I would like to share some exciting information on the IRB Newsletter. Since the initiation of our newsletter in May of 2006, I have received excellent feedback, which we're incorporating into future editions. The IRB staff works hard on this publication and takes great pride in providing the NYU research community with these regular updates.

Recently, our newsletter team was interviewed by The IRB Advisor, an IRB trade journal. We've been told the article will cover several IRB newsletters throughout the country. The interview focused on how we put together our newsletter from a philosophical stand point, what our editorial priorities are, and what practical considerations we face when producing the newsletter: how often it is published, how much work it requires, the costs of producing it, etc.. We'll have more on our newsletter's coverage in The IRB Advisor after the article is published.

On a related note, the IRB is starting several internal projects which will force us to, at least temporarily, move the IRB NYU SoM Newsletter to a bi-monthly schedule. This change will allow us to continue to provide you with informative and interesting material.

Next, I want to thank those of you who have participated in and given us feedback on our new IRB Education Sessions. We are reviewing all your comments in order to improve our 2007 sessions. Look for schedule and sign-up information on these new sessions in our next newsletter.

Finally, I want to share with all of you an important announcement that affects the entire NYU research community. Many of you may are already aware of this change: effective November 15, 2006, the clinical research billing compliance process underwent a significant operational revision. Research teams no longer need to fill out billing plan forms. These forms are now part of the Initial IRB Application. The Office of Clinical Trials (OCT) will review a copy of the IRB application along with each study's protocol to determine if a billing plan is necessary. If it is, the OCT will create the billing plan and contact the PI with questions as necessary. For full information, please see theOCT website at http://www.med.nyu.edu/oct or call them at (212) 263-4210.

— Elan Czeisler, Director

NYU School of Medicine IRB

A traditional understanding of the informed consent process includes presenting information to potential research subjects in a written document - the Informed Consent Document (ICD). A discussion then ensues between the researcher and potential subject; in which the subject is provided with information about the study and is given the opportunity to ask questions that are answered by the research team. This approach should enable each subject to voluntarily decide whether or not to participate in a research study. The written presentation of information in the ICD is used to document the basis for consent.

If the ICD is viewed as an integral part of the consent process it would then follow that the ICD must be provided to the subject in the appropriate reading level and in the appropriate language. However, the ICD is a lengthy document that encompasses federal requirements translated in legalese and medical terms. The result is an ICD that confuse and intimidate individuals and often inhibits their interest in participating in any research study. If we de-emphasize the use of the ICD and focus on alternative approaches to consent, perhaps the consent process can be enhanced for research subjects. Yet, the question inevitably arises; can this be accomplished while remaining compliant with regulations? In certain types of research - we think - a simplified informed consent process can be achieved with alternative strategies outlined within federal regulations.

Diversity in culture, religion and language in the United States has not forced alternative strategies to the consent process, yet federal regulations do provide some latitude in the informed consent document and process. Federal regulations contain alternatives to the traditional informed consent through alterations to consent; waivers of documentation of consent, waivers of consent, use of a short form and exceptions in emergency research. Thinking out of the box when it comes to informed consent processes and ICD can be achieved when using these alternatives. Options 1-3 outlined below may be used when the research does not involve investigational drugs or devices. Option 4 below is the only option for studies involving drugs and devices.

An alteration and/or a waiver of informed consent means there is a departure from the traditional consent process. A waiver of informed consent allows researchers to conduct research involving human subjects with out obtaining the subject's express consent - written or verbal - and must be approved by the IRB. An alteration of informed consent allows a researcher to conduct research and obtain consent in a different way, e.g. verbally. In order to be granted a waiver or an alteration of informed consent the researcher must answer four questions: is the research minimal risk; will the waiver adversely affect the rights and welfare of the subjects; is it impracticable to conduct the research without the waiver; will new information be provided to the subject when appropriate.

Data/tissue/specimen collected for research purposes: Information is being collected as part of study X. No additional interventions are needed to collect this information that would otherwise be discarded. Participants in study X, from which the information was obtained, have all signed a consent document specifying that this information would be taken, rights will not be adversely affected. Study involves data analysis only so it would be impracticable since there is no participant contact. Not able to provide future findings because information will be disseminated in aggregate form only.

