1. What is an Institutional Review Board (IRB)?

An Institutional Review Board (IRB) is a group of people formally designated to review and monitor research involving human subjects. The purpose of the IRB is to protect, before and during the research study, the rights and welfare of humans participating as subjects in the research. The IRB has the authority to approve, disapprove, and require modifications to research projects involving human subjects. In addition, the IRB must review and approve or disapprove the investigator for the research. Once approved, the IRB must monitor the progress of the ongoing research and, if necessary, terminate a research project.

2. Who reviews my application?

Federal agencies that govern human subject research, such as the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS), require that the IRB have at least five members with varying backgrounds. For example, each IRB must include at least: one member who has no affiliation with Columbia University other than their IRB membership; one member who is a non-scientist; and one member who is a scientist. To satisfy the requirement for at least one non-scientist, most IRBs include attorneys or clergy. To satisfy the requirement for at least one scientist, most IRBs include physicians and PhD level scientists.

3. Who has access to the IRB records?

Only investigators, study staff, and authorized IRB members, officers and staff have access to the materials provided to the IRB.

4. What criteria will the IRB use for reviewing my protocol?

An IRB may approve research only after it has determined that the following requirements, as described by federal regulations, have been satisfied:

1 - Risks to subjects are minimal;
2 - Risks to subjects are reasonable in relation to the anticipated benefits and the importance of the knowledge that may be gained;
3 - Selection of subjects is reasonable in view of the purpose of the research and the setting in which it will be conducted.
4 - Informed consent will be sought from each prospective subject, or the subject's legally authorized representative, that provides the appropriate information and is understandable to a lay person;
5 - Informed consent will be appropriately documented in a written consent form;
6 - When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects;
7 - When appropriate, adequate provisions exist to protect the privacy of subjects and to maintain the confidentiality of data; and
8 - Additional safeguards have been included in the study to protect the rights and welfare of vulnerable populations, such as children; prisoners; pregnant women; mentally disabled persons; or, economically or educationally disadvantaged individuals.

If any of these requirements are not met, the IRB will either disapprove the study or recommend modifications that will ensure the study satisfies these requirements.

1. If I don't have funding for my research, do I need IRB review?

Yes. All research studies that involve human subjects are subject to IRB review, irrespective of funding.

2. I'm working on a project with faculty from another university. If my co-investigators receive IRB approval from their university, do I still need to file?

For a University researcher to participate in a research project at another site, the project needs to be reviewed by the IRB as well as by the other institution's IRB. Changes in protocol or consent forms required by the other IRB should be brought to the attention of the University IRB.

3. I've already started a research project and didn't realize that I needed to receive IRB approval first. What should I do?

As a general matter, there is no retrospective IRB review. However, you should submit an application to the IRB for approval and include an explanation for why you did not think you needed IRB approval. Based on the information provided, the IRB will conduct an inquiry. The research may be exempt from IRB review. If the research is not exempt, the research would have required IRB approval in advance and, therefore, the research is not in compliance with federal regulations.

4. What happens if I conduct human research without IRB approval?

Federal regulations require that research on human subjects must include a prior review of the project by an IRB. Any instances of non-compliance must be reported to the appropriate governing agencies. The University's 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.

5. I intend to run a pilot study before my large research project begins. Do I need IRB approval before starting the pilot study?

Pilot studies and feasibility studies, including those involving only one human subject, require the same scrutiny as full-scale research projects. Pilot studies should be identified as such in applications to the IRB. Ordinarily the data collected from subjects in a pilot or feasibility study are not used for study findings.

6. I teach a course and several of my students want to conduct a research project involving human subjects. Do they need to file with the IRB?

If students are conducting human subject research as part of a class assignment, or to satisfy a degree requirement, the IRB must review the proposed research. When students conduct research as part of a course of study, a faculty member ultimately is responsible for the protection of subjects, even if the student is the primary researcher and actually directs the project.

7. Do I need IRB approval to do a retrospective chart review?

As a general matter, there is no retrospective IRB review. However, you should submit an application to the IRB for approval and include an explanation for why you did not think you needed IRB approval. Based on the information provided, the IRB will conduct an inquiry. The research may be exempt from IRB review. If the research is not exempt, the research would have required IRB approval in advance and, therefore, the research is not in compliance with federal regulations. Therefore, if there is any chance that the chart review could turn into a research project, and even publication, you should submit an application to the IRB for approval in advance. Quality assurance activities or evaluation projects designed for self-improvement or program evaluation, not meant to contribute to "generalizable" knowledge, do not need IRB.

8.Are projects involving oral histories subject to review by the IRB?

Yes. However, the research may qualify for an expedited review if it involves materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-research purposes.

