the English version.

Example:

• The approved consent form is in English and needs to be translated into Spanish.
• The approved English version (document 1) is converted to a Spanish version (document 2) by translator 1.
• The Spanish version (document 2) is converted back to an English version (document 3) by translator 2.
• The original approved English version (document 1) is compared to the re-converted English version (document 3) for content and language. If it compares sufficiently to ensure to the IRB that the translated version (document 2) is comparable to the original approved version (document 1), the translation is then approved.