An alteration of consent may include altering the process in which subjects are approached. A recent project proposed to the NYUSoM IRB involved subjects who were in labor. The project proposed using a standard diagnostic tool to evaluate of the fetus progress during labor. Working with the IRB Office the researchers developed a potential alteration in the consent process; in which mother's are approached during labor verbal consent is obtained and the research is conducted. After the mother delivers and is in less stressed environment, the mother is again approached - this time with the full ICD. The consent process takes place again and the mother is given the opportunity to withdraw her results from the study. The alteration was proposed to the IRB at a fully convened meeting. The IRB approved the alteration in consent because the board found the study involves minimal risk of harm to the mother and the fetus. The study could not practicably be conducted without the alteration. The IRB agreed with the researcher that since timing is an issue in this study of women in labor and obtaining consent (pre-consenting) before labor would require the researchers to consent thousands of mothers and then meet up with the subjects during labor. The execution of pre- consenting would make it impracticable to complete the study. Finally the alteration would not affect the mother's rights or welfare since verbal consent would be sought and pertinent results would be shared with the mothers.

A waiver of documentation of consent allows for the IRB to waive the requirement for the investigator to obtain a signed ICD. The informed consent of the subject must still be sought. However, once a subject agrees to participate they are not required to sign an ICD. A waiver of documentation of consent is allowed when either: (1) the ICD is the only record linking the subject to the research and the principal risk would be potential harm resulting from a breach of confidentiality. In this case each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; OR (2) the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

Each subject must be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern.

Study X if study is collecting information on ultra-sound use in the Emergency Department prior to standard of care x-ray. Ultra-sound does not normally require consent outside the research context. An ultrasound does not present more than minimal risk of harm to the subjects involved Study X. In this case, the IRB may require the Investigator provide subjects with a written statement regarding the research.

Unfortunately a 'short form' does not mean an abridged version of the informed consent form. A short form is used when a the researchers are uncertain when developing the project whether non-English speaking subjects might be enrolled in a study, or believe there might be a very small number of subjects will not understand English,. The federal regulations allow the use of a short form that provides confirmation that : (1) subject was orally consented in their spoken language and (2) provided with the ICD in English.

When presenting the consent orally there must be a witness present for the duration of the consent process.

When relying on oral translation the Investigators should carefully consider the ethical/legal ramifications of enrolling subjects when a language barrier exists. If the subject does not clearly understand the information presented, the subject's consent will not truly be informed and may not be legally effective. If investigators enroll subjects without an IRB approved written translation, a "short form" document in a language the subject understands, should be used. This short form will document that the elements of informed consent required by 21 CFR 50.25 were presented orally. The required signatures on a short form: (1) Person consenting, (2) Subject, (3) Witness to the oral presentation given to the subject. A witness is used in the process to ensure the information was appropriately conveyed to the subject, that the subject was given the information and has volunteered with an understanding of what is involved in the research. Witnesses should be those not related to the study staff such as a family member along with the patient, additional personnel not related to the study, etc. However, this is ideal and may not be completed for all situations. This should be the practice when possible.

To increase research evidence data on life-threatening situations such as traumatic brain injury, the Food and Drug Administration (FDA) adopted exceptions to the consent process. The FDA recognized that there are situations where patients can not give informed consent nor refuse enrollment therefore, promulgating regulations under 21 CFR 50.24 - Exception from informed consent. This is permitted when each of the following is met and documented:

1. Human subjects are in a life-threatening situation, available treatments are unproven, unsatisfactory, collection of valid scientific evidence is necessary to determine the safety and effectiveness of particular interventions;
2. Obtaining consent is not feasible because: (i) due to medical condition of patient; (ii) intervention must be administered before LAR's consent is feasible; (iii) no reasonable way to identify prospectively individuals who may be eligible for participation;
3. Participation holds out prospect for direct benefit because: (i) life-threatening situation needs intervention; (ii) animal and pre-clinical research data supports potential for intervention to provide direct benefit; (iii) risks are reasonable to what is known about the medical condition of class of subjects, risks and benefits of standard therapy, if any, and what is known about risks and benefits of the intervention.
4. Research could not be practicably be carried out with the waiver.
5. Proposal defines therapeutic window the LAR may be contacted and provided with opportunity to consent to the procedure without proceeding without consent which can be completed as outlined above in the Short Form section.
6. IRB must review and approve informed consent procedures and ICD. The ICD must be used with subjects or the LAR in situations where it is feasible. IRB must review and approve procedures when providing an opportunity for a family member to object to the subject's participation.
7. Additional protections of rights and welfare of subjects including at least: (i) consultation with representatives of the communities in which the clinical investigation will be conducted and from which the subjects will be drawn; (ii) public disclosure to the communities in which the clinical investigation will be conducted and from which the subjects will be drawn, prior to initiation of the clinical investigation, of plans for the investigation and its risks and expected benefits; (iii) public disclosure of sufficient information following the completion of the clinical investigation to apprise the community and researchers of the study, including demographic characteristics of the research population and its results; (iv) data monitoring safety committee established for oversight.