9. My research will be done in another country. Do I have to obtain IRB review and approval?

Research conducted by University investigators in foreign countries remains under University purview and guidelines. While human subjects in foreign countries merit the same level of protection as subjects in the United States, acceptable practices vary from place to place. Different mores, traditions, and institutions may require different research protocols, particularly in informed consent, recruitment practices, and documentation. Research projects must have been approved by the local equivalent of an IRB before they are presented to the IRB. Where there is no equivalent board or panel, investigators must rely on a review panel of local experts or community leaders to provide approval. The IRB requires documentation of this "local approval" before it will give approval. Researchers should describe what if any, knowledge or experience they possess regarding the language and culture of the country in question. Researchers proposing international research should allow additional time for this review process.

10. Will the IRB accept approval for research by a foreign country's review panel?

No. After a research project has been approved by a foreign country's review panel, the research must be submitted for approval to the IRB. The IRB will independently review the research.

11. I'm only interviewing a few people. Do I need to submit a protocol?

Yes. Research on human subjects must include a prior review by the IRB, including those studies involving only a few subjects.

12. Can I videotape children, in a classroom, as part of my research project without consent since I won't be talking to the students?

Yes. The parental consent form and the child or youth assent form should include the following information: whether the tape will be used for studying the actions of children doing certain projects; whether the tape will be used for any other purpose; how will the tapes be kept confidential; where will the tapes be stored; when will the tapes be destroyed.

13. If I am using data compiled by someone else such as a governmental agency or another researcher, do I need IRB approval?

The research may be exempt from IRB approval if the research involves the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by an investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Additionally, if the data is not publicly available, you must submit documentation that the original researcher has provided permission.

14. I'm taking a course - is IRB approval needed for projects conducted as a course requirement?

Courses in research methods and class assignments that involve research with human subjects require IRB approval even if the class exercise does not seem to qualify as "true research": when, for example, the results are not intended for publication, will not advance work in another area, or will not contribute to generalizable knowledge. The IRB reviews research for risk assessment and provisions for informed consent.

15. Do I need IRB approval if my work will be conducted off campus?

Yes. For a University researcher to conduct a research project at another site, the project needs to be reviewed by the IRB

16.My study doesn't involve any risk of any kind.Do I still need to submit an application?

Yes. Research on human subjects must include a prior review by the IRB, including those studies that do not involve any risk.

1. Does everyone listed on my protocol have to have training?

All personnel listed on the protocol that will have contact with participants involved in the study are required to complete Human Subjects Training. Human Subjects Training is available on the CITI Program Website.

Does the training requirement apply to students conducting interviews?

Yes, anyone contacting the human subjects in any way needs to complete training.

1. What is the definition of "research"?

"Research" is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. (45 CFR 46.102(d)).

2. What is the definition of a "human subject"?

"Human subject" is defined as a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. (45 CFR 46.102(f)).

3. What is "informed consent"?

"Informed consent" is an ongoing process. It starts well before any consent forms are signed and continues until the subject's participation is complete. If consent is to be informed, the subjects must genuinely understand the study. It involves meeting with a potential subject, finding out whether he or she is capable of giving consent, and discussing the purpose, risks, and benefits of participation. The informed consent process is different from the consent form. The consent form formalizes the agreement to participate and should be designed to document the process. Obtaining informed consent is not just giving a prospective subject a consent form and getting it signed.

4. What is the difference between "confidential" and "anonymous"?

Anonymous data can never be linked to the subject (directly or indirectly) either because the name/identity of the subject is never obtained by the investigator, or because there is no code linking the data to the subject's name/identity. Confidential data is recorded so that the information is not immediately identified with the subject who supplied it, but such a link is possible. Confidential data is usually "coded". That is, the subject is assigned a unique identifier that will be used to identify the data. The code identifies the data, and the subject's identity is kept separate from the code and data. Coded data is not anonymous.

5. What is "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.

6. What is a medical device?

A "medical device" is defined as a diagnostic or therapeutic article that does not achieve any of its principal intended purposes through chemical action within or on the body. Such devices include diagnostic test kits, crutches, electrodes, pacemakers, arterial grafts, intraocular lenses, and orthopedic pins or other orthopedic equipment.

7. Does exempt mean I don't have to apply to the IRB?

No. Only the IRB may make the determination that research is exempt from IRB review. Therefore, the investigator must submit an application to the IRB, which details the research.

8. What is the difference between "exempt" and "expedited" review?

Research studies can be categorized by the amount of risk involved. If a research study involves little or no risk to the subject, the research is exempt from further IRB review. Exemption waives the need for further IRB review; however, it does not negate the need for the consent of subjects where applicable.

If the research study presents no more than minimal risk, it may qualify for an expedited review if the involvement of human subjects falls into one or more categories approved by DHHS. An expedited review is conducted by a qualified member of the IRB. The member reviews the appropriate materials and determines to either approve the research or return it for modification. A research study may only be disapproved by a full IRB meeting.