Research on varied approaches to informed consent is emerging in areas where the act of obtaining consent in itself is often an obstacle to conducting the research. Recruiting patients for studies in the Neonatal Intensive Care Unit is one such complex endeavor. Various studies have proposed models that incorporate different approaches to the inclusion of neonates in research. These studies have found that breaking down the informed consent process enhances the comprehension. One such approach first informs the parents about research and their rights as research subjects prior to any solicitation. The parents are asked if they wish to be approached for research and they are approached about one study at a time. The parents are assured that the study is relevant to the infants' current clinical status. In these initial stages of the informed consent process the neonatal researchers minimize information overload and allow the parents appropriate time (which will vary from study to study) to consider their choices. It is argued that parental ability to make a truly informed choice may be improved when following this proposed model1.

Another varied approach to the informed consent process, currently underway, can be found with the Vermont Diabetes Information System. This project is a multi-state randomized trial of a quality improvement intervention that uses a novel alteration of informed consent. Subjects are notified by mail that they are eligible for the study and that they may opt out of the study by calling a toll-free number. Seven thousand five hundred and fifty-eight patients were invited to participate. Two hundred and ten (2.8%) opted out. Three patients (0.04%) filed complaints, all of which were addressed satisfactorily. modifications to the consent process, including passive consent methods, are useful tools to overcome these challenges. It is possible to recruit a broad and representative population under current law while maintaining appropriate protections for research subjects2.

In May 2000, as a response to the incorporation of emergency research regulations (described above), the National Institute of Neurological Disorders and Stroke, sponsored a workshop to bring forth key individuals from the field to provide insight on the planning and design of emergency research projects related to traumatic brain injury. This is a key disorder where consent may not be feasible from the patient. A presenter at this meeting, Charles Wade, Ph.D. Consultant from Sausalito, CA, who has experience looking at work in hypotensive patients research in the emergency department, discusses how consent should be completed to comply with the regulations contained above:

1. Try to get consent from the patient when feasible. The patient may decline and you have to give him/her that right, even if the patient is dizzy, drunk, etc.
2. Propose consent by family or the Legal Authorized Representative (LAR) when feasible. In TBI trials, this is usually within the first six hours. Consent processes should be started in the field, prior to admission to the ED.
3. Have a scripted, abbreviated form that the LAR or family can read and sign. One page can be reviewed, the lengthy document comes later.
4. Independent approval or the use of consent exception by a second physician prior to enrollment.
5. Repeat consent to continue when an exception to consent has been utilized. Periodically ask the patient if they want to stay enrolled in the study.

Children's Centers across the country are helping educating their staff to understand that informed consent is an ongoing process. These Centers take time to train their staff to solicit and answer participant questions creating an environment that fosters dialogue and builds trust between the researcher and the subject. Typically staff read the consent forms aloud to subjects. This ensures the research team that all subjects, including those who are embarrassed of their low literacy level, are given the appropriate information in order to make an adequate decision about participation. Additionally, some center use timetables or schedules to communicate study procedures and lists outlining the important items on the consent are helpful in increasing the subject's comprehension of the study requirements. One center developed a short checklist to verify that the participants understood key aspects of the study. Staggering consent information at different visits for the patient will assist in having the patient to digest all of the information at once.

At the University of California in San Francisco a modified consent process was applied to a study of geriatric patients. The study was designed to evaluate modifications to the standard consent process in order to enhance understanding. As part of a randomized trial to improve the forms used for advance directives, they modified the consent process for all participants by: (1) using a consent form written at the sixth grade reading level, (2) having bilingual research assistants read this form to potential subjects, and (3) by using an iterative, educational strategy in which formal assessment of comprehension is linked to repeated passes through targeted education until understanding is obtained (a process also known as ''teach-to-goal''). At the conclusion of the project, 98% of participants, including those with literacy and language barriers, who engaged in the consent process achieved complete comprehension by using a modified consent approach (improving the readability and design of the consent form, reading the consent form to participants in their native language, and using an iterative, teach-to-goal strategy). For the majority of these participants, little additional education was required3.

A prospective questionnaire study completed at large teaching hospital surveyed 732 subjects who had undergone surgery in obstetrics and gynecology over a six month period. The subjects were sent questionnaires regarding their awareness of the legal implications of written consent and their views on the function and remit of the consent form. The study found subjects had limited understanding of the legal standing of written consent. Nearly half 46%,) of the subjects believed the primary function of consent forms was to protect hospitals and 68% thought consent forms allowed doctors to assume control. Only 41% of patients believed consent forms made their wishes known.

The study concluded that subjects seem to have limited awareness of the legal implications of signing or not signing consent forms, and they do not recognize written consent as primarily serving their interests4.

A study evaluating a genetic cause of respiratory distress syndrome evaluated the reasons that parents/ subjects refused consent for their infant's participation in the study. Of the 465 families that were approached for consent, 135 families refused consent and were asked to completed a survey regarding their reason for not consenting to the research. Of the non -consenting families, 79% identified institutionally required language in the consent form concerning the risk of denial of access to health insurance and employment as the primary reason for refusal; 97% indicated that their fears resulted directly from language in our consent form. Only20% of families who refused consent cited inadequate time to consider the study5.

Researchers at Columbia Presbyterian looked at the recruitment/consenting of the parents of pediatric patients in critical care situations, such as the PICU, using the Exception from Informed Consent process. The researchers asked parents about their preferences when approached to enroll their child in research. The parents were provided with three one-page handouts describing proposed studies:

1. Version 1 described a trial of a new medication given during cardiac arrest
2. Versions 2a and 2b described of a trial of induced hypothermia, with version 2a in paragraph format and version 2b in bullet format

Study staff asked parents to review the handouts, and then they administered a verbal questionnaire to assess parental reactions to the handouts and to determine how many parents would allow their child to participate.

One or both parents of 91 patients were asked to participate; 100% agreed. Sixty-three percent said they would likely allow their child to participate in resuscitation research with Exception from Informed Consent if they were given a prospective opportunity to opt out. Parents who reviewed version 2b (bullet format) were more likely than parents who reviewed version 2a (paragraph format) to say that they would let their child participate. Parents were more supportive of a trial of induced hypothermia than of a trial of a new medication given during cardiopulmonary resuscitation. Parents endorsed conducting the community consultation process for inpatient resuscitation research with families and healthcare providers of critically ill patients.

The researchers concluded inpatient pediatric resuscitation research is feasible using handouts to inform parents of a study and provide a prospective opportunity to opt out. Succinct, bullet-format handouts will yield higher participation rates than paragraph-format handouts6.

One key element to the exception from the informed consent process is the inclusion of community consultation. The Columbia research team discussed the question of what community to consult with for information on the proposed study . In regards to this particular study, they felt it was whom parents believe should be involved in a community consultation process for inpatient pediatric resuscitation research. Parents were asked: Who Should Be Involved in a Community Consultation Process? Parents unanimously said that parents of PICU patients are the most important population to involve in a community consultation process for an inpatient pediatric resuscitation research study with EFIC. We then asked whether the consultation process should take place entirely within the hospital community (including doctors, nurses, administrators, and parents of hospitalized children) or whether it should include people outside of the hospital community. Seventy-five of 91 parents (82%) believed that the hospital community represents the entire relevant community, and 16 of 91 (18%) suggested including people outside of the hospital community (eight suggested consulting with "everybody," four with parents of healthy children, two with clergy, and two with parents of children with congenital cardiac disease).