1. How long will it take for the IRB to review my application?

Depending on the nature of the study, IRB review may take one day or as long as one month. The IRB may request additional information from the investigator which could lengthen the process.

2. How long is my approval valid?

Your approval is valid for one year from the date of approval

3. Can I begin my research as soon as I file my application with the IRB?

No - research can only begin once you have written approval from the IRB.

4. If I do begin my research before IRB approval, what will happen?

Under 45 CFR 46.103, the IRB must review and approve all non-exempt human subject research. Failure to obtain IRB approval before conducting research could result in the researcher being unable to use data and other information collected through the research process.

5. Do I need to let the IRB know when I have completed the study?

Yes. An investigator needs to inform the IRB that the study is being terminated or closed. The IRB will continue oversight of the study for follow-up purposes.

6. Does the IRB continue to review my projects once it has been approved?

Yes. Under 45 CFR 46.111, the IRB must determine risks, potential benefits, informed consent and safeguards for human subjects. According to the OHRP -IRB members should receive and review a protocol summary and a status report on the progress of the research including:
1. the number of subjects accrued
2. a summary of adverse events
3. unanticipated problems involving risks to subjects or others
4. any withdrawal of subjects from the research or complaints about the research since the last IRB review
5. amendments or modifications.

7. My study is very short - can I get less than 12 months approval?

Yes.

8. Can I get approval for a five year study all in one application?

Yes, but it must be reviewed at least on an annual basis.

9. Am I required to list all of the research faculty that might participate on my protocol - or only ones giving significant time?

The Principal Investigator (PI) must be listed along with all other research staff.

1. What should I do if I receive a complaint from a participant about the project or if a participant is injured in some way during the course of the project?

Your consent form should have a detailed account of compensation for injury, if any, as well as what a subject should do in the event of a complaint. Complaints and injuries should be dealt with promptly. Where a participant has a question about their rights in the study, they should contact the IRB. The IRB should also be informed of any complaints or dissatisfaction on the part of the subjects.

2. Suppose I want to make a minor change in the study--add or remove a new question or new task, put an ad in the newspaper to recruit more participants, do I need to do anything?

You must send this modification to the IRB for review and approval. While a minor change may not need full board approval, the IRB does need to review and approve such a change.

3. If I'm changing the study when do I need to tell my participants about the changes?

As stated above, changes to a study must be received and approved by the IRB before they are implemented. Subjects enrolled and actively participating in the study should be informed of the change if it might relate to the subjects' willingness to continue their participation in the study (21 CFR 50.25(b) (5)).

1. Who keeps the informed consent?

Informed consent is drafted by the investigator, reviewed and approved by the IRB and kept by the investigator and on file with the IRB.

2. What's the difference between an Assent Form and a Consent Form?

Study subjects who cannot give consent, but who are able to participate in the process to some degree can do so through the assent process. For older children, for example, the assent process can be similar to the consent process used with a competent adult. For a younger child, the process may be less detailed.

3. How can I manage consent forms if the survey is conducted on a web page?

A survey on a web page should include the elements of informed consent. As with a survey that is not on a web page, a reply is considered to be implied consent. If confidentiality is necessary, the survey could be printed and mailed back to the investigator. Where subjects are to reply via e-mail, they should be told that in the cover letter that the confidentiality of their response can not be guaranteed.

4. Do I always have to get consent of everyone participating in the study?

The regulations generally require that the investigator obtain informed consent from subjects or, where warranted from a legally authorized representative of the subject. There are circumstances where consent can be waived (see 45 CFR 46.116) however waiver of consent requires IRB approval.

5. How do I obtain consent from children?

45 CFR 46.408(a) requires that "adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent." The section goes on to state that "[i]n determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved."

6. How can I get signed consent forms for the surveys that will be mailed to research participants and still maintain confidentiality?

There should be a cover letter that accompanies the survey and which contains the elements of informed consent.

7. I'm doing research with a group of children, is it possible not to have parental consent?

Under 45 CFR 46.404-407, researchers are required to obtain parental consent in order to do research on children. However, pursuant to 45 CFR 46.116, there are certain situations where consent can be waived (i.e. where waiving consent would be in the best interest of the child). Waiving consent must be specific to the study and must detail what protections will be put in place for the children in the study.

8. Can I obtain informed consent by telephone?

In general, under 45 CFR 46.117, written informed consent is required to comply with federal regulations and standards. Where an investigator feels that written consent is not feasible or otherwise not warranted, the investigator can apply for a waiver of consent through the IRB. The investigator should be detailed as to why written consent is not warranted. Generally, however, written informed consent is necessary.