In the development of future ED research study and the use of Exception from Informed Consent in other areas of research, community involvement should commence in the development process. Forming focus groups as suggested above and including populations to be studied may assist the Investigator in tailoring a consent process that nor only fits the patients but families and LARs who will be approached for enrollment of their loved one. If the time is taken before to develop a solid process with input of those who will be the subjects, may assist in higher recruitment numbers and informed subjects.

Clearly current consent procedures seem inadequate as a means for the expression of autonomous choice, and their ethical standing and credibility have can be called into question. Clinical trial patients are now also filing litigation post research alleging the lack of informed consent. Most of these cases may have been avoided with proper communication

Do you know about our program the NYU SOM IRB Feedback Project? Take some time and (as the title says) to let us know how we're doing! The information you provide is completely confidential.

Your submission is reviewed by a non-project reviewing administrative staff member, and kept strictly anonymous. You will not be identified in any way to any of the IRB staff. Please send us ideas on what services we could provide to promote faster review, enhance protection of human subjects, make your interactions with the IRB better, etc.

Let us know by e-mailing the IRB Feedback Project at IRB-FEEDBACK@med.nyu.edu. Look for these stickers and posters around the institution:

Informed consent is twofold; there is the informed consent process (ICP) and there is the informed consent document (ICD). The distinction is an important one since informed consent is one of the primary ethical requirements underpinning research with human subjects. The ICP embodies the basic principle of respect for persons while the ICD acts the basis of informed consent. Many believe informed consent ends after the subject agrees to participate in the research and signs the ICD. True informed consent is an ongoing process that is not merely captured on a piece of paper. The informed consent process assures that prospective human subjects will be provided with a discussion in which the ultimate goal - is understanding the nature of the research so that the subject can knowledgeably and voluntarily decide whether or not to participate in the research. The prospective subject should be presented with the information, given an opportunity to read the document and take it home. This allows the subject to discuss participation with relevant family members and his/her Primary Care Physician. Also, this provides time and an opportunity to ask questions and have them answered before signing the consent document.

No not really…. The consent document is a written summary of the information that should be provided to the subject. Many researchers use the consent document as a guide for the verbal explanation of the study. The subject's signature provides documentation of agreement to participate in a study, but is only one part of the consent process. The entire informed consent process involves giving a subject adequate information concerning the study, providing adequate opportunity for the subject to consider all options, responding to the subject's questions, ensuring that the subject has comprehended this information, obtaining the subject's voluntary agreement to participate and, continuing to provide information as the subject or situation requires. To be effective, the process should provide ample opportunity for the researcher and the subject to exchange information and ask questions.

Protocol amendments must receive IRB review and approval before they are implemented, unless an immediate change is necessary to eliminate an apparent hazard to the subjects. Those subjects who are presently 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. Federal regulations and NYU Policy do not require re-consenting of subjects that have completed their active participation in the study, or of subjects who are still actively participating when the change will not affect their participation. For example when the change will be implemented only for subsequently enrolled subjects or when the change is minor and will not affect the subject's willingness to continue their participation, hence minor administrative changes such as editorial changes would not require re-consenting of enrolled subjects.

Phone: (212) 263-4110

Fax: (212) 263-4147

Web: http://www.med.nyu.edu/irb

  Meeting Schedule: http://www.med.nyu.edu/irb/schedule/

  Contact List: http://www.med.nyu.edu/irb/contact.html

eMail - general questions: irb-info@med.nyu.edu

eMail - questions for a study that has already been submitted (submit questions to the board your study was assigned to; include your study's IRB# in all communication): irb-board-a@med.nyu.edu irb-board-b@med.nyu.edu

newsletter feedback irb-feedback@med.nyu.edu

The IRB generally requires that you only submit the latest version of our forms. For this reason, we ask that you go to our website each time to download the form you need, as it may have recently changed.

Request for Initial IRB Review - November 15, 2006

Request for Initial IRB + GCRC Review - November 15, 2006

Bellevue Appendix (for initial review forms involving BHC) - November 15, 2006

Request for Continuation - November 20, 2006

HIPPA Forms

Request for Waiver of Authorization and/or Consent - November 20, 2006

Consent Templates

Short Consent Form - Spanish - October 18, 2006

Short Consent Form - English - October 18, 2006

Bellevue Non-English-Speaking Subject Questionnaire - October 18, 2006

Other

Our 2006-2007 IRB Board Meetings (and submissions deadline) Calendar has been updated