9. Who should be present when the informed consent interview is conducted?

Under 21 CFR 50.27(b), a third person is not required to witness the consent interview unless the subject or representative is not given the opportunity to read the consent document before signing. The person authorized to conduct the consent interview should have adequate information about the study to answer questions that may arise. Federal regulations do not specify who this "authorized" individual should be. If someone other than the clinical investigator conducts the interview and obtains consent, this person should be authorized by the clinical investigator and the person so delegated should have received appropriate training to perform this activity.

10. How do you obtain informed consent from someone who speaks and understands English but cannot read?

Study subjects are given a copy of the consent to refer to and clarify the parameters of the study.Under 21 CFR 50.20 the consent document must be in language understandable to the subject. Where the subject is English-speaking, and the consent interview is conducted in English, the consent document should be in English. Where a large number of subjects are non-English speaking, the PI should submit a translated consent form for IRB review. A copy of the translated consent document must be given to each subject who requires it.

11. Does a witness to the consent interview have to be there the entire time or only to witness the signature of the participant?

Under 21 CFR 50.27 (b) (1) there is no requirement for a witness' signature where the subject can read and understand the consent process. A witness becomes necessary under 21 CFR 50.27(b) (2) where the subject has not had the opportunity to thoroughly read and understand the consent document. At that point, a witness is necessary to attest to the fact that the consent was presented in a certain manner that the subject understood.

1. How do I figure out what is a reasonable compensation for my participants?

The amount as well as schedule of payments to research subjects should be presented to the IRB at the time of initial review and under 21 CFR 50.20, the IRB should review the amount of payment and the proposed method and timing of the disbursement of payment to assure that the amount and method are fair to the subjects involved. (see also www.fda.gov/oc/ohrt/irbs/toc4.html#payment).

2. Can I reward my participants with items such as discount coupons, movie tickets, or free food items?

This implies to the subjects a certainty of favorable outcome of the study. Also, if the study product is approved, the coupon may create a financial coercion for the subjects for that specific product, which may not be sound for them to take. ( see also www.fda.gov/oc/ohrt/irbs/faqs.html)

1. How do I submit a protocol?

Rascal is currently only accepting new protocols.

Click on 'create a protocol'
Complete and save the general page - when you save, links will be added for additional pages you will need to complete
Complete (and save) all appriopriate pages
Attach your consent forms (see below to use Consent Form Builder), brochures, questionnaires, funding information, additional documents, etc.
Add your department approvers if applicable, and notify them by clicking on the 'Notify Approvers' link.
If you are the PI, approve your protocol (the system will automatically ask you to complete a 'Protocol Specific Conflict of Interest' disclosure).
Submit your protoocol.

2. How do I create a consent form?

Use the Rascal Consent Form Builder - it is located under the Compliance section on the Rascal home page.

3. I have an approved 'paper' protocol - how do I do my renewal?

Rascal is currently only accepting new protocols. In the next few months, Rascal will allow you to have your approved protocol validated. Once validated, you will be able to create your renewal in Rascal.

4. I need access to WebCIS?

In the next few months, you will be able to use a module in Rascal to verify your approved paper protocols, the personnel on them, and then access will be granted to WebCIS.

5. What should I do if I am doing genetic testing as part of my protocol?

You should modify and then insert the following language in your consent form. Note: this text is also available in Consent Form Builder in sample pages for 'Additional Information'.

Your blood or tissue sample will be tested for genetic factors that may relate to [an increased risk of developing a disease, an increased chance of disability, etc.] in you or your offspring. [State the specific test(s) to be done, i.e. specify phenotype.]. Genetic factors are personal traits or characteristics that are inherited and run in families. The information obtained from these tests will include genetic information about you. To protect your identity, we will give your sample(s) a unique code number. Your name will not be linked to this code number. Your sample(s) will be analyzed with those of other research participants and the results will be combined in such a way that your sample(s) cannot be specifically identified and linked to you personally.

[If there is a level of certainty that positive test results indicate the individual has or is predisposed to the condition being tested for, use the following statement.] If there is a positive test result, you may want to undergo further independent testing and/or consultation with specialist physicians and/or genetic counselors. Genetic consultation and counseling are not provided through the study, however. You should be aware that insurance companies sometimes use information from genetic testing to deny coverage to applicants.
[If there is no level of certainty about the significance of positive test results, use the following statement.] Because the possible significance of any results of this genetic research is not known, the results of these studies will not be given to you. You should be aware that insurance companies sometimes use information from genetic testing to deny coverage to applicants. This study involves research in genetics that could be used to develop such genetic testing in the future. At present, any information obtained from this research cannot be considered to provide meaningful information about the health of a study participant. Therefore, if you decide to participate in this research study and agree to genetic research, and if you are asked, you should state that you have not had a genetic test.

Please initial the appropriate statement to indicate whether or not you give permission for genetic testing.

YES __ NO __ I agree to have my specimen [blood, tissue] used for genetic research as described above.

Please contact Rascal @ 212-851-0